ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older.

{ "type": "p", "children": [], "text": "ASMANEX® TWISTHALER® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older." }

Limitations of Use

{ "type": "p", "children": [], "text": "\nLimitations of Use\n" }

ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm.

{ "type": "p", "children": [], "text": "ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm." }

ASMANEX TWISTHALER is not indicated in children less than 4 years of age.

{ "type": "p", "children": [], "text": "ASMANEX TWISTHALER is not indicated in children less than 4 years of age." }

The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 1: Recommended Dosages for ASMANEX TWISTHALER Treatment</span> </caption> <col align="left" valign="middle" width="45%"/> <col align="center" valign="middle" width="20%"/> <col align="center" valign="middle" width="35%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule">Previous Therapy</th><th align="center" class="Lrule">Recommended Starting Dose</th><th align="center" class="Lrule Rrule">Highest Recommended Daily Dose</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>When administered once daily, ASMANEX TWISTHALER should be taken only in the evening.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily. </dd> <dt> <a href="#footnote-reference-3" name="footnote-3">‡</a> </dt> <dd> <span class="Bold">For Patients Currently Receiving Chronic Oral Corticosteroid Therapy:</span> Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy<span class="Italics"> [see <a href="#S5.5">Warnings and Precautions (5.5)</a>]</span>. </dd> <dt> <a href="#footnote-reference-4" name="footnote-4">§</a> </dt> <dd>Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule">Patients ≥12 years who received bronchodilators alone</td><td align="center" class="Lrule">220 mcg once daily in the evening<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="center" class="Lrule Rrule">440 mcg<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule">Patients ≥12 years who received inhaled corticosteroids</td><td align="center" class="Lrule">220 mcg once daily in the evening<a class="Sup" href="#footnote-1">*</a></td><td align="center" class="Lrule Rrule">440 mcg<a class="Sup" href="#footnote-2">†</a></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule">Patients ≥12 years who received oral corticosteroids<a class="Sup" href="#footnote-3" name="footnote-reference-3">‡</a></td><td align="center" class="Lrule">440 mcg twice daily</td><td align="center" class="Lrule Rrule">880 mcg</td> </tr> <tr class="Last"> <td align="left" class="Lrule">Children 4-11 years of age<a class="Sup" href="#footnote-4" name="footnote-reference-4">§</a></td><td align="center" class="Lrule">110 mcg once daily in the evening<a class="Sup" href="#footnote-1">*</a></td><td align="center" class="Lrule Rrule">110 mcg<a class="Sup" href="#footnote-1">*</a></td> </tr> </tbody> </table></div>

Inhalation powder:

{ "type": "p", "children": [], "text": "Inhalation powder: " }

{ "type": "ul", "children": [ "ASMANEX TWISTHALER 220 mcg delivers 200 mcg mometasone furoate per actuation from the mouthpiece.", "ASMANEX TWISTHALER 110 mcg delivers 100 mcg mometasone furoate per actuation from the mouthpiece." ], "text": "" }

ASMANEX TWISTHALER is contraindicated:

{ "type": "p", "children": [], "text": "ASMANEX TWISTHALER is contraindicated:" }

{ "type": "ul", "children": [ "Status Asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ", "Hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER [see Warnings and Precautions (5.3) and Description (11)].\n" ], "text": "" }

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in 195 of 3007 patients treated with ASMANEX TWISTHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX TWISTHALER therapy, but at times therapy with the ASMANEX TWISTHALER may need to be interrupted. After administration, advise patients to rinse the mouth with water and spit out contents without swallowing.

ASMANEX TWISTHALER is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma. A short acting beta2-agonist, such as albuterol, should be available at all times to treat acute asthma symptoms. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with ASMANEX TWISTHALER. During such episodes, patients may require therapy with oral corticosteroids.

Hypersensitivity reactions including rash, pruritus, angioedema, and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER. Discontinue ASMANEX TWISTHALER if such reactions occur [see Contraindications (4) and Adverse Reactions (6.2)].

ASMANEX TWISTHALER contains small amounts of lactose, which contains trace levels of milk proteins. In postmarketing experience with ASMANEX TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported [see Contraindications (4) and Adverse Reactions (6.2)].

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

HPA Suppression/Adrenal Insufficiency

Particular care is needed for patients who are transferred from systemically active corticosteroids to ASMANEX TWISTHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although ASMANEX TWISTHALER may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity necessary for coping with these emergencies.

During periods of stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or severe asthma attack.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ASMANEX TWISTHALER. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during treatment with ASMANEX TWISTHALER [see Dosage and Administration (2.1)]. Lung function (FEV1 or PEFR), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Unmasking of Allergic Conditions Previously Suppressed by Systemic Corticosteroids

Transfer of patients from systemic corticosteroid therapy to ASMANEX TWISTHALER may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

Corticosteroid Withdrawal Symptoms

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

ASMANEX TWISTHALER will often help control asthma symptoms with less suppression of HPA function than therapeutically similar oral doses of prednisone. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing ASMANEX TWISTHALER. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly when ASMANEX TWISTHALER is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ASMANEX TWISTHALER should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma.

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate. The clinical significance of small changes in BMD with regard to long-term outcomes is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

In a 2-year double-blind study in 103 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (baseline FEV1 85%–88% predicted), treatment with ASMANEX TWISTHALER 220 mcg twice daily resulted in significant reductions in lumbar spine (LS) BMD at the end of the treatment period compared to placebo. The mean change from baseline to endpoint in the lumbar spine BMD was -0.015 (-1.43%) for the ASMANEX TWISTHALER group compared to 0.002 (0.25%) for the placebo group. In another 2-year double-blind study in 87 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (baseline FEV1 82%–83% predicted), treatment with ASMANEX TWISTHALER 440 mcg twice daily demonstrated no statistically significant changes in lumbar spine BMD at the end of the treatment period compared to placebo. The mean change from baseline to endpoint in the lumbar spine BMD was -0.018 (-1.57%) for the ASMANEX TWISTHALER group compared to -0.006 (-0.43%) for the placebo group.

Orally inhaled corticosteroids, including ASMANEX TWISTHALER, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ASMANEX TWISTHALER routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX TWISTHALER, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

In clinical trials, glaucoma, increased intraocular pressure, and cataracts have been reported in 8 of 3007 patients following the administration of ASMANEX TWISTHALER. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX TWISTHALER long term.

As with other inhaled asthma medications, bronchospasm may occur with an immediate increase in wheezing after dosing. If bronchospasm occurs following dosing with ASMANEX TWISTHALER, it should be treated immediately with a fast-acting inhaled bronchodilator.

Treatment with ASMANEX TWISTHALER should be discontinued and alternative therapy instituted.

Caution should be exercised when considering the coadministration of ASMANEX TWISTHALER with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

The safety data described below reflect exposure to ASMANEX TWISTHALER in 2380 patients with asthma exposed for 8 to 12 weeks and 627 patients with asthma exposed for 1 year in a total of 17 clinical trials.

In adult and adolescent patients 12 years of age and older, ASMANEX TWISTHALER was studied in 10 placebo-controlled clinical trials of 8 to 12 weeks duration with a total of 1750 patients receiving ASMANEX TWISTHALER. There were also 3 trials with a total of 475 patients receiving ASMANEX TWISTHALER for 1 year. In the 8- to 12-week clinical trials, the population was 12 to 83 years of age; 38% males and 62% females; and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). In 3 long-term safety trials (two 9-month extensions of efficacy trials and one 52-week active-controlled safety trial), 475 patients with asthma (12-83 years of age, 44% males, 56% females, 87% Caucasian, 8% black, 4% Hispanic, and 1% other race/ethnicity) received various doses of ASMANEX TWISTHALER for 1 year.

In pediatric patients 4 to 11 years of age, ASMANEX TWISTHALER was studied in 3 placebo-controlled clinical trials of 12 weeks duration with a total of 630 patients receiving ASMANEX TWISTHALER and a 52-week, active-controlled safety trial with a total of 152 patients receiving ASMANEX TWISTHALER. In the 12-week clinical trials, the population was 4 to 11 years of age; 63% males and 37% females; and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). In the long-term active-controlled safety trial (n=152), patients with asthma (4 to 11 years of age, 60% males and 40% females, 84% Caucasian, 11% Black, and 5% Hispanic) received ASMANEX TWISTHALER 110 mcg twice daily or 220 mcg once daily in the morning for 52 weeks.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older: The safety results of the 10 trials that were 8 to 12 weeks in duration were pooled because patients with asthma in these studies were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results of the one 12-week clinical trial in patients with asthma previously treated with oral corticosteroids are presented separately.

In the pooled 8- to 12-week clinical trials, adverse reactions were reported in 70% of patients treated with ASMANEX TWISTHALER (n=1750) compared to 65% of patients taking placebo (n=720). Table 2 displays the common adverse reactions (≥3% in any patient group receiving ASMANEX TWISTHALER) that occurred more frequently in patients treated with ASMANEX TWISTHALER compared to patients treated with placebo.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2: Adverse Reactions with ≥3% Incidence in 10 Controlled Clinical Trials with ASMANEX TWISTHALER in Patients 12 Years of Age and Older Previously on Bronchodilators and/or Inhaled Corticosteroids</span> </caption> <col align="left" valign="top" width="30%"/> <col align="center" valign="top" width="18%"/> <col align="center" valign="top" width="18%"/> <col align="center" valign="top" width="22%"/> <col align="center" valign="top" width="12%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Botrule Rrule" colspan="4">(%) of Patients</th> </tr> <tr> <th align="left" class="Botrule Lrule Rrule"></th><th align="center" class="Botrule Rrule" colspan="3">ASMANEX TWISTHALER</th><th align="center" class="Rrule"></th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule" rowspan="2">  Adverse Reaction</th><th align="center" class="Rrule" valign="top">220 mcg twice daily<br/>(n=433)</th><th align="center" class="Rrule" valign="top">440 mcg once daily<br/>(n=497)</th><th align="center" class="Rrule" valign="top">220 mcg once daily in the evening<br/>(n=232)</th><th align="center" class="Rrule" valign="bottom">Placebo<br/>(n=720)</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="5"> <dl class="Footnote"> <dt> <a href="#footnote-reference-5" name="footnote-5">*</a> </dt> <dd>Percentages are based on the number of female patients.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule"><span class="Bold">Headache</span></td><td align="center" class="Rrule">22</td><td align="center" class="Rrule">17</td><td align="center" class="Rrule">20</td><td align="center" class="Rrule">20</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Allergic Rhinitis</span></td><td align="center" class="Rrule">15</td><td align="center" class="Rrule">11</td><td align="center" class="Rrule">14</td><td align="center" class="Rrule">13</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Pharyngitis</span></td><td align="center" class="Rrule">11</td><td align="center" class="Rrule">8</td><td align="center" class="Rrule">13</td><td align="center" class="Rrule">7</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Upper Respiratory Infection</span></td><td align="center" class="Rrule">10</td><td align="center" class="Rrule">8</td><td align="center" class="Rrule">15</td><td align="center" class="Rrule">7</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Sinusitis</span></td><td align="center" class="Rrule">6</td><td align="center" class="Rrule">6</td><td align="center" class="Rrule">5</td><td align="center" class="Rrule">5</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Candidiasis, oral</span></td><td align="center" class="Rrule">6</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Dysmenorrhea</span><a class="Sup" href="#footnote-5" name="footnote-reference-5">*</a></td><td align="center" class="Rrule">9</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">4</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Musculoskeletal Pain</span></td><td align="center" class="Rrule">8</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">5</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Back Pain</span></td><td align="center" class="Rrule">6</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">4</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Dyspepsia</span></td><td align="center" class="Rrule">5</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">3</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Myalgia</span></td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Abdominal Pain</span></td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Nausea</span></td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">1</td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">2</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule"><span class="Bold">Average Duration of Exposure (Days)</span></td><td align="center" class="Rrule">81</td><td align="center" class="Rrule">70</td><td align="center" class="Rrule">80</td><td align="center" class="Rrule">62</td> </tr> </tbody> </table></div>

The following other adverse reactions occurred in these clinical trials with an incidence of at least 1% but less than 3% and were more common on ASMANEX TWISTHALER therapy than on placebo:

Body as a Whole: fatigue, flu-like symptoms, pain

Gastrointestinal: gastroenteritis, vomiting, anorexia

Hearing, Vestibular: earache

Resistance Mechanism: infection

Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry

In the 12-week trial in adult asthmatics who previously required oral corticosteroids, the effects of ASMANEX TWISTHALER therapy administered as two 220-mcg inhalations twice daily (n=46) were compared with those of placebo (n=43). Adverse reactions, whether considered drug-related or not by the investigators, reported in more than 3 patients in the ASMANEX TWISTHALER treatment group, and which occurred more frequently than in placebo were (ASMANEX TWISTHALER % vs. placebo %): musculoskeletal pain (22% vs. 14%), oral candidiasis (22% vs. 9%), sinusitis (22% vs. 19%), allergic rhinitis (20% vs. 5%), upper respiratory infection (15% vs. 14%), arthralgia (13% vs. 7%), fatigue (13% vs. 2%), depression (11% vs. 0%), and sinus congestion (9% vs. 0%). In considering these data, an increased duration of exposure for patients on ASMANEX TWISTHALER treatment (77 days vs. 58 days on placebo) should be taken into account.

Long-Term Clinical Trials Experience - 12 Years of Age and Older: In 3 long-term safety trials, 475 patients with asthma 12 years of age and older were treated with ASMANEX TWISTHALER 220 mcg twice daily (n=60), 220 mcg once daily in the morning (n=41), 220 mcg once daily in the evening (n=40), 440 mcg once daily in the morning (n=44), 440 mcg once daily in the evening (n=41), 440 mcg twice daily (n=62), 880 mcg once daily (n=59), or at variable doses (n=128) for 52 weeks. The safety profile of ASMANEX TWISTHALER in the 52-week trials was similar to the findings in the 8- to 12-week clinical trials. In patients previously on inhaled corticosteroids, cataracts were reported in 3 patients (0.9%) treated with ASMANEX TWISTHALER, compared to 1 patient (1.7%) treated with the active comparator medication. Increased ocular pressure at the end of the study was observed in 2 patients, both on ASMANEX TWISTHALER 880 mcg once daily in the morning. Oral candidiasis, dysphonia, and dysmenorrhea were seen at a higher frequency with long-term administration than in the 8- to 12-week trials.

Pediatric Patients 4 to 11 Years of Age: In the three 12-week clinical trials in pediatric patients 4 to 11 years of age, patients with asthma were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results from 1 trial are described in Table 3 for ASMANEX TWISTHALER 110 mcg once daily in the evening. The safety results from the other 2 trials showed similar findings.

Overall adverse reactions were reported with approximately the same frequency by patients treated with ASMANEX TWISTHALER and those receiving placebo. Table 3 displays the common adverse reactions (≥2% in any patient group receiving ASMANEX TWISTHALER) that occurred more frequently in patients 4 to 11 years of age treated with ASMANEX TWISTHALER compared with placebo-treated patients.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: Adverse Reactions with ≥2% Incidence in a 12-Week Study with ASMANEX TWISTHALER in Patients 4 to 11 Years of Age Previously on Bronchodilators and/or Inhaled Corticosteroids</span> </caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="40%"/> <col align="center" valign="top" width="20%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Botrule Rrule" colspan="2">(%) of Patients</th> </tr> <tr> <th align="left" class="Botrule Lrule Rrule"></th><th align="center" class="Botrule Rrule" colspan="2">ASMANEX TWISTHALER</th> </tr> <tr class="Last"> <th align="left" class="Lrule Rrule">  Adverse Reaction</th><th align="center" class="Rrule">110 mcg once daily in the evening<br/>(n=98)</th><th align="center" class="Rrule">Placebo<br/>(n=99)</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule"><span class="Bold">Fever</span></td><td align="center" class="Rrule">7</td><td align="center" class="Rrule">5</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Allergic Rhinitis</span></td><td align="center" class="Rrule">4</td><td align="center" class="Rrule">3</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Abdominal Pain</span></td><td align="center" class="Rrule">6</td><td align="center" class="Rrule">2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Vomiting</span></td><td align="center" class="Rrule">3</td><td align="center" class="Rrule">2</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Urinary Tract Infection</span></td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">1</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Bruise</span></td><td align="center" class="Rrule">2</td><td align="center" class="Rrule">0</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule"><span class="Bold">Average Duration of Exposure (Days)</span></td><td align="center" class="Rrule">72</td><td align="center" class="Rrule">68</td> </tr> </tbody> </table></div>

Long-Term Clinical Trials Experience in Children 4 to 11 Years of Age: In a 52-week, active-controlled, long-term safety trial, 152 patients with asthma 4 to 11 years of age were treated with ASMANEX TWISTHALER 110 mcg twice daily (n=74) or 220 mcg once daily (n=78). The safety profile for ASMANEX TWISTHALER in the 52-week trial was similar to the findings in the 12-week clinical trials.

The following adverse reactions have been reported during post-approval use of ASMANEX TWISTHALER. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: Vision blurred [see Warnings and Precautions (5.9)].

Immune System Disorders: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction [see Warnings and Precautions (5.3) and Contraindications (4)].

Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.

Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects [see Clinical Pharmacology (12.3)]. Caution should be exercised when considering the coadministration of ASMANEX TWISTHALER with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

Risk Summary

There are no adequate and well-controlled studies of ASMANEX TWISTHALER in pregnant women. There are clinical considerations with the use of ASMANEX TWISTHALER in pregnant women [see Clinical Considerations]. In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis [see Data]. However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.

Data

Animal Data

In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at an exposure approximately 1/3 of the MRHD (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at an exposure approximately equivalent to the MRHD (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure approximately 1/10 of the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above).

In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 6 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at exposures approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above).

In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at an exposure that was approximately 6 times the MRHD (on an area under the curve (AUC) basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings with an exposure approximately 3 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 7.5 mcg/kg).

Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at an exposure approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at an exposure approximately 1/2 of the MRHD (on an AUC basis with a maternal oral dose of 700 mcg/kg). At an exposure approximately 2 times the MRHD (on an AUC basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. No effects were observed at an exposure approximately 1/10 of the MRHD (on an AUC basis with a maternal oral dose of 140 mcg/kg).

Risk Summary

There are no available data on the presence of ASMANEX TWISTHALER in human milk, the effects on the breastfed child, or the effects on milk production. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ASMANEX TWISTHALER and any potential adverse effects on the breastfed infant from ASMANEX TWISTHALER or from the underlying maternal condition.

The safety and effectiveness of ASMANEX TWISTHALER for maintenance treatment of asthma as prophylactic therapy have been established in children 4 years of age and older. Use of ASMANEX TWISTHALER in pediatric patients 12 years of age and older is supported by evidence from adequate and well-controlled clinical trials in this patient population [see Clinical Studies (14.1) and Adverse Reactions (6.1)].

Use of ASMANEX TWISTHALER in pediatric patients 4 to 11 years of age is supported by evidence from adequate and well-controlled clinical trials of 12 weeks duration in 630 patients 4 to 11 years of age receiving ASMANEX TWISTHALER and one 52-week safety trial in 152 patients [see Clinical Studies (14.1) and Adverse Reactions (6.1)].

Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth in pediatric patients. In these studies, the mean reduction in growth velocity was approximately 1 cm per year (range: 0.3–1.8 per year) and appears to depend upon dose and duration of exposure. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. The growth of children and adolescents (4 years of age and older) receiving orally inhaled corticosteroids, including ASMANEX TWISTHALER, should be monitored routinely (e.g., via stadiometry).

A 52-week, placebo-controlled, parallel-group study was conducted to assess the potential growth effects of ASMANEX TWISTHALER in 187 prepubescent children (131 males and 56 females) 4 to 9 years of age with asthma who were previously maintained on an inhaled beta-agonist. Treatment groups included ASMANEX TWISTHALER 110 mcg twice daily (n=44), 220 mcg once daily in the morning (n=50), 110 mcg once daily in the morning (n=48), and placebo (n=45). For each patient, an average growth rate was determined using an individual regression approach. The mean growth rates, expressed as least-squares mean in cm per year, for ASMANEX TWISTHALER 110 mcg twice daily, 220 mcg once daily in the morning, 110 mcg once daily in the morning, and placebo were 5.34, 5.93, 6.15, and 6.44, respectively. The differences from placebo and the corresponding 2-sided 95% CI of growth rates for ASMANEX TWISTHALER 110 mcg twice daily, 220 mcg once daily in the morning, and 110 mcg once daily in the morning were -1.11 (95% CI: -2.34, 0.12), -0.51 (95% CI: -1.69, 0.67), and -0.30 (95% CI: -1.48, 0.89), respectively.

The potential growth effects of prolonged treatment with orally inhaled corticosteroids should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX TWISTHALER, each patient should be titrated to his/her lowest effective dose.

A total of 175 patients 65 years of age and over (23 of whom were 75 years of age and older) have been treated with ASMANEX TWISTHALER in controlled clinical trials. No overall differences in safety or effectiveness were observed between these and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3)].

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.6)]. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies, acute overdose is unlikely to require any treatment other than observation.

{ "type": "p", "children": [], "text": "Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.6)]. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies, acute overdose is unlikely to require any treatment other than observation." }

Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure:

{ "type": "p", "children": [], "text": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure:" }

Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons.

{ "type": "p", "children": [], "text": "Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons." }

The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins).

{ "type": "p", "children": [], "text": "The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins)." }

Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).

{ "type": "p", "children": [], "text": "Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)." }

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation and in the asthmatic response. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Mometasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor, which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. The clinical significance of these findings is unknown.

Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Adrenal Function: The effects of ASMANEX TWISTHALER on adrenal function have been evaluated in 2 clinical studies: 1 in adults 18 years of age and older and 1 in pediatric patients 6 to 11 years of age. Both clinical studies were specifically designed to assess the effect of ASMANEX TWISTHALER on adrenal function.

In a 29-day, randomized, double-blind, placebo-controlled study in 64 adult and adolescent patients 18 years of age and older with asthma, ASMANEX TWISTHALER 440 mcg twice daily and 880 mcg twice daily (twice the highest recommended daily dose) were compared to both placebo and prednisone 10 mg once daily as a positive control. The 30-minute post-Cosyntropin stimulation serum cortisol concentration on Day 29 was 23.2 mcg/dL for the ASMANEX 440 mcg twice daily group (n=16) and 20.8 mcg/dL for the ASMANEX 880 mcg twice daily group (n=16), compared to 14.5 mcg/dL for the oral prednisone 10-mg group (n=16) and 25 mcg/dL for the placebo group (n=16). The difference between ASMANEX 880 mcg twice daily (twice the maximum recommended dose) and placebo was statistically significant.

In a 29-day, randomized, double-blind, placebo-controlled, parallel-group clinical trial in 50 pediatric patients 6 to 11 years of age with asthma, ASMANEX TWISTHALER 110 mcg twice daily, 220 mcg twice daily, and 440 mcg twice daily (2-8 times the highest pediatric daily recommended daily dose) were compared to placebo. HPA-axis function was assessed by 12-hour plasma cortisol AUC and 24-hour urinary-free cortisol concentrations. After 29 days of treatment, the mean changes in plasma cortisol AUC0–12h from baseline were -0.11, -19.5, -21.3, and -3.47 mcg•hr/dL for the treatment groups of ASMANEX TWISTHALER 110 mcg twice daily (n=12), 220 mcg twice daily (n=12), 440 mcg twice daily (n=11), and placebo (n=7), respectively. The mean differences from placebo in the groups treated with ASMANEX TWISTHALER 110 mcg twice daily, 220 mcg twice daily, and 440 mcg twice daily were 3.4 mcg•hr/dL (95% CI: -14.0, 20.7), -16.0 mcg•hr/dL (95% CI: -33.9, 1.9), and -17.9 mcg•hr/dL (95% CI: -35.8, 0.0), respectively. For 24-hour urinary-free cortisol, after 29 days of treatment, the mean changes from baseline were -1.53, -1.33, -6.70, and -4.68 mcg/day for the groups treated with ASMANEX TWISTHALER 110 mcg twice daily (n=12), 220 mcg twice daily (n=12), 440 mcg twice daily (n=12), and placebo (n=10), respectively. The mean differences in urinary-free cortisol changes from baseline compared to placebo were 3.1 mcg/day (95% CI: -3.3, 9.6), 3.3 mcg/day (95% CI: -3.0, 9.7), and -2.0 mcg/day (95% CI: -8.6, 4.6) for the groups treated with 110 mcg twice daily, 220 mcg twice daily, and 440 mcg twice daily, respectively.

Absorption: Following a 1000 mcg inhaled dose of tritiated mometasone furoate inhalation powder to 6 healthy human subjects, plasma concentrations of unchanged mometasone furoate were shown to be very low compared to the total radioactivity in plasma. Following an inhaled single 400 mcg dose of ASMANEX TWISTHALER treatment to 24 healthy subjects, plasma concentrations for most subjects were near or below the lower limit of quantitation for the assay (50 pcg/mL). The mean absolute systemic bioavailability of the above single inhaled 400 mcg dose, compared to an intravenous 400 mcg dose of mometasone furoate, was determined to be less than 1%. Following administration of the recommended highest inhaled dose (400 mcg twice daily) to 64 patients for 28 days, concentration-time profiles were discernible, but with large intersubject variability. The coefficient of variation for Cmax and AUC ranged from approximately 50% to 100%. The mean peak plasma concentrations at steady state ranged from approximately 94 to 114 pcg/mL and the mean time to peak levels ranged from approximately 1.0 to 2.5 hours.

Distribution: Based on the study employing a 1000 mcg inhaled dose of tritiated mometasone furoate inhalation powder in humans, no appreciable accumulation of mometasone furoate in the red blood cells was found. Following an intravenous 400 mcg dose of mometasone furoate, the plasma concentrations showed a biphasic decline, with a mean terminal half-life of about 5 hours and the mean steady-state volume of distribution of 152 L. The in vitro protein binding for mometasone furoate was reported to be 98% to 99% (in a concentration range of 5–500 ng/mL).

Elimination:

Metabolism: Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of CYP3A4 in the metabolism of this compound; however, no major metabolites were identified.

Excretion: Following an intravenous dosing, the terminal half-life was reported to be about 5 hours. Following the inhaled dose of tritiated 1000 mcg mometasone furoate, the radioactivity is excreted mainly in the feces (a mean of 74%), and to a small extent in the urine (a mean of 8%) up to 7 days. No radioactivity was associated with unchanged mometasone furoate in the urine.

Specific Populations:

Pharmacokinetics have not been adequately investigated with ASMANEX TWISTHALER by gender, race or in pediatric patients.

Patients with Hepatic Impairment: Administration of a single inhaled dose of 400 mcg mometasone furoate to subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment resulted in only 1 or 2 subjects in each group having detectable peak plasma concentrations of mometasone furoate (ranging from 50–105 pcg/mL). The observed peak plasma concentrations appear to increase with severity of hepatic impairment; however, the numbers of detectable levels were few.

Patients with Renal Impairment: The effects of renal impairment on mometasone furoate pharmacokinetics have not been adequately investigated.

Drug Interaction Studies: Inhibitors of Cytochrome P450 3A4: In a drug interaction study, an inhaled dose of mometasone furoate 400 mcg was given to 24 healthy subjects twice daily for 9 days and ketoconazole 200 mg (as well as placebo) were given twice daily concomitantly on Days 4 to 9. Mometasone furoate plasma concentrations were <150 pcg/mL on Day 3 prior to coadministration of ketoconazole or placebo. Following concomitant administration of ketoconazole, 4 out of 12 subjects in the ketoconazole treatment group (n=12) had peak plasma concentrations of mometasone furoate >200 pcg/mL on Day 9 (211–324 pcg/mL).

In a 2-year carcinogenicity study in Sprague Dawley® rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 8 times the maximum recommended daily inhalation dose in adults on an AUC basis and 2 times the maximum recommended daily inhalation dose in pediatric patients based on an mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 10 times the maximum recommended daily inhalation dose in adults on an AUC basis and 2 times the maximum recommended daily inhalation dose in pediatric patients based on an mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not have this effect in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (approximately 6 times the maximum recommended daily inhalation dose in adults on an AUC basis).

Reproductive Toxicology Studies: In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the maximum recommended daily inhalation dose in adults on an mcg/m2 basis). Fetal survival was reduced at 180 mcg/kg (approximately equal to the maximum recommended daily inhalation dose in adults on an mcg/m2 basis). No toxicity was observed at 20 mcg/kg (less than the maximum recommended daily inhalation dose in adults on an mcg/m2 basis).

In rats, mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg/kg and above (approximately 6 times the maximum recommended daily inhalation dose in adults on an mcg/m2 basis). A dose of 300 mcg/kg (approximately 3 times the maximum recommended daily inhalation dose in adults on an mcg/m2 basis) produced delays in ossification but no malformations.

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg (approximately 6 times the maximum recommended daily inhalation dose in adults on an AUC basis) caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg (approximately 3 times the maximum recommended daily inhalation dose in adults on an AUC basis).

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses of 150 mcg/kg and above (approximately 3 times the maximum recommended daily inhalation dose in adults on an mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg (less than the maximum recommended daily inhalation dose in adults on an area under the curve [AUC] basis). At 2800 mcg/kg (approximately 2 times the maximum recommended daily inhalation dose in adults on an AUC basis) most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg (less than the maximum recommended daily inhalation dose in adults on an AUC basis).

Adults and Adolescents 12 Years of Age and Older: The efficacy of ASMANEX TWISTHALER in patients with asthma 12 years and older was evaluated in ten 8- to 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trials. These trials included 1750 patients ranging from 12 to 83 years of age; 38% male and 62% female; and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). The results of the clinical trials are presented based upon previous asthma therapy.

Patients ≥12 Years of Age Previously Maintained on Bronchodilators Alone: ASMANEX TWISTHALER was studied in three 12-week, double-blind trials in 737 patients with mild to moderate asthma (mean baseline FEV1≅2.6 L, 72% of predicted normal) who were maintained on short-acting beta2-agonists alone. The first 2 trials evaluated doses of 440 mcg administered as 2 inhalations once daily in the morning and 1 of these studies also evaluated 220 mcg twice daily. In both trials, morning predose FEV1 was significantly improved at endpoint (last observation) following treatment with 440 mcg ASMANEX TWISTHALER once daily in the morning as compared to placebo (14% vs. 2.5%, respectively, in 1 trial and 16% vs. 5.5% in the other). There was also a significant improvement in morning predose FEV1 at endpoint following treatment with ASMANEX TWISTHALER 220 mcg twice daily. Other measures of lung function (morning and evening PEFR) also showed improvement compared to placebo. Patients receiving ASMANEX TWISTHALER treatment had reduced frequency of beta2-agonist rescue medication use compared to those on placebo (mean reductions at endpoint 2.2 and 0.5 puffs per day, respectively, from a baseline of 4.1 puffs/day). Additionally, fewer patients receiving ASMANEX TWISTHALER 440 mcg once daily experienced asthma worsening than did patients receiving placebo.

In the third trial, 195 asthmatic patients were treated with ASMANEX TWISTHALER 220 mcg once daily in the evening or placebo. The morning FEV1 at endpoint was significantly improved compared to placebo (mean change at endpoint 0.43 L or 16.8% vs. 0.16 L or 6%, respectively, see Figure 1). Evening PEF increased 24.96 L/min (7%) from baseline in the ASMANEX TWISTHALER group compared to 8.67 L/min (4%) in placebo.

Patients ≥12 Years of Age Previously Maintained on Inhaled Corticosteroids: The efficacy and safety of ASMANEX TWISTHALER in doses ranging from 110 mcg twice daily to 440 mcg twice daily was evaluated in 3 trials in 1072 patients previously maintained on inhaled corticosteroids. In the first 2 trials, asthmatic patients (mean baseline FEV1 ~2.6 L, 76% predicted) were previously on either beclomethasone dipropionate [84–1200 mcg/day], flunisolide [100–2000 mcg/day], fluticasone propionate [110–880 mcg/day], or triamcinolone acetonide [300–2400 mcg/day]. The first trial included 307 patients who were treated in an open-label fashion with ASMANEX TWISTHALER 220 mcg (110 mcg × 2 inhalations) twice daily for 2 weeks followed by 12 weeks of double-blind treatment with ASMANEX TWISTHALER 440 mcg once daily in the morning or placebo. The second trial involved 365 patients who continued on their previous dose of inhaled corticosteroids during a 2-week screening period before being switched to ASMANEX TWISTHALER 440 mcg twice daily, 220 mcg twice daily, 110 mcg twice daily, beclomethasone dipropionate 168 mcg twice daily, or placebo for 12 weeks.

In the first trial, morning predose FEV1 was effectively maintained (-1.4% change from baseline to endpoint) over the 12 weeks in the patients who were randomized to ASMANEX TWISTHALER 440 mcg once daily in the morning, while decreasing 10% at endpoint in those switched to placebo. In addition, fewer patients treated with ASMANEX TWISTHALER experienced worsening of asthma compared to placebo.

In the second trial, morning predose FEV1 was significantly increased at endpoint when patients were switched to ASMANEX TWISTHALER 220 mcg twice daily (7% increase) or 440 mcg twice daily (6.2% increase) as compared to a decrease of 7% when switched to placebo. Additionally, beta2-agonist rescue medication use was decreased for patients who received ASMANEX TWISTHALER treatment relative to those on placebo (mean reduction from baseline to endpoint 1.1 puffs/day vs. increase of 0.7 puffs/day). Fewer patients receiving ASMANEX TWISTHALER treatment experienced asthma worsening than did patients receiving placebo.

The third trial evaluated the efficacy and safety of ASMANEX TWISTHALER compared to placebo in 400 asthmatic patients (mean FEV1 67% predicted at baseline) previously maintained on beclomethasone dipropionate (hydrofluoroalkane [HFA] or chlorofluorocarbon [CFC]) 168–600 mcg/day, budesonide 200–1200 mcg/day, flunisolide 500–2000 mcg/day, fluticasone propionate 88–880 mcg/day, or triamcinolone acetonide 400–1600 mcg/day. Following a 28-day inhaled corticosteroid dose-reduction phase, patients were randomized to ASMANEX TWISTHALER 440 mcg once daily in the evening, 220 mcg once daily in the evening, 220 mcg twice daily, or placebo. At endpoint, patients who received ASMANEX TWISTHALER 220 mcg once daily in the evening, 440 mcg once daily in the evening, or 220 mcg twice daily had a significant improvement in morning FEV1 [0.41 L (19%), 0.49 L (22%), and 0.51 L (24%) in the 220 mcg once daily in the evening, 440 mcg once daily in the evening, and 220 mcg twice daily treatment group, respectively] compared to placebo [0.16 L (8%)] (see Figure 2). Evening PEF increased 15.65 L/min (4.1%) with the 220 mcg once daily in the evening dose, 39.26 L/min (10.7%) with the 440 mcg once daily in the evening dose, and 36.7 L/min (10.8%) with the 220 mcg twice daily dose, respectively, compared to a 1.4 L/min (1%) increase with placebo. Patients receiving all doses of ASMANEX TWISTHALER treatment had reduced frequency of beta-agonist rescue medication use compared to those on placebo (mean reductions at endpoint of 1.4–1.8 puffs/day from a baseline of more than 3 puffs/day compared to an increase in use by 0.5 puffs/day for placebo). In addition, fewer patients receiving ASMANEX TWISTHALER experienced asthma worsening than did those on placebo.

Patients ≥12 Years of Age Previously Maintained on Oral Corticosteroids: The efficacy of ASMANEX TWISTHALER 440 mcg and 880 mcg twice daily was evaluated in one 12-week, double-blind trial in patients previously maintained on oral corticosteroids. A total of 132 patients requiring oral prednisone (baseline mean daily oral prednisone requirement approximately 12 mg; baseline FEV1 of 1.8 L, 59% of predicted normal), most of whom were also on inhaled corticosteroids (baseline inhaled steroid: beclomethasone dipropionate [168–840 mcg/day], budesonide [800–1600 mcg/day], flunisolide [1000–2000 mcg/day], fluticasone propionate [440–1760 mcg/day], or triamcinolone acetonide [400–2400 mcg/day]) were studied. Patients who received ASMANEX TWISTHALER 440 mcg twice daily had a significant reduction in their oral prednisone (46%) as compared to placebo (164% increase in oral prednisone dose). Additionally, 40% of patients on ASMANEX TWISTHALER 440 mcg twice daily were able to completely discontinue their use of prednisone, whereas 60% of patients on placebo had an increase in daily prednisone use. Patients on ASMANEX TWISTHALER had significant improvement in lung function (14% increase) compared to a 12% decrease in FEV1 in the placebo group. Additionally, mean rescue beta2-agonist use was reduced to approximately 3 puffs/day from a baseline of 4–5 puffs/day with ASMANEX TWISTHALER treatment, compared to an increase of 0.3 puffs/day on placebo. Patients who received ASMANEX TWISTHALER 880 mcg twice daily experienced no additional benefit beyond that seen with 440 mcg twice daily.

Pediatric Patients 4 to 11 Years of Age: The efficacy of ASMANEX TWISTHALER in patients with asthma 4 to 11 years of age was evaluated in three 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trials. These trials included 630 patients receiving ASMANEX TWISTHALER, ranging from 4 to 11 years of age; 63% male and 37% female; and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received ASMANEX TWISTHALER 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). The results for 1 clinical trial are described below. The other 2 clinical trials support the efficacy of ASMANEX TWISTHALER.

A 12-week, placebo-controlled trial of 296 patients 4 to 11 years of age with asthma of at least 6 months duration (mean % predicted FEV1 at baseline ranging from 77.3%–79.7%) was conducted to demonstrate the efficacy of the ASMANEX TWISTHALER in the treatment of asthma. Patients were treated with ASMANEX TWISTHALER 110 mcg once daily in the evening (n=98) or placebo (n=99) for 12 weeks. Assessment of efficacy was based upon morning predose FEV1. The primary endpoint was the mean change from baseline to endpoint in percent-predicted FEV1. For the primary endpoint, improvement in the ASMANEX TWISTHALER 110 mcg once daily in the evening treatment group (4.73) was statistically significant compared to placebo (-1.77). Figure 3 displays the results for % predicted FEV1 change from baseline at endpoint.

In this study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of efficacy of ASMANEX TWISTHALER.

Storage and Handling

Store in a dry place at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Discard the inhaler 45 days after opening the foil pouch or when dose counter reads "00", whichever comes first.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)." }

Oropharyngeal Candidiasis

{ "type": "p", "children": [], "text": "\nOropharyngeal Candidiasis\n" }

Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with ASMANEX TWISTHALER therapy, but at times therapy with ASMANEX TWISTHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with ASMANEX TWISTHALER therapy, but at times therapy with ASMANEX TWISTHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1)].\n" }

Acute Asthma Episodes

{ "type": "p", "children": [], "text": "\nAcute Asthma Episodes\n" }

Patients should be advised that ASMANEX TWISTHALER is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms. Acute asthma symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Patients should be advised that ASMANEX TWISTHALER is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms. Acute asthma symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol [see Warnings and Precautions (5.2)].\n" }

Hypersensitivity Reactions Including Anaphylaxis

{ "type": "p", "children": [], "text": "\nHypersensitivity Reactions Including Anaphylaxis\n" }

Hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER. Discontinue ASMANEX TWISTHALER if such reactions occur [see Contraindications (4), Warnings and Precautions (5.3), and Adverse Reactions (6.2)].

{ "type": "p", "children": [], "text": "Hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction have been reported with use of ASMANEX TWISTHALER. Discontinue ASMANEX TWISTHALER if such reactions occur [see Contraindications (4), Warnings and Precautions (5.3), and Adverse Reactions (6.2)].\n" }

ASMANEX TWISTHALER contains small amounts of lactose, which contains trace levels of milk proteins. In postmarketing experience with ASMANEX TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported [see Contraindications (4) and Adverse Reactions (6.2)].

{ "type": "p", "children": [], "text": "\nASMANEX TWISTHALER contains small amounts of lactose, which contains trace levels of milk proteins. In postmarketing experience with ASMANEX TWISTHALER, anaphylactic reactions in patients with milk protein allergy have been reported [see Contraindications (4) and Adverse Reactions (6.2)].\n" }

Immunosuppression and Risk of Infections

{ "type": "p", "children": [], "text": "\nImmunosuppression and Risk of Infections\n" }

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].\n" }

Hypercorticism and Adrenal Suppression

{ "type": "p", "children": [], "text": "\nHypercorticism and Adrenal Suppression\n" }

Patients should be advised that ASMANEX TWISTHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to ASMANEX TWISTHALER [see Warnings and Precautions (5.6)].

{ "type": "p", "children": [], "text": "Patients should be advised that ASMANEX TWISTHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to ASMANEX TWISTHALER [see Warnings and Precautions (5.6)]." }

Reduction in Bone Mineral Density

{ "type": "p", "children": [], "text": "\nReduction in Bone Mineral Density\n" }

Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk and should be monitored and, where appropriate, be treated for this condition [see Warnings and Precautions (5.7)].

{ "type": "p", "children": [], "text": "Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk and should be monitored and, where appropriate, be treated for this condition [see Warnings and Precautions (5.7)].\n" }

Reduced Growth Velocity

{ "type": "p", "children": [], "text": "\nReduced Growth Velocity\n" }

Patients should be informed that orally inhaled corticosteroids, including mometasone furoate inhalation powder, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.8)].

{ "type": "p", "children": [], "text": "Patients should be informed that orally inhaled corticosteroids, including mometasone furoate inhalation powder, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.8)].\n" }

Use Daily for Best Effect

{ "type": "p", "children": [], "text": "\nUse Daily for Best Effect\n" }

Patients should be advised to use ASMANEX TWISTHALER at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. If symptoms do not improve in that time frame or if the condition worsens, patients should be instructed to contact their physician.

{ "type": "p", "children": [], "text": "Patients should be advised to use ASMANEX TWISTHALER at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. If symptoms do not improve in that time frame or if the condition worsens, patients should be instructed to contact their physician." }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

Patients should be instructed to record the date of pouch opening on the cap label and discard the inhaler 45 days after opening the foil pouch or when the dose counter reads "00" and the final dose has been inhaled, whichever comes first. The inhaler should be held upright while removing the cap. The medication should be taken as directed, breathing rapidly and deeply, and patients should not breathe out through the inhaler. The mouthpiece should be wiped dry and the cap replaced immediately following each inhalation and rotated fully until the click is heard. After administration, the patient should rinse their mouth with water and spit out contents without swallowing. Patients should store the unit as instructed. The dose counter displays the doses remaining. When the dose counter indicates zero, the cap will lock and the unit must be discarded. Patients should be advised that if the dose counter is not working correctly, the unit should not be used and it should be brought to their physician or pharmacist.

{ "type": "p", "children": [], "text": "Patients should be instructed to record the date of pouch opening on the cap label and discard the inhaler 45 days after opening the foil pouch or when the dose counter reads \"00\" and the final dose has been inhaled, whichever comes first. The inhaler should be held upright while removing the cap. The medication should be taken as directed, breathing rapidly and deeply, and patients should not breathe out through the inhaler. The mouthpiece should be wiped dry and the cap replaced immediately following each inhalation and rotated fully until the click is heard. After administration, the patient should rinse their mouth with water and spit out contents without swallowing. Patients should store the unit as instructed. The dose counter displays the doses remaining. When the dose counter indicates zero, the cap will lock and the unit must be discarded. Patients should be advised that if the dose counter is not working correctly, the unit should not be used and it should be brought to their physician or pharmacist." }

Manufactured for: Organon LLC, a subsidiary of ORGANON & Co.,Jersey City, NJ 07302, USA

{ "type": "p", "children": [], "text": "Manufactured for: Organon LLC, a subsidiary of\n\t\t\t\t\t\t\tORGANON & Co.,Jersey City, NJ 07302, USA" }

Manufactured by:MSD International GmbH (Singapore Branch)Singapore 638030, Singapore

{ "type": "p", "children": [], "text": "Manufactured by:MSD International GmbH (Singapore Branch)Singapore 638030, Singapore" }

For patent information: www.organon.com/our-solutions/patent/

{ "type": "p", "children": [], "text": "For patent information: www.organon.com/our-solutions/patent/" }

The trademarks above are owned by their respective owners.

{ "type": "p", "children": [], "text": "The trademarks above are owned by their respective owners." }

Copyright © 2021 Organon Global Inc. All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2021 Organon Global Inc.\nAll rights reserved." }

uspi-og0887-pwih-2106r001

{ "type": "p", "children": [], "text": "uspi-og0887-pwih-2106r001" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="16%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <thead> <tr class="First Last"> <th align="center" class="BotRule Lrule Rrule" colspan="7">Patient Information <br/> ASMANEX<span class="Sup">®</span> TWISTHALER<span class="Sup">®</span> (AZ-ma-neks) <br/> (mometasone furoate inhalation powder) <br/>for oral inhalation use only</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="5" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align="right" colspan="2" valign="top">Revised Date: 6/2021  </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">What is ASMANEX TWISTHALER?</span> <br/> ASMANEX TWISTHALER is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 4 years of age and older. <ul> <li>ASMANEX TWISTHALER is not used to treat sudden severe symptoms of asthma.</li> <li>ASMANEX TWISTHALER should not be used as a rescue inhaler.</li> <li>It is not known if ASMANEX TWISTHALER is safe and effective in children less than 4 years of age.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">Do not use ASMANEX TWISTHALER:</span> <ul class="Disc"> <li>to treat sudden severe symptoms of asthma.</li> <li>if you are allergic to milk proteins, mometasone furoate, or any of the ingredients in ASMANEX TWISTHALER. See the end of this Patient Information leaflet for a complete list of ingredients in ASMANEX TWISTHALER.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"> Before you use ASMANEX TWISTHALER, tell your healthcare provider about all of your medical conditions including if you: <ul class="Disc"> <li>have liver problems.</li> <li>have osteoporosis.</li> <li>have an immune system problem.</li> <li>have eye problems such as increased pressure in the eye (glaucoma), cataracts, blurred vision, or other changes in your vision.</li> <li>are allergic to any medicines.</li> <li>are exposed to chickenpox or measles.</li> <li>have or have had tuberculosis (TB), any untreated fungal, bacterial or viral infections or parasitic infections, or eye infections caused by herpes.</li> <li>are pregnant or planning to become pregnant. It is not known if ASMANEX TWISTHALER may harm your unborn baby.</li> <li>are breastfeeding. It is not known if ASMANEX TWISTHALER passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will either take ASMANEX TWISTHALER or breastfeed.</li> </ul> <p class="First"> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/>ASMANEX TWISTHALER may affect the way other medicines work, and other medicines may affect how ASMANEX TWISTHALER works.</p> <p> <span class="Bold">Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIV medicines such as:</span> </p> </td> </tr> <tr class="Lrule Rrule"> <td align="left" class="Lrule"> <ul class="Disc"> <li>ritonavir</li> <li>atazanavir</li> <li>cobicistat-containing products</li> </ul> </td><td align="left"> <ul class="Disc"> <li>ketoconazole</li> <li>clarithromycin</li> </ul> </td><td align="left"> <ul class="Disc"> <li>nefazodone</li> <li>saquinavir</li> </ul> </td><td align="left"> <ul class="Disc"> <li>nelfinavir</li> <li>telithromycin</li> </ul> </td><td align="left" class="Rrule" colspan="3"> <ul class="Disc"> <li>indinavir</li> <li>itraconazole</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7"> <p class="First">Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.</p> <p>For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your healthcare provider may wish to monitor you carefully.</p> <p>Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.</p> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">How should I use ASMANEX TWISTHALER?<br/>Read the step-by-step instructions for using ASMANEX TWISTHALER in the Instructions for Use.</span> <ul class="Disc"> <li>Use ASMANEX TWISTHALER exactly as prescribed. <span class="Bold">Do not</span> use ASMANEX TWISTHALER more often than prescribed.</li> <li>You must use ASMANEX TWISTHALER regularly. It may take 1 week to 2 weeks or longer after you start using ASMANEX TWISTHALER for your asthma symptoms to get better. <span class="Bold">Do not</span> stop using ASMANEX TWISTHALER even if you are feeling better, unless your healthcare provider tells you to.</li> <li> <span class="Bold">Do not</span> change or stop using ASMANEX TWISTHALER or other asthma medicines used to control or threat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.</li> <li>ASMANEX TWISTHALER comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between ASMANEX TWISTHALER and your other inhaled medicines, including their prescribed use and the way they look.</li> <li> ASMANEX TWISTHALER gives the medicine in a fine powder that you or your child may not taste, smell, or feel.</li> <li>If you take more ASMANEX TWISTHALER than your healthcare provider has prescribed, call your healthcare provider right away.</li> <li>ASMANEX TWISTHALER does not relieve sudden asthma symptoms. Always have a rescue inhaler such as albuterol with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX TWISTHALER. If you do not have a rescue inhaler such as albuterol, call your healthcare provider to have a rescue inhaler prescribed for you.</li> <li>Rinse your mouth with water after each dose of ASMANEX TWISTHALER. Spit out the water. <span class="Bold">Do not</span> swallow it. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.</li> <li> <span class="Bold">Call your healthcare provider or get medical care right away if</span> you have asthma and your symptoms do not improve after using ASMANEX TWISTHALER regularly for 1 to 2 weeks.</li> <li> <span class="Bold">Do not</span> use the ASMANEX TWISTHALER if the inhaler or any of its parts are not working properly. Take it to your healthcare provider or pharmacist.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">What are the possible side effects of ASMANEX TWISTHALER?<br/>ASMANEX TWISTHALER can cause serious side effects, including:</span> <ul class="Disc"> <li> <span class="Bold">Thrush in your mouth and throat.</span> This is a serious but common side effect. You may develop thrush, a yeast (Candida albicans), in your mouth or throat. After each dose of ASMANEX TWISTHALER, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.</li> <li> <span class="Bold">Increased wheezing right after taking ASMANEX TWISTHALER.</span> Always have a rescue inhaler with you to treat sudden wheezing.</li> <li> <span class="Bold">Serious allergic reactions.</span> Stop taking ASMANEX TWISTHALER and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule"> <ul class="Circle"> <li>rash</li> </ul> </td><td align="left"> <ul class="Circle"> <li>itching</li> </ul> </td><td align="left" colspan="3"> <ul class="Circle"> <li>swelling, including swelling of the face, mouth, and tongue</li> </ul> </td><td align="left" class="Rrule" colspan="2"> <ul class="Circle"> <li>breathing problems</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"> <ul class="Disc"> <li> <span class="Bold">Immune system effects and a higher chance for infections.</span> You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using ASMANEX TWISTHALER.<br/> Tell your healthcare provider about any signs of infection such as:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule"> <ul class="Circle"> <li>fever</li> </ul> </td><td align="left"> <ul class="Circle"> <li>feeling tired</li> </ul> </td><td align="left"> <ul class="Circle"> <li>body aches</li> </ul> </td><td align="left"> <ul class="Circle"> <li>vomiting</li> </ul> </td><td align="left"> <ul class="Circle"> <li>pain</li> </ul> </td><td align="left"> <ul class="Circle"> <li>nausea</li> </ul> </td><td align="left" class="Rrule"> <ul class="Circle"> <li>chills</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"> <ul class="Disc"> <li> <span class="Bold">Adrenal insufficiency that can lead to death</span> can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX TWISTHALER than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:</li> </ul> </td> </tr> <tr class="Lrule Rrule"> <td align="left" class="Lrule" colspan="2"> <ul class="Circle"> <li>feeling tired or exhausted (fatigue)</li> <li>weakness</li> </ul> </td><td align="left" colspan="2"> <ul class="Circle"> <li>lack of energy</li> <li>nausea and vomiting</li> </ul> </td><td align="left" class="Rrule" colspan="3"> <ul class="Circle"> <li>low blood pressure (hypotension)</li> <li>dizziness or feeling faint</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"> <ul class="Disc"> <li> <span class="Bold">Lower bone mineral density.</span> This may be a problem for people who already have a higher chance for low bone density (osteoporosis).</li> <li> <span class="Bold">Slowed growth in children.</span> A child’s growth should be checked often.</li> <li> <span class="Bold">Eye problems including glaucoma, cataracts, and blurred vision.</span> You should have regular eye exams while using ASMANEX TWISTHALER.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">The most common side effects reported while using ASMANEX TWISTHALER include:</span></td> </tr> <tr class="Lrule Rrule"> <td align="left" class="Lrule" colspan="4"> <ul class="Disc"> <li>headache</li> <li>painful menstrual periods</li> <li>sinus infection</li> <li>upper respiratory tract infection</li> <li>upset stomach</li> </ul> </td><td align="left" class="Rrule" colspan="3"> <ul class="Disc"> <li>muscle and bone pain</li> <li>back pain</li> <li>nasal allergy symptoms</li> <li>sore throat</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">Other side effects:</span> Worsening asthma or sudden asthma attacks have been reported with the use of inhaled mometasone furoate.<br/>Tell your healthcare provider about any side effect that bothers you or that does not go away.<br/>These are not all the side effects with ASMANEX TWISTHALER. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">General information about the safe and effective use of ASMANEX TWISTHALER.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ASMANEX TWISTHALER for a condition for which it was not prescribed. Do not give your ASMANEX TWISTHALER to other people, even if they have the same condition that you have. It may harm them.<br/>You can ask your healthcare provider or pharmacist for information about ASMANEX TWISTHALER that was written for healthcare professionals.<br/>For more information about ASMANEX TWISTHALER go to www.ASMANEX.com or to report side effects call 1-844-674-3200.</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">What are the ingredients in ASMANEX TWISTHALER?</span> <br/> Active ingredient: mometasone furoate<br/> Inactive ingredient: anhydrous lactose (which contains trace amounts of milk proteins).</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"16%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"BotRule Lrule Rrule\" colspan=\"7\">Patient Information\n\t\t\t\t\t\t\t\t\t\t<br/>\n\t\t\t\t\t\t\t\t\t\tASMANEX<span class=\"Sup\">®</span> TWISTHALER<span class=\"Sup\">®</span> (AZ-ma-neks)\n\t\t\t\t\t\t\t\t\t\t<br/>\n\t\t\t\t\t\t\t\t\t\t(mometasone furoate inhalation powder)\n\t\t\t\t\t\t\t\t\t\t<br/>for oral inhalation use only</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"5\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\" colspan=\"2\" valign=\"top\">Revised Date: 6/2021  </td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">What is ASMANEX TWISTHALER?</span>\n<br/>\n\t\t\t\t\t\t\t\t\t\tASMANEX TWISTHALER is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 4 years of age and older.\n\t\t\t\t\t\t\t\t\t\t<ul>\n<li>ASMANEX TWISTHALER is not used to treat sudden severe symptoms of asthma.</li>\n<li>ASMANEX TWISTHALER should not be used as a rescue inhaler.</li>\n<li>It is not known if ASMANEX TWISTHALER is safe and effective in children less than 4 years of age.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">Do not use ASMANEX TWISTHALER:</span>\n<ul class=\"Disc\">\n<li>to treat sudden severe symptoms of asthma.</li>\n<li>if you are allergic to milk proteins, mometasone furoate, or any of the ingredients in ASMANEX TWISTHALER. See the end of this Patient Information leaflet for a complete list of ingredients in ASMANEX TWISTHALER.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">\n\t\t\t\t\t\t\t\t\t\tBefore you use ASMANEX TWISTHALER, tell your healthcare provider about all of your medical conditions including if you:\n\t\t\t\t\t\t\t\t\t\t<ul class=\"Disc\">\n<li>have liver problems.</li>\n<li>have osteoporosis.</li>\n<li>have an immune system problem.</li>\n<li>have eye problems such as increased pressure in the eye (glaucoma), cataracts, blurred vision, or other changes in your vision.</li>\n<li>are allergic to any medicines.</li>\n<li>are exposed to chickenpox or measles.</li>\n<li>have or have had tuberculosis (TB), any untreated fungal, bacterial or viral infections or parasitic infections, or eye infections caused by herpes.</li>\n<li>are pregnant or planning to become pregnant. It is not known if ASMANEX TWISTHALER may harm your unborn baby.</li>\n<li>are breastfeeding. It is not known if ASMANEX TWISTHALER passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will either take ASMANEX TWISTHALER or breastfeed.</li>\n</ul>\n<p class=\"First\">\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/>ASMANEX TWISTHALER may affect the way other medicines work, and other medicines may affect how ASMANEX TWISTHALER works.</p>\n<p>\n<span class=\"Bold\">Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIV medicines such as:</span>\n</p>\n</td>\n</tr>\n<tr class=\"Lrule Rrule\">\n<td align=\"left\" class=\"Lrule\">\n<ul class=\"Disc\">\n<li>ritonavir</li>\n<li>atazanavir</li>\n<li>cobicistat-containing products</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Disc\">\n<li>ketoconazole</li>\n<li>clarithromycin</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Disc\">\n<li>nefazodone</li>\n<li>saquinavir</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Disc\">\n<li>nelfinavir</li>\n<li>telithromycin</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"3\">\n<ul class=\"Disc\">\n<li>indinavir</li>\n<li>itraconazole</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">\n<p class=\"First\">Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.</p>\n<p>For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your healthcare provider may wish to monitor you carefully.</p>\n<p>Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.</p>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">How should I use ASMANEX TWISTHALER?<br/>Read the step-by-step instructions for using ASMANEX TWISTHALER in the Instructions for Use.</span>\n<ul class=\"Disc\">\n<li>Use ASMANEX TWISTHALER exactly as prescribed. <span class=\"Bold\">Do not</span> use ASMANEX TWISTHALER more often than prescribed.</li>\n<li>You must use ASMANEX TWISTHALER regularly. It may take 1 week to 2 weeks or longer after you start using ASMANEX TWISTHALER for your asthma symptoms to get better. <span class=\"Bold\">Do not</span> stop using ASMANEX TWISTHALER even if you are feeling better, unless your healthcare provider tells you to.</li>\n<li>\n<span class=\"Bold\">Do not</span> change or stop using ASMANEX TWISTHALER or other asthma medicines used to control or threat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.</li>\n<li>ASMANEX TWISTHALER comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between ASMANEX TWISTHALER and your other inhaled medicines, including their prescribed use and the way they look.</li>\n<li>\n\t\t\t\t\t\t\t\t\t\t\t\tASMANEX TWISTHALER gives the medicine in a fine powder that you or your child may not taste, smell, or feel.</li>\n<li>If you take more ASMANEX TWISTHALER than your healthcare provider has prescribed, call your healthcare provider right away.</li>\n<li>ASMANEX TWISTHALER does not relieve sudden asthma symptoms. Always have a rescue inhaler such as albuterol with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX TWISTHALER. If you do not have a rescue inhaler such as albuterol, call your healthcare provider to have a rescue inhaler prescribed for you.</li>\n<li>Rinse your mouth with water after each dose of ASMANEX TWISTHALER. Spit out the water. <span class=\"Bold\">Do not</span> swallow it. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.</li>\n<li>\n<span class=\"Bold\">Call your healthcare provider or get medical care right away if</span> you have asthma and your symptoms do not improve after using ASMANEX TWISTHALER regularly for 1 to 2 weeks.</li>\n<li>\n<span class=\"Bold\">Do not</span> use the ASMANEX TWISTHALER if the inhaler or any of its parts are not working properly. Take it to your healthcare provider or pharmacist.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">What are the possible side effects of ASMANEX TWISTHALER?<br/>ASMANEX TWISTHALER can cause serious side effects, including:</span>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Thrush in your mouth and throat.</span> This is a serious but common side effect. You may develop thrush, a yeast (Candida albicans), in your mouth or throat. After each dose of ASMANEX TWISTHALER, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.</li>\n<li>\n<span class=\"Bold\">Increased wheezing right after taking ASMANEX TWISTHALER.</span> Always have a rescue inhaler with you to treat sudden wheezing.</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions.</span> Stop taking ASMANEX TWISTHALER and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul class=\"Circle\">\n<li>rash</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>itching</li>\n</ul>\n</td><td align=\"left\" colspan=\"3\">\n<ul class=\"Circle\">\n<li>swelling, including swelling of the face, mouth, and tongue</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"2\">\n<ul class=\"Circle\">\n<li>breathing problems</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Immune system effects and a higher chance for infections.</span> You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using ASMANEX TWISTHALER.<br/>\n\t\t\t\t\t\t\t\t\t\t\t\tTell your healthcare provider about any signs of infection such as:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul class=\"Circle\">\n<li>fever</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>feeling tired</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>body aches</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>vomiting</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>pain</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>nausea</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\">\n<ul class=\"Circle\">\n<li>chills</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Adrenal insufficiency that can lead to death</span> can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX TWISTHALER than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Lrule Rrule\">\n<td align=\"left\" class=\"Lrule\" colspan=\"2\">\n<ul class=\"Circle\">\n<li>feeling tired or exhausted (fatigue)</li>\n<li>weakness</li>\n</ul>\n</td><td align=\"left\" colspan=\"2\">\n<ul class=\"Circle\">\n<li>lack of energy</li>\n<li>nausea and vomiting</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"3\">\n<ul class=\"Circle\">\n<li>low blood pressure (hypotension)</li>\n<li>dizziness or feeling faint</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Lower bone mineral density.</span> This may be a problem for people who already have a higher chance for low bone density (osteoporosis).</li>\n<li>\n<span class=\"Bold\">Slowed growth in children.</span> A child’s growth should be checked often.</li>\n<li>\n<span class=\"Bold\">Eye problems including glaucoma, cataracts, and blurred vision.</span> You should have regular eye exams while using ASMANEX TWISTHALER.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">The most common side effects reported while using ASMANEX TWISTHALER include:</span></td>\n</tr>\n<tr class=\"Lrule Rrule\">\n<td align=\"left\" class=\"Lrule\" colspan=\"4\">\n<ul class=\"Disc\">\n<li>headache</li>\n<li>painful menstrual periods</li>\n<li>sinus infection</li>\n<li>upper respiratory tract infection</li>\n<li>upset stomach</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"3\">\n<ul class=\"Disc\">\n<li>muscle and bone pain</li>\n<li>back pain</li>\n<li>nasal allergy symptoms</li>\n<li>sore throat</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">Other side effects:</span> Worsening asthma or sudden asthma attacks have been reported with the use of inhaled mometasone furoate.<br/>Tell your healthcare provider about any side effect that bothers you or that does not go away.<br/>These are not all the side effects with ASMANEX TWISTHALER. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">General information about the safe and effective use of ASMANEX TWISTHALER.</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ASMANEX TWISTHALER for a condition for which it was not prescribed. Do not give your ASMANEX TWISTHALER to other people, even if they have the same condition that you have. It may harm them.<br/>You can ask your healthcare provider or pharmacist for information about ASMANEX TWISTHALER that was written for healthcare professionals.<br/>For more information about ASMANEX TWISTHALER go to www.ASMANEX.com or to report side effects call 1-844-674-3200.</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">What are the ingredients in ASMANEX TWISTHALER?</span>\n<br/>\n\t\t\t\t\t\t\t\t\t\tActive ingredient: mometasone furoate<br/>\n\t\t\t\t\t\t\t\t\t\tInactive ingredient: anhydrous lactose (which contains trace amounts of milk proteins).</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <tbody class="Headless"> <tr> <td align="center"> <p class="First"> <span class="Bold"> Instructions for Use</span> <br/>ASMANEX<span class="Sup">®</span> TWISTHALER<span class="Sup">®</span> (AZ-ma-neks)<br/>(mometasone furoate inhalation powder)<br/> <span class="Bold">for oral inhalation use only</span> </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\">\n<p class=\"First\">\n<span class=\"Bold\"> Instructions for Use</span>\n<br/>ASMANEX<span class=\"Sup\">®</span> TWISTHALER<span class=\"Sup\">®</span> (AZ-ma-neks)<br/>(mometasone furoate inhalation powder)<br/>\n<span class=\"Bold\">for oral inhalation use only</span>\n</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

It is important that you read this information as the ASMANEX TWISTHALER may work differently from inhalers you have used before.Read this Instructions for Use before you start using ASMANEX TWISTHALER and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

{ "type": "p", "children": [], "text": "\n\t\t\t\t\t\t\tIt is important that you read this information as the ASMANEX TWISTHALER may work differently from inhalers you have used before.Read this Instructions for Use before you start using ASMANEX TWISTHALER and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment." }

TWISTHALER Parts: See Figures A and B below to become familiar with the TWISTHALER parts.

{ "type": "p", "children": [], "text": "\nTWISTHALER Parts:\n\nSee Figures A and B below to become familiar with the TWISTHALER parts.\n" }

{ "type": "ul", "children": [ "\nRemove the ASMANEX TWISTHALER from its foil pouch and write the date on the cap label.\n" ], "text": "" }

{ "type": "ul", "children": [ "\nFollow Steps 1 and 2 below each time you inhale a dose from your ASMANEX TWISTHALER.\n" ], "text": "" }

Step 1: Open TWISTHALER

{ "type": "p", "children": [], "text": "\nStep 1: Open TWISTHALER\n" }

Hold the TWISTHALER straight up (upright position) with the colored portion (the base) on the bottom (see Figure C). It is important that you remove the cap of the TWISTHALER while it is in this upright position to make sure that you get the right amount of medicine with each dose.

{ "type": "p", "children": [], "text": "Hold the TWISTHALER straight up (upright position) with the colored portion (the base) on the bottom (see Figure C). It is important that you remove the cap of the TWISTHALER while it is in this upright position to make sure that you get the right amount of medicine with each dose." }

Holding the colored base, twist the cap in a counterclockwise direction to remove it (see Figure C). As you lift off the cap, the dose counter on the base will count down by one. Removing the cap loads the TWISTHALER with the medicine that you are now ready to inhale.

{ "type": "p", "children": [], "text": "Holding the colored base, twist the cap in a counterclockwise direction to remove it (see Figure C). As you lift off the cap, the dose counter on the base will count down by one. Removing the cap loads the TWISTHALER with the medicine that you are now ready to inhale." }

Important: The indented arrow (located on the white portion of the TWISTHALER, directly above the colored base) should now be pointing to the dose counter below. (see Figure C).

{ "type": "p", "children": [], "text": "\nImportant: The indented arrow (located on the white portion of the TWISTHALER, directly above the colored base) should now be pointing to the dose counter below. (see Figure C)." }

Step 2: Inhale dose

{ "type": "p", "children": [], "text": "\nStep 2: Inhale dose\n" }

{ "type": "ul", "children": [ "Breathe out fully.", "Bring the TWISTHALER up to your mouth or your child’s mouth with the mouthpiece facing toward you or your child.", "Place the mouthpiece in your mouth or your child’s mouth, holding it in a horizontal (on its side) position as shown below (see Figure D).", "Firmly close your lips around the mouthpiece and take in a fast, deep breath. Since the medicine is a very fine powder, you may not be able to taste, smell, or feel it after inhalation.", "\nDo not cover the ventilation holes while inhaling the dose." ], "text": "" }

Step 3: Hold breath

{ "type": "p", "children": [], "text": "\nStep 3: Hold breath\n" }

{ "type": "ul", "children": [ "Remove the TWISTHALER from your mouth and hold your breath for about 10 seconds, or as long as you comfortably can." ], "text": "" }

Important: Do not breathe out (exhale) into the TWISTHALER.

{ "type": "p", "children": [], "text": "\nImportant: Do not breathe out (exhale) into the TWISTHALER.\n\t\t\t\t\t\t" }

Step 4: Replace Cap and Close TWISTHALER

{ "type": "p", "children": [], "text": "\nStep 4: Replace Cap and Close TWISTHALER\n" }

{ "type": "ul", "children": [ "After you take your medicine, it is important that you wipe the mouthpiece dry, if needed, and then replace the cap right away, firmly closing the TWISTHALER right away (see Figures E and F)." ], "text": "" }

Be sure that the indented arrow is in line with the dose counter. Put the cap back onto the TWISTHALER and turn it in a clockwise direction, as you gently press down. You will hear a "click" to let you know that the cap is fully closed. This is the only way to be sure that your next dose is loaded the right way.

{ "type": "p", "children": [], "text": "Be sure that the indented arrow is in line with the dose counter. Put the cap back onto the TWISTHALER and turn it in a clockwise direction, as you gently press down. You will hear a \"click\" to let you know that the cap is fully closed. This is the only way to be sure that your next dose is loaded the right way." }

Step 5: Rinse mouth

{ "type": "p", "children": [], "text": "\nStep 5: Rinse mouth\n" }

{ "type": "ul", "children": [ "After using your TWISTHALER, rinse your mouth with water. Spit out the water. Do not swallow it." ], "text": "" }

How should I clean and store the ASMANEX TWISTHALER?

{ "type": "p", "children": [], "text": "\nHow should I clean and store the ASMANEX TWISTHALER?\n" }

{ "type": "ul", "children": [ "Store ASMANEX TWISTHALER at room temperature between 68°F to 77°F (20°C to 25°C).", "Keep dry. Avoid contact with liquids.", "Do not wash the ASMANEX TWISTHALER.", "Clean mouthpiece if needed by gently wiping with a dry cloth or tissue.", "Throw away the ASMANEX TWISTHALER 45 days after opening the foil pouch or when the dose counter reads “00” and you have inhaled the final dose, whichever comes first.", "\nKeep the ASMANEX TWISTHALER and all medicines out of the reach of children.\n" ], "text": "" }

How to know when the ASMANEX TWISTHALER is empty.

{ "type": "p", "children": [], "text": "\nHow to know when the ASMANEX TWISTHALER is empty.\n" }

{ "type": "ul", "children": [ "The TWISTHALER has a dose counter on the colored base, which shows the number of doses left to use.", "As you lift off the cap to take your dose, the dose counter on the base will count down by 1 (if you began with the dose counter reading “30” this will cause the dose counter to now read “29”).", "Read the numbers from top to bottom.", "When the unit reads “01” this means this is the last dose.", "After dose “01” the counter will read “00”.", "When you replace the cap, the unit will lock and then must be thrown away.", "Start using a new ASMANEX TWISTHALER as instructed by your healthcare provider." ], "text": "" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration" }

Manufactured for: Organon LLC, a subsidiary of ORGANON & Co.,Jersey City, NJ 07302, USA

{ "type": "p", "children": [], "text": "Manufactured for: Organon LLC, a subsidiary of\n\t\t\t\t\t\t\tORGANON & Co.,Jersey City, NJ 07302, USA" }

Manufactured by:MSD International GmbH (Singapore Branch)Singapore 638030, Singapore

{ "type": "p", "children": [], "text": "Manufactured by:MSD International GmbH (Singapore Branch)Singapore 638030, Singapore" }

For patent information: www.organon.com/our-solutions/patent/

{ "type": "p", "children": [], "text": "For patent information: www.organon.com/our-solutions/patent/" }

The trademarks above are owned by their respective owners.

{ "type": "p", "children": [], "text": "The trademarks above are owned by their respective owners." }

Copyright © 2021 Organon Global Inc. All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2021 Organon Global Inc.\nAll rights reserved." }

Revised: 6/2021

{ "type": "p", "children": [], "text": "Revised: 6/2021" }

usppi-og0887-pwih-2106r001

{ "type": "p", "children": [], "text": "usppi-og0887-pwih-2106r001" }

NDC 78206-114-01

{ "type": "p", "children": [], "text": "NDC 78206-114-01" }

For Oral InhalationRx only

{ "type": "p", "children": [], "text": "\nFor Oral InhalationRx only\n" }

Asmanex® Twisthaler® mometasone furoate inhalation powder 220 mcg per actuation

{ "type": "p", "children": [], "text": "\nAsmanex®\nTwisthaler®\nmometasone furoate inhalation powder\n\n220 mcg per actuation\n" }

120 Metered Doses(For more than 2 inhalations daily)

{ "type": "p", "children": [], "text": "\n120 Metered Doses(For more than 2 inhalations daily)\n" }

Discard Twisthaler inhaler 45 days afteropening foil pouch or when dose counterreads "00", whichever comes first.

{ "type": "p", "children": [], "text": "\nDiscard Twisthaler inhaler 45 days afteropening foil pouch or when dose counterreads \"00\", whichever comes first.\n" }

Attention Pharmacist: Detach Patient'sInstructions for Use and dispense with inhaler

{ "type": "p", "children": [], "text": "\nAttention Pharmacist: Detach Patient'sInstructions for Use and dispense with inhaler\n" }

NDC 78206-115-01

{ "type": "p", "children": [], "text": "NDC 78206-115-01" }

For Oral InhalationRx only

{ "type": "p", "children": [], "text": "\nFor Oral InhalationRx only\n" }

Asmanex® Twisthaler® mometasone furoate inhalation powder 110 mcg per actuation

{ "type": "p", "children": [], "text": "\nAsmanex®\nTwisthaler®\nmometasone furoate inhalation powder\n\n110 mcg per actuation\n" }

Usual Dose for 4 to 11 years of age is 110 mcg

{ "type": "p", "children": [], "text": "\nUsual Dose for 4 to 11 years of age is 110 mcg\n" }

30 Metered Doses

{ "type": "p", "children": [], "text": "\n30 Metered Doses\n" }

Discard Twisthaler inhaler 45 days afteropening foil pouch or when dose counterreads "00", whichever comes first.

{ "type": "p", "children": [], "text": "\nDiscard Twisthaler inhaler 45 days afteropening foil pouch or when dose counterreads \"00\", whichever comes first.\n" }

Attention Pharmacist: Detach Patient'sInstructions for Use and dispense with inhaler

{ "type": "p", "children": [], "text": "\nAttention Pharmacist: Detach Patient'sInstructions for Use and dispense with inhaler\n" }

SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥18 years of age who have had ethmoid sinus surgery.

{ "type": "p", "children": [], "text": "SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥18 years of age who have had ethmoid sinus surgery." }

The recommended dosage is one SINUVA Sinus Implant (1350 mcg of mometasone furoate) placed in an ethmoid sinus [see Dosage and Administration (2.3)]. The SINUVA Sinus Implant may be left in the sinus to gradually release the corticosteroid over 90 days. Remove the SINUVA Sinus Implant by 90 days or earlier at the physician's discretion [see Dosage and Administration (2.4)].

The SINUVA Sinus Implant is to be used by physicians trained in otolaryngology. Specialized training is not required for these physicians.

The SINUVA Sinus Implant is designed for single patient use only. Do not reprocess or reuse.

Patient Preparation

The patient should be prepared following routine protocols for in-office sinonasal endoscopic procedures.

Implant Preparation

The SINUVA Sinus Implant (Figure 1) is loaded into a Delivery System and placed in the ethmoid sinus.

Remove the Crimper (Figure 2) and the Delivery System (Figure 3) from their protective packaging using sterile technique. Inspect the SINUVA Sinus Implant located inside of the Crimper (Figure 2). Do not remove the Implant from the Crimper. Prior to use, the SINUVA Sinus Implant must be crimped and loaded into the Delivery System.

If the SINUVA Sinus Implant is not fully seated inside of the Crimper, secure the SINUVA Sinus Implant before proceeding. See instructions to secure the SINUVA Sinus Implant (Figure 12–15).

<div class="scrollingtable"><table width="70%"> <col align="center" valign="middle" width="40%"/> <col align="left" valign="middle" width="45%"/> <col align="center" valign="middle" width="15%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule" rowspan="2"><span class="Bold">IMPLANT</span></td><td align="left">Length (nominal):</td><td align="center" class="Rrule">20 mm</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule">Expanded Diameter (nominal):</td><td align="center" class="Rrule">34 mm</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule"><span class="Bold">DELIVERY SYSTEM</span></td><td align="left">Shaft Length</td><td align="center" class="Rrule">117 mm</td> </tr> </tbody> </table></div>

Figure 1: Implant

Figure 2: Crimper with Implant

Figure 3: Delivery System

CAUTION: Do not leave the SINUVA Sinus Implant in the crimped state for more than 5 minutes prior to placement.

Instructions to Secure the SINUVA Sinus Implant in the Crimper

If necessary, the Implant may be reloaded into the Crimper for a second time.

CAUTION: The SINUVA Sinus Implant should not be used if the second attempt to crimp is unsuccessful.

Instructions for the SINUVA Sinus Implant Placement

Advance the Delivery System under endoscopic visualization into the ethmoid sinus cavity.

Post Placement Instructions

Reposition the Implant if its ends are perpendicular to and in contact with the nasal septum. Avoid excessive manipulation of the Implant during follow-up, as this can cause dislodgement.

The SINUVA Sinus Implant is made from bioabsorbable polymers designed to gradually soften over time. Remove the SINUVA Sinus Implant by day 90 or earlier at the physician's discretion using standard endoscopic instruments.

Implant: a sterile, single-use, bioabsorbable implant, coated with a formulation containing 1350 mcg mometasone furoate that is gradually released over 90 days.

{ "type": "p", "children": [], "text": "Implant: a sterile, single-use, bioabsorbable implant, coated with a formulation containing 1350 mcg mometasone furoate that is gradually released over 90 days." }

Patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the SINUVA Sinus Implant [see Description (11)].

{ "type": "p", "children": [], "text": "Patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the SINUVA Sinus Implant [see Description (11)]." }

Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma.

Nasal steroids may result in development of glaucoma and/or cataracts. Glaucoma, cataracts, and clinically significant elevation of intraocular pressure were not observed in patients from the treatment group of one randomized controlled clinical study (N = 53) who underwent bilateral placement of SINUVA Sinus Implants. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with use of corticosteroids.

Persons who are using drugs that suppress the immune system, such as corticosteroids, including SINUVA Sinus Implant are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of SINUVA Sinus Implant have not been established in pediatric patients less than 18 years of age and SINVA is not indicated for use in this population.

The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (See the respective Prescribing Information for VZIG and IG). If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Hypercorticism and adrenal suppression were not evaluated as part of the SINUVA Sinus Implant clinical program.

Since individual sensitivity to effects of cortisol production exists, physicians should consider this information when prescribing SINUVA Sinus Implant. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in patients, particularly when systemic mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consider sinus implant removal.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of the SINUVA Sinus Implant was evaluated and demonstrated in 400 patients in 2 controlled, randomized, parallel group, single-blind studies. In Study 1, one-hundred (100) subjects were followed for 6 months. In Study 2, three-hundred (300) subjects were followed for 90 days. Of the 400 patients, 254 were assigned to the treatment group and underwent bilateral placement of SINUVA Sinus Implants in the ethmoid sinuses, totaling 2700 mcg of mometasone furoate, and 146 patients were assigned to the control group and underwent a sham procedure consisting of advancement of the Delivery System with the SINUVA Sinus Implant followed by removal without deployment. The Implants were removed by Day 60. All patients were required to use mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through Day 90.

Table 1 shows the common adverse reactions (in greater than 1% of subjects) that occurred more frequently in patients treated with SINUVA Sinus Implant compared to the control group.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1: Adverse Reactions with &gt; 1% Incidence and More Common than Control in 90-Day Controlled Clinical Trials with SINUVA Sinus Implant</span> </caption> <col align="left" valign="bottom" width="45%"/> <col align="center" valign="bottom" width="30%"/> <col align="center" valign="bottom" width="25%"/> <thead> <tr class="First"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Botrule Rrule" colspan="2">Study 1 &amp; Study 2 Combined Data</th> </tr> <tr class="Last"> <th align="center" class="Lrule Rrule">Adverse Reaction</th><th align="center" class="Rrule">Treatment <a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a> <br/>(N = 254)<br/>n (%)</th><th align="center" class="Rrule">Control <a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a> <br/>(N = 146)<br/>n (%)</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="3">Values represent patient counts and percentages. A patient reporting more than one adverse event for a particular MedDRA preferred term is counted only once. </td> </tr> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Patients in the treatment group received SINUVA Sinus Implants placed bilaterally in the ethmoid sinuses and used mometasone furoate nasal spray once daily (200 mcg mometasone furoate) through Day 90. </dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>Patients in the control group underwent a sham procedure and used mometasone furoate nasal spray once daily (200 mcg mometasone furoate) through Day 90. </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Asthma</td><td align="center" class="Rrule">12 (4.7)</td><td align="center" class="Rrule">6 (4.1)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Headache</td><td align="center" class="Rrule">9 (3.5)</td><td align="center" class="Rrule">5 (3.4)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Epistaxis</td><td align="center" class="Rrule">6 (2.4)</td><td align="center" class="Rrule">2 (1.4)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Presyncope</td><td align="center" class="Rrule">6 (2.4)</td><td align="center" class="Rrule">3 (2.1)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Bronchitis</td><td align="center" class="Rrule">5 (2.0)</td><td align="center" class="Rrule">2 (1.4)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Otitis media</td><td align="center" class="Rrule">5 (2.0)</td><td align="center" class="Rrule">2 (1.4)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Nasopharyngitis</td><td align="center" class="Rrule">3 (1.2)</td><td align="center" class="Rrule">1 (0.7)</td> </tr> </tbody> </table></div>

Study 1 monitored patients from Day 90 through 6 months. Hypersensitivity (4% (n=2) vs. 0), chronic rhinosinusitis (11% (n=6) vs. 9% (n=4)), and upper respiratory tract infections (8% (n=4) vs. 2% (n=1)) were reported in more than 2 subjects in the treatment group, and more commonly than the control group during this time period.

The safety of repeat administration of the SINUVA Sinus Implant was evaluated in Study 3 that was an open-label, single-arm, multicenter study in 50 patients. All patients underwent an in- office bilateral placement of the SINUVA Sinus Implant in each ethmoid sinus (totaling 2 implants) and were followed for 365 days. Patients were required to use mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through 365 days. At 90 days, the remaining implants were removed. To maximize the size of the safety population, patients with ethmoid sinus polyps grade ≥ 1 on any side were considered for repeat implant placement. Repeat placement was not performed if polyp grade was < 1, or if the patient declined it. Of the 50 patients, 41 received repeat implant placement (33 bilaterally and 8 unilaterally). Acute sinusitis (29%, n=12), upper respiratory infection (17%, n=7) epistaxis (12%, n=5), nasal discomfort or rhinalgia (12%, n=5), headache (7%, n=3), were the common adverse reactions that occurred in at least 3 subjects who underwent repeat placement during the study period.

The following adverse reactions have been identified during postapproval use of the SINUVA sinus implant. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to SINUVA, or a combination of these factors, include: implant migration, lack of efficacy, nasal pain, headache, epistaxis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug experience.

Co-administration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concentrations of mometasone furoate [see Clinical Pharmacology (12.3)].

Risk Summary

There are no randomized clinical studies of SINUVA Sinus Implant or mometasone furoate in pregnant women. The active pharmaceutical ingredient, mometasone furoate is systemically available when administered topically or when inhaled. In animal reproduction studies, subcutaneous administration of mometasone furoate to pregnant mice, rats, or rabbits caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis (see Data). However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at an exposure approximately one-third of the MRHD (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at an exposure approximately equivalent to the MRHD (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure approximately one-tenth of the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above).

In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 6 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at exposures approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above).

In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at an exposure that was approximately 8 times the MRHD (on an area under the curve (AUC) basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings with an exposure approximately 4 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 7.5 mcg/kg).

Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at an exposure approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at an exposure approximately 1/2 of the MRHD (on AUC basis with a maternal oral dose of 700 mcg/kg). At an exposure approximately 2 times the MRHD (on an AUC basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. No effects were observed at an exposure approximately 1/10 of the MRHD (on an AUC basis with a maternal oral dose of 140 mcg/kg).

Risk Summary

There are no available data on the presence of SINUVA Sinus Implant in human milk, the effects on the breastfed child or the effects on milk production. Systemic absorption of a single inhaled 400 mcg mometasone dose was less than 1%. It is not known if mometasone furoate is excreted in human milk. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the SINUVA Sinus Implant and any potential adverse effects on the breastfed infant from the SINUVA Sinus Implant.

The safety and effectiveness of the SINUVA Sinus Implant have not been established in pediatric patients less than 18 years of age.

A total of 33 patients 65 years of age or older received the SINUVA Sinus Implant in 2 controlled randomized clinical trials. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3)].

There are no data available on the effects of acute or chronic overdosage with SINUVA Sinus Implant. Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "There are no data available on the effects of acute or chronic overdosage with SINUVA Sinus Implant. Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]." }

The SINUVA Sinus Implant is a self-expanding, bioabsorbable, drug eluting implant provided with a crimper and a single-use delivery system. SINUVA Sinus Implant is comprised of poly(L-lactide-co-glycolide) and poly(L-lactide-co-⃞-caprolactone) coated with mometasone furoate embedded in a bioabsorbable polymer matrix containing poly(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides for gradual release of the drug. The SINUVA Sinus Implant is packaged in a tray, which is then sealed in a foil pouch and placed in the product carton. The SINUVA Sinus Implant is provided sterile.

{ "type": "p", "children": [], "text": "The SINUVA Sinus Implant is a self-expanding, bioabsorbable, drug eluting implant provided with a crimper and a single-use delivery system. SINUVA Sinus Implant is comprised of poly(L-lactide-co-glycolide) and poly(L-lactide-co-⃞-caprolactone) coated with mometasone furoate embedded in a bioabsorbable polymer matrix containing poly(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides for gradual release of the drug. The SINUVA Sinus Implant is packaged in a tray, which is then sealed in a foil pouch and placed in the product carton. The SINUVA Sinus Implant is provided sterile." }

Mometasone furoate, the active component of the SINUVA Sinus Implant, is a corticosteroid with the chemical name 9,21-dichloro-11(⃞),17-dihydroxy-16(⃞)-methylpregna-1,4-diene-3,20- dione 17 (2-furoate). Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons.

{ "type": "p", "children": [], "text": "Mometasone furoate, the active component of the SINUVA Sinus Implant, is a corticosteroid with the chemical name 9,21-dichloro-11(⃞),17-dihydroxy-16(⃞)-methylpregna-1,4-diene-3,20- dione 17 (2-furoate). Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons." }

The chemical structure of mometasone furoate is shown below:

{ "type": "p", "children": [], "text": "The chemical structure of mometasone furoate is shown below:" }

The inactive ingredients are poly-(DL-lactide-co-glycolide) and polyethylene glycol. Poly-(DL-lactide-co-glycolide) is an amorphous biodegradable polymer.

{ "type": "p", "children": [], "text": "The inactive ingredients are poly-(DL-lactide-co-glycolide) and polyethylene glycol. Poly-(DL-lactide-co-glycolide) is an amorphous biodegradable polymer." }

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on inflammation is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

Adrenal Function

The effects of the SINUVA Sinus Implant on adrenal function have not been evaluated in clinical studies.

One pharmacokinetics study was conducted with the SINUVA Sinus Implant. The remaining information is from other products containing mometasone furoate.

Absorption

A pharmacokinetics study was conducted to evaluate the potential for systemic exposure to mometasone furoate from the sinonasal route of administration following bilateral placement of the SINUVA Sinus Implant. Baseline blood samples were taken before the procedure, and on Days 3, 7, 14, 21 and 30 to assess systemic concentrations of mometasone furoate in plasma. Six out of fifteen PK samples from five subjects had measurable mometasone furoate plasma concentrations from Day 3 to Day 14. All the measurable concentrations were within 2.5-fold of the lower limit of quantitation (LLOQ; 30 pg/mL). No PK samples had measurable mometasone furoate plasma concentrations after Day 14.

Distribution

Following an intravenous 400 mcg dose of mometasone furoate, the mean steady state volume of distribution was 152 L. The in vitro protein binding for mometasone furoate was reported to be 98% to 99% (in concentration range of 5 to 500 ng/mL).

Elimination

Metabolism

Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of CYP 3A4 in the metabolism of this compound; however, no major metabolites were identified.

Excretion

Following intravenous dosing, the terminal half-life was reported to be about 5 hours.

Specific Populations

The effects of renal impairment, hepatic impairment, age, or gender on mometasone furoate pharmacokinetics have not been adequately investigated.

Drug Interaction Studies

Formal drug-drug interaction studies have not been conducted with the SINUVA Sinus Implant.

In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 14 times the MRHD on an AUC basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 9 times the MRHD on an AUC basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not have this effect in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (approximately 8 times the MRHD on an AUC basis).

The SINUVA Sinus Implant was evaluated in 450 patients, 18 years of age and older, with chronic rhinosinusitis with nasal polyps and a history of ethmoid sinus surgery. The development program included a trial of 6 months duration (Study 1: NCT01732536), another trial of 90 days duration (Study 2: NCT02291549), and a repeat placement study of 1-year duration (Study 3: NCT03358329) [see Adverse Reactions (6.1)]. The efficacy of SINUVA Sinus Implant is based primarily on Study 2 as described below.

{ "type": "p", "children": [], "text": "The SINUVA Sinus Implant was evaluated in 450 patients, 18 years of age and older, with chronic rhinosinusitis with nasal polyps and a history of ethmoid sinus surgery. The development program included a trial of 6 months duration (Study 1: NCT01732536), another trial of 90 days duration (Study 2: NCT02291549), and a repeat placement study of 1-year duration (Study 3: NCT03358329) [see Adverse Reactions (6.1)]. The efficacy of SINUVA Sinus Implant is based primarily on Study 2 as described below." }

Study 2 was a randomized, controlled, single-blind, multicenter (all sites were in the US) study with 300 patients: 201 patients were assigned to the treatment group and underwent bilateral placement of the SINUVA Sinus Implants in the ethmoid sinuses. The remaining 99 patients were assigned to the control group and underwent a placebo (sham) procedure, consisting of advancement of the Delivery System with the SINUVA Sinus Implant into the ethmoid sinuses, followed by removal of the Delivery System without deployment of the SINUVA Sinus Implant. The Implants were removed by Day 60 to allow blinded grading at Day 90. All patients [treatment (T) and control (C) groups] were required to use a mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through Day 90.

{ "type": "p", "children": [], "text": "Study 2 was a randomized, controlled, single-blind, multicenter (all sites were in the US) study with 300 patients: 201 patients were assigned to the treatment group and underwent bilateral placement of the SINUVA Sinus Implants in the ethmoid sinuses. The remaining 99 patients were assigned to the control group and underwent a placebo (sham) procedure, consisting of advancement of the Delivery System with the SINUVA Sinus Implant into the ethmoid sinuses, followed by removal of the Delivery System without deployment of the SINUVA Sinus Implant. The Implants were removed by Day 60 to allow blinded grading at Day 90. All patients [treatment (T) and control (C) groups] were required to use a mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through Day 90." }

The co-primary efficacy endpoints were:

{ "type": "p", "children": [], "text": "The co-primary efficacy endpoints were:" }

{ "type": "ul", "children": [ "Change from baseline to Day 30 in Nasal Obstruction/Congestion score, as determined by patients using a daily diary; and", "Change from baseline to Day 90 in bilateral polyp grade, as determined from video- endoscopies reviewed by an independent panel of 3 sinus surgeons who were masked to treatment assignment." ], "text": "" }

The study population consisted of adult patients (≥ 18 years of age) diagnosed with chronic rhinosinusitis who had undergone prior bilateral total ethmoidectomy but were indicated for revision endoscopic sinus surgery because they presented with recurrent nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to nasal polyps. Subjects were excluded for other grade 3 or 4 adhesions/synechiae, grade 4 polyps, acute bacterial or invasive fungal sinusitis, and immune deficiency, including cystic fibrosis. There were no statistically significant differences between groups in baseline demographics and clinical characteristics, except the treatment group had a higher proportion of asthma patients (T: 74% vs. C: 62%) and higher mean Percent Ethmoid Sinus Obstruction score [T: 76 (SD 17.4) vs. C: 69 (SD 19.9)]. The random imbalances did not impact treatment effect.

{ "type": "p", "children": [], "text": "The study population consisted of adult patients (≥ 18 years of age) diagnosed with chronic rhinosinusitis who had undergone prior bilateral total ethmoidectomy but were indicated for revision endoscopic sinus surgery because they presented with recurrent nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to nasal polyps. Subjects were excluded for other grade 3 or 4 adhesions/synechiae, grade 4 polyps, acute bacterial or invasive fungal sinusitis, and immune deficiency, including cystic fibrosis. There were no statistically significant differences between groups in baseline demographics and clinical characteristics, except the treatment group had a higher proportion of asthma patients (T: 74% vs. C: 62%) and higher mean Percent Ethmoid Sinus Obstruction score [T: 76 (SD 17.4) vs. C: 69 (SD 19.9)]. The random imbalances did not impact treatment effect." }

The co-primary efficacy results are presented in Table 2. The treatment group demonstrated a statistically significant difference from baseline to Day 30 in Nasal Obstruction/Congestion score and from baseline to Day 90 in bilateral polyp grade, compared to the control group.

{ "type": "p", "children": [], "text": "The co-primary efficacy results are presented in Table 2. The treatment group demonstrated a statistically significant difference from baseline to Day 30 in Nasal Obstruction/Congestion score and from baseline to Day 90 in bilateral polyp grade, compared to the control group." }

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 2: Co-Primary Efficacy Results with the SINUVA Sinus Implant (Study 2)</span> </caption> <col align="right" valign="top" width="30%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="30%"/> <col align="center" valign="top" width="20%"/> <thead> <tr class="First Last"> <th align="right" class="Lrule Rrule" colspan="2"></th><th align="center" class="Rrule">Treatment<br/>(N = 201)</th><th align="center" class="Rrule">Control<br/>(N = 99)</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-3" name="footnote-3">*</a> </dt> <dd>Change from baseline in Nasal Obstruction/Congestion was assessed on a scale of 0–3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. Scores were assessed using a daily diary for 7 days immediately preceding the baseline and Day 30 visits. </dd> <dt> <a href="#footnote-reference-4" name="footnote-4">†</a> </dt> <dd>Based on analysis of covariance (ANCOVA) model with baseline value as a covariate and site and treatment group as fixed effects. </dd> <dt> <a href="#footnote-reference-5" name="footnote-5">‡</a> </dt> <dd>c) Change from baseline to Day 90 in bilateral polyp grade was assessed based on grading of video-endoscopies by an independent panel of 3 sinus surgeons who were blinded to treatment assignment. Polyps were graded as follows: 0=no visible polyps, 1=Small amount of polyps confined in middle meatus, 1.5= 1+ polypoid edema obstructing ≥ 25% of the ethmoid sinus cavity, 2=Expanded amount of polyps confined in middle meatus, 2.5 = 2 + polypoid edema obstructing ≥ 50% of the ethmoid sinus cavity, 3= Polyps extending beyond middle meatus, but not totally obstructing the nasal cavity, 3.5= 3 + polypoid edema obstructing ≥ 75% of the ethmoid sinus cavity, 4= Polyps completely obstructing the nasal cavity.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">Nasal Obstruction/Congestion Score<a class="Sup" href="#footnote-3" name="footnote-reference-3">*</a></span></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2">N</td><td align="center" class="Rrule">201</td><td align="center" class="Rrule">99</td> </tr> <tr class="Botrule"> <td align="right" class="Lrule">Baseline, Mean (SD)</td><td align="center" class="Rrule"></td><td align="center" class="Rrule">2.36 (0.49)</td><td align="center" class="Rrule">2.35 (0.48)</td> </tr> <tr class="Botrule"> <td align="right" class="Lrule">Change from Baseline, Mean (SD)</td><td align="center" class="Rrule"></td><td align="center" class="Rrule">-0.80 (0.73)</td><td align="center" class="Rrule">-0.56 (0.62)</td> </tr> <tr class="Botrule"> <td align="right" class="Lrule">Difference vs. Control (95% CI)<a class="Sup" href="#footnote-4" name="footnote-reference-4">†</a></td><td align="center" class="Rrule"></td><td align="center" class="Rrule">-0.23 (-0.39, -0.06)</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="4"><span class="Bold">Bilateral Polyp Grade<a class="Sup" href="#footnote-5" name="footnote-reference-5">‡</a></span></td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule" colspan="2">N</td><td align="center" class="Rrule">195</td><td align="center" class="Rrule">97</td> </tr> <tr class="Botrule"> <td align="right" class="Lrule">Baseline, Mean (SD)</td><td align="center" class="Rrule"></td><td align="center" class="Rrule">5.48 (1.13)</td><td align="center" class="Rrule">5.43 (1.01)</td> </tr> <tr class="Botrule"> <td align="right" class="Lrule">Change from Baseline, Mean (SD)</td><td align="center" class="Rrule"></td><td align="center" class="Rrule">-0.56 (1.06)</td><td align="center" class="Rrule">-0.15 (0.91)</td> </tr> <tr class="Last"> <td align="right" class="Lrule">Difference vs. Control (95% CI)<a class="Sup" href="#footnote-4">†</a></td><td align="center" class="Rrule"></td><td align="center" class="Rrule">-0.35 (-0.60, -0.09)</td><td align="center" class="Rrule"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"85%\">\n<caption>\n<span>Table 2:\tCo-Primary Efficacy Results with the SINUVA Sinus Implant (Study 2)</span>\n</caption>\n<col align=\"right\" valign=\"top\" width=\"30%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<col align=\"center\" valign=\"top\" width=\"30%\"/>\n<col align=\"center\" valign=\"top\" width=\"20%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"right\" class=\"Lrule Rrule\" colspan=\"2\"></th><th align=\"center\" class=\"Rrule\">Treatment<br/>(N = 201)</th><th align=\"center\" class=\"Rrule\">Control<br/>(N = 99)</th>\n</tr>\n</thead>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"4\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-3\" name=\"footnote-3\">*</a>\n</dt>\n<dd>Change from baseline in Nasal Obstruction/Congestion was assessed on a scale of 0–3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. Scores were assessed using a daily diary for 7 days immediately preceding the baseline and Day 30 visits. </dd>\n<dt>\n<a href=\"#footnote-reference-4\" name=\"footnote-4\">†</a>\n</dt>\n<dd>Based on analysis of covariance (ANCOVA) model with baseline value as a covariate and site and treatment group as fixed effects. </dd>\n<dt>\n<a href=\"#footnote-reference-5\" name=\"footnote-5\">‡</a>\n</dt>\n<dd>c)\tChange from baseline to Day 90 in bilateral polyp grade was assessed based on grading of video-endoscopies by an independent panel of 3 sinus surgeons who were blinded to treatment assignment. Polyps were graded as follows: 0=no visible polyps, 1=Small amount of polyps confined in middle meatus, 1.5= 1+ polypoid edema obstructing ≥ 25% of the ethmoid sinus cavity, 2=Expanded amount of polyps confined in middle meatus, 2.5 = 2 + polypoid edema obstructing ≥ 50% of the ethmoid sinus cavity, 3= Polyps extending beyond middle meatus, but not totally obstructing the nasal cavity, 3.5= 3 + polypoid edema obstructing ≥ 75% of the ethmoid sinus cavity, 4= Polyps completely obstructing the nasal cavity.</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\"><span class=\"Bold\">Nasal Obstruction/Congestion Score<a class=\"Sup\" href=\"#footnote-3\" name=\"footnote-reference-3\">*</a></span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\">N</td><td align=\"center\" class=\"Rrule\">201</td><td align=\"center\" class=\"Rrule\">99</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"right\" class=\"Lrule\">Baseline, Mean (SD)</td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\">2.36 (0.49)</td><td align=\"center\" class=\"Rrule\">2.35 (0.48)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"right\" class=\"Lrule\">Change from Baseline, Mean (SD)</td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\">-0.80 (0.73)</td><td align=\"center\" class=\"Rrule\">-0.56 (0.62)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"right\" class=\"Lrule\">Difference vs. Control (95% CI)<a class=\"Sup\" href=\"#footnote-4\" name=\"footnote-reference-4\">†</a></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\">-0.23 (-0.39, -0.06)</td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"4\"><span class=\"Bold\">Bilateral Polyp Grade<a class=\"Sup\" href=\"#footnote-5\" name=\"footnote-reference-5\">‡</a></span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\">N</td><td align=\"center\" class=\"Rrule\">195</td><td align=\"center\" class=\"Rrule\">97</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"right\" class=\"Lrule\">Baseline, Mean (SD)</td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\">5.48 (1.13)</td><td align=\"center\" class=\"Rrule\">5.43 (1.01)</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"right\" class=\"Lrule\">Change from Baseline, Mean (SD)</td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\">-0.56 (1.06)</td><td align=\"center\" class=\"Rrule\">-0.15 (0.91)</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"right\" class=\"Lrule\">Difference vs. Control (95% CI)<a class=\"Sup\" href=\"#footnote-4\">†</a></td><td align=\"center\" class=\"Rrule\"></td><td align=\"center\" class=\"Rrule\">-0.35 (-0.60, -0.09)</td><td align=\"center\" class=\"Rrule\"></td>\n</tr>\n</tbody>\n</table></div>" }

Change from baseline to Day 90 in the mean Percent Ethmoid Sinus Obstruction score (100 mm VAS), as judged by the independent panel [Difference vs. control: -7.96%; 95% CI (-12.1, -3.8)], met statistical significance and supported the co-primary endpoints.

{ "type": "p", "children": [], "text": "Change from baseline to Day 90 in the mean Percent Ethmoid Sinus Obstruction score (100 mm VAS), as judged by the independent panel [Difference vs. control: -7.96%; 95% CI (-12.1, -3.8)], met statistical significance and supported the co-primary endpoints." }

Store the SINUVA Sinus Implant at 20° C– 25°C (68°F–77°F); excursions permitted at 15°C –30°C (59°F– 86°F) [see USP Controlled Room Temperature].

The NDC code for the SINUVA Sinus Implant is 10599-003-01.

Risks Relating to the Insertion and Removal Procedure

Inform patients that there are risks associated with the insertion and removal of the SINUVA Sinus Implant. These risks are similar to those associated with other endoscopic sinus procedures.

Local Nasal Adverse Reactions

Patients should be informed that treatment with the SINUVA Sinus Implant may be associated with local adverse reactions such as nose-bleed (epistaxis), injury to nerves or blood vessels of the middle turbinate or septum, bacterial or candida infection. Because of the potential inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, pruritus, and angioedema, have been reported with use of mometasone furoate. Remove the SINUVA Sinus Implant if such reactions occur [see Contraindications (4), Warnings and Precautions (5.3), and Adverse Reactions (6)].

Immunosuppression and Risk of Infections

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

This product and/or the use of this product in a method may be covered by one or more patents or patent applications, available at www.sinuva.com

{ "type": "p", "children": [], "text": "This product and/or the use of this product in a method may be covered by one or more patents or patent applications, available at www.sinuva.com" }

© 2020 Intersect ENT, Inc. All rights reserved. INTERSECT ENT and SINUVA are trademarks or registered trademarks of Intersect ENT, Inc.

{ "type": "p", "children": [], "text": "© 2020 Intersect ENT, Inc. All rights reserved. INTERSECT ENT and SINUVA are trademarks or registered trademarks of Intersect ENT, Inc." }

Manufactured by:Intersect ENT1555 Adams Dr. Menlo Park, CA 94025

{ "type": "p", "children": [], "text": "Manufactured by:Intersect ENT1555 Adams Dr. Menlo Park, CA 94025" }

SINUVA™ (mometasone furoate) sinus implant

{ "type": "p", "children": [], "text": "\nSINUVA™\n(mometasone furoate) sinus implant\n" }

Mometasone furoate topical solution USP, 0.1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.

{ "type": "p", "children": [], "text": "Mometasone furoate topical solution USP, 0.1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older." }

Apply a few drops of mometasone furoate lotion to the affected skin areas once daily and massage lightly until it disappears. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]. Do not use mometasone furoate lotion with occlusive dressings unless directed by a physician. Do not apply mometasone furoate lotion in the diaper area if the patient requires diapers or plastic pants, as these garments may constitute occlusive dressing. Mometasone furoate lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application.

{ "type": "p", "children": [], "text": "Apply a few drops of mometasone furoate lotion to the affected skin areas once daily and massage lightly until it disappears. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]. Do not use mometasone furoate lotion with occlusive dressings unless directed by a physician. Do not apply mometasone furoate lotion in the diaper area if the patient requires diapers or plastic pants, as these garments may constitute occlusive dressing. Mometasone furoate lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application." }

Lotion, 0.1%. Each gram of mometasone furoate lotion contains 1 mg of mometasone furoate in a colorless, clear to translucent lotion base.

{ "type": "p", "children": [], "text": "Lotion, 0.1%. Each gram of mometasone furoate lotion contains 1 mg of mometasone furoate in a colorless, clear to translucent lotion base." }

Mometasone furoate lotion is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

{ "type": "p", "children": [], "text": "Mometasone furoate lotion is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation." }

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure and young age.Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.In a study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].    

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [see Adverse Reactions (6.2)]. Avoid contact of Mometasone furoate lotion with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

If irritation develops, mometasone furoate lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate lotion should be discontinued until the infection has been adequately controlled.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.In clinical trials involving 209 subjects, the incidence of adverse reactions associated with the use of mometasone furoate lotion was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate lotion during a clinical trial in 14% of 65 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 subjects treated with mometasone furoate lotion in a clinical observed among 65 subjects treated with mometasone furoate lotion in a clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3.

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings. Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

No drug-drug interaction studies have been conducted with mometasone furoate lotion.

{ "type": "p", "children": [], "text": "No drug-drug interaction studies have been conducted with mometasone furoate lotion." }

Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate lotion is administered to a nursing woman.

Since safety and efficacy of mometasone furoate lotion have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.Mometasone furoate lotion caused HPA axis suppression in approximately 29% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute poststimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2)].Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone furoate lotion should not be used in the treatment of diaper dermatitis.

Clinical trials of mometasone furoate lotion did no include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.

Topically applied mometasone furoate lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Topically applied mometasone furoate lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]." }

Mometasone furoate topical solution USP, 0.1% (lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene- 3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:

{ "type": "p", "children": [], "text": "Mometasone furoate topical solution USP, 0.1% (lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene- 3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:" }

Mometasone furoate is a white to off-white powder Soluble in acetone and methylene chloride. Each gram of mometasone furoate topical solution USP, 0.1% (lotion) contains 1 mg mometasone furoate in a colorless, clear to light haziness lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5.

{ "type": "p", "children": [], "text": "Mometasone furoate is a white to off-white powder Soluble in acetone and methylene chloride. Each gram of mometasone furoate topical solution USP, 0.1% (lotion) contains 1 mg mometasone furoate in a colorless, clear to light haziness lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5." }

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Studies performed with mometasone furoate lotion indicate that it is in the medium range of potency as compared with other topical corticosteroids.

In a study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline [see Warnings and Precautions (5.1)]. Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open label, HPA axis safety trial. Mometasone furoate lotion was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16%-90%). In approximately 29% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate lotion. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute poststimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria [see Use in Specific Populations (8.4)].

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate ointment enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis).Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis).

The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12 to 95 years) received mometasone furoate lotion (205 subjects) or the vehicle lotion applied once daily for 21 days.

{ "type": "p", "children": [], "text": "The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12 to 95 years) received mometasone furoate lotion (205 subjects) or the vehicle lotion applied once daily for 21 days." }

Mometasone furoate topical solution USP, 0.1% (lotion) is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 21922-072-21) and 60-mL (55 gram) (NDC 21922-072-01) bottles; boxes of one.

{ "type": "p", "children": [], "text": "Mometasone furoate topical solution USP, 0.1% (lotion) is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 21922-072-21) and 60-mL (55 gram) (NDC 21922-072-01) bottles; boxes of one." }

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]." }

Advise the patient to read the FDA-approved patient labeling (Patient Information).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information)." }

Inform patients of the following: • Use mometasone furoate lotion as directed by the physician. It is for external use only. • Avoid contact with the eyes. • Advise patients to report any visual symptoms to their healthcare providers. • Do not use mometasone furoate lotion on the face, underarms, or groin areas. • Do not use mometasone furoate lotion for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician. • Report any signs of local adverse reactions to the physician. • Advise patients not to use mometasone furoate lotion in the treatment of diaper dermatitis. Do not apply mometasone furoate lotion in the diaper area, as diapers or plastic pants may constitute occlusive dressing. • Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Do not use other corticosteroid-containing products with mometasone furoate lotion without first consulting with the physician.

{ "type": "p", "children": [], "text": "Inform patients of the following: • Use mometasone furoate lotion as directed by the physician. It is for external use only. • Avoid contact with the eyes. • Advise patients to report any visual symptoms to their healthcare providers. • Do not use mometasone furoate lotion on the face, underarms, or groin areas. • Do not use mometasone furoate lotion for any disorder other than that for which it was prescribed. • Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician. • Report any signs of local adverse reactions to the physician. • Advise patients not to use mometasone furoate lotion in the treatment of diaper dermatitis. Do not apply mometasone furoate lotion in the diaper area, as diapers or plastic pants may constitute occlusive dressing. • Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Do not use other corticosteroid-containing products with mometasone furoate lotion without first consulting with the physician." }

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.

{ "type": "p", "children": [], "text": "Manufactured by:\nEncube Ethicals Pvt. Ltd.\nPlot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India." }

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA

{ "type": "p", "children": [], "text": "Distributed by:\nEncube Ethicals, Inc.\n 200 Meredith Drive, Suite 202 Durham, NC 27713 USA" }

Revised:12/2024

{ "type": "p", "children": [], "text": "\nRevised:12/2024\n" }

Mometasone Furoat Topical Solution USP, 0.1% (lotion) (moe met' a sone fure' oh ate) Important information: Mometasone furoate lotion is for use on skin only. Do not use Mometasone furoate lotion in your eyes, mouth, or vagina. What is mometasone furoate lotion?• Mometasone furoate lotion is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 12 years of age and older. • It is not known if mometasone furoate lotion is safe and effective for use in children under 12 years of age. • Mometasone furoate lotion should not be used in children under 12 years of age. Do not use mometasone furoate lotion if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate lotion. See the end of this leaflet for a complete list of ingredients in mometasone furoate lotion.Before using mometasone furoate lotion, tell your healthcare provider about all your medical conditions, including if you: • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • are pregnant or plan to become pregnant. It is not known if mometasone furoate lotion will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if mometasone furoate lotion passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. How should I use mometasone furoate lotion? • Use mometasone furoate lotion exactly as your healthcare provider tells you to use it.• Apply a few drops of mometasone furoate lotion to the affected skin area 1 time each day and rub it in lightly until it disappears. • Use mometasone furoate lotion until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. • Do not bandage, cover, or wrap the treated skin area unless your health care provider tells you to. • Mometasone furoate lotion should not be used to treat diaper rash or redness. Avoid using mometasone furoate lotion in the diaper area if wearing diapers or plastic pants. • Avoid using mometasone furoate lotion the face, groin, or underarms (armpits). • Wash your hands after applying mometasone furoate lotion.

{ "type": "p", "children": [], "text": "\nMometasone Furoat Topical Solution USP, 0.1% (lotion) (moe met' a sone fure' oh ate) Important information: Mometasone furoate lotion is for use on skin only. Do not use Mometasone furoate lotion in your eyes, mouth, or vagina. What is mometasone furoate lotion?• Mometasone furoate lotion is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 12 years of age and older. • It is not known if mometasone furoate lotion is safe and effective for use in children under 12 years of age. • Mometasone furoate lotion should not be used in children under 12 years of age.\nDo not use mometasone furoate lotion if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate lotion. See the end of this leaflet for a complete list of ingredients in mometasone furoate lotion.Before using mometasone furoate lotion, tell your healthcare provider about all your medical conditions, including if you: • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • are pregnant or plan to become pregnant. It is not known if mometasone furoate lotion will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if mometasone furoate lotion passes into your breast milk.\nTell your healthcare provider about all the medicines you take,\n including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.\nHow should I use mometasone furoate lotion?\n• Use mometasone furoate lotion exactly as your healthcare provider tells you to use it.• Apply a few drops of mometasone furoate lotion to the affected skin area 1 time each day and rub it in lightly until it disappears. • Use mometasone furoate lotion until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. • Do not bandage, cover, or wrap the treated skin area unless your health care provider tells you to. • Mometasone furoate lotion should not be used to treat diaper rash or redness. Avoid using mometasone furoate lotion in the diaper area if wearing diapers or plastic pants. • Avoid using mometasone furoate lotion the face, groin, or underarms (armpits). • Wash your hands after applying mometasone furoate lotion." }

What are the possible side effects of mometasone furoate lotion? Mometasone furoate lotion may cause serious side effects, including:

{ "type": "p", "children": [], "text": "What are the possible side effects of mometasone furoate lotion? Mometasone furoate lotion may cause serious side effects, including:" }

• Mometasone furoate lotion can pass through your skin. Too much mometasone furoate lotion passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.

{ "type": "p", "children": [], "text": "• Mometasone furoate lotion can pass through your skin. Too much mometasone furoate lotion passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems." }

• Vision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate lotion.

{ "type": "p", "children": [], "text": "• Vision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate lotion." }

• Skin problems. Skin problems may happen during treatment with mometasone furoate lotion, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate lotion and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate lotion.

{ "type": "p", "children": [], "text": "• Skin problems. Skin problems may happen during treatment with mometasone furoate lotion, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate lotion and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate lotion." }

The most common side effects of mometasone furoate lotion include buring, itching, and inflammation of the hair follicle (folliculitis). These are not all the possible side effects of mometasone furoate lotion. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "\nThe most common side effects of mometasone furoate lotion include buring, itching, and inflammation of the hair follicle (folliculitis). These are not all the possible side effects of mometasone furoate lotion. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." }

How should I store mometasone furoate lotion? • Store mometasone furoate lotion at room temperature between 68°F to 77°F (20°C to 25°C). • Keep mometasone furoate lotion and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "How should I store mometasone furoate lotion? • Store mometasone furoate lotion at room temperature between 68°F to 77°F (20°C to 25°C). • Keep mometasone furoate lotion and all medicines out of the reach of children." }

General information about the safe and effective use of mometasone furoate lotion. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate lotion for a condition for which it was not prescribed. Do not give mometasone furoate lotion to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate lotion that is written for health professionals.

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of mometasone furoate lotion.\nMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate lotion for a condition for which it was not prescribed. Do not give mometasone furoate lotion to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate lotion that is written for health professionals." }

What are the ingredients in mometasone furoate lotion? Active ingredient: mometasone furoate Inactive ingredients: hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5.

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in mometasone furoate lotion? Active ingredient: mometasone furoate\nInactive ingredients: hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5." }

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.

{ "type": "p", "children": [], "text": "Manufactured by:\nEncube Ethicals Pvt. Ltd.\nPlot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India." }

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA

{ "type": "p", "children": [], "text": "Distributed by:\nEncube Ethicals, Inc.\n 200 Meredith Drive, Suite 202 Durham, NC 27713 USA" }

Revised:12/2024

{ "type": "p", "children": [], "text": "\nRevised:12/2024\n" }

Carton - 30ml

{ "type": "p", "children": [], "text": "Carton - 30ml" }

NDC 21922-072-21

{ "type": "p", "children": [], "text": "NDC 21922-072-21" }

For dermatologic use only. Not for ophthalmic use.

{ "type": "p", "children": [], "text": "For dermatologic use only. Not for ophthalmic use.\n" }

Rx Only 

{ "type": "p", "children": [], "text": "\n Rx Only \n" }

30ml (27.5g)

{ "type": "p", "children": [], "text": "30ml (27.5g)" }

Carton - 60ml

{ "type": "p", "children": [], "text": "Carton - 60ml" }

NDC 21922-072-01

{ "type": "p", "children": [], "text": "NDC 21922-072-01" }

For dermatologic use only. Not for ophthalmic use.

{ "type": "p", "children": [], "text": "For dermatologic use only. Not for ophthalmic use.\n" }

Rx Only 

{ "type": "p", "children": [], "text": "\n Rx Only \n" }

60ml (55g)

{ "type": "p", "children": [], "text": "60ml (55g)" }

Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.

{ "type": "p", "children": [], "text": "Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older." }

Apply a thin film of mometasone furoate cream to the affected skin areas once daily. Mometasone furoate cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)] .

{ "type": "p", "children": [], "text": "Apply a thin film of mometasone furoate cream to the affected skin areas once daily. Mometasone furoate cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)] . " }

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)] .

{ "type": "p", "children": [], "text": "Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)] . " }

Do not use mometasone furoate cream with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

{ "type": "p", "children": [], "text": "Do not use mometasone furoate cream with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing." }

Avoid contact with eyes. Wash hands after each application.

{ "type": "p", "children": [], "text": "Avoid contact with eyes. Wash hands after each application." }

Avoid use on the face, groin, or axillae.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae." }

Mometasone furoate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "Mometasone furoate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use." }

Cream, 0.1%. Each gram of mometasone furoate cream contains 1 mg of mometasone furoate in a white to off-white cream base.

{ "type": "p", "children": [], "text": "Cream, 0.1%. Each gram of mometasone furoate cream contains 1 mg of mometasone furoate in a white to off-white cream base." }

Mometasone furoate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

{ "type": "p", "children": [], "text": "Mometasone furoate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation." }

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.

If HPA axis suppression is noted, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)] .

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroids, including the topical mometasone products [see Adverse Reactions (6.2)] .

Avoid contact of mometasone furoate cream with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

If irritation develops, mometasone furoate cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate cream should be discontinued until the infection has been adequately controlled.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.

The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with mometasone furoate cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.

Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

No drug-drug interaction studies have been conducted with mometasone furoate cream.

{ "type": "p", "children": [], "text": "No drug-drug interaction studies have been conducted with mometasone furoate cream." }

Teratogenic Effects:

There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20 mcg/kg, 60 mcg/kg, and 180 mcg/kg in the mouse are approximately 0.01 times, 0.02 times, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 mcg/kg and 600 mcg/kg in the rat are approximately 0.2 times and 0.4 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis.)

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140 mcg/kg, 700 mcg/kg, and 2800 mcg/kg in the rabbit are approximately 0.2 times, 0.9 times, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 mcg/kg and 15 mcg/kg in the rat are approximately 0.005 times and 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis.)

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate cream is administered to a nursing woman.

Mometasone furoate cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.

In a pediatric trial, 24 atopic dermatitis subjects, of whom 19 subjects were age 2 to 12 years, were treated with mometasone furoate cream once daily. The majority of subjects cleared within 3 weeks.

Mometasone furoate cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Mometasone furoate cream should not be used in the treatment of diaper dermatitis.

Clinical studies of mometasone furoate cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Topically applied mometasone furoate cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)] .

{ "type": "p", "children": [], "text": "Topically applied mometasone furoate cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)] . " }

Mometasone Furoate Cream USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.

{ "type": "p", "children": [], "text": "Mometasone Furoate Cream USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity." }

Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.4 and the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.4 and the following structural formula: " }

Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.

{ "type": "p", "children": [], "text": "Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol." }

Each gram of Mometasone Furoate Cream USP, 0.1% contains 1 mg mometasone furoate in a white to off-white cream base of aluminum starch octenylsuccinate, ceteareth-20, phosphoric acid, propylene glycol, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum and white wax.

{ "type": "p", "children": [], "text": "Each gram of Mometasone Furoate Cream USP, 0.1% contains 1 mg mometasone furoate in a white to off-white cream base of aluminum starch octenylsuccinate, ceteareth-20, phosphoric acid, propylene glycol, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum and white wax." }

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2.

Studies performed with mometasone furoate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.

In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The cream was applied without occlusion to at least 30% of the body surface. The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion [see Warnings and Precautions (5.1)] .

Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. Mometasone furoate cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate cream. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations (8.4)] .

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.4% of the applied dose of mometasone furoate cream enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate cream. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis).

Mometasone furoate increased chromosomal aberrations in an in vitroChinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitroChinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivomouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivoin rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2basis).

The safety and efficacy of mometasone furoate cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total of 366 subjects (12 to 81 years of age), of whom 177 received mometasone furoate cream and 181 subjects received vehicle cream, were evaluated in these trials. Mometasone furoate cream or the vehicle cream were applied once daily for 21 days. The two trials showed mometasone furoate cream is effective in the treatment of psoriasis and atopic dermatitis.

{ "type": "p", "children": [], "text": "The safety and efficacy of mometasone furoate cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total of 366 subjects (12 to 81 years of age), of whom 177 received mometasone furoate cream and 181 subjects received vehicle cream, were evaluated in these trials. Mometasone furoate cream or the vehicle cream were applied once daily for 21 days. The two trials showed mometasone furoate cream is effective in the treatment of psoriasis and atopic dermatitis." }

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Avoid excessive heat.

Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following:

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following:" }

{ "type": "", "children": [], "text": "" }

Manufactured for Padagis® by Taro Pharmaceuticals Inc.

{ "type": "p", "children": [], "text": "Manufactured for Padagis® by Taro Pharmaceuticals Inc." }

Brampton, Ontario, Canada L6T 1C1

{ "type": "p", "children": [], "text": "Brampton, Ontario, Canada L6T 1C1" }

www.padagis.com

{ "type": "p", "children": [], "text": "www.padagis.com" }

Rev 01-24

{ "type": "p", "children": [], "text": "Rev 01-24" }

OF400 RC PH6

{ "type": "p", "children": [], "text": "OF400 RC PH6" }

Made in Canada 5239914 54

{ "type": "p", "children": [], "text": "Made in Canada 5239914 54" }

Relabeled By: Preferred Pharmaceuticals Inc.

{ "type": "p", "children": [], "text": "\nRelabeled By: Preferred Pharmaceuticals Inc.\n" }

<div class="scrollingtable"><table width="100%"> <col width="15%"/> <col width="85%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="2" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Patient Information</span> <br/> <span class="Bold">Mometasone Furoate</span> <br/> <span class="Bold">(moe met</span>' <span class="Bold">a sone fure</span>' <span class="Bold">oh ate)</span> <br/> <span class="Bold">Cream USP, 0.1%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Important information: Mometasone furoate cream is for use on skin only.</span>Do not use mometasone furoate cream in your eyes, mouth, or vagina. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What is mometasone furoate cream?</span> </p> <dl> <dt>1.</dt> <dd>Mometasone furoate cream is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. <dl> <dt>1.</dt> <dd>It is not known if mometasone furoate cream is safe and effective for use in children under 2 years of age.</dd> <dt>2.</dt> <dd>Mometasone furoate cream should not be used in children under 2 years of age.</dd> <dt>3.</dt> <dd>It is not known if mometasone furoate cream is safe and effective for use in children longer than 3 weeks.</dd> </dl> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Do not use mometasone furoate cream if you</span>are allergic to mometasone furoate or any of the ingredients in mometasone furoate cream. See the end of this leaflet for a complete list of ingredients in mometasone furoate cream. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Before using mometasone furoate cream, tell your healthcare provider about all your medical conditions, including if you:</span> </p> <dl> <dt>1.</dt> <dd>have a skin infection at the site to be treated. You may also need medicine to treat the skin infection.</dd> <dt>2.</dt> <dd>are pregnant or plan to become pregnant. It is not known if mometasone furoate cream will harm your unborn baby.</dd> <dt>3.</dt> <dd>are breastfeeding or plan to breastfeed. It is not known if mometasone furoate passes into your breast milk.</dd> </dl> <p> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I use mometasone furoate cream?</span> </p> <dl> <dt>1.</dt> <dd>Use mometasone furoate cream exactly as your healthcare provider tells you to use it.</dd> <dt>2.</dt> <dd>Apply a thin film of mometasone furoate cream to the affected skin area 1 time each day.</dd> <dt>3.</dt> <dd>Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment.</dd> <dt>4.</dt> <dd>Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.</dd> <dt>5.</dt> <dd>Mometasone furoate cream should not be used to treat diaper rash or redness. Do not apply mometasone furoate cream in the diaper area if wearing diapers or plastic pants.</dd> <dt>6.</dt> <dd>Avoid using mometasone furoate cream on the face, groin, or underarms (armpits).</dd> <dt>7.</dt> <dd>Wash your hands after applying mometasone furoate cream.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of mometasone furoate cream?</span> <br/> <span class="Bold">Mometasone furoate cream may cause serious side effects, including:</span> </p> <dl> <dt>1.</dt> <dd> <span class="Bold">Mometasone furoate cream can pass through your skin.</span>Too much mometasone furoate cream passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. </dd> <dt>2.</dt> <dd>V <span class="Bold">ision problems.</span>Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate cream. </dd> <dt>3.</dt> <dd> <span class="Bold">Skin problems.</span>Skin problems may happen during treatment with mometasone furoate cream, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate cream and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate cream. </dd> </dl> <p> <span class="Bold">The most common side effects of mometasone furoate cream include</span>burning, itching, and thinning of the skin (atrophy). <br/> These are not all the possible side effects of mometasone furoate cream. <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">How should I store mometasone furoate cream?</span> </p> <dl> <dt>1.</dt> <dd>Store mometasone furoate cream at room temperature between 68°F to 77°F (20°C to 25°C).</dd> <dt>2.</dt> <dd> <span class="Bold">Keep mometasone furoate cream and all medicines out of the reach of children.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of mometasone furoate cream.</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate cream for a condition for which it was not prescribed. Do not give mometasone furoate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate cream that is written for health professionals. </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in mometasone furoate cream?</span> <br/> <span class="Bold">Active ingredient:</span>mometasone furoate <br/> <span class="Bold">Inactive ingredients:</span>aluminum starch octenylsuccinate, ceteareth-20, phosphoric acid, propylene glycol, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum and white wax </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="2" valign="top"> <p class="First">Manufactured for Padagis® by Taro Pharmaceuticals Inc.</p> <p>Brampton, Ontario, Canada L6T 1C1</p> <p>www.padagis.com</p> <p>Rev 01-24</p> <p>OF400 RC PH6</p> <p>Made in Canada 5239914 54</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Relabeled By: Preferred Pharmaceuticals Inc.</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"15%\"/>\n<col width=\"85%\"/>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"2\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Patient Information</span>\n<br/>\n<span class=\"Bold\">Mometasone Furoate</span>\n<br/>\n<span class=\"Bold\">(moe met</span>' <span class=\"Bold\">a sone fure</span>' <span class=\"Bold\">oh ate)</span>\n<br/>\n<span class=\"Bold\">Cream USP, 0.1%</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important information: Mometasone furoate cream is for use on skin only.</span>Do not use mometasone furoate cream in your eyes, mouth, or vagina. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is mometasone furoate cream?</span>\n</p>\n<dl>\n<dt>1.</dt>\n<dd>Mometasone furoate cream is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. \t <dl>\n<dt>1.</dt>\n<dd>It is not known if mometasone furoate cream is safe and effective for use in children under 2 years of age.</dd>\n<dt>2.</dt>\n<dd>Mometasone furoate cream should not be used in children under 2 years of age.</dd>\n<dt>3.</dt>\n<dd>It is not known if mometasone furoate cream is safe and effective for use in children longer than 3 weeks.</dd>\n</dl>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use mometasone furoate cream if you</span>are allergic to mometasone furoate or any of the ingredients in mometasone furoate cream. See the end of this leaflet for a complete list of ingredients in mometasone furoate cream. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Before using mometasone furoate cream, tell your healthcare provider about all your medical conditions, including if you:</span>\n</p>\n<dl>\n<dt>1.</dt>\n<dd>have a skin infection at the site to be treated. You may also need medicine to treat the skin infection.</dd>\n<dt>2.</dt>\n<dd>are pregnant or plan to become pregnant. It is not known if mometasone furoate cream will harm your unborn baby.</dd>\n<dt>3.</dt>\n<dd>are breastfeeding or plan to breastfeed. It is not known if mometasone furoate passes into your breast milk.</dd>\n</dl>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> \tEspecially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use mometasone furoate cream?</span>\n</p>\n<dl>\n<dt>1.</dt>\n<dd>Use mometasone furoate cream exactly as your healthcare provider tells you to use it.</dd>\n<dt>2.</dt>\n<dd>Apply a thin film of mometasone furoate cream to the affected skin area 1 time each day.</dd>\n<dt>3.</dt>\n<dd>Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment.</dd>\n<dt>4.</dt>\n<dd>Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.</dd>\n<dt>5.</dt>\n<dd>Mometasone furoate cream should not be used to treat diaper rash or redness. Do not apply mometasone furoate cream in the diaper area if wearing diapers or plastic pants.</dd>\n<dt>6.</dt>\n<dd>Avoid using mometasone furoate cream on the face, groin, or underarms (armpits).</dd>\n<dt>7.</dt>\n<dd>Wash your hands after applying mometasone furoate cream.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of mometasone furoate cream?</span>\n<br/>\n<span class=\"Bold\">Mometasone furoate cream may cause serious side effects, including:</span>\n</p>\n<dl>\n<dt>1.</dt>\n<dd>\n<span class=\"Bold\">Mometasone furoate cream can pass through your skin.</span>Too much mometasone furoate cream passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. </dd>\n<dt>2.</dt>\n<dd>V <span class=\"Bold\">ision problems.</span>Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate cream. </dd>\n<dt>3.</dt>\n<dd>\n<span class=\"Bold\">Skin problems.</span>Skin problems may happen during treatment with mometasone furoate cream, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate cream and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate cream. </dd>\n</dl>\n<p>\n<span class=\"Bold\">The most common side effects of mometasone furoate cream include</span>burning, itching, and thinning of the skin (atrophy). <br/> \tThese are not all the possible side effects of mometasone furoate cream. <br/> \tCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store mometasone furoate cream?</span>\n</p>\n<dl>\n<dt>1.</dt>\n<dd>Store mometasone furoate cream at room temperature between 68°F to 77°F (20°C to 25°C).</dd>\n<dt>2.</dt>\n<dd>\n<span class=\"Bold\">Keep mometasone furoate cream and all medicines out of the reach of children.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of mometasone furoate cream.</span>\n<br/> \tMedicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate cream for a condition for which it was not prescribed. Do not give mometasone furoate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate cream that is written for health professionals. </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in mometasone furoate cream?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span>mometasone furoate <br/>\n<span class=\"Bold\">Inactive ingredients:</span>aluminum starch octenylsuccinate, ceteareth-20, phosphoric acid, propylene glycol, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum and white wax </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Manufactured for Padagis® by Taro Pharmaceuticals Inc.</p>\n<p>Brampton, Ontario, Canada L6T 1C1</p>\n<p>www.padagis.com</p>\n<p>Rev 01-24</p>\n<p>OF400 RC PH6</p>\n<p>Made in Canada 5239914 54</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Relabeled By: Preferred Pharmaceuticals Inc.</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"top\"></td><td class=\"Botrule Rrule\" valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only " }

NDC 45802-257-42

{ "type": "p", "children": [], "text": "NDC 45802-257-42" }

Mometasone Furoate Cream USP, 0.1% For Dermatologic Use Only. Not for Ophthalmic Use.

{ "type": "p", "children": [], "text": "Mometasone Furoate Cream USP, 0.1% For Dermatologic Use Only. Not for Ophthalmic Use. " }

45 g

{ "type": "p", "children": [], "text": "45 g" }

Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.

{ "type": "p", "children": [], "text": "Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older." }

Apply a few drops of Mometasone Furoate Topical Solution 0.1% to the affected skin areas once daily and massage lightly until it disappears.

{ "type": "p", "children": [], "text": "Apply a few drops of Mometasone Furoate Topical Solution 0.1% to the affected skin areas once daily and massage lightly until it disappears." }

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

{ "type": "p", "children": [], "text": "Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]." }

Do not use Mometasone Furoate Topical Solution, 0.1% with occlusive dressings unless directed by a physician. Do not apply Mometasone Furoate Topical Solution, 0.1% in the diaper area if the patient requires diapers or plastic pants, as these garments constitute occlusive dressing.

{ "type": "p", "children": [], "text": "Do not use Mometasone Furoate Topical Solution, 0.1% with occlusive dressings unless directed by a physician. Do not apply Mometasone Furoate Topical Solution, 0.1% in the diaper area if the patient requires diapers or plastic pants, as these garments constitute occlusive dressing." }

Mometasone Furoate Topical Solution 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "Mometasone Furoate Topical Solution 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use. " }

Avoid use on the face, groin, or axillae.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae." }

Avoid contact with eyes. Wash hands after each application.

{ "type": "p", "children": [], "text": "Avoid contact with eyes. Wash hands after each application." }

Solution, 0.1%. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg of mometasone furoate in a colorless, clear to translucent solution base.

{ "type": "p", "children": [], "text": "Solution, 0.1%. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg of mometasone furoate in a colorless, clear to translucent solution base." }

Mometasone Furoate Topical Solution, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

{ "type": "p", "children": [], "text": "Mometasone Furoate Topical Solution, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation." }

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure and young age.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [see Adverse Reactions (6.2)].

Avoid contact of Mometasone Furoate Topical Solution, 0.1% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

If irritation develops, Mometasone Furoate Topical Solution USP, 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Mometasone Furoate Topical Solution USP, 0.1% should be discontinued until the infection has been adequately controlled.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In clinical trials involving 209 subjects, the incidence of adverse reactions associated with the use of mometasone furoate lotion was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).

The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate lotion during a clinical trial in 14% of 65 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 subjects treated with mometasone furoate lotion in a clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3.

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and malaria. These adverse reactions may occur more frequently with the use of occlusive dressings.

Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

No drug-drug interaction studies have been conducted with Mometasone Furoate Topical Solution 0.1%.

{ "type": "p", "children": [], "text": "No drug-drug interaction studies have been conducted with Mometasone Furoate Topical Solution 0.1%." }

There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Topical Solution 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis.)

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mometasone Furoate Topical Solution 0.1% is administered to a nursing woman.

Since safety and efficacy of Mometasone Furoate Topical Solution 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.

Mometasone furoate lotion caused HPA axis suppression in approximately 29% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16%-90%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Mometasone Furoate Topical Solution 0.1% should not be used in the treatment of diaper dermatitis.

Clinical trials of mometasone furoate lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.

Topically applied Mometasone Furoate Topical Solution 0.1% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Topically applied Mometasone Furoate Topical Solution 0.1% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]." }

Mometasone Furoate Topical Solution USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.

{ "type": "p", "children": [], "text": "Mometasone Furoate Topical Solution USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity." }

Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:" }

Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane.

{ "type": "p", "children": [], "text": "Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane." }

Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg mometasone furoate in a colorless, clear to translucent solution base of isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5.

{ "type": "p", "children": [], "text": "Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg mometasone furoate in a colorless, clear to translucent solution base of isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5." }

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Studies performed with mometasone furoate lotion indicate that it is in the medium range of potency as compared with other topical corticosteroids.

In a study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline [see Warnings and Precautions (5.1)].

Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Mometasone furoate lotion was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16%-90%). In approximately 29% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate lotion. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria [see Use in Specific Populations (8.4)].

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate ointment enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion on a mcg/m2 basis).

The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12-95 years) received mometasone furoate lotion (205 subjects) or the vehicle lotion applied once daily for 21 days.

{ "type": "p", "children": [], "text": "The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12-95 years) received mometasone furoate lotion (205 subjects) or the vehicle lotion applied once daily for 21 days." }

Mometasone Furoate Topical Solution USP, 0.1% is colorless, clear to translucent and supplied in 60-mL (55 gram) (NDC 63629-8686-1) bottle.

{ "type": "p", "children": [], "text": "Mometasone Furoate Topical Solution USP, 0.1% is colorless, clear to translucent and supplied in 60-mL (55 gram) (NDC 63629-8686-1) bottle." }

Store Mometasone Furoate Topical Solution, 0.1% at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store Mometasone Furoate Topical Solution, 0.1% at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]." }

Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504

{ "type": "p", "children": [], "text": "Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504" }

Advise the patient to read the FDA-approved patient labeling (Patient Information).

{ "type": "p", "children": [], "text": "Advise the patient to read the FDA-approved patient labeling (Patient Information)." }

Inform patients of the following:

{ "type": "p", "children": [], "text": "Inform patients of the following:" }

{ "type": "", "children": [], "text": "" }

Made in Israel

{ "type": "p", "children": [], "text": "Made in Israel" }

Manufactured By Perrigo

{ "type": "p", "children": [], "text": "Manufactured By Perrigo" }

Yeruham, Israel

{ "type": "p", "children": [], "text": "Yeruham, Israel" }

Distributed By

{ "type": "p", "children": [], "text": "Distributed By" }

Perrigo®

{ "type": "p", "children": [], "text": "Perrigo®" }

Allegan, MI 49010 • www.perrigo.com

{ "type": "p", "children": [], "text": "Allegan, MI 49010 • www.perrigo.com" }

Rev 02-19

{ "type": "p", "children": [], "text": "Rev 02-19" }

5D800 RC J6

{ "type": "p", "children": [], "text": "5D800 RC J6" }

Mometasone Furoate (moe-MET-a-sone fur-oate) Topical Solution USP, 0.1%

{ "type": "p", "children": [], "text": "\nMometasone Furoate (moe-MET-a-sone fur-oate) Topical Solution USP, 0.1%\n" }

Important information: Mometasone Furoate Topical Solution, 0.1% is for use on skin only.

{ "type": "p", "children": [], "text": "\nImportant information: Mometasone Furoate Topical Solution, 0.1% is for use on skin only.\n" }

Do not use Mometasone Furoate Topical Solution, 0.1% in your eyes, mouth, or vagina.

{ "type": "p", "children": [], "text": "Do not use Mometasone Furoate Topical Solution, 0.1% in your eyes, mouth, or vagina." }

What is Mometasone Furoate Topical Solution, 0.1%?

{ "type": "p", "children": [], "text": "\nWhat is Mometasone Furoate Topical Solution, 0.1%?\n" }

{ "type": "", "children": [], "text": "" }

Do not use Mometasone Furoate Topical Solution, 0.1% if you are allergic to mometasone furoate or any of the ingredients in Mometasone Furoate Topical Solution, 0.1%. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Topical Solution, 0.1%.

{ "type": "p", "children": [], "text": "\nDo not use Mometasone Furoate Topical Solution, 0.1% if you are allergic to mometasone furoate or any of the ingredients in Mometasone Furoate Topical Solution, 0.1%. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Topical Solution, 0.1%." }

Before using Mometasone Furoate Topical Solution, 0.1%, tell your healthcare provider about all your medical conditions, including if you:

{ "type": "p", "children": [], "text": "\nBefore using Mometasone Furoate Topical Solution, 0.1%, tell your healthcare provider about all your medical conditions, including if you:\n" }

{ "type": "", "children": [], "text": "" }

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

{ "type": "p", "children": [], "text": "\nTell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements." }

Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

{ "type": "p", "children": [], "text": "Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids." }

How should I use Mometasone Furoate Topical Solution, 0.1%?

{ "type": "p", "children": [], "text": "\nHow should I use Mometasone Furoate Topical Solution, 0.1%?\n" }

{ "type": "", "children": [], "text": "" }

What are the possible side effects of Mometasone Furoate Topical Solution, 0.1%?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of Mometasone Furoate Topical Solution, 0.1%?\n" }

Mometasone Furoate Topical Solution, 0.1% may cause serious side effects, including:

{ "type": "p", "children": [], "text": "\nMometasone Furoate Topical Solution, 0.1% may cause serious side effects, including:\n" }

{ "type": "", "children": [], "text": "" }

The most common side effects of Mometasone Furoate Topical Solution, 0.1% include burning, itching, and inflammation of the hair follicle (folliculitis).

{ "type": "p", "children": [], "text": "\nThe most common side effects of Mometasone Furoate Topical Solution, 0.1% include burning, itching, and inflammation of the hair follicle (folliculitis)." }

These are not all the possible side effects of Mometasone Furoate Topical Solution, 0.1%.

{ "type": "p", "children": [], "text": "These are not all the possible side effects of Mometasone Furoate Topical Solution, 0.1%." }

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." }

How should I store Mometasone Furoate Topical Solution, 0.1%?

{ "type": "p", "children": [], "text": "\nHow should I store Mometasone Furoate Topical Solution, 0.1%?\n" }

{ "type": "", "children": [], "text": "" }

General information about the safe and effective use of Mometasone Furoate Topical Solution, 0.1%.

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of Mometasone Furoate Topical Solution, 0.1%.\n" }

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mometasone Furoate Topical Solution, 0.1% for a condition for which it was not prescribed. Do not give Mometasone Furoate Topical Solution, 0.1% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Mometasone Furoate Topical Solution, 0.1% that is written for health professionals.

{ "type": "p", "children": [], "text": "Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mometasone Furoate Topical Solution, 0.1% for a condition for which it was not prescribed. Do not give Mometasone Furoate Topical Solution, 0.1% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Mometasone Furoate Topical Solution, 0.1% that is written for health professionals." }

What are the ingredients in Mometasone Furoate Topical Solution, 0.1%?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in Mometasone Furoate Topical Solution, 0.1%?\n" }

Active ingredient: mometasone furoate

{ "type": "p", "children": [], "text": "\nActive ingredient: mometasone furoate" }

Inactive ingredients: isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5.

{ "type": "p", "children": [], "text": "\nInactive ingredients: isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5." }

Made in Israel

{ "type": "p", "children": [], "text": "Made in Israel" }

Manufactured by Perrigo

{ "type": "p", "children": [], "text": "Manufactured by Perrigo" }

Yeruham, Israel

{ "type": "p", "children": [], "text": "Yeruham, Israel" }

Distributed By

{ "type": "p", "children": [], "text": "Distributed By" }

Perrigo®

{ "type": "p", "children": [], "text": "Perrigo®" }

Allegan, MI 49010 • www.perrigo.com

{ "type": "p", "children": [], "text": "Allegan, MI 49010 • www.perrigo.com" }

Rev 02-19

{ "type": "p", "children": [], "text": "Rev 02-19" }

This Patient Information has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration." }

Mometasone Furoate 0.1% Solution, #60

{ "type": "p", "children": [], "text": "Mometasone Furoate 0.1% Solution, #60" }

ASMANEX® HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.

Important Limitations of Use

Administer ASMANEX HFA only by the orally inhaled route [see Instructions for Use in the Patient Information leaflet]. After each dose, advise patients to rinse their mouth with water and, without swallowing, spit out the contents to help reduce the risk of oropharyngeal candidiasis.

Remove the cap from the mouthpiece of the actuator before using ASMANEX HFA.

Prime ASMANEX HFA before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

Only use the ASMANEX HFA canister with the ASMANEX HFA actuator. Do not use the ASMANEX HFA actuator with any other inhalation drug product. Do not use actuators from other products with the ASMANEX HFA canister.

Administer ASMANEX HFA as two inhalations twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation. If symptoms arise between doses, use an inhaled short-acting beta2-agonist for immediate relief. The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief.

Adult and Adolescent Patients Aged 12 Years and Older

For patients 12 years of age and older, the dosage is either 2 inhalations twice daily of ASMANEX HFA 100 mcg or 200 mcg. The starting dosage is based on previous asthma therapy and disease severity, including considerations of the patients' current control of asthma symptoms and risk of future exacerbations. The recommended starting dosage for patients 12 years of age and older who are not on an inhaled corticosteroid is ASMANEX HFA 100 mcg, 2 inhalations twice daily. It is recommended that patients currently receiving chronic oral corticosteroid therapy (e.g., prednisone) begin with ASMANEX HFA 200 mcg (2 inhalations twice daily). For patients who do not respond adequately to the initial dosage after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day).

After asthma stability has been achieved, it may be desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.

If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, re-evaluate the therapeutic regimen and consider additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids.

Pediatric Patients Aged 5 to Less Than 12 Years

For patients aged 5 to less than 12 years, the dosage is 2 inhalations of ASMANEX HFA 50 mcg twice daily. The maximum daily dosage is 200 mcg.

ASMANEX HFA is a pressurized metered dose inhaler (MDI) that is available in 2 strengths (100 mcg and 200 mcg) for adult and adolescent patients aged 12 years and older; and 1 strength (50 mcg) for pediatric patients aged 5 to less than 12 years.

{ "type": "p", "children": [], "text": "ASMANEX HFA is a pressurized metered dose inhaler (MDI) that is available in 2 strengths (100 mcg and 200 mcg) for adult and adolescent patients aged 12 years and older; and 1 strength (50 mcg) for pediatric patients aged 5 to less than 12 years." }

ASMANEX HFA 50 mcg delivers 50 mcg of mometasone furoate per actuation.

{ "type": "p", "children": [], "text": "ASMANEX HFA 50 mcg delivers 50 mcg of mometasone furoate per actuation." }

ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation.

{ "type": "p", "children": [], "text": "ASMANEX HFA 100 mcg delivers 100 mcg of mometasone furoate per actuation." }

ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation.

{ "type": "p", "children": [], "text": "ASMANEX HFA 200 mcg delivers 200 mcg of mometasone furoate per actuation." }

Each strength of ASMANEX HFA is supplied with a blue colored actuator and pink dust cap [see How Supplied/Storage and Handling (16.1)].

{ "type": "p", "children": [], "text": "Each strength of ASMANEX HFA is supplied with a blue colored actuator and pink dust cap [see How Supplied/Storage and Handling (16.1)]." }

ASMANEX HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

ASMANEX HFA is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in ASMANEX HFA [see Warnings and Precautions (5.8)].

ASMANEX HFA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not ASMANEX HFA, should be used to relieve acute symptoms such as shortness of breath. When prescribing ASMANEX HFA, the physician must also provide the patient with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of ASMANEX HFA. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with ASMANEX HFA. During such episodes, patients may require therapy with oral corticosteroids.

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans have occurred in patients treated with ASMANEX HFA. If oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while remaining on treatment with ASMANEX HFA therapy, but at times therapy with ASMANEX HFA may need to be interrupted. To reduce the risk of oropharyngeal candidiasis, after dosing with ASMANEX HFA, advise patients to rinse their mouth with water and spit out the contents without swallowing.

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals.

Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Particular care is needed for patients who are transferred from systemically active corticosteroids to ASMANEX HFA because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although ASMANEX HFA may improve control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity necessary for coping with these emergencies.

During periods of stress or severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or severe asthma attack.

Patients requiring oral or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to ASMANEX HFA. Lung function (FEV1 or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to ASMANEX HFA may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

ASMANEX HFA will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since mometasone furoate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of ASMANEX HFA in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with ASMANEX HFA should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ASMANEX HFA should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

Caution should be exercised when considering the coadministration of ASMANEX HFA with ketoconazole, and other known strong cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

ASMANEX HFA may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs, it should be treated immediately with an inhaled, short-acting bronchodilator. ASMANEX HFA should be discontinued immediately and alternative therapy instituted.

Hypersensitivity reactions such as urticaria, flushing, allergic dermatitis, and bronchospasm, may occur after administration of ASMANEX HFA. Discontinue ASMANEX HFA if such reactions occur [see Contraindications (4.2)].

The following additional hypersensitivity reactions, such as rash, pruritus, angioedema, and anaphylactic reaction, have been reported after administration of mometasone furoate dry powder inhaler (DPI) [see Adverse Reactions (6.2)].

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids, including mometasone furoate. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

In a 2-year double-blind study in 103 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (Baseline FEV1 85%-88% predicted), treatment with mometasone furoate dry powder inhaler 200 mcg twice daily resulted in significant reductions in lumbar spine (LS) BMD at the end of the treatment period compared to placebo. The mean change from Baseline to Endpoint in the lumbar spine BMD was -0.015 (-1.43%) for the mometasone furoate dry powder inhaler group compared to 0.002 (0.25%) for the placebo group. In another 2-year double-blind study in 87 male and female asthma patients 18 to 50 years of age previously maintained on bronchodilator therapy (Baseline FEV1 82%-83% predicted), treatment with mometasone furoate dry powder inhaler 400 mcg twice daily demonstrated no statistically significant changes in lumbar spine BMD at the end of the treatment period compared to placebo. The mean change from Baseline to Endpoint in the lumbar spine BMD was -0.018 (-1.57%) for the mometasone furoate group compared to -0.006 (-0.43%) for the placebo group.

Orally inhaled corticosteroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ASMANEX HFA routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX HFA, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

Glaucoma, increased intraocular pressure, and cataracts have been reported following the use of long-term administration of inhaled corticosteroids, including mometasone furoate. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX HFA long term [see Adverse Reactions (6)].

Adult and Adolescent Patients Aged 12 Years and Older

The safety of ASMANEX HFA was evaluated in 2 randomized placebo and active-controlled trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program, which enrolled 1509 patients with persistent asthma. Patient ages ranged from 12 to 84 years of age, 41% were male and 59% female, 73% were Caucasian and 27% non-Caucasian. Of the total population enrolled in the 2 trials, 432 patients received two inhalations twice daily of either ASMANEX HFA, 100 mcg or 200 mcg/actuation. In the 26-week trial (Trial 1) 192 patients received two inhalations twice daily of ASMANEX HFA 100 mcg/actuation and 196 patients received placebo. In the 12 week trial (Trial 2) 240 patients received two inhalations twice daily of ASMANEX HFA 200 mcg/actuation and 233 and 255 patients received mometasone furoate and formoterol fumarate 100 mcg/5 mcg and 200 mcg/5 mcg/actuation combination products, respectively, as comparators.

In these trials, the proportion of patients who discontinued study treatment early due to adverse reactions was 3% and 2% for ASMANEX HFA 100 and 200 mcg treated patients, respectively, and 4% for placebo-treated patients. Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in ASMANEX HFA-treated patients included colitis ulcerative, colonic polyp, chest pain, gastroenteritis, endometriosis, asthma, and hemoptysis; all events occurred at rates less than 1%.

The incidence of treatment emergent adverse events associated with ASMANEX HFA are shown in Tables 1 and 2. These are based upon data from each of the 2 clinical trials of 12 or 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of ASMANEX HFA (100 mcg or 200 mcg), mometasone furoate/formoterol fumarate (100 mcg/5 mcg or 200 mcg/5 mcg), or placebo.

<div class="scrollingtable"><table width="75%"> <caption> <span>TABLE 1: Trial 1: Treatment-Emergent Adverse Events Occurring at an Incidence of ≥3% and More Commonly than Placebo Over 26 Weeks</span> </caption> <col align="left" valign="top" width="33%"/> <col align="center" valign="top" width="35%"/> <col align="center" valign="top" width="32%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">ASMANEX HFA 100 mcg<br/>N=192<br/>n (%)</th><th align="center" class="Rrule">Placebo<br/>N=196<br/>n (%)</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Nasopharyngitis</td><td align="center" class="Rrule">15 (8)</td><td align="center" class="Rrule">7 (4)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Headache</td><td align="center" class="Rrule">10 (5)</td><td align="center" class="Rrule">7 (4)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Influenza</td><td align="center" class="Rrule">7 (4)</td><td align="center" class="Rrule">5 (3)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Sinusitis</td><td align="center" class="Rrule">6 (3)</td><td align="center" class="Rrule">2 (1)</td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="75%"> <caption> <span>TABLE 2: Trial 2: Treatment-Emergent Adverse Events Occurring at an Incidence of ≥3% Over 12 Weeks</span> </caption> <col align="left" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule"></th><th align="center" class="Rrule">ASMANEX HFA<br/>200 mcg<br/>N=240<br/>n (%)</th><th align="center" class="Rrule">MF/F<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a> <br/>100/5 mcg <br/>N=233 <br/>n (%)</th><th align="center" class="Rrule">MF/F<a class="Sup" href="#footnote-1">*</a> <br/>200/5 mcg <br/>N=255 <br/>n (%)</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>MF/F = mometasone furoate/formoterol fumarate.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Nasopharyngitis</td><td align="center" class="Rrule">13 (5)</td><td align="center" class="Rrule">8 (3)</td><td align="center" class="Rrule">12 (5)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Headache</td><td align="center" class="Rrule">8 (3)</td><td align="center" class="Rrule">10 (4)</td><td align="center" class="Rrule">5 (2)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Bronchitis</td><td align="center" class="Rrule">6 (3)</td><td align="center" class="Rrule">2 (1)</td><td align="center" class="Rrule">7 (3)</td> </tr> </tbody> </table></div>

Oral candidiasis has been reported in clinical trials at an incidence of 0.5% in patients using ASMANEX HFA 100 mcg, 0.8% in patients using ASMANEX HFA 200 mcg and 0.5% in the placebo group.

Pediatric Patients Aged 5 to Less Than 12 Years

The safety profile for ASMANEX HFA 50 mcg, 2 inhalations twice daily, is based on two clinical trials consisting of a total of 759 patients aged 5 to less than 12 years with persistent asthma. The first trial was a placebo-controlled trial comparing ASMANEX HFA 50 mcg (administered as 2 inhalations, twice daily) to 2 other dosage strengths of mometasone furoate MDI (25 mcg or 100 mcg, each administered as two inhalations, twice daily) as well as mometasone furoate DPI 100 mcg, administered as one evening inhalation. The second trial compared ASMANEX HFA 50 mcg to the combination of mometasone furoate and formoterol fumarate 50 mcg/5 mcg, each administered by MDI as two inhalations, twice daily.

Overall, the safety profile for pediatric patients is similar to that observed in patients aged 12 years and older.

There are no postmarketing adverse experiences reported to date with ASMANEX HFA. However, the postmarketing safety experience with mometasone furoate dry powder inhaler is relevant to ASMANEX HFA since they contain the same active ingredient. The following adverse reactions have been reported during post-approval use of mometasone furoate dry powder inhaler. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye Disorders: Vision blurred [see Warnings and Precautions (5.11)].

Immune System Disorders: Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction [see Contraindications (4.2) and Warnings and Precautions (5.8)].

Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.

The main route of metabolism of corticosteroids, including mometasone furoate, is via CYP3A4. After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally inhaled mometasone furoate increased. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of ASMANEX HFA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)]. Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

Risk Summary

There are no randomized clinical studies of ASMANEX HFA in pregnant women. There are clinical considerations with the use of ASMANEX HFA in pregnant women [see Clinical Considerations]. In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis [see Data]. However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.

Data

Animal Data

In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at an exposure approximately one-third of the MRHD (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at an exposure approximately equivalent to the MRHD (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure approximately one-tenth of the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above).

In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 6 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at exposures approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above).

In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at an exposure that was approximately 8 times the MRHD (on an area under the curve (AUC) basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings with an exposure approximately 4 times the MRHD (on an AUC basis with a maternal subcutaneous dose of 7.5 mcg/kg).

Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at an exposure approximately 3 times the MRHD (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at an exposure approximately 1/2 of the MRHD (on AUC basis with a maternal oral dose of 700 mcg/kg). At an exposure approximately 2 times the MRHD (on an AUC basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. No effects were observed at an exposure approximately 1/10 of the MRHD (on an AUC basis with a maternal oral dose of 140 mcg/kg).

Risk Summary

There are no available data on the presence of ASMANEX HFA in human milk, the effects on the breastfed child, or the effects on milk production. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ASMANEX HFA and any potential adverse effects on the breastfed infant from ASMANEX HFA or from the underlying maternal condition.

The safety and effectiveness of ASMANEX HFA have been established in patients 12 years of age and older in 2 clinical trials of 12 and 26 weeks in duration. In the 2 clinical trials, 32 patients 12 to 17 years of age were treated with ASMANEX HFA. No overall differences in effectiveness were observed between patients in this age group compared to those observed in patients 18 years of age and older. There were no obvious differences in the type or frequency of adverse reactions reported in this age group compared to patients 18 years of age and older.

The safety and effectiveness of ASMANEX HFA 50 mcg, two inhalations twice daily, have been established in patients with asthma aged 5 to less than 12 years in clinical trials up to 24 weeks of treatment duration. The safety profile and overall effectiveness in this age group were consistent with that observed in patients aged 12 years and older who also received ASMANEX HFA [see Adverse Reactions (6.1) and Clinical Studies (14.1)].

The safety and effectiveness of ASMANEX HFA have not been established in children younger than 5 years of age.

Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies, the mean reduction in growth velocity was approximately 1 cm per year (range 0.3 to 1.8 per year) and appears to depend upon dose and duration of exposure. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied.

The growth of children and adolescents receiving orally inhaled corticosteroids, including ASMANEX HFA, should be monitored routinely (e.g., via stadiometry). If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect should be considered. The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including ASMANEX HFA, each patient should be titrated to his/her lowest effective dose [see Dosage and Administration (2.2)].

A total of 38 patients 65 years of age and older (3 of whom were 75 years and older) have been treated with ASMANEX HFA in 2 clinical trials of 12 and 26 weeks in duration. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Based on available data for ASMANEX HFA, no adjustment of dosage in geriatric patients is warranted.

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3)].

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. Single oral doses up to 8000 mcg of mometasone furoate have been studied on adult subjects with no adverse reactions reported.

{ "type": "p", "children": [], "text": "Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. Single oral doses up to 8000 mcg of mometasone furoate have been studied on adult subjects with no adverse reactions reported." }

ASMANEX HFA is a metered dose inhaler for oral inhalation only, consisting of 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation.

{ "type": "p", "children": [], "text": "ASMANEX HFA is a metered dose inhaler for oral inhalation only, consisting of 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation." }

Mometasone furoate, the active component of ASMANEX HFA, is a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure:

{ "type": "p", "children": [], "text": "Mometasone furoate, the active component of ASMANEX HFA, is a corticosteroid having the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16 (alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) with the following chemical structure:" }

Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight 521.44. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone.

{ "type": "p", "children": [], "text": "Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight 521.44. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone." }

ASMANEX HFA 50 mcg, 100 mcg, and 200 mcg are each formulated as a hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane) propelled pressurized metered dose inhaler containing sufficient amount of drug for 120 actuations [see How Supplied/Storage and Handling (16)]. After priming, each actuation of the inhaler delivers 60, 115, or 225 mcg of mometasone furoate in 69.6 mg of suspension from the valve and delivers 50, 100, or 200 mcg of mometasone furoate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. ASMANEX HFA also contains ethanol as a cosolvent and oleic acid as a surfactant.

{ "type": "p", "children": [], "text": "ASMANEX HFA 50 mcg, 100 mcg, and 200 mcg are each formulated as a hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane) propelled pressurized metered dose inhaler containing sufficient amount of drug for 120 actuations [see How Supplied/Storage and Handling (16)]. After priming, each actuation of the inhaler delivers 60, 115, or 225 mcg of mometasone furoate in 69.6 mg of suspension from the valve and delivers 50, 100, or 200 mcg of mometasone furoate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. ASMANEX HFA also contains ethanol as a cosolvent and oleic acid as a surfactant." }

ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

{ "type": "p", "children": [], "text": "ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray." }

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation and in the asthmatic response. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Mometasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor, which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. The clinical significance of these findings is unknown.

Systemic effects of inhaled corticosteroids are related to systemic exposure. Pharmacokinetic data have demonstrated that, in adults, systemic exposure to mometasone furoate administered by MDI is the same or lower than that of equivalent doses of inhaled mometasone furoate administered via DPI [see Clinical Pharmacology (12.3)]. Based upon the pharmacokinetic data, the systemic effects (e.g., HPA-axis suppression and growth retardation) of mometasone furoate delivered by MDI in adult and pediatric patients would be expected to be no greater than what is reported for inhaled mometasone furoate when administered at comparable doses via DPI [see Use in Specific Populations (8.4)].

HPA Axis Effects (Adults)

The effects of inhaled mometasone furoate administered via ASMANEX HFA on adrenal function have not been directly evaluated. However, the effects of inhaled mometasone furoate, administered as part of a mometasone furoate/formoterol fumarate inhalation aerosol combination product, on adrenal function were evaluated in two clinical trials in patients with asthma. As no evidence of a pharmacokinetic drug interaction between mometasone furoate and formoterol was observed when the two drugs were administered in combination, the HPA axis effects from the combination product are applicable to ASMANEX HFA. For the mometasone furoate/formoterol fumarate combination product clinical program, HPA-axis function was assessed by 24-hour plasma cortisol AUC. Although both these trials have open-label design and contain a small number of subjects per treatment arm, results from these trials taken together demonstrated suppression of 24-hour plasma cortisol AUC for the combination mometasone furoate/formoterol fumarate 200 mcg/5 mcg compared to placebo consistent with the known systemic effects of inhaled corticosteroid.

In a 42-day, open-label, placebo- and active-controlled study, the mean change from baseline plasma cortisol AUC(0-24 hr) was 8%, 22% and 34% lower compared to placebo for the mometasone furoate/formoterol fumarate 100 mcg/5 mcg (n=13), mometasone furoate/formoterol fumarate 200 mcg/5 mcg (n=15) and fluticasone propionate/salmeterol xinafoate 230 mcg/21 mcg (n=16) treatment groups, respectively.

In a 52-week, open-label safety study, the mean plasma cortisol AUC(0-24 hr) was 2.2%, 29.6%, 16.7%, and 32.2% lower from baseline for the mometasone furoate/formoterol fumarate 100 mcg/5 mcg (n=18), mometasone furoate/formoterol fumarate 200 mcg/5 mcg (n=20), fluticasone propionate/salmeterol xinafoate 125/25 mcg (n=8), and fluticasone propionate/salmeterol xinafoate 250/25 mcg (n=11) treatment groups, respectively.

The potential effect of mometasone furoate via a dry powder inhaler (DPI) on the HPA axis was also assessed in a 29-day study. A total of 64 adult patients with mild to moderate asthma were randomized to one of 4 treatment groups: mometasone furoate DPI 440 mcg twice daily, mometasone furoate DPI 880 mcg twice daily, oral prednisone 10 mg once daily, or placebo. The 30-minute post-Cosyntropin stimulation serum cortisol concentration on Day 29 was 23.2 mcg/dL for the mometasone furoate DPI 440 mcg twice daily group and 20.8 mcg/dL for the mometasone furoate DPI 880 mcg twice daily group, compared to 14.5 mcg/dL for the oral prednisone 10 mg group and 25 mcg/dL for the placebo group. The difference between mometasone furoate DPI 880 mcg twice daily (twice the maximum recommended dose) and placebo was statistically significant.

HPA Axis Effects (Pediatrics)

The potential effect of mometasone furoate via a DPI on the HPA axis was assessed in 50 children aged 6 to 11 years in a 29-day, randomized, double-blind, placebo-controlled, parallel-group clinical trial. In this study, the mean difference from placebo in plasma cortisol AUC(0-12hr) for DPI 110 mcg twice daily was 3.4 mcg∙hr/dL (95% CI: -14.0, 20.7) and for 220 mcg twice daily was -16.0 mcg∙hr/dL (95% CI: -33.9, 1.9). The mean difference from placebo in plasma cortisol AUC(0-12hr) for the 440 mcg twice daily group (eight times the currently recommended mometasone furoate dose via a DPI in children ages 4-11) was -17.9 mcg∙hr/dL (95% CI: -35.8, 0.0). The mean differences in urinary-free cortisol changes from baseline compared to placebo were 3.1 mcg/day (95% CI: -3.3, 9.6), 3.3 mcg/day (95% CI: -3.0, 9.7), and -2.0 mcg/day (95% CI: -8.6, 4.6) for the groups treated with 110 mcg twice daily, 220 mcg twice daily, and 440 mcg twice daily, respectively.

As no evidence of a pharmacokinetic drug interaction between mometasone furoate and formoterol was observed when the two drugs were administered from a mometasone furoate/formoterol fumarate combination product, the pharmacokinetics information from the combination product is applicable to ASMANEX HFA.

Absorption

Adult Healthy Subjects: Following oral inhalation of single doses of ASMANEX HFA, mometasone furoate was absorbed in healthy subjects with median Tmax values ranging from 0.50 to 2 hours. Following single-dose administration of higher than recommended dose of ASMANEX HFA (4 inhalations of ASMANEX HFA 200 mcg) in healthy subjects, the arithmetic mean (CV%) Cmax and AUC(0-tf) values for mometasone furoate were 53 (102) pg/mL and 992 (80) pg∙hr/mL, respectively. Studies using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of mometasone furoate is negligible (<1%).

Following single-dose administration of a higher than recommended dose of mometasone furoate (4 inhalations of mometasone furoate/formoterol fumarate 200 mcg/5 mcg) in healthy subjects, the arithmetic mean (CV%) Cmax and AUC(0-12 hr) values for mometasone furoate were 67.8 (49) pg/mL and 650 (51) pg∙hr/mL, respectively, while the corresponding estimates following 5 days of BID dosing with mometasone furoate 800 mcg/20 mcg were 241 (36) pg/mL and 2200 (35) pg∙hr/mL. The systemic exposure to mometasone furoate (based on AUC) was approximately 52% and 25% lower on Day 1 and Day 5, respectively, following mometasone furoate administration compared to mometasone furoate via a DPI.

Adult Asthma Patients: Following oral inhalation of single and multiple doses of the mometasone furoate/formoterol fumarate combination product, mometasone furoate was absorbed in asthma patients with median Tmax values ranging from 1 to 2 hours. Following single-dose administration of mometasone furoate/formoterol fumarate 400 mcg/10 mcg, the arithmetic mean (CV%) Cmax and AUC(0-12 hr) values for mometasone furoate were 20 (88) pg/mL and 170 (94) pg∙hr/mL, respectively, while the corresponding estimates following twice daily dosing of mometasone furoate/formoterol fumarate 400 mcg/10 mcg at steady-state were 60 (36) pg/mL and 577 (40) pg∙hr/mL.

Distribution

Based on the study employing a 1000 mcg inhaled dose of tritiated mometasone furoate inhalation powder in humans, no appreciable accumulation of mometasone furoate in the red blood cells was found. Following an intravenous 400 mcg dose of mometasone furoate, the plasma concentrations showed a biphasic decline, with a mean steady-state volume of distribution of 152 liters. The in vitro protein binding for mometasone furoate was reported to be 98% to 99% (in a concentration range of 5 to 500 ng/mL).

Metabolism

Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of human liver CYP3A4 in the metabolism of this compound; however, no major metabolites were identified. Human liver CYP3A4 metabolizes mometasone furoate to 6-beta hydroxy mometasone furoate.

Excretion

Following an intravenous dosing, the terminal half-life was reported to be about 5 hours. Following the inhaled dose of tritiated 1000 mcg mometasone furoate, the radioactivity is excreted mainly in the feces (a mean of 74%), and to a small extent in the urine (a mean of 8%) up to 7 days. No radioactivity was associated with unchanged mometasone furoate in the urine. Absorbed mometasone furoate is cleared from plasma at a rate of approximately 12.5 mL/min/kg, independent of dose. The effective t½ for mometasone furoate following inhalation was 25 hours in adult healthy subjects and in adult patients with asthma.

Special Populations

Hepatic/Renal Impairment: There are no data regarding the specific use of ASMANEX HFA in patients with hepatic or renal impairment.

A study evaluating the administration of a single inhaled dose of 400 mcg mometasone furoate by a dry powder inhaler to adult subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment resulted in only 1 or 2 subjects in each group having detectable peak plasma concentrations of mometasone furoate (ranging from 50-105 pg/mL). The observed peak plasma concentrations appear to increase with severity of hepatic impairment; however, the numbers of detectable levels were few.

Gender and Race: Specific studies to examine the effects of gender and race on the pharmacokinetics of ASMANEX HFA have not been specifically studied.

Geriatrics: The pharmacokinetics of ASMANEX HFA have not been specifically studied in the elderly population.

Drug-Drug Interactions

A single-dose crossover study was conducted to compare the pharmacokinetics of 4 inhalations of the following: mometasone furoate MDI, formoterol MDI, mometasone furoate/formoterol fumarate MDI combination product, and mometasone furoate MDI plus formoterol fumarate MDI administered concurrently. The results of the study indicated that there was no evidence of a pharmacokinetic interaction between mometasone furoate and formoterol.

Inhibitors of Cytochrome P450 Enzymes: Ketoconazole: In a drug interaction study, an inhaled dose of mometasone furoate 400 mcg delivered by a dry powder inhaler was given to 24 adult healthy subjects twice daily for 9 days and ketoconazole 200 mg (as well as placebo) were given twice daily concomitantly on Days 4 to 9. Mometasone furoate plasma concentrations were <150 pg/mL on Day 3 prior to coadministration of ketoconazole or placebo. Following concomitant administration of ketoconazole, 4 out of 12 subjects in the ketoconazole treatment group (n=12) had peak plasma concentrations of mometasone furoate >200 pg/mL on Day 9 (211-324 pg/mL). Mometasone furoate plasma levels appeared to increase and plasma cortisol levels appeared to decrease upon concomitant administration of ketoconazole.

In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 14 times the MRHD on an AUC basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 9 times the MRHD on an AUC basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not have this effect in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (approximately 8 times the MRHD on an AUC basis).

Adult and Adolescent Patients Aged 12 Years of Age and Older

The safety and efficacy of ASMANEX HFA was demonstrated in two randomized, double-blind, placebo- or active-controlled multi-center clinical trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate 100/5 mcg or 200/5 mcg combination product development program. A total of 1509 patients 12 years of age and older with persistent asthma (mean baseline FEV1 of 66% to 73% predicted) were evaluated.

Trial 1: Clinical Trial with ASMANEX HFA 100 mcg

This 26-week, placebo-controlled trial (NCT00383240) conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program evaluated 781 patients 12 years of age and older. Of these patients, 192 patients received ASMANEX HFA 100 mcg and 196 patients received placebo, each administered as 2 inhalations twice daily by metered dose inhalation aerosols. All other maintenance therapies were discontinued. The study included a 2- to 3-week run-in period with ASMANEX HFA 100 mcg, 2 inhalations twice daily. Patients ranged from 12 to 76 years of age, 41% were male and 59% female, and 72% were Caucasian and 28% non-Caucasian. Patients had persistent asthma and were not well controlled on medium dose of inhaled corticosteroids prior to randomization. Mean FEV1 and mean percent predicted FEV1 were similar among all treatment groups (2.33 L, 73%). Thirteen (7%) patients receiving ASMANEX HFA 100 mcg and 46 (23%) patients receiving placebo discontinued the study early due to treatment failure.

The change in mean trough FEV1 from baseline to Week 12 compared to placebo was assessed to evaluate the efficacy of ASMANEX HFA 100 mcg. The change from baseline to week 12 in the mean trough FEV1 was greater among patients receiving ASMANEX HFA 100 mcg 2 inhalations twice daily than among those receiving placebo (treatment difference from placebo 0.12 L and 95% confidence interval [0.05, 0.20]).

Clinically judged deteriorations in asthma or reductions in lung function were also assessed to evaluate the efficacy of ASMANEX HFA 100 mcg. Deteriorations in asthma were defined as any of the following: a 20% decrease in FEV1; a 30% decrease in PEF on two or more consecutive days; emergency treatment, hospitalization, or treatment with systemic corticosteroids or other asthma medications not allowed per protocol. Sixty-five (34%) patients who received ASMANEX HFA 100 mcg reported an event compared to 109 (56%) patients who received placebo.

Treatment of asthma patients with ASMANEX HFA 100 mcg, two inhalations twice daily also resulted in fewer nocturnal awakenings and improved morning peak flow compared to those who received placebo.

Trial 2: Clinical Trial with ASMANEX HFA 200 mcg

This 12-week randomized, double-blind, active-controlled trial (NCT00381485) also conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program evaluated a total of 728 patients 12 years of age and older comparing ASMANEX HFA 200 mcg (n=240 patients), mometasone furoate/formoterol fumarate 200 mcg/5 mcg (n=255 patients), and mometasone furoate/formoterol fumarate 100 mcg/5 mcg (n=233 patients), each administered as 2 inhalations twice daily by metered dose inhalation aerosols. All other maintenance therapies were discontinued. This trial included a 2- to 3-week run-in period with ASMANEX HFA 200 mcg, 2 inhalations twice daily. Patients had persistent asthma and were uncontrolled on high-dose inhaled corticosteroids prior to study entry. Patients ranged from 12 to 84 years of age, 44% were male and 56% female, and 89% were Caucasian and 11% non-Caucasian. Mean FEV1 and mean percent predicted FEV1 values were similar among all treatment groups (2.05 L, 66%). The number of patients who discontinued the trial early due to treatment failure were 11 (5%) in the mometasone furoate/formoterol fumarate 100 mcg/5 mcg group, 8 (3%) in the mometasone furoate/formoterol fumarate 200 mcg/5 mcg group, and 13 (5%) in the ASMANEX HFA 200 mcg group.

In order to assess the added benefit of a higher dose of mometasone in the 200 mcg/actuation mometasone furoate product compared to the lower dose 100 mcg/actuation product, trough FEV1 at 12 weeks was compared between the combination mometasone furoate/formoterol fumarate 200 mcg/5 mcg and 100 mcg/5 mcg treatment groups as a secondary endpoint. Improvement in trough FEV1 from baseline to week 12 in patients who received mometasone furoate 200 mcg in combination with formoterol fumarate 5 mcg was numerically greater than among patients who received mometasone furoate 100 mcg in combination with formoterol fumarate 5 mcg (treatment difference of 0.05 L and 95% confidence interval [-0.02, 0.10]).

Other Studies in Adult and Adolescent Patients

In addition to Trial 1 and Trial 2, the safety and efficacy of mometasone furoate MDI 100 mcg and 200 mcg (each administered as 2 inhalations, twice daily), in comparison to placebo were demonstrated in two other 12-week, placebo-controlled trials which evaluated the mean change in FEV1 from baseline as a primary endpoint. A 26-week trial (NCT00383552) also evaluated the same endpoint with a lower dose of mometasone furoate MDI.

Pediatric Patients Aged 5 to Less Than 12 Years

The safety and efficacy of ASMANEX HFA were demonstrated in a 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial in a total of 583 patients aged 5 to less than 12 years with persistent asthma (mean baseline FEV1 of 79%-predicted) who had been using a low-to-medium dose of ICS with or without LABA for at least 12 weeks prior to study entry. After an approximate 2-week run-in period, subjects were randomized to ASMANEX HFA 50 mcg dose (administered as two inhalations, twice daily), two other doses of ASMANEX HFA, ASMANEX dry-powder inhaler (DPI) or placebo. Patients were 60% male, 71% were Caucasian, and 13% were aged 5 to 6 years old. Primary endpoint results show that after 12 weeks of treatment, ASMANEX HFA 50 mcg (administered as two inhalations, twice daily) was statistically superior to placebo with respect to the improvement from baseline in AM pre-dose percent predicted FEV1 at the end of the dosing interval (6.29%, 95% CI: 3.05, 9.53).

ASMANEX HFA is available in three strengths and supplied in the following package size (TABLE 3):

<div class="scrollingtable"><table width="75%"> <caption> <span>TABLE 3</span> </caption> <col align="center" valign="top" width="40%"/> <col align="center" valign="top" width="30%"/> <col align="center" valign="top" width="30%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Package</th><th align="center" class="Rrule">NDC</th><th align="center" class="Rrule">Strength Identifier <br/>(Color Band)<a class="Sup" href="#footnote-2" name="footnote-reference-2">*</a></th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-2" name="footnote-2">*</a> </dt> <dd>Included on the outer carton, actuator, and canister labels.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule">ASMANEX HFA 50 mcg <br/>120 metered actuations</td><td align="center" class="Rrule">78206-111-01</td><td align="center" class="Rrule">Orange</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule">ASMANEX HFA 100 mcg<br/>120 metered actuations</td><td align="center" class="Rrule">78206-112-01</td><td align="center" class="Rrule">Green</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">ASMANEX HFA 200 mcg<br/>120 metered actuations</td><td align="center" class="Rrule">78206-113-01</td><td align="center" class="Rrule">Blue</td> </tr> </tbody> </table></div>

Each strength is supplied as a pressurized aluminum canister that has a blue plastic actuator integrated with a dose counter and a pink dust cap. Each canister has a net fill weight of 13 grams. Each inhaler is placed into a carton. Each carton contains 1 inhaler.

Initially the dose counter will display "124" actuations. After the initial priming with 4 actuations, the dose counter will read "120" and the inhaler is now ready for use.

Only use the ASMANEX HFA canister with the ASMANEX HFA actuator. Do not use the ASMANEX HFA actuator with any other inhalation drug product. Do not use actuators from other products with the ASMANEX HFA canister.

Do not remove the canister from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.

The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Discard the inhaler when the labeled number of actuations has been used (the dose counter will read "0").

Store at controlled room temperature 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

After priming, store the inhaler with the mouthpiece down or in a horizontal position.

For best results, keep the canister at room temperature before use. Shake well and remove the cap from the mouthpiece of the actuator before using. Keep out of reach of children. Avoid spraying in eyes.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.

Not for Acute Symptoms

Advise patients that ASMANEX HFA is not indicated to relieve acute asthma symptoms, and extra doses should not be used for that purpose. ASMANEX HFA is not a bronchodilator and should not be used to treat status asthmaticus or to relieve acute asthma symptoms. Treat acute asthma symptoms with an inhaled, short-acting beta2-agonist such as albuterol. Prescribe the patient with such medication and instruct the patient on how to use it [see Warnings and Precautions (5.1)].

Instruct patients to seek medical attention immediately if they experience any of the following:

Advise patients not to increase the dose or frequency of ASMANEX HFA. Do not exceed the daily dosage of ASMANEX HFA two inhalations twice daily. If they miss a dose, instruct patients to take their next dose at the same time they normally do.

Advise patients not to stop or reduce ASMANEX HFA therapy without physician/provider guidance since symptoms may recur after discontinuation.

Local Effects

Advise patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with ASMANEX HFA therapy, but at times therapy with ASMANEX HFA may need to be temporarily interrupted under close medical supervision. After dosing, advise patients to rinse their mouth with water and spit out contents without swallowing [see Warnings and Precautions (5.2)].

Immunosuppression

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see Warnings and Precautions (5.3)].

Hypercorticism and Adrenal Suppression

Advise patients that ASMANEX HFA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, instruct patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Instruct patients to slowly taper from systemic corticosteroids if transferring to ASMANEX HFA [see Warnings and Precautions (5.4 and 5.5)].

Reduction in Bone Mineral Density

Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk and should be monitored and, where appropriate, be treated for this condition [see Warnings and Precautions (5.9)].

Reduced Growth Velocity

Inform patients that orally inhaled corticosteroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of pediatric patients taking corticosteroids by any route [see Warnings and Precautions (5.10)].

Glaucoma and Cataracts

Advise patients that long-term use of inhaled corticosteroids may increase the risk of some eye problems (glaucoma or cataracts); consider regular eye examinations [see Warnings and Precautions (5.11)].

Hypersensitivity Reactions Including Anaphylaxis

Advise patients that hypersensitivity reactions, such as urticaria, flushing, allergic dermatitis, bronchospasm, rash, pruritus, angioedema, and anaphylactic reaction, may occur after administration of ASMANEX HFA. Instruct patients to discontinue ASMANEX HFA if such reactions occur [see Warnings and Precautions (5.8)].

Use Daily for Best Effect

Advise patients to use ASMANEX HFA at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 week or longer after starting treatment. If symptoms do not improve after 2 weeks of therapy or if the condition worsens, instruct patients to contact their physician.

Instructions for Use

Instruct patients regarding the following:

Manufactured for: Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USA

{ "type": "p", "children": [], "text": "Manufactured for: Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USA" }

Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom.

{ "type": "p", "children": [], "text": "Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom." }

For patent information: www.organon.com/our-solutions/patent/

{ "type": "p", "children": [], "text": "For patent information: www.organon.com/our-solutions/patent/" }

© 2025 Organon group of companies. All rights reserved.

{ "type": "p", "children": [], "text": "© 2025 Organon group of companies. All rights reserved." }

uspi-og0887-ao-2506r001

{ "type": "p", "children": [], "text": "uspi-og0887-ao-2506r001" }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="16%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <col align="left" valign="top" width="14%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule" colspan="7">Patient Information<br/>ASMANEX<span class="Sup">®</span> HFA (AZ-ma-neks) 50 mcg <br/>ASMANEX<span class="Sup">®</span> HFA 100 mcg<br/>ASMANEX<span class="Sup">®</span> HFA 200 mcg <br/>(mometasone furoate) <br/>Inhalation Aerosol</th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="5" valign="top">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align="right" colspan="2" valign="top">Revised Date: 6/2025</td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">What is ASMANEX HFA?</span> <br/>ASMANEX HFA is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 5 years of age and older. <ul> <li>ASMANEX HFA is not used to treat sudden severe symptoms of asthma.</li> <li>ASMANEX HFA should not be used as a rescue inhaler.</li> <li>It is not known if ASMANEX HFA is safe and effective in children less than 5 years of age.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">Who should not use ASMANEX HFA?<br/>Do not use ASMANEX HFA: </span> <ul> <li>to treat sudden severe symptoms of asthma.</li> <li>if you are allergic to mometasone furoate or any of the ingredients in ASMANEX HFA. See the end of this Patient Information leaflet for a complete list of ingredients in ASMANEX HFA.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">What should I tell my doctor before and during treatment with ASMANEX HFA?<br/>Before you use ASMANEX HFA, tell your healthcare provider if you:</span> <ul> <li>have liver problems.</li> <li>have osteoporosis.</li> <li>have an immune system problem.</li> <li>have eye problems such as increased pressure in the eye, glaucoma, cataracts, blurred vision, or other changes in your vision.</li> <li>are allergic to any medicines.</li> <li>are exposed to chickenpox or measles.</li> <li>have or had tuberculosis (TB).</li> <li>have any other medical problems.</li> <li>are pregnant or planning to become pregnant. It is not known if ASMANEX HFA may harm your unborn baby.</li> <li>are breastfeeding. It is not known if ASMANEX HFA passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will either take ASMANEX HFA or breastfeed.</li> </ul> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/>ASMANEX HFA may affect the way other medicines work, and other medicines may affect how ASMANEX HFA works.<br/> <span class="Bold">Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIV medicines such as:</span></td> </tr> <tr> <td align="left" class="Lrule"> <ul> <li>ritonavir</li> <li>atazanavir</li> <li>cobicistat-containing products</li> </ul> </td><td align="left"> <ul> <li>ketoconazole</li> <li>clarithromycin</li> </ul> </td><td align="left"> <ul> <li>nefazodone</li> <li>saquinavir</li> </ul> </td><td align="left"> <ul> <li>nelfinavir</li> <li>telithromycin</li> </ul> </td><td align="left" class="Rrule" colspan="3"> <ul> <li>indinavir</li> <li>itraconazole</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7">Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.<br/>For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your doctor may wish to monitor you carefully.<br/> Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7"><span class="Bold">How should I use ASMANEX HFA?<br/>Read the step-by-step instructions for using ASMANEX HFA in the Instructions for Use.</span> <ul> <li>Use ASMANEX HFA exactly as prescribed. <span class="Bold">Do not</span> use ASMANEX HFA more often than prescribed.</li> <li>You must use ASMANEX HFA regularly. It may take 1 week or longer after you start using ASMANEX HFA for your asthma symptoms to get better. Do not stop using ASMANEX HFA even if you are feeling better, unless your healthcare provider tells you to.</li> <li> <span class="Bold">Do not</span> change or stop using ASMANEX HFA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.</li> <li>ASMANEX HFA comes in 3 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between ASMANEX HFA and your other inhaled medicines, including their prescribed use and the way they look.</li> <li>For children aged 5 to less than 12 years, use ASMANEX HFA 50 mcg.</li> <li>For adults and adolescents 12 years of age and older, use ASMANEX HFA 100 mcg or 200 mcg.</li> <li>Take ASMANEX HFA every day, with 2 puffs in the morning and 2 puffs in the evening.</li> <li>If you miss a dose of ASMANEX HFA, skip your missed dose and take your next dose at your regular time. Do not take ASMANEX HFA more often or use more puffs than you have been prescribed.</li> <li>If you take more ASMANEX HFA than your healthcare provider has prescribed, call your healthcare provider right away. </li> <li>ASMANEX HFA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX HFA. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you. </li> <li>Do not use the ASMANEX HFA canister or actuator with any other medicines. Do not use any other medicine canister or actuator with ASMANEX HFA.</li> <li>Rinse your mouth with water after each dose (2 puffs) of ASMANEX HFA. Spit out the water. Do not swallow it. This will help to lessen the chance of getting a yeast infection (thrush) in your mouth and throat.</li> <li>Do not spray ASMANEX HFA in your eyes. If you accidentally get ASMANEX HFA in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.</li> <li> <span class="Bold">Call your healthcare provider or get medical care right away if:</span> <ul> <li>your breathing problems worsen with ASMANEX HFA</li> <li>you need to use your rescue inhaler more often than usual </li> <li>your rescue inhaler does not work as well for you at relieving symptoms </li> <li>you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row </li> <li>you use 1 whole canister of your rescue inhaler within 8 weeks </li> <li>your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you</li> <li>you have asthma and your symptoms do not improve after using ASMANEX HFA regularly for 1 to 2 weeks </li> </ul> </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">What are the possible side effects of ASMANEX HFA?<br/>ASMANEX HFA can cause serious side effects, including</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7"> <ul> <li> <span class="Bold">Thrush in your mouth and throat.</span> You may develop thrush, a yeast infection (Candida albicans), in your mouth or throat. After each dose (2 puffs) of ASMANEX HFA, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.</li> <li> <span class="Bold">Immune system effects and a higher chance for infections.</span> <br/>Tell your healthcare provider about any signs of infection such as:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule"> <ul class="Circle"> <li>fever</li> </ul> </td><td align="left"> <ul class="Circle"> <li>feeling tired</li> </ul> </td><td align="left"> <ul class="Circle"> <li>body aches</li> </ul> </td><td align="left"> <ul class="Circle"> <li>vomiting</li> </ul> </td><td align="left"> <ul class="Circle"> <li>pain</li> </ul> </td><td align="left"> <ul class="Circle"> <li>nausea</li> </ul> </td><td align="left" class="Rrule"> <ul class="Circle"> <li>chills</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7" valign="top"> <ul> <li> <span class="Bold">Adrenal insufficiency that can lead to death</span> can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX HFA than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule" colspan="2" valign="top"> <ul class="Circle"> <li>feeling tired or exhausted (fatigue)</li> <li>weakness</li> </ul> </td><td align="left" colspan="2"> <ul class="Circle"> <li>lack of energy</li> <li>nausea and vomiting</li> </ul> </td><td align="left" class="Rrule" colspan="3"> <ul class="Circle"> <li>low blood pressure (hypotension)</li> <li>dizziness or feeling faint</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7" valign="top"> <ul> <li> <span class="Bold">Increased wheezing right after taking ASMANEX HFA.</span> Always have a rescue inhaler with you to treat sudden wheezing.</li> <li> <span class="Bold">Serious allergic reactions. </span>Stop taking ASMANEX HFA and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule"> <ul class="Circle"> <li>rash</li> </ul> </td><td align="left"> <ul class="Circle"> <li>hives</li> </ul> </td><td align="left" colspan="3"> <ul class="Circle"> <li>swelling, including swelling of the face, mouth, and tongue</li> </ul> </td><td align="left" class="Rrule" colspan="2"> <ul class="Circle"> <li>breathing problems</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"> <ul> <li> <span class="Bold">Lower bone mineral density. </span>This may be a problem for people who already have a higher chance for low bone density (osteoporosis).</li> <li> <span class="Bold">Slowed growth in children. </span>A child's growth should be checked often.</li> <li> <span class="Bold">Eye problems including glaucoma, cataracts, and blurred vision. </span>You should have regular eye exams while using ASMANEX HFA.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">The most common side effects reported while using ASMANEX HFA include:</span></td> </tr> <tr> <td align="left" class="Lrule" colspan="3"> <ul> <li>inflammation of the nose and throat (nasopharyngitis)</li> <li>inflammation of the sinuses (sinusitis)</li> </ul> </td><td align="left" colspan="2"> <ul> <li>headache</li> <li>bronchitis</li> </ul> </td><td align="left" class="Rrule" colspan="2"> <ul> <li>flu infection (influenza)</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">Other side effects: </span>Worsening asthma or sudden asthma attacks have been reported with the use of inhaled mometasone furoate. <br/>Tell your healthcare provider about any side effect that bothers you or that does not go away.<br/>These are not all the side effects with ASMANEX HFA. Ask your healthcare provider or pharmacist for more information.<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">How should I store ASMANEX HFA?</span> <ul> <li>Store ASMANEX HFA at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>After priming, store the inhaler with the mouthpiece down or sideways. </li> <li>The contents of your ASMANEX HFA are under pressure. <span class="Bold">Do not</span> puncture. <span class="Bold">Do not</span> use or store near heat or open flame. Storage above 120°F may cause the canister to burst.</li> <li> <span class="Bold">Do not</span> throw container into fire or incinerator.</li> <li> <span class="Bold">Keep ASMANEX HFA and all medicines out of the reach of children.</span> </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">General Information about the safe and effective use of ASMANEX HFA.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ASMANEX HFA for a condition for which it was not prescribed. Do not give your ASMANEX HFA to other people, even if they have the same condition that you have. It may harm them.<br/>This Patient Information leaflet summarizes the most important information about ASMANEX HFA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ASMANEX HFA that was written for healthcare professionals.<br/>For more information about ASMANEX HFA go to www.ASMANEX.com, or to report side effects call 1-844-674-3200.</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="7" valign="top"><span class="Bold">What are the ingredients in ASMANEX HFA?</span> <br/>Active ingredient: mometasone furoate <br/>Inactive ingredients: hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane), ethanol and oleic acid</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"16%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<col align=\"left\" valign=\"top\" width=\"14%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"center\" class=\"Lrule Rrule\" colspan=\"7\">Patient Information<br/>ASMANEX<span class=\"Sup\">®</span> HFA (AZ-ma-neks) 50 mcg <br/>ASMANEX<span class=\"Sup\">®</span> HFA 100 mcg<br/>ASMANEX<span class=\"Sup\">®</span> HFA 200 mcg <br/>(mometasone furoate) <br/>Inhalation Aerosol</th>\n</tr>\n</thead>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" colspan=\"5\" valign=\"top\">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\" colspan=\"2\" valign=\"top\">Revised Date: 6/2025</td>\n</tr>\n</tfoot>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">What is ASMANEX HFA?</span>\n<br/>ASMANEX HFA is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 5 years of age and older. \t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t<ul>\n<li>ASMANEX HFA is not used to treat sudden severe symptoms of asthma.</li>\n<li>ASMANEX HFA should not be used as a rescue inhaler.</li>\n<li>It is not known if ASMANEX HFA is safe and effective in children less than 5 years of age.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">Who should not use ASMANEX HFA?<br/>Do not use ASMANEX HFA: </span>\n<ul>\n<li>to treat sudden severe symptoms of asthma.</li>\n<li>if you are allergic to mometasone furoate or any of the ingredients in ASMANEX HFA. See the end of this Patient Information leaflet for a complete list of ingredients in ASMANEX HFA.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">What should I tell my doctor before and during treatment with ASMANEX HFA?<br/>Before you use ASMANEX HFA, tell your healthcare provider if you:</span>\n<ul>\n<li>have liver problems.</li>\n<li>have osteoporosis.</li>\n<li>have an immune system problem.</li>\n<li>have eye problems such as increased pressure in the eye, glaucoma, cataracts, blurred vision, or other changes in your vision.</li>\n<li>are allergic to any medicines.</li>\n<li>are exposed to chickenpox or measles.</li>\n<li>have or had tuberculosis (TB).</li>\n<li>have any other medical problems.</li>\n<li>are pregnant or planning to become pregnant. It is not known if ASMANEX HFA may harm your unborn baby.</li>\n<li>are breastfeeding. It is not known if ASMANEX HFA passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will either take ASMANEX HFA or breastfeed.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/>ASMANEX HFA may affect the way other medicines work, and other medicines may affect how ASMANEX HFA works.<br/>\n<span class=\"Bold\">Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIV medicines such as:</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul>\n<li>ritonavir</li>\n<li>atazanavir</li>\n<li>cobicistat-containing products</li>\n</ul>\n</td><td align=\"left\">\n<ul>\n<li>ketoconazole</li>\n<li>clarithromycin</li>\n</ul>\n</td><td align=\"left\">\n<ul>\n<li>nefazodone</li>\n<li>saquinavir</li>\n</ul>\n</td><td align=\"left\">\n<ul>\n<li>nelfinavir</li>\n<li>telithromycin</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"3\">\n<ul>\n<li>indinavir</li>\n<li>itraconazole</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.<br/>For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your doctor may wish to monitor you carefully.<br/> Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\"><span class=\"Bold\">How should I use ASMANEX HFA?<br/>Read the step-by-step instructions for using ASMANEX HFA in the Instructions for Use.</span>\n<ul>\n<li>Use ASMANEX HFA exactly as prescribed. <span class=\"Bold\">Do not</span> use ASMANEX HFA more often than prescribed.</li>\n<li>You must use ASMANEX HFA regularly. It may take 1 week or longer after you start using ASMANEX HFA for your asthma symptoms to get better. Do not stop using ASMANEX HFA even if you are feeling better, unless your healthcare provider tells you to.</li>\n<li>\n<span class=\"Bold\">Do not</span> change or stop using ASMANEX HFA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.</li>\n<li>ASMANEX HFA comes in 3 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between ASMANEX HFA and your other inhaled medicines, including their prescribed use and the way they look.</li>\n<li>For children aged 5 to less than 12 years, use ASMANEX HFA 50 mcg.</li>\n<li>For adults and adolescents 12 years of age and older, use ASMANEX HFA 100 mcg or 200 mcg.</li>\n<li>Take ASMANEX HFA every day, with 2 puffs in the morning and 2 puffs in the evening.</li>\n<li>If you miss a dose of ASMANEX HFA, skip your missed dose and take your next dose at your regular time. Do not take ASMANEX HFA more often or use more puffs than you have been prescribed.</li>\n<li>If you take more ASMANEX HFA than your healthcare provider has prescribed, call your healthcare provider right away. </li>\n<li>ASMANEX HFA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX HFA. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you. </li>\n<li>Do not use the ASMANEX HFA canister or actuator with any other medicines. Do not use any other medicine canister or actuator with ASMANEX HFA.</li>\n<li>Rinse your mouth with water after each dose (2 puffs) of ASMANEX HFA. Spit out the water. Do not swallow it. This will help to lessen the chance of getting a yeast infection (thrush) in your mouth and throat.</li>\n<li>Do not spray ASMANEX HFA in your eyes. If you accidentally get ASMANEX HFA in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.</li>\n<li>\n<span class=\"Bold\">Call your healthcare provider or get medical care right away if:</span>\n<ul>\n<li>your breathing problems worsen with ASMANEX HFA</li>\n<li>you need to use your rescue inhaler more often than usual </li>\n<li>your rescue inhaler does not work as well for you at relieving symptoms </li>\n<li>you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row </li>\n<li>you use 1 whole canister of your rescue inhaler within 8 weeks </li>\n<li>your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you</li>\n<li>you have asthma and your symptoms do not improve after using ASMANEX HFA regularly for 1 to 2 weeks </li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">What are the possible side effects of ASMANEX HFA?<br/>ASMANEX HFA can cause serious side effects, including</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\">\n<ul>\n<li>\n<span class=\"Bold\">Thrush in your mouth and throat.</span> You may develop thrush, a yeast infection (Candida albicans), in your mouth or throat. After each dose (2 puffs) of ASMANEX HFA, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.</li>\n<li>\n<span class=\"Bold\">Immune system effects and a higher chance for infections.</span>\n<br/>Tell your healthcare provider about any signs of infection such as:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul class=\"Circle\">\n<li>fever</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>feeling tired</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>body aches</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>vomiting</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>pain</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>nausea</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\">\n<ul class=\"Circle\">\n<li>chills</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\">\n<ul>\n<li>\n<span class=\"Bold\">Adrenal insufficiency that can lead to death</span> can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX HFA than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"2\" valign=\"top\">\n<ul class=\"Circle\">\n<li>feeling tired or exhausted (fatigue)</li>\n<li>weakness</li>\n</ul>\n</td><td align=\"left\" colspan=\"2\">\n<ul class=\"Circle\">\n<li>lack of energy</li>\n<li>nausea and vomiting</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"3\">\n<ul class=\"Circle\">\n<li>low blood pressure (hypotension)</li>\n<li>dizziness or feeling faint</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\">\n<ul>\n<li>\n<span class=\"Bold\">Increased wheezing right after taking ASMANEX HFA.</span> Always have a rescue inhaler with you to treat sudden wheezing.</li>\n<li>\n<span class=\"Bold\">Serious allergic reactions. </span>Stop taking ASMANEX HFA and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul class=\"Circle\">\n<li>rash</li>\n</ul>\n</td><td align=\"left\">\n<ul class=\"Circle\">\n<li>hives</li>\n</ul>\n</td><td align=\"left\" colspan=\"3\">\n<ul class=\"Circle\">\n<li>swelling, including swelling of the face, mouth, and tongue</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"2\">\n<ul class=\"Circle\">\n<li>breathing problems</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\">\n<ul>\n<li>\n<span class=\"Bold\">Lower bone mineral density. </span>This may be a problem for people who already have a higher chance for low bone density (osteoporosis).</li>\n<li>\n<span class=\"Bold\">Slowed growth in children. </span>A child's growth should be checked often.</li>\n<li>\n<span class=\"Bold\">Eye problems including glaucoma, cataracts, and blurred vision. </span>You should have regular eye exams while using ASMANEX HFA.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">The most common side effects reported while using ASMANEX HFA include:</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" colspan=\"3\">\n<ul>\n<li>inflammation of the nose and throat (nasopharyngitis)</li>\n<li>inflammation of the sinuses (sinusitis)</li>\n</ul>\n</td><td align=\"left\" colspan=\"2\">\n<ul>\n<li>headache</li>\n<li>bronchitis</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\" colspan=\"2\">\n<ul>\n<li>flu infection (influenza)</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">Other side effects: </span>Worsening asthma or sudden asthma attacks have been reported with the use of inhaled mometasone furoate. <br/>Tell your healthcare provider about any side effect that bothers you or that does not go away.<br/>These are not all the side effects with ASMANEX HFA. Ask your healthcare provider or pharmacist for more information.<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">How should I store ASMANEX HFA?</span>\n<ul>\n<li>Store ASMANEX HFA at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>After priming, store the inhaler with the mouthpiece down or sideways. </li>\n<li>The contents of your ASMANEX HFA are under pressure. <span class=\"Bold\">Do not</span> puncture. <span class=\"Bold\">Do not</span> use or store near heat or open flame. Storage above 120°F may cause the canister to burst.</li>\n<li>\n<span class=\"Bold\">Do not</span> throw container into fire or incinerator.</li>\n<li>\n<span class=\"Bold\">Keep ASMANEX HFA and all medicines out of the reach of children.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">General Information about the safe and effective use of ASMANEX HFA.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ASMANEX HFA for a condition for which it was not prescribed. Do not give your ASMANEX HFA to other people, even if they have the same condition that you have. It may harm them.<br/>This Patient Information leaflet summarizes the most important information about ASMANEX HFA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ASMANEX HFA that was written for healthcare professionals.<br/>For more information about ASMANEX HFA go to www.ASMANEX.com, or to report side effects call 1-844-674-3200.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"7\" valign=\"top\"><span class=\"Bold\">What are the ingredients in ASMANEX HFA?</span>\n<br/>Active ingredient: mometasone furoate <br/>Inactive ingredients: hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane), ethanol and oleic acid</td>\n</tr>\n</tbody>\n</table></div>" }

ASMANEX® HFA (AZ-ma-neks) 50 mcg ASMANEX® HFA 100 mcg ASMANEX® HFA 200 mcg (mometasone furoate)Inhalation Aerosol

{ "type": "p", "children": [], "text": "\nASMANEX® HFA (AZ-ma-neks) 50 mcg ASMANEX® HFA 100 mcg ASMANEX® HFA 200 mcg (mometasone furoate)Inhalation Aerosol\n" }

Read these Instructions for Use before you start using ASMANEX HFA and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.

{ "type": "p", "children": [], "text": "Read these Instructions for Use before you start using ASMANEX HFA and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment." }

The parts of your ASMANEX HFA:

{ "type": "p", "children": [], "text": "\nThe parts of your ASMANEX HFA:\n" }

There are 2 main parts to your ASMANEX HFA inhaler: the metal canister that holds the medicine and the blue plastic actuator that sprays the medicine from the canister.

{ "type": "p", "children": [], "text": "There are 2 main parts to your ASMANEX HFA inhaler: the metal canister that holds the medicine and the blue plastic actuator that sprays the medicine from the canister." }

{ "type": "ul", "children": [ "The inhaler also has a pink cap that covers the mouthpiece of the actuator (see Figure 1). The cap from the mouthpiece must be removed before use. The inhaler contains \"120\" actuations (puffs).\n" ], "text": "" }

                         Figure 1

{ "type": "p", "children": [], "text": "                         Figure 1" }

{ "type": "ul", "children": [ "The inhaler comes with a dose counter located on the plastic actuator (see Figure 1). The counter display will show the number of actuations (puffs) of medicine remaining. The first time you use ASMANEX HFA the dose counter will show \"124\" actuations remaining. Each time you press the canister, a puff of medicine is released and the counter will count down by 1. The counter will stop counting at 0." ], "text": "" }

Important Information:

{ "type": "p", "children": [], "text": "\nImportant Information:\n" }

{ "type": "ul", "children": [ "Use ASMANEX HFA exactly as your healthcare provider tells you to. Adults may assist children with using ASMANEX HFA as prescribed. Children may use ASMANEX HFA with or without a spacer device.", "\nRemove the cap from the mouthpiece of the actuator before using ASMANEX HFA.\n", "\nDo not remove the canister from the actuator because:\nyou may not receive the correct amount of medication.\nthe dose counter may not function properly. \nif you try to insert the canister back into the actuator this may cause the dose counter to count down by 1 and may discharge a puff. \n\n", "Use the ASMANEX HFA canister only with the actuator supplied with the product. Do not use parts of the ASMANEX HFA inhaler with parts from any other inhalation medicine." ], "text": "" }

Before using your ASMANEX HFA:

{ "type": "p", "children": [], "text": "\nBefore using your ASMANEX HFA:\n" }

Remove the cap from the mouthpiece of the actuator before using ASMANEX HFA (see Figure 2). Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

{ "type": "p", "children": [], "text": "\nRemove the cap from the mouthpiece of the actuator before using ASMANEX HFA (see Figure 2). Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator." }

                Figure 2

{ "type": "p", "children": [], "text": "                Figure 2" }

Priming your ASMANEX HFA Inhaler:

{ "type": "p", "children": [], "text": "\nPriming your ASMANEX HFA Inhaler:\n" }

Before you use ASMANEX HFA for the first time, you must prime the inhaler.

{ "type": "p", "children": [], "text": "\nBefore you use ASMANEX HFA for the first time, you must prime the inhaler.\n" }

{ "type": "", "children": [], "text": "" }

Using your ASMANEX HFA:

{ "type": "p", "children": [], "text": "\nUsing your ASMANEX HFA:\n" }

{ "type": "", "children": [], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="bottom" width="50%"/> <col align="center" valign="bottom" width="50%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig3"></a><img alt="Figure 3" src="/dailymed/image.cfm?name=asmanex-hfa-04.jpg&amp;setid=0c6d63da-41bc-4894-bead-198e66c848ac"/></td><td align="center"><a name="fig4"></a><img alt="Figure 4" src="/dailymed/image.cfm?name=asmanex-hfa-05.jpg&amp;setid=0c6d63da-41bc-4894-bead-198e66c848ac"/></td> </tr> <tr> <td align="left"><span class="Bold">                              Figure 3</span></td><td align="center"><span class="Bold">Figure 4</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"bottom\" width=\"50%\"/>\n<col align=\"center\" valign=\"bottom\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig3\"></a><img alt=\"Figure 3\" src=\"/dailymed/image.cfm?name=asmanex-hfa-04.jpg&amp;setid=0c6d63da-41bc-4894-bead-198e66c848ac\"/></td><td align=\"center\"><a name=\"fig4\"></a><img alt=\"Figure 4\" src=\"/dailymed/image.cfm?name=asmanex-hfa-05.jpg&amp;setid=0c6d63da-41bc-4894-bead-198e66c848ac\"/></td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">                              Figure 3</span></td><td align=\"center\"><span class=\"Bold\">Figure 4</span></td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "", "children": [], "text": "" }

After using your ASMANEX HFA inhaler:

{ "type": "p", "children": [], "text": "\nAfter using your ASMANEX HFA inhaler:\n" }

{ "type": "", "children": [], "text": "" }

                  Figure 5

{ "type": "p", "children": [], "text": "                  Figure 5" }

{ "type": "", "children": [], "text": "" }

Reading the counter:

{ "type": "p", "children": [], "text": "\nReading the counter:\n" }

{ "type": "ul", "children": [ "The dose counter identifies the number of inhalations (puffs) left in your inhaler (see Figure 6).", "The counter will count down each time you release a puff of medicine (either when preparing your ASMANEX HFA inhaler for use or when using the medicine)." ], "text": "" }

         Figure 6

{ "type": "p", "children": [], "text": "         Figure 6" }

When to replace your ASMANEX HFA:

{ "type": "p", "children": [], "text": "\nWhen to replace your ASMANEX HFA:\n" }

{ "type": "ul", "children": [ "It is important that you pay attention to the number of inhalations (puffs) left in your ASMANEX HFA inhaler by reading the counter.", "When the counter reads \"20\", you should refill your prescription or ask your healthcare provider if you need a new prescription for ASMANEX HFA. ", "Throw away ASMANEX HFA after the counter reaches \"0\", indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.", "Never try to change the numbers on the counter or remove the counter from the actuator.", "Do not use the inhaler after the expiration date." ], "text": "" }

How to clean your ASMANEX HFA:

{ "type": "p", "children": [], "text": "\nHow to clean your ASMANEX HFA:\n" }

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

{ "type": "p", "children": [], "text": "The mouthpiece should be cleaned using a dry wipe after every 7 days of use." }

Routine cleaning instructions:

{ "type": "p", "children": [], "text": "Routine cleaning instructions:" }

{ "type": "ul", "children": [ "Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth. Do not wash or put any parts of your inhaler in water. Put the cap back on the mouthpiece after cleaning.", "Do not remove the canister from the actuator.", "Do not attempt to unblock the actuator with a sharp object, such as a pin." ], "text": "" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Manufactured for: Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USA

{ "type": "p", "children": [], "text": "Manufactured for: Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USA" }

Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom.For patent information: www.organon.com/our-solutions/patent/The trademarks depicted herein are owned by their respective companies.© 2025 Organon group of companies. All rights reserved.

{ "type": "p", "children": [], "text": "Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom.For patent information: www.organon.com/our-solutions/patent/The trademarks depicted herein are owned by their respective companies.© 2025 Organon group of companies. All rights reserved." }

Revised: 6/2025usppi-og0887-ao-2506r001

{ "type": "p", "children": [], "text": "Revised: 6/2025usppi-og0887-ao-2506r001" }

NDC 78206-112-01

{ "type": "p", "children": [], "text": "NDC 78206-112-01" }

Asmanex® HFA(mometasone furoate) Inhalation Aerosol

{ "type": "p", "children": [], "text": "\nAsmanex® HFA(mometasone furoate)\nInhalation Aerosol\n" }

100 mcg per actuation

{ "type": "p", "children": [], "text": "\n100 mcg per actuation\n" }

For oral inhalation only

{ "type": "p", "children": [], "text": "\nFor oral inhalation only\n" }

Asmanex HFA canister to be usedwith Asmanex HFA actuator only.

{ "type": "p", "children": [], "text": "Asmanex HFA canister to be usedwith Asmanex HFA actuator only." }

SHAKE WELL BEFORE USING.

{ "type": "p", "children": [], "text": "\nSHAKE WELL BEFORE USING.\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

120 Metered ActuationsNet Wt. 13g

{ "type": "p", "children": [], "text": "120 Metered ActuationsNet Wt. 13g" }

NDC 78206-113-01

{ "type": "p", "children": [], "text": "NDC 78206-113-01" }

Asmanex® HFA(mometasone furoate) Inhalation Aerosol

{ "type": "p", "children": [], "text": "\nAsmanex® HFA(mometasone furoate)\nInhalation Aerosol\n" }

200 mcg per actuation

{ "type": "p", "children": [], "text": "\n200 mcg per actuation\n" }

For oral inhalation only

{ "type": "p", "children": [], "text": "\nFor oral inhalation only\n" }

Asmanex HFA canister to be usedwith Asmanex HFA actuator only.

{ "type": "p", "children": [], "text": "Asmanex HFA canister to be usedwith Asmanex HFA actuator only." }

SHAKE WELL BEFORE USING.

{ "type": "p", "children": [], "text": "\nSHAKE WELL BEFORE USING.\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

120 Metered ActuationsNet Wt. 13g

{ "type": "p", "children": [], "text": "120 Metered ActuationsNet Wt. 13g" }

NDC 78206-111-01

{ "type": "p", "children": [], "text": "NDC 78206-111-01" }

Asmanex® HFA(mometasone furoate) Inhalation Aerosol

{ "type": "p", "children": [], "text": "\nAsmanex® HFA(mometasone furoate)\n\nInhalation Aerosol\n" }

50 mcg per actuation

{ "type": "p", "children": [], "text": "\n50 mcg per actuation\n" }

For oral inhalation only

{ "type": "p", "children": [], "text": "\nFor oral inhalation only\n" }

Asmanex HFA canister to be usedwith Asmanex HFA actuator only.

{ "type": "p", "children": [], "text": "Asmanex HFA canister to be usedwith Asmanex HFA actuator only." }

SHAKE WELL BEFORE USING.

{ "type": "p", "children": [], "text": "\nSHAKE WELL BEFORE USING.\n" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

120 Metered ActuationsNet Wt. 13g

{ "type": "p", "children": [], "text": "120 Metered ActuationsNet Wt. 13g" }

Mometasone furoate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older.

Mometasone furoate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older.

Administer mometasone furoate nasal spray by the nasal route only.

Initial Priming

Prior to initial use of mometasone furoate nasal spray, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming.

Repriming (as needed)

If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.

The recommended dosage for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older is mometasone furoate nasal spray 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril once daily (total daily dose of 200 mcg).

In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril once daily (total daily dose of 200 mcg) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

The recommended dosage for the treatment of chronic rhinosinusitis with nasal polyps in adults 18 years and older is mometasone furoate nasal spray 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril twice daily (total daily dose of 400 mcg). A dose of 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients.

Nasal spray: 50 mcg of mometasone furoate in each spray.

{ "type": "p", "children": [], "text": "Nasal spray: 50 mcg of mometasone furoate in each spray. " }

Mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients [see Warnings and Precautions (5.3), Description (11)].

{ "type": "p", "children": [], "text": "Mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients [see Warnings and Precautions (5.3), Description (11)].\n" }

Epistaxis

Epistaxis was observed more frequently in patients with allergic rhinitis and patients with chronic rhinosinusitis with nasal polyps who received mometasone furoate nasal spray than those who received placebo [see Adverse Reactions (6.1)].

Candida Infection

Localized infections of the nose and pharynx with Candida albicans has occurred from nasal administration of mometasone furoate. When such an infection develops, use of mometasone furoate nasal spray should be discontinued and appropriate local or systemic therapy instituted, if needed.

Nasal Septum Perforation

Instances of nasal septum perforation occurred in patients following the nasal application of corticosteroids, including mometasone furoate nasal spray. As with any long-term topical treatment of the nasal cavity, patients using mometasone furoate nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Glaucoma and cataracts may be reported with systemic and topical (including nasal, inhaled and ophthalmic) corticosteroid use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use mometasone furoate nasal spray long term [see Adverse Reactions (6)].

Hypersensitivity reactions including instances of wheezing may occur after the nasal administration of mometasone furoate monohydrate. Discontinue mometasone furoate nasal spray if such reactions occur [see Contraindications (4)].

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective Prescribing Information for VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.

Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including mometasone furoate nasal spray, are used at higher-than-recommended dosages [see Dosage and Administration (2)] or in patients at risk for such effects. If such changes occur, the dosage of mometasone furoate nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

Corticosteroids, including mometasone furoate nasal spray may cause a reduction in growth velocity when administered to pediatric patients. Routinely, monitor the growth of pediatric patients receiving mometasone furoate nasal spray. To minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Allergic Rhinitis

Adults and pediatric patients 12 years of age and older

In controlled U.S. and international clinical studies, a total of 3,210 adult and pediatric patients 12 years and older with allergic rhinitis received treatment with mometasone furoate nasal spray at doses of 50 to 800 mcg/day. The majority of patients (n=2,103) were treated with 200 mcg/day. A total of 350 adult and pediatric patients 12 years and older have been treated for one year or longer. Adverse reactions did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators.

All adverse reactions (regardless of relationship to treatment) reported by 5% or more of adult and pediatric patients ages 12 years and older who received mometasone furoate nasal spray, 200 mcg/day vs. placebo and that were more common with mometasone furoate nasal spray than placebo, are displayed in Table 1 below.

Table 1: Adult and Pediatric Patients 12 Years and Older – Adverse Reactions from Controlled Clinical Trials in Seasonal Allergic and Perennial Allergic Rhinitis (Percent of Patients Reporting)

<div class="scrollingtable"><table frame="box" rules="all"> <thead> <tr align="center" class="First Last"> <td><span class="Bold"> </span></td><td align="center"><span class="Bold">Mometasone Furoate Nasal Spray</span><span class="Bold"> <br/>200 mcg </span><span class="Bold"> <br/>(n = 2,103)</span><span class="Bold"> <br/>%</span></td><td><span class="Bold">Vehicle Placebo </span><span class="Bold"> <br/>(n = 1,671)</span><span class="Bold"> <br/>%</span></td> </tr> </thead> <tbody> <tr class="First"> <td> Headache </td><td align="center"> 26 </td><td align="center"> 22 </td> </tr> <tr> <td> Viral Infection </td><td align="center"> 14 </td><td align="center"> 11 </td> </tr> <tr> <td> Pharyngitis </td><td align="center"> 12 </td><td align="center"> 10 </td> </tr> <tr> <td> Epistaxis/Blood-Tinged Mucus </td><td align="center"> 11 </td><td align="center"> 6 </td> </tr> <tr> <td> Coughing </td><td align="center"> 7 </td><td align="center"> 6 </td> </tr> <tr> <td> Upper Respiratory Tract Infection </td><td align="center"> 6 </td><td align="center"> 2 </td> </tr> <tr> <td> Dysmenorrhea </td><td align="center"> 5 </td><td align="center"> 3 </td> </tr> <tr> <td> Musculoskeletal Pain </td><td align="center"> 5 </td><td align="center"> 3 </td> </tr> <tr class="Last"> <td> Sinusitis </td><td align="center"> 5 </td><td align="center"> 3 </td> </tr> </tbody> </table></div>

Other adverse reactions which occurred in less than 5% but greater than or equal to 2% of adult and pediatric patients (ages 12 years and older) treated with mometasone furoate nasal spray 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis.

Chronic Rhinosinusitis with Nasal Polyps

Adults 18 years of age and older

In controlled clinical studies, the types of adverse reactions observed in patients with chronic rhinosinusitis with nasal polyps were similar to those observed in patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received mometasone furoate nasal spray at doses of 200 mcg once or twice daily for up to 4 months for treatment of chronic rhinosinusitis with nasal polyps. The overall incidence of adverse reactions for patients treated with mometasone furoate nasal spray was comparable to patients with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo.

Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with mometasone furoate nasal spray primarily in patients treated for longer than 4 weeks.

The following adverse reactions have been identified during the post-marketing period for mometasone furoate nasal spray: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell, nasal septal perforation, and vision blurred. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Inhibitors of Cytochrome P450 3A4:  Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome CYP3A4 in the metabolism of this compound.

Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of mometasone furoate nasal spray with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Clinical Pharmacology (12.3)]. Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

Risk Summary

Mometasone is minimally absorbed systemically following nasal use, and maternal use is not expected to result in fetal exposure to the drug. Available data from observational studies of mometasone use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies with pregnant mice, rats, or rabbits (subcutaneous, subcutaneous/topical dermal/oral, and topical dermal/oral, respectively), mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m2 or AUC basis [see Data]. However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 

Data

Animal Data

In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily intranasal dose (MRDID) (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the MRDID (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). No toxicity was observed with a dose that produced an exposure less than the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above). 

In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the MRDID (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above). 

In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the MRDID (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg). There were no findings at a dose less than the MRDID (on a mcg/m2 basis with a maternal subcutaneous dose of 7.5 mcg/kg). 

Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the MRDID (on mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the MRDID (on a mcg/m2 basis with a maternal oral dose of 700 mcg/kg). At approximately 110 times the MRDID (on a mcg/m2 basis with a maternal oral dose of 2,800 mcg/kg), most litters were aborted or resorbed. No effects were observed at a dose approximately 6 times the MRDID (on a mcg/m2 basis with a maternal oral dose of 140 mcg/kg).

Risk Summary

There are no available data on the presence of mometasone furoate nasal spray in human milk, the effects on the breastfed child, or the effects on milk production. However, mometasone is minimally absorbed systemically by the mother following nasal use, and breastfeeding is not expected to result in exposure of the infant to mometasone. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mometasone furoate nasal spray and any potential adverse effects on the breastfed infant from mometasone furoate nasal spray or from the underlying maternal condition. 

The safety and effectiveness of mometasone furoate nasal spray for prophylaxis of the nasal symptoms of seasonal allergic rhinitis in pediatric patients 12 years of age and older have been established [see Adverse Reactions (6.1) and Clinical Studies (14.1)]. Use of mometasone furoate nasal spray forthis indication is supported by evidence from controlled trials in adult and pediatric patients 12 years of age and older [see Clinical Studies (14.1)]. 

The safety and effectiveness of mometasone furoate nasal spray for the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients less than 18 years of age have not been established. Effectiveness was not demonstrated in one 4-month trial conducted to evaluate the safety and efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients 6 to 17 years of age. The primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. A total of 127 patients with chronic rhinosinusitis with nasal polyps were randomized to placebo or mometasone furoate nasal spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). The results of this trial did not support the efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients. The adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with chronic rhinosinusitis with nasal polyps.

Effect on Growth

Controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving nasal corticosteroids, including mometasone furoate nasal spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, each patient should be titrated to his/her lowest effective dose.

A clinical study to assess the effect of mometasone furoate nasal spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. No statistically significant effect on growth velocity was observed for mometasone furoate nasal spray compared to placebo following one year of treatment. No evidence of clinically relevant HPA axis suppression was observed following a 30-minute cosyntropin infusion.

The potential of mometasone furoate nasal spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.

A total of 280 patients above 64 years of age with allergic rhinitis or chronic rhinosinusitis with nasal polyps (age range 64 to 86 years) have been treated with mometasone furoate nasal spray for up to 3 or 4 months, respectively. No observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients.  

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3)].

There are no data available on the effects of acute or chronic overdosage with mometasone furoate nasal spray. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism. [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "There are no data available on the effects of acute or chronic overdosage with mometasone furoate nasal spray. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism. [see Warnings and Precautions (5.5)]." }

Mometasone furoate, the active component of mometasone furoate nasal spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione17-(2 furoate), and the following chemical structure:

{ "type": "p", "children": [], "text": "Mometasone furoate, the active component of mometasone furoate nasal spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione17-(2 furoate), and the following chemical structure:" }

Mometasone furoate is a white to off-white powder, with an molecular formula of C27H30Cl2O6, and a molecular weight of 521.43. It is practically insoluble in water, slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone, chloroform, and methylene chloride; and freely soluble in tetrahydrofuran, acetone and dichloromethane. Its partition coefficient between octanol and water is greater than 5,000.

{ "type": "p", "children": [], "text": "Mometasone furoate is a white to off-white powder, with an molecular formula of C27H30Cl2O6, and a molecular weight of 521.43. It is practically insoluble in water, slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone, chloroform, and methylene chloride; and freely soluble in tetrahydrofuran, acetone and dichloromethane. Its partition coefficient between octanol and water is greater than 5,000. " }

Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of 0.05% w/w mometasone furoate in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, and sodium citrate. The pH is between 4.3 and 4.9.

{ "type": "p", "children": [], "text": "Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of 0.05% w/w mometasone furoate in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, and sodium citrate. The pH is between 4.3 and 4.9." }

Mometasone furoate nasal spray is a corticosteroid demonstrating potent anti-inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

In two clinical studies utilizing nasal antigen challenge, mometasone furoate nasal spray decreased some markers of the early- and late-phase allergic response. These observations included decreases (vs. placebo) in histamine and eosinophil cationic protein levels, and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. The clinical significance of these findings is not known.

The effect of mometasone furoate nasal spray on nasal mucosa following 12 months of treatment was examined in 46 patients with allergic rhinitis. There was no evidence of atrophy and there was a marked reduction in intraepithelial eosinophilia and inflammatory cell infiltration (e.g., eosinophils, lymphocytes, monocytes, neutrophils, and plasma cells).

Adrenal Function in Adults: Four clinical pharmacology studies have been conducted in humans to assess the effect of mometasone furoate nasal spray at various doses on adrenal function. In one study, daily doses of 200 and 400 mcg of mometasone furoate nasal spray and 10 mg of prednisone were compared to placebo in 64 patients (22 to 44 years of age) with allergic rhinitis. Adrenal function before and after 36 consecutive days of treatment was assessed by measuring plasma cortisol levels following a 6-hour Cortrosyn (ACTH) infusion and by measuring 24-hour urinary free cortisol levels. Mometasone furoate nasal spray at both the 200- and 400-mcg dose, was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo. A statistically significant decrease in the mean plasma cortisol levels post-Cortrosyn infusion and 24-hour urinary free cortisol levels was detected in the prednisone treatment group compared to placebo.

A second study assessed adrenal response to mometasone furoate nasal spray (400 and 1,600 mcg/day), prednisone (10 mg/day), and placebo, administered for 29 days in 48 male volunteers (21 to 40 years of age). The 24-hour plasma cortisol area under the curve (AUC0–24), during and after an 8-hour Cortrosyn infusion and 24-hour urinary free cortisol levels were determined at baseline and after 29 days of treatment. No statistically significant differences in adrenal function were observed with mometasone furoate nasal spray compared to placebo.

A third study evaluated single, rising doses of mometasone furoate nasal spray (1,000, 2,000, and 4,000 mcg/day), orally administered mometasone furoate (2,000, 4,000, and 8,000 mcg/day), orally administered dexamethasone (200, 400, and 800 mcg/day), and placebo (administered at the end of each series of doses) in 24 male volunteers (22 to 39 years of age). Dose administrations were separated by at least 72 hours. Determination of serial plasma cortisol levels at 8 AM and for the 24-hour period following each treatment were used to calculate the plasma cortisol area under the curve (AUC0–24). In addition, 24-hour urinary free cortisol levels were collected prior to initial treatment administration and during the period immediately following each dose. No statistically significant decreases in the plasma cortisol AUC, 8 AM cortisol levels, or 24-hour urinary free cortisol levels were observed in volunteers treated with either mometasone furoate nasal spray or oral mometasone, as compared with placebo treatment. Conversely, nearly all volunteers treated with the three doses of dexamethasone demonstrated abnormal 8 AM cortisol levels (defined as a cortisol level <10 mcg/dL), reduced 24-hour plasma AUC values, and decreased 24-hour urinary free cortisol levels, as compared to placebo treatment.

In a fourth study, adrenal function was assessed in 213 patients (18 to 81 years of age) with chronic rhinosinusitis with nasal polyps before and after 4 months of treatment with either mometasone furoate nasal spray (200 mcg once or twice daily) or placebo by measuring 24-hour urinary free cortisol levels. Mometasone furoate nasal spray at both doses (200 and 400 mcg/day), was not associated with statistically significant decreases in the 24-hour urinary free cortisol levels compared to placebo.

Three clinical pharmacology studies have been conducted in pediatric patients to assess the effect of mometasone furoate nasal spray on the adrenal function at daily doses of 50, 100, and 200 mcg vs. placebo. In one study, adrenal function before and after 7 consecutive days of treatment was assessed in 48 pediatric patients with allergic rhinitis (ages 6 to 11 years) by measuring morning plasma cortisol and 24-hour urinary free cortisol levels. Mometasone furoate nasal spray, at all three doses, was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo. In the second study, adrenal function before and after 14 consecutive days of treatment was assessed in 48 pediatric patients (ages 3 to 5 years) with allergic rhinitis by measuring plasma cortisol levels following a 30-minute Cortrosyn infusion. Mometasone furoate nasal spray, 50 mcg, at all three doses (50, 100, and 200 mcg/day), was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion compared to placebo. All patients had a normal response to Cortrosyn. In the third study, adrenal function before and after up to 42 consecutive days of once-daily treatment was assessed in 52 patients with allergic rhinitis (ages 2 to 5 years), 28 of whom received mometasone furoate nasal spray, 50 mcg per nostril (total daily dose 100 mcg), by measuring morning plasma cortisol and 24-hour urinary free cortisol levels. Mometasone furoate nasal spray was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo.

Absorption:

Mometasone furoate monohydrate administered as a nasal spray suspension has very low bioavailability (<1%) in plasma using a sensitive assay with a lower quantitation limit (LOQ) of 0.25 pcg/mL.

Distribution:

The in vitro protein binding for mometasone furoate was reported to be 98% to 99% in concentration range of 5 to 500 ng/mL.

Elimination:

Following intravenous administration, the effective plasma elimination half-life of mometasone furoate is 5.8 hours. Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine.

Metabolism:

Studies have shown that any portion of a mometasone furoate dose which is swallowed and absorbed undergoes extensive metabolism to multiple metabolites. There are no major metabolites detectable in plasma. Upon in vitro incubation, one of the minor metabolites formed is 6ß-hydroxymometasone furoate. In human liver microsomes, the formation of the metabolite is regulated by cytochrome P-450 3A4 (CYP3A4).

Specific Populations:

Patients with Hepatic Impairment:

Administration of a single inhaled dose of 400 mcg mometasone furoate to subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment resulted in only 1 or 2 subjects in each group having detectable peak plasma concentrations of mometasone furoate (ranging from 50 to 105 pcg/mL). The observed peak plasma concentrations appear to increase with severity of hepatic impairment, however, the numbers of detectable levels were few.

Patients with Renal Impairment:

The effects of renal impairment on mometasone furoate pharmacokinetics have not been adequately investigated.

Pediatric Patients:

Mometasone furoate pharmacokinetics have not been investigated in the pediatric population [see Use in Specific Populations (8.4)].

Male and Female Patients:

The effects of gender on mometasone furoate pharmacokinetics have not been adequately investigated.

Racial or Ethnic Groups:

The effects of race on mometasone furoate pharmacokinetics have not been adequately investigated.

Drug Interaction Studies:

Inhibitors of Cytochrome P450 3A4: In a drug interaction study, an inhaled dose of mometasone furoate 400 mcg was given to 24 healthy subjects twice daily for 9 days and ketoconazole 200 mg (as well as placebo) were given twice daily concomitantly on Days 4 to 9. Mometasone furoate plasma concentrations were <150 pcg/mL on Day 3 prior to coadministration of ketoconazole or placebo. Following concomitant administration of ketoconazole, 4 out of 12 subjects in the ketoconazole treatment group (n=12) had peak plasma concentrations of mometasone furoate >200 pcg/mL on Day 9 (211 to 324 pcg/mL).

In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 1 and 2 times the maximum recommended daily nasal dose [MRDID] in adults [400 mcg] and children [100 mcg], respectively, on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 2 times the MRDID in adults and children, respectively, on a mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary-cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse-lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay and a rat bone marrow chromosomal aberration assay or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

Reproduction Toxicology Studies

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the MRDID in adults on a mcg/m2 basis). Fetal survival was reduced at 180 mcg/kg (approximately 2 times the MRDID in adults on a mcg/m2 basis). No toxicity was observed at 20 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

In rats, mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg/kg and above (approximately 10 times the MRDID in adults on a mcg/m2 basis). A dose of 300 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m2 basis) produced delays in ossification, but no malformations. In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses of 150 mcg/kg and above (approximately 6 times the MRDID in adults on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly or domed head) at 700 mcg/kg (approximately 30 times the MRDID in adults on a mcg/m2 basis). At 2,800 mcg/kg (approximately 110 times the MRDID in adults on a mcg/m2 basis), most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m2 basis).

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg (less than the MRDID in adults on a mcg/m2 basis) caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

The efficacy and safety of mometasone furoate nasal spray in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis have been evaluated in 18 controlled trials, and one uncontrolled clinical trial, in approximately 3,000 adults (ages 17 to 85 years) and pediatric patients (ages 12 to 16 years). Of the total number of patients, there were 1,757 males and 1,453 females, including a total of 283 adolescents (182 boys and 101 girls) with seasonal allergic or perennial allergic rhinitis. Patients were treated with mometasone furoate nasal spray at doses ranging from 50 to 800 mcg/day. The majority of patients were treated with 200 mcg/day. The allergic rhinitis trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing. Patients treated with mometasone furoate nasal spray 200 mcg/day had a statistically significant decrease in total nasal symptom scores compared to placebo-treated patients. No additional benefit was observed for mometasone furoate doses greater than 200 mcg/day. A total of 350 patients have been treated with mometasone furoate nasal spray for 1 year or longer.

Prophylaxis of seasonal allergic rhinitis for patients 12 years of age and older with mometasone furoate nasal spray given at a dose of 200 mcg/day, was evaluated in two clinical studies in 284 patients. These studies were designed such that patients received 4 weeks of prophylaxis with mometasone furoate nasal spray prior to the anticipated onset of the pollen season; however, some patients received only 2 to 3 weeks of prophylaxis. Patients receiving 2 to 4 weeks of prophylaxis with mometasone furoate nasal spray demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.

Two studies were performed to evaluate the efficacy and safety of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps. These studies involved 664 patients with chronic rhinosinusitis with nasal polyps, 441 of whom received mometasone furoate nasal spray. These studies were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies in patients 18 to 86 years of age with bilateral nasal polyps. Patients were randomized to receive mometasone furoate nasal spray 200 mcg once daily, 200 mcg twice daily or placebo for a period of 4 months. The co-primary efficacy endpoints were 1) change from baseline in nasal congestion/obstruction averaged over the first month of treatment; and 2) change from baseline to last assessment in bilateral polyp grade during the entire 4 months of treatment as assessed by endoscopy. Efficacy was demonstrated in both studies at a dose of 200 mcg twice daily and in one study at a dose of 200 mcg once a day (see Table 2 below).

Table 2: Effect of Mometasone Furoate Nasal Spray in Two Randomized, Placebo-Controlled Trials in Patients with Chronic Rhinosinusitis with Nasal Polyps

<div class="scrollingtable"><table rules="all"> <tbody align="center" class="Headless"> <tr class="First"> <td>   </td><td align="center"><span class="Bold">Mometasone Furoate Nasal Spray</span><span class="Bold"> <br/>200 mcg qd</span></td><td align="center"><span class="Bold">Mometasone Furoate Nasal Spray</span> <br/> <span class="Bold">200 mcg bid</span></td><td align="center"><span class="Bold">Placebo</span></td><td align="center"><span class="Bold Italics">P</span><span class="Bold">-</span><span class="Bold">value for Mometasone Furoate Nasal Spray</span><span class="Bold"> <br/>200 mcg qd vs. placebo</span></td><td align="center"><span class="Bold Italics">P</span><span class="Bold">-</span><span class="Bold">value for Mometasone Furoate Nasal Spray <br/>200 mcg bid vs. placebo</span></td> </tr> <tr> <td align="left"><span class="Bold">Study 1</span></td><td> N=115 </td><td> N=122 </td><td> N=117 </td><td>   </td><td>   </td> </tr> <tr> <td align="left"> Baseline bilateral polyp grade<span class="Sup">*</span></td><td> 4.21 </td><td> 4.27 </td><td> 4.25 </td><td>   </td><td>   </td> </tr> <tr> <td align="left"> Mean change from baseline in bilateral polyps grade </td><td> -1.15 </td><td> -0.96 </td><td> -0.50 </td><td> &lt;0.001 </td><td> 0.01 </td> </tr> <tr> <td align="left"> Baseline nasal congestion<span class="Sup">†</span></td><td> 2.29 </td><td> 2.35 </td><td> 2.28 </td><td>   </td><td>   </td> </tr> <tr> <td align="left"> Mean change from baseline in nasal congestion </td><td> -0.47 </td><td> -0.61 </td><td> -0.24 </td><td> 0.001 </td><td> &lt;0.001 </td> </tr> <tr> <td align="left"><span class="Bold">Study </span><span class="Bold">2</span></td><td> N=102 </td><td> N=102 </td><td> N=106 </td><td>   </td><td>   </td> </tr> <tr> <td align="left"> Baseline bilateral polyp grade* </td><td> 4.00 </td><td> 4.10 </td><td> 4.17 </td><td>   </td><td>   </td> </tr> <tr> <td align="left"> Mean change from baseline in bilateral polyps grade </td><td> -0.78 </td><td> -0.96 </td><td> -0.62 </td><td> 0.33 </td><td> 0.04 </td> </tr> <tr> <td align="left"> Baseline nasal congestion<span class="Sup">†</span></td><td> 2.23 </td><td> 2.20 </td><td> 2.18 </td><td>   </td><td>   </td> </tr> <tr class="Last"> <td align="left"> Mean change from baseline in nasal congestion </td><td> -0.42 </td><td> -0.66 </td><td> -0.23 </td><td> 0.01 </td><td> &lt;0.001 </td> </tr> </tbody> </table></div>

* polyps in each nasal fossa were graded by the investigator based on endoscopic visualization, using a scale of 0-3 where 0=no polyps; 1=polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2=polyps reaching below the inferior border of the middle turbinate but not the inferior border of the inferior turbinate; 3=polyps reaching to or below the border of the inferior turbinate, or polyps medial to the middle turbinate (score reflects sum of left and right nasal fossa grades).

†nasal congestion/obstruction was scored daily by the patient using a 0-3 categorical scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms.

There were no clinically relevant differences in the effectiveness of mometasone furoate nasal spray in the studies evaluating treatment of chronic rhinosinusitis with nasal polyps across subgroups of patients defined by gender, age, or race.

Mometasone Furoate Nasal Spray:

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light.  

When mometasone furoate nasal spray is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.  

SHAKE WELL BEFORE EACH USE.  

Patients should be informed that treatment with mometasone furoate nasal spray may be associated with adverse reactions which include epistaxis (nose bleed) and nasal septum perforation. Candida infection may also occur. Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred [see Warnings and Precautions (5.1)]. Patients should be cautioned not to spray mometasone furoate nasal spray directly onto the nasal septum.

Advise patients that long-term use of nasal and inhaled corticosteroids may increase the risk of some eye problems (glaucoma or cataracts); regular eye examinations should be considered. Patients should be cautioned not to spray mometasone furoate nasal spray into the eyes [see Warnings and Precautions (5.2)].

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and patients should also be advised that if they are exposed, medical advice should be sought without delay [see Warnings and Precautions (5.4)].

Patients should use mometasone furoate nasal spray on a regular basis for optimal effect. Improvement in nasal symptoms of allergic rhinitis has been shown to occur within 1 to 2 days after initiation of dosing. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Patients should not increase the prescribed dosage but should contact their physician if symptoms do not improve, or if the condition worsens. Administration to young children should be aided by an adult.

If a patient missed a dose, the patient should be advised to administer the dose as soon as they remember. The patient should not use more than the recommended dose for the day.

APOTEX INC.

{ "type": "p", "children": [], "text": "\nAPOTEX INC.\n" }

MOMETASONE FUROATE NASAL SPRAY

{ "type": "p", "children": [], "text": "\nMOMETASONE FUROATE NASAL SPRAY\n" }

50 mcg

{ "type": "p", "children": [], "text": "\n50 mcg\n" }

<div class="scrollingtable"><table border="null" frame="void" rules="groups"> <tbody align="left" class="Headless"> <tr class="First"> <th colspan="1" rowspan="1">Manufactured by:</th><th colspan="50" rowspan="1"></th><th>Manufactured for:</th> </tr> <tr> <th colspan="1">Apotex Inc.</th><th colspan="50"></th><th colspan="1">Apotex Corp.</th> </tr> <tr> <th colspan="1">Toronto, Ontario</th><th colspan="50"></th><th colspan="1">Weston, FL</th> </tr> <tr class="Last"> <th colspan="1">M9L 1T9</th><th colspan="50"></th><th colspan="1">33326</th> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"null\" frame=\"void\" rules=\"groups\">\n<tbody align=\"left\" class=\"Headless\">\n<tr class=\"First\">\n<th colspan=\"1\" rowspan=\"1\">Manufactured by:</th><th colspan=\"50\" rowspan=\"1\"></th><th>Manufactured for:</th>\n</tr>\n<tr>\n<th colspan=\"1\">Apotex Inc.</th><th colspan=\"50\"></th><th colspan=\"1\">Apotex Corp.</th>\n</tr>\n<tr>\n<th colspan=\"1\">Toronto, Ontario</th><th colspan=\"50\"></th><th colspan=\"1\">Weston, FL</th>\n</tr>\n<tr class=\"Last\">\n<th colspan=\"1\">M9L 1T9</th><th colspan=\"50\"></th><th colspan=\"1\">33326</th>\n</tr>\n</tbody>\n</table></div>" }

PATIENT INFORMATION

{ "type": "p", "children": [], "text": "\nPATIENT INFORMATION\n" }

Mometasone Furoate (moe met' a sone fure' oh ate) Nasal Spray, 50 mcg

{ "type": "p", "children": [], "text": "\nMometasone Furoate (moe met' a sone fure' oh ate) Nasal Spray, 50 mcg\n" }

For Nasal Use Only

{ "type": "p", "children": [], "text": "\nFor Nasal Use Only \n" }

Read the Patient Information that comes with mometasone furoate nasal spray before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about mometasone furoate nasal spray, ask your healthcare provider.

{ "type": "p", "children": [], "text": "Read the Patient Information that comes with mometasone furoate nasal spray before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about mometasone furoate nasal spray, ask your healthcare provider." }

What is mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nWhat is mometasone furoate nasal spray?\n" }

Mometasone furoate nasal spray is a man-made (synthetic) corticosteroid medicine that is used to:

{ "type": "p", "children": [], "text": "Mometasone furoate nasal spray is a man-made (synthetic) corticosteroid medicine that is used to:" }

{ "type": "ul", "children": [ "prevent nasal symptoms of seasonal allergic rhinitis in people 12 years of age and older. ", "treat chronic rhinosinusitis with nasal polyps in people 18 years and older." ], "text": "" }

It is not known if mometasone furoate nasal spray is safe and effective in children under:

{ "type": "p", "children": [], "text": "It is not known if mometasone furoate nasal spray is safe and effective in children under:" }

{ "type": "ul", "children": [ "12 years of age to prevent nasal symptoms of seasonal allergic rhinitis.", "18 years of age to treat chronic rhinosinusitis with nasal polyps." ], "text": "" }

Who should not use mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nWho should not use mometasone furoate nasal spray?\n" }

Do not use mometasone furoate nasal sprayif you are allergic to mometasone furoate or any of the ingredients in mometasone furoate nasal spray.See the end of this leaflet for a complete list of ingredients in mometasone furoate nasal spray.

{ "type": "p", "children": [], "text": "\nDo not use mometasone furoate nasal sprayif you are allergic to mometasone furoate or any of the ingredients in mometasone furoate nasal spray.See the end of this leaflet for a complete list of ingredients in mometasone furoate nasal spray. " }

What should I tell my healthcare provider before and during treatment with mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nWhat should I tell my healthcare provider before and during treatment with mometasone furoate nasal spray?\n" }

Before you take mometasone furoate nasal spray, tell your healthcare provider about all of your medical conditions, including if you:

{ "type": "p", "children": [], "text": "\nBefore you take mometasone furoate nasal spray, tell your healthcare provider about all of your medical conditions, including if you: \n" }

{ "type": "ul", "children": [ "have had recent nasal sores, nasal surgery, or nasal injury. ", "have eye or vision problems, such as cataracts, glaucoma (increased pressure in your eye), and blurred vision, or other changes in your vision. ", "have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes. ", "have been near someone who has chickenpox or measles. ", "are not feeling well or have any other symptoms that you do not understand. \n", "\nare pregnant or planning to become pregnant. It is not known if mometasone furoate nasal spray will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. \n", "\nare breastfeeding or planning to breastfeed. It is not known whether mometasone furoate passes into your breast milk. " ], "text": "" }

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

{ "type": "p", "children": [], "text": "\nTell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. " }

Especially tell your healthcare provider if you take:

{ "type": "p", "children": [], "text": "Especially tell your healthcare provider if you take: " }

{ "type": "ul", "children": [ " certain medicines for HIV (such as ritonavir, atazanavir, indinavir, nelfinavir, and saquinavir)", "cobicistat-containing products", "certain antifungals (such as ketoconazole and itraconazole)", "certain antibiotics (such as clarithromycin and telithromycin)", "certain antidepressants (such as nefazodone)If you take these medicines with mometasone furoate nasal spray, your healthcare provider should monitor you for side effects. Mometasone furoate nasal spray may affect the way other medicines work, and other medicines may affect how mometasone furoate nasal spray works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.\n" ], "text": "" }

How should I use mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nHow should I use mometasone furoate nasal spray?\n" }

{ "type": "ul", "children": [ "Use mometasone furoate nasal spray exactly as prescribed by your healthcare provider.", "This medicine is for use in the nose only. Do not spray it into your mouth or eyes.", "An adult should supervise a child using this medicine.", "For best results, you should keep using mometasone furoate nasal spray regularly each day without missing a dose. If you do miss a dose of mometasone furoate nasal spray, take it as soon as you remember. However, do not take more than the daily dose prescribed by your healthcare provider.", "Do not use mometasone furoate nasal spray more often than prescribed. Ask your healthcare provider if you have any questions.", "For detailed instructions on how to use mometasone furoate nasal spray, see the \"Patient Instructions for Use\" at the end of this leaflet. ", "See your healthcare provider regularly to check your symptoms while taking mometasone furoate nasal spray and to check for side effects." ], "text": "" }

What should I avoid while taking mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nWhat should I avoid while taking mometasone furoate nasal spray? \n" }

If you are taking other corticosteroid medicines for allergy, by mouth or injection, your healthcare provider may advise you to stop taking them after you begin using mometasone furoate nasal spray.

{ "type": "p", "children": [], "text": "If you are taking other corticosteroid medicines for allergy, by mouth or injection, your healthcare provider may advise you to stop taking them after you begin using mometasone furoate nasal spray. " }

What are the possible side effects of mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of mometasone furoate nasal spray? \n" }

Mometasone furoate nasal spray may cause serious side effects, including:

{ "type": "p", "children": [], "text": "\nMometasone furoate nasal spray may cause serious side effects, including:\n" }

{ "type": "ul", "children": [ "\nthrush (candida), a fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or throat.\n", "\nhole in the cartilage of the nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septum perforation.\n", "\nslow wound healing. Do not use mometasone furoate nasal spray until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.\n", "\neye problems, including glaucoma, cataracts, and blurred vision. You should have regular eye exams.\n", "\nallergic reactions. Allergic reactions including wheezing may happen after using mometasone furoate nasal spray. If wheezing happens stop using mometasone furoate nasal spray. Tell your healthcare provider or get medical help right away. \n", "\nimmune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using mometasone furoate nasal spray. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea, and vomiting. Tell your healthcare provider about any signs of infection while you are using mometasone furoate nasal spray. \n", "\nadrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea and vomiting, and low blood pressure. \n", "\nslowed growth in children. Your child’s growth should be checked regularly while using mometasone furoate nasal spray. " ], "text": "" }

The most common side effects of mometasone furoate nasal spray include:

{ "type": "p", "children": [], "text": "The most common side effects of mometasone furoate nasal spray include:" }

{ "type": "ul", "children": [ "headache", "viral infection", "sore throat", "nosebleeds", "cough" ], "text": "" }

These are not all the possible side effects of mometasone furoate nasal spray. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

{ "type": "p", "children": [], "text": "These are not all the possible side effects of mometasone furoate nasal spray. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." }

How should I store mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nHow should I store mometasone furoate nasal spray?\n" }

{ "type": "ul", "children": [ "Store mometasone furoate nasal spray at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. ", "Protect from light. ", "Avoid prolonged exposure of mometasone furoate nasal spray container to direct light.", "Shake well before each use.", "\n\nKeep mometasone furoate nasal spray and all medicines out of the reach of children.\n\n" ], "text": "" }

General information about the safe and effective use of mometasone furoate nasal spray

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of mometasone furoate nasal spray\n" }

Medicines are sometimes prescribed for conditions that are not listed in a Patient Information leaflet. Do not use mometasone furoate nasal spray for a condition for which it was not prescribed. Do not give mometasone furoate nasal spray to other people even if they have the same symptoms you have. It may harm them.

{ "type": "p", "children": [], "text": "Medicines are sometimes prescribed for conditions that are not listed in a Patient Information leaflet. Do not use mometasone furoate nasal spray for a condition for which it was not prescribed. Do not give mometasone furoate nasal spray to other people even if they have the same symptoms you have. It may harm them." }

You can ask your healthcare provider or pharmacist for information about mometasone furoate nasal spray that is written for health professionals.

{ "type": "p", "children": [], "text": " You can ask your healthcare provider or pharmacist for information about mometasone furoate nasal spray that is written for health professionals." }

What are the ingredients in mometasone furoate nasal spray?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in mometasone furoate nasal spray?\n" }

Active ingredients: mometasone furoate

{ "type": "p", "children": [], "text": "\nActive ingredients: mometasone furoate " }

Inactive ingredients: benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, and sodium citrate.

{ "type": "p", "children": [], "text": "\nInactive ingredients: benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, and sodium citrate. " }

For more information, go to www.apotex.com/products or call 1-800-706-5575.

{ "type": "p", "children": [], "text": "For more information, go to www.apotex.com/products or call 1-800-706-5575." }

This Patient Information has been approved by the U.S. Food and Drug Administration  

{ "type": "p", "children": [], "text": "\n This Patient Information has been approved by the U.S. Food and Drug Administration   " }

APOTEX INC.

{ "type": "p", "children": [], "text": "\nAPOTEX INC.\n" }

MOMETASONE FUROATE NASAL SPRAY

{ "type": "p", "children": [], "text": "\nMOMETASONE FUROATE NASAL SPRAY\n" }

50 mcg 

{ "type": "p", "children": [], "text": "\n50 mcg \n" }

<div class="scrollingtable"><table> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Manufactured by:</span></td><td><span class="Bold">Manufactured for:</span><span class="Bold"> </span></td> </tr> <tr class="Last"> <td> Apotex Inc. <br/> Toronto, Ontario <br/> M9L 1T9<span class="Bold"></span></td><td> Apotex Corp. <br/> Weston, FL <br/> 33326<span class="Bold"></span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Manufactured by:</span></td><td><span class=\"Bold\">Manufactured for:</span><span class=\"Bold\"> </span></td>\n</tr>\n<tr class=\"Last\">\n<td> Apotex Inc. <br/> Toronto, Ontario <br/> M9L 1T9<span class=\"Bold\"></span></td><td> Apotex Corp. <br/> Weston, FL <br/> 33326<span class=\"Bold\"></span></td>\n</tr>\n</tbody>\n</table></div>" }

Patient Instructions for Use

{ "type": "p", "children": [], "text": "\nPatient Instructions for Use\n" }

Mometasone Furoate (moe met' a sone fure' oh ate) Nasal Spray, 50 mcg

{ "type": "p", "children": [], "text": "\nMometasone Furoate (moe met' a sone fure' oh ate) Nasal Spray, 50 mcg\n" }

For use in your nose only.

{ "type": "p", "children": [], "text": "\nFor use in your nose only. \n" }

Read the Patient Instructions for Use carefully before you start to use your mometasone furoate nasal spray. If you have any questions, ask your healthcare provider.

{ "type": "p", "children": [], "text": "\nRead the Patient Instructions for Use carefully before you start to use your mometasone furoate nasal spray. If you have any questions, ask your healthcare provider.\n" }

Shake the bottle well before each use.

{ "type": "p", "children": [], "text": "\nShake the bottle well before each use. \n" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

Each bottle of mometasone furoate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use the bottle of mometasone furoate nasal spray after 120 sprays. Additional sprays after the 120 sprays may not contain the right amount of medicine, you should keep track of the number of sprays used from each bottle of mometasone furoate nasal spray, and throw away the bottle even if it has medicine still left in. Do not count any sprays used for priming the device. Talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine.

{ "type": "p", "children": [], "text": "Each bottle of mometasone furoate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use the bottle of mometasone furoate nasal spray after 120 sprays. Additional sprays after the 120 sprays may not contain the right amount of medicine, you should keep track of the number of sprays used from each bottle of mometasone furoate nasal spray, and throw away the bottle even if it has medicine still left in. Do not count any sprays used for priming the device. Talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine." }

Pediatric Use: Administration to children should be supervised by an adult. Steps 1 through 7 from the Patient Instructions for Use should be followed.

{ "type": "p", "children": [], "text": "\nPediatric Use: Administration to children should be supervised by an adult. Steps 1 through 7 from the Patient Instructions for Use should be followed." }

Cleaning: Do not try to unblock the nasal applicator with a sharp object. Please see Patient Instructions for Cleaning Applicator.

{ "type": "p", "children": [], "text": "\nCleaning: Do not try to unblock the nasal applicator with a sharp object. Please see Patient Instructions for Cleaning Applicator. \n" }

Patient Instructions for Cleaning Applicator

{ "type": "p", "children": [], "text": "\nPatient Instructions for Cleaning Applicator\n" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

{ "type": "", "children": [], "text": "" }

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.  

{ "type": "p", "children": [], "text": "This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.  \n" }

APOTEX INC.

{ "type": "p", "children": [], "text": "\nAPOTEX INC.\n" }

MOMETASONE FUROATE NASAL SPRAY

{ "type": "p", "children": [], "text": "\nMOMETASONE FUROATE NASAL SPRAY\n" }

50 mcg

{ "type": "p", "children": [], "text": "\n50 mcg\n" }

<div class="scrollingtable"><table border="null" frame="void" rules="groups"> <tbody align="left" class="Headless"> <tr class="First"> <th colspan="1" rowspan="1">Manufactured by:</th><th colspan="50" rowspan="1"></th><th colspan="1" rowspan="1">Manufactured for:</th> </tr> <tr> <th colspan="1" rowspan="1">Apotex Inc.</th><th colspan="50" rowspan="1"></th><th colspan="1" rowspan="1">Apotex Corp.</th> </tr> <tr> <th colspan="1" rowspan="1">Toronto, Ontario</th><th colspan="50" rowspan="1"></th><th colspan="1" rowspan="1">Weston, FL</th> </tr> <tr class="Last"> <th colspan="1" rowspan="1">M9L 1T9</th><th colspan="50" rowspan="1"></th><th colspan="1" rowspan="1">33326</th> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"null\" frame=\"void\" rules=\"groups\">\n<tbody align=\"left\" class=\"Headless\">\n<tr class=\"First\">\n<th colspan=\"1\" rowspan=\"1\">Manufactured by:</th><th colspan=\"50\" rowspan=\"1\"></th><th colspan=\"1\" rowspan=\"1\">Manufactured for:</th>\n</tr>\n<tr>\n<th colspan=\"1\" rowspan=\"1\">Apotex Inc.</th><th colspan=\"50\" rowspan=\"1\"></th><th colspan=\"1\" rowspan=\"1\">Apotex Corp.</th>\n</tr>\n<tr>\n<th colspan=\"1\" rowspan=\"1\">Toronto, Ontario</th><th colspan=\"50\" rowspan=\"1\"></th><th colspan=\"1\" rowspan=\"1\">Weston, FL</th>\n</tr>\n<tr class=\"Last\">\n<th colspan=\"1\" rowspan=\"1\">M9L 1T9</th><th colspan=\"50\" rowspan=\"1\"></th><th colspan=\"1\" rowspan=\"1\">33326</th>\n</tr>\n</tbody>\n</table></div>" }

Revised: March 2025

{ "type": "p", "children": [], "text": "Revised: March 2025" }

PRINCIPAL DISPLAY PANEL - Bottle Label

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL - Bottle Label\n" }

NDC 60505-0830-1

{ "type": "p", "children": [], "text": "\nNDC 60505-0830-1\n" }

Net Contents: 17 g

{ "type": "p", "children": [], "text": " Net Contents: 17 g\n" }

120 Metered Sprays

{ "type": "p", "children": [], "text": "\n120 Metered Sprays" }

For Intranasal Use Only

{ "type": "p", "children": [], "text": "For Intranasal Use Only" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

Apotex Corp.

{ "type": "p", "children": [], "text": "Apotex Corp.\n" }

PRINCIPAL DISPLAY PANEL - Carton Label

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL - Carton Label\n" }

NDC 60505-0830-1

{ "type": "p", "children": [], "text": "\nNDC 60505-0830-1\n" }

Net Contents: 17 g

{ "type": "p", "children": [], "text": " Net Contents: 17 g\n" }

120 Metered Sprays

{ "type": "p", "children": [], "text": "\n120 Metered Sprays" }

For Intranasal Use Only

{ "type": "p", "children": [], "text": "For Intranasal Use Only" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

Apotex Corp.

{ "type": "p", "children": [], "text": "Apotex Corp.\n" }

Mometasone Furoate Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.

Apply a thin film of Mometasone Furoate Ointment to the affected skin areas once daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [ see Warnings and Precautions(5.1)].

Do not use Mometasone Furoate Ointment with occlusive dressings unless directed by a physician. Do not apply Mometasone Furoate Ointment in the diaper area, as diapers or plastic pants constitute occlusive dressing.

          Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application.

          Mometasone Furoate Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Ointment, 0.1%. Each gram of Mometasone Furoate Ointment USP contains 1 mg of mometasone furoate in a white to off-white uniform ointment base.

Mometasone Furoate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.  Factors that predispose  a  patient  using a  topical corticosteroid  to  HPA  axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study evaluating the effects of Mometasone Furoate Ointment on the HPA axis, 15 grams were applied twice daily for 7 days to 6 adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [see Adverse reactions (6.2)]

           Avoid contact of Mometasone Furoate Ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

If irritation develops, Mometasone Furoate Ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Mometasone Furoate Ointment should be discontinued until the infection has been adequately controlled.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In controlled clinical trials involving 812 subjects, the incidence of adverse reactions associated with the use of Mometasone Furoate Ointment was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Cases of rosacea associated with the use of Mometasone Furoate Ointment have been reported.

The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Ointment during a clinical study in 5% of 63 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1. The following signs of skin atrophy were also observed among 63 subjects treated with Mometasone Furoate Ointment in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; and thinness,1.

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.

Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

No drug-drug interaction studies have been conducted with Mometasone Furoate Ointment.

{ "type": "p", "children": [], "text": "\nNo drug-drug interaction studies have been conducted with Mometasone Furoate Ointment." }

Teratogenic Effects Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2basis.)

In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis.)

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses of 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis.)

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis.)

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mometasone Furoate Ointment is administered to a nursing woman.

Mometasone Furoate Ointment may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of Mometasone Furoate Ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.

Mometasone Furoate Ointment caused HPA axis suppression in approximately 27% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 39% (range 15%-99%). The criteria for suppression were: basal cortisol level of  5 mcg/dL, 30-minute post-stimulation level of  18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 3 subjects, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Mometasone Furoate Ointment should not be used in the treatment of diaper dermatitis.

Clinical trials of Mometasone Furoate Ointment included 310 subjects who were 65 years of age and over and 57 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. However, greater sensitivity of some older individuals cannot be ruled out.

Topically applied Mometasone Furoate Ointment can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "\nTopically applied Mometasone Furoate Ointment can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].\n" }

Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.

{ "type": "p", "children": [], "text": "\nMometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity." }

Chemically, mometasone furoate is 9a,21-dichloro-11b,17-dihydroxy-16a-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, mometasone furoate is 9a,21-dichloro-11b,17-dihydroxy-16a-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:" }

Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.

{ "type": "p", "children": [], "text": "\nMometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol." }

Each gram of Mometasone Furoate Ointment USP, 0.1% contains 1 mg mometasone furoate in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum.

{ "type": "p", "children": [], "text": "Each gram of Mometasone Furoate Ointment USP, 0.1% contains 1 mg mometasone furoate in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum." }

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2

Studies performed with Mometasone Furoate Ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids.

In a study evaluating the effects of Mometasone Furoate Ointment on the HPA axis, 15 grams were applied twice daily for 7 days to 6 adult subjects with psoriasis or atopic dermatitis. The ointment was applied without occlusion to at least 30% of the body surface. The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion [see Warnings and Precautions (5.1)].

Sixty-three pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label HPA axis safety study. Mometasone Furoate Ointment was applied once daily for approximately 3 weeks over a mean body surface area of 39% (range 15% to 99%). In approximately 27% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with Mometasone Furoate Ointment. The criteria for suppression were: basal cortisol level of  5 mcg/dL, 30-minute post-stimulation level of  18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 3 subjects, using these same criteria [see Use in Specific Populations (8.4)].

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of Mometasone Furoate Ointment enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Mometasone Furoate Ointment. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from Mometasone Furoate Ointment on a mcg/m 2 basis).

The safety and efficacy of Mometasone Furoate Ointment, 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in psoriasis and one in atopic dermatitis. A total of 218 subjects received Mometasone Furoate Ointment (109 subjects) or the vehicle ointment applied once daily for 21 days.

{ "type": "p", "children": [], "text": "\nThe safety and efficacy of Mometasone Furoate Ointment, 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in psoriasis and one in atopic dermatitis. A total of 218 subjects received Mometasone Furoate Ointment (109 subjects) or the vehicle ointment applied once daily for 21 days." }

Mometasone Furoate Ointment USP is a white to off-white uniform ointment and supplied in 15-gram (NDC 13668-527-01) and 45-gram (NDC 13668-527-04) tubes; boxes of one.

{ "type": "p", "children": [], "text": "\nMometasone Furoate Ointment USP is a white to off-white uniform ointment and supplied in 15-gram (NDC 13668-527-01) and 45-gram (NDC 13668-527-04) tubes; boxes of one." }

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]." }

Advise the patient to read the FDA-approved patient labelling (Patient Information).

{ "type": "p", "children": [], "text": "\nAdvise the patient to read the FDA-approved patient labelling (Patient Information)." }

Inform patients of the following:

{ "type": "p", "children": [], "text": "Inform patients of the following:" }

{ "type": "ul", "children": [ "Use Mometasone Furoate Ointment as directed by the physician. It is for external use only.", "Avoid contact with the eyes.", "Advise patients to report any visual symptoms to their healthcare providers.", "Do not use Mometasone Furoate Ointment on the face, underarms, or groin areas.", "Do not use Mometasone Furoate Ointment for any disorder other than that for which it was prescribed.", "Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician.", "Report any signs of local adverse reactions to the physician.", "Advise patients not to use Mometasone Furoate Ointment in the treatment of diaper dermatitis. Do not apply Mometasone Furoate Ointment in the diaper area, as diapers or plastic pants may constitute occlusive dressing.", "Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.", "Do not use other corticosteroid-containing products with Mometasone Furoate Ointment without first consulting with the physician." ], "text": "" }

<div class="scrollingtable"><table width="0"> <colgroup> <col width="644"/> </colgroup> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold"> Patient Information</span> <br/> <span class="Bold"> Mometasone Furoate (moe—MET—a—sone)</span><span class="Bold"> Ointment 0.1 %</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Important information: </span><span class="Bold"> Mometasone Furoate Ointment is for use on skin only. </span> Do not use Mometasone Furoate Ointment in your eyes, mouth, or vagina.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> W</span><span class="Bold">hat is </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> ?</span> <br/> • Mometasone Furoate Ointment is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. <br/> • It is not known if Mometasone Furoate Ointment is safe and effective for use in children under 2 years of age. <br/> • Mometasone Furoate Ointment should not be used in children under 2 years of age. <br/> • It is not known if Mometasone Furoate Ointment is safe and effective for use in children longer than 3 weeks.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Do not use </span><span class="Bold"> Mometasone Furoate Ointment if you </span> are allergic to mometasone furoate or any of the ingredients in Mometasone Furoate Ointment. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Ointment.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Before using </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> , tell your healthcare provider about all your medical conditions, including if you:</span> <br/> • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. <br/> • are pregnant or plan to become pregnant. It is not known if Mometasone Furoate Ointment will harm your unborn baby. <br/> • are breastfeeding or plan to breastfeed. It is not known if Mometasone Furoate Ointment passes into your breast milk. <br/> <span class="Bold"> T</span><span class="Bold">el</span><span class="Bold">l your healthcare provider about all the medicines you take, </span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> How should I use </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> ?</span> <br/> • Use Mometasone Furoate Ointment exactly as your healthcare provider tells you to use it. <br/> • Apply a thin film of Mometasone Furoate Ointment to the affected skin area 1 time each day. <br/> • Use Mometasone Furoate Ointment until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. <br/> • Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. <br/> • Mometasone Furoate Ointment should not be used to treat diaper rash or redness. Do not apply Mometasone Furoate Ointment in the diaper area if wearing diapers or plastic pants. <br/> • Avoid using Mometasone Furoate Ointment on the face, groin, or underarms (armpits). <br/> • Wash your hands after applying Mometasone Furoate Ointment.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> W</span><span class="Bold">hat are the possible side effects of </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> ? </span><span class="Bold"> Mometasone Furoate Ointment </span><span class="Bold"> may cause serious side effects, including:</span> <br/> • <span class="Bold"> Mometasone Furoate Ointment </span><span class="Bold"> ca</span><span class="Bold"> n pass through your skin</span> . Too much Mometasone Furoate Ointment passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. <br/> • <span class="Bold"> Vision problems. </span> Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Mometasone Furoate Ointment. <br/> • <span class="Bold"> Skin problems.</span> Skin problems may happen during treatment with Mometasone Furoate Ointment, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using Mometasone Furoate Ointment and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or other problems healing during treatment with Mometasone Furoate Ointment. <br/> <span class="Bold"> T</span><span class="Bold">he most common side effects of </span><span class="Bold"> Mometasone Furoate Ointment </span><span class="Bold"> i</span><span class="Bold"> nclude </span> burning, itching, thinning of the skin (atrophy), tingling, stinging, and boils. <br/> These are not all the possible side effects of Mometasone Furoate Ointment. <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> How should I store </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> ?</span> <br/> Store Mometasone Furoate Ointment at room temperature between 68°F to 77°F (20°C to 25°C).</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">• <span class="Bold"> Keep </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> a</span><span class="Bold"> nd all medicines out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> G</span><span class="Bold"> e</span><span class="Bold"> neral information about the safe and effective use of </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> .</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mometasone Furoate Ointment for a condition for which it was not prescribed. Do not give Mometasone Furoate Ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Mometasone Furoate Ointment that is written for health professionals.</td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> W</span><span class="Bold"> hat are the ingredients in </span><span class="Bold"> Mometasone Furoate Ointment</span><span class="Bold"> ? </span> <br/> <span class="Bold">A</span><span class="Bold">c</span><span class="Bold">tive ingredient: </span> mometasone furoate <br/> <span class="Bold"> I</span><span class="Bold">nactive ingredients: </span> hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum. <br/> <img alt="Image" src="/dailymed/image.cfm?name=ca36668d-1381-42bd-98a8-c85ad4d47802-120-2.jpg&amp;setid=18ef90de-f74d-492f-a125-49da1875bd29"/><br/> <span class="Bold"> Manufactured by:</span> <br/> TORRENT PHARMACEUTICALS LTD. <br/> Pithampur, Dist. Dhar-454 775 (M.P.) INDIA <br/> <span class="Bold"> For:</span> <br/> TORRENT PHARMA INC. <br/>Basking Ridge, NJ 07920. <br/> 8091179                                                                                                      Revised: 12/2022</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"0\">\n<colgroup>\n<col width=\"644\"/>\n</colgroup>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Patient Information</span>\n<br/>\n<span class=\"Bold\"> Mometasone Furoate (moe—MET—a—sone)</span><span class=\"Bold\"> Ointment 0.1 %</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Important information: </span><span class=\"Bold\"> Mometasone Furoate Ointment is for use on skin only. </span> Do not use Mometasone Furoate Ointment in your eyes, mouth, or vagina.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> W</span><span class=\"Bold\">hat is </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> ?</span>\n<br/> • Mometasone Furoate Ointment is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. <br/> • It is not known if Mometasone Furoate Ointment is safe and effective for use in children under 2 years of age. <br/> • Mometasone Furoate Ointment should not be used in children under 2 years of age. <br/> • It is not known if Mometasone Furoate Ointment is safe and effective for use in children longer than 3 weeks.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Do not use </span><span class=\"Bold\"> Mometasone Furoate Ointment if you </span> are allergic to mometasone furoate or any of the ingredients in Mometasone Furoate Ointment. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Ointment.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Before using </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> , tell your healthcare provider about all your medical conditions, including if you:</span>\n<br/> • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. <br/> • are pregnant or plan to become pregnant. It is not known if Mometasone Furoate Ointment will harm your unborn baby. <br/> • are breastfeeding or plan to breastfeed. It is not known if Mometasone Furoate Ointment passes into your breast milk. <br/>\n<span class=\"Bold\"> T</span><span class=\"Bold\">el</span><span class=\"Bold\">l your healthcare provider about all the medicines you take, </span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> How should I use </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> ?</span>\n<br/> • Use Mometasone Furoate Ointment exactly as your healthcare provider tells you to use it. <br/> • Apply a thin film of Mometasone Furoate Ointment to the affected skin area 1 time each day. <br/> • Use Mometasone Furoate Ointment until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. <br/> • Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. <br/> • Mometasone Furoate Ointment should not be used to treat diaper rash or redness. Do not apply Mometasone Furoate Ointment in the diaper area if wearing diapers or plastic pants. <br/> • Avoid using Mometasone Furoate Ointment on the face, groin, or underarms (armpits). <br/> • Wash your hands after applying Mometasone Furoate Ointment.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> W</span><span class=\"Bold\">hat are the possible side effects of </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> ? </span><span class=\"Bold\"> Mometasone Furoate Ointment </span><span class=\"Bold\"> may cause serious side effects, including:</span>\n<br/> • <span class=\"Bold\"> Mometasone Furoate Ointment </span><span class=\"Bold\"> ca</span><span class=\"Bold\"> n pass through your skin</span> . Too much Mometasone Furoate Ointment passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. <br/> • <span class=\"Bold\"> Vision problems. </span> Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Mometasone Furoate Ointment. <br/> • <span class=\"Bold\"> Skin problems.</span> Skin problems may happen during treatment with Mometasone Furoate Ointment, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using Mometasone Furoate Ointment and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or other problems healing during treatment with Mometasone Furoate Ointment. <br/>\n<span class=\"Bold\"> T</span><span class=\"Bold\">he most common side effects of </span><span class=\"Bold\"> Mometasone Furoate Ointment </span><span class=\"Bold\"> i</span><span class=\"Bold\"> nclude </span> burning, itching, thinning of the skin (atrophy), tingling, stinging, and boils. <br/> These are not all the possible side effects of Mometasone Furoate Ointment. <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> How should I store </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> ?</span>\n<br/> Store Mometasone Furoate Ointment at room temperature between 68°F to 77°F (20°C to 25°C).</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">• <span class=\"Bold\"> Keep </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> a</span><span class=\"Bold\"> nd all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> G</span><span class=\"Bold\"> e</span><span class=\"Bold\"> neral information about the safe and effective use of </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> .</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mometasone Furoate Ointment for a condition for which it was not prescribed. Do not give Mometasone Furoate Ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Mometasone Furoate Ointment that is written for health professionals.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> W</span><span class=\"Bold\"> hat are the ingredients in </span><span class=\"Bold\"> Mometasone Furoate Ointment</span><span class=\"Bold\"> ? </span>\n<br/>\n<span class=\"Bold\">A</span><span class=\"Bold\">c</span><span class=\"Bold\">tive ingredient: </span> mometasone furoate <br/>\n<span class=\"Bold\"> I</span><span class=\"Bold\">nactive ingredients: </span> hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum. <br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=ca36668d-1381-42bd-98a8-c85ad4d47802-120-2.jpg&amp;setid=18ef90de-f74d-492f-a125-49da1875bd29\"/><br/>\n<span class=\"Bold\"> Manufactured by:</span>\n<br/> TORRENT PHARMACEUTICALS LTD. <br/> Pithampur, Dist. Dhar-454 775 (M.P.) INDIA <br/>\n<span class=\"Bold\"> For:</span>\n<br/> TORRENT PHARMA INC. <br/>Basking Ridge, NJ 07920. <br/> 8091179                                                                                                      Revised: 12/2022</td>\n</tr>\n</tbody>\n</table></div>" }

Mometasone Furoate 15 gm tube

{ "type": "p", "children": [], "text": "\nMometasone Furoate 15 gm tube" }

Mometasone Furoate 15 gm carton

{ "type": "p", "children": [], "text": "\nMometasone Furoate 15 gm carton\n" }

Mometasone Furoate 45 gm tube

{ "type": "p", "children": [], "text": "\nMometasone Furoate 45 gm tube\n" }

Mometasone Furoate 45 gm carton

{ "type": "p", "children": [], "text": "\nMometasone Furoate 45 gm carton\n" }