EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults.

{ "type": "p", "children": [], "text": "EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults." }

Limitations of Use

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

{ "type": "ul", "children": [ "This formulation of minocycline has not been evaluated in the treatment or prevention of infections.", "To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated." ], "text": "" }

The recommended dosage of EMROSI is one capsule taken orally, once daily. Higher doses have not shown to be of additional benefit in the treatment of rosacea.

{ "type": "p", "children": [], "text": "The recommended dosage of EMROSI is one capsule taken orally, once daily. Higher doses have not shown to be of additional benefit in the treatment of rosacea." }

EMROSI may be taken with or without food [see Clinical Pharmacology (12.3)] . Ingestion of food along with EMROSI may help to reduce the risk of esophageal irritation and ulceration.

{ "type": "p", "children": [], "text": "EMROSI may be taken with or without food\n \n [see\n \n Clinical Pharmacology (12.3)]\n \n . Ingestion of food along with EMROSI may help to reduce the risk of esophageal irritation and ulceration.\n\n " }

Swallow the capsule whole. Do not crush or chew the extended-release capsule.

{ "type": "p", "children": [], "text": "Swallow the capsule whole. Do not crush or chew the extended-release capsule." }

Extended-release capsules: 40 mg.

{ "type": "p", "children": [], "text": "Extended-release capsules: 40 mg." }

EMROSI is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "EMROSI is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines\n \n [see\n \n Warnings and Precautions (5.1)].\n \n \n" }

Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue EMROSI immediately.

The use of tetracycline class drugs, including EMROSI during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of EMROSI is not recommended during tooth development.

Advise the patient of the potential risk to the fetus if EMROSI is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].

The use of tetracycline-class drugs, including EMROSI, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including EMROSI, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Advise the patient of the potential risk to the fetus if EMROSI is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].

Clostridium difficileassociated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis.

C. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficilecause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, discontinue EMROSI.

Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. Discontinue EMROSI if liver injury is suspected.

Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Caution patients who experience these symptoms about driving vehicles or using hazardous machinery while on EMROSI. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.

Idiopathic Intracranial hypertension has been associated with the use of tetracyclines. Clinical manifestations of idiopathic intracranial hypertension include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of idiopathic intracranial hypertension are at a greater risk for developing idiopathic intracranial hypertension. Avoid concomitant use of isotretinoin and EMROSI because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension.

Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, monitor patients until they stabilize.

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Evaluate symptomatic patients. If symptoms occur, immediately discontinue EMROSI.

The anti-anabolic action of the tetracyclines, including EMROSI, may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired renal function, higher serum levels of EMROSI may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, monitor serum levels of EMROSI during treatment, and discontinue EMROSI if necessary.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using EMROSI. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided.

Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Bacterial resistance to the tetracyclines may develop in patients using EMROSI, Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated.

Use of EMROSI may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue EMROSI and institute appropriate therapy.

Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies.

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.

In two clinical trials, MVOR-1 and MVOR-2, a total of 638 adult subjects were analyzed under the safety population with 243 subjects in EMROSI group, 237 subjects in doxycycline (40 mg) group and 158 subjects in placebo group [see Clinical Studies (14)].

The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia, which was reported in 2% of subjects treated with EMROSI and none of the subjects receiving placebo.

The following adverse reactions have been reported with post-approval use of minocycline hydrochloride in a variety of indications. 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.

Skin and hypersensitivity reactions:anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet’s syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura photosensitivity, pigmentation of skin and mucous membranes.

Autoimmune conditions:polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome.

Central nervous system:idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing.

Endocrine:brown-black microscopic thyroid discoloration, abnormal thyroid function.

Oncology:thyroid cancer.

Oral:glossitis, dysphagia, tooth discoloration.

Gastrointestinal:enterocolitis, pancreatitis, hepatitis, liver failure.

Renal:acute renal failure.

Hematology:hemolytic anemia, thrombocytopenia, eosinophilia.

Because tetracyclines have been shown to decrease plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving EMROSI in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Risk Summary

Tetracycline-class drugs, including EMROSI, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.4)]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, bent limb bones were observed following oral administration of minocycline hydrochloride during organogenesis at systemic exposure of approximately 7.1 and 4.8 times, respectively, the maximum recommended human dose (MRHD) based on AUC exposures (see Data).

If the patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and discontinue treatment.

The 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Human Data

The use of tetracycline class drugs, including EMROSI, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions (5.2)].

Animal Data

Results of animal studies indicate that minocycline hydrochloride crosses the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3)].

Minocycline hydrochloride induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (7.1 and 4.8 times, respectively, the MRHD based on AUC comparison). Reduced mean fetal body weight was observed in studies in which minocycline hydrochloride was administered to pregnant rats at an oral dose of 10 mg/kg/day (2.4 times the MRHD based on AUC comparison).

Minocycline hydrochloride was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (6 times the MRHD based on AUC comparison). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline hydrochloride at 50 mg/kg/day included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline hydrochloride.

Risk Summary

Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during EMROSI therapy and for 4 days after the final dose [see Warnings and Precautions (5.2, 5.3)].

The safety and effectiveness of EMROSI have not been established in pediatric patients.

Tooth discoloration and inhibition of bone growth have been observed in pediatric patients with the use of tetracycline class antibiotics [see Warnings and Precaution (5.2, 5.3)].

Of the 653 subjects in the phase 3 clinical trials of EMROSI, 101 (15.5%) subjects were 65 years of age and older and 25 (3.8%) were 75 years of age and older. No overall differences in safety or effectiveness of EMROSI have been observed between subjects 65 years of age and older and younger adult subjects.

Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue EMROSI, treat symptomatically and institute supportive measures. Call Poison Control Center at 1-800-222-1222 for the latest recommendations.

{ "type": "p", "children": [], "text": "Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue EMROSI, treat symptomatically and institute supportive measures. Call Poison Control Center at 1-800-222-1222 for the latest recommendations." }

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a- tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. Its molecular formula is C 23H 27N 3O 7•HCl with a molecular weight of 493.95. Minocycline hydrochloride has the following structure:

{ "type": "p", "children": [], "text": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a- tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. Its molecular formula is C\n \n 23H\n \n 27N\n \n 3O\n \n 7•HCl with a molecular weight of 493.95. Minocycline hydrochloride has the following structure: \n \n\n" }

Minocycline hydrochloride is a yellow, hygroscopic, crystalline powder. It is sparingly soluble in water, slightly soluble in ethanol (96%). A 1% w/v solution in water has pH between 3.5 and 4.5.

{ "type": "p", "children": [], "text": "Minocycline hydrochloride is a yellow, hygroscopic, crystalline powder. It is sparingly soluble in water, slightly soluble in ethanol (96%). A 1% w/v solution in water has pH between 3.5 and 4.5." }

Each EMROSI extended-release capsule contains 40 mg of minocycline (equivalent to 43.19 mg of minocycline hydrochloride) as 10 mg immediate-release and 30 mg extended-release beads and the following inactive ingredients: ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry ®clear, polyethylene glycol 400, triethyl citrate and talc. Opadry ®clear contains: hydroxypropyl cellulose and hypromellose. Capsule shell contains gelatin, iron oxide red and titanium dioxide. White ink contains ammonia, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, titanium dioxide and shellac.

{ "type": "p", "children": [], "text": "Each EMROSI extended-release capsule contains 40 mg of minocycline (equivalent to 43.19 mg of minocycline hydrochloride) as 10 mg immediate-release and 30 mg extended-release beads and the following inactive ingredients: ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry\n \n ®clear, polyethylene glycol 400, triethyl citrate and talc. Opadry\n \n ®clear contains: hydroxypropyl cellulose and hypromellose. Capsule shell contains gelatin, iron oxide red and titanium dioxide. White ink contains ammonia, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, titanium dioxide and shellac.\n\n " }

The mechanism of action of EMROSI for the treatment of rosacea is unknown.

The pharmacodynamics of EMROSI for the treatment of rosacea are unknown.

EMROSI is not bioequivalent to any other minocycline products. The pharmacokinetics of minocycline following administration of EMROSI was investigated in two studies that enrolled 32 healthy, adult subjects. In Study 1, the plasma pharmacokinetic parameters for EMROSI following single dose administration under fasting and fed states are presented in Table 1.

Table 1: Plasma Pharmacokinetic Parameters [Mean (%CV)] for EMROSI (40 mg)

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0" width="70%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">N</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">C <span class="Sub">max</span></span> </p> <p> <span class="Bold">(ng/mL)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">T <span class="Sub">max</span>* <br/> (hr) </span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">AUC <span class="Sub">inf</span> <br/> (ng.hr/mL) </span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">t <span class="Sub">1/2</span> <br/> (hr) </span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">EMROSI (Fasting)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">23</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">243.9 <br/> (37.3) </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">1.50 <br/> (1.00 – 4.17) </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">3933.6 <br/> (31.2) </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">14.67 <br/> (26.7) </p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">EMROSI (Fed)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">23</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">225.0 <br/> (16.7) </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">4.50 <br/> (3.00 – 8.00) </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">4404.1 <br/> (21.0) </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">14.93 <br/> (21.5) </p> </td> </tr> </tbody> </table></div>

Note: * Median (Range)

In Study 2, minocycline plasma PK following EMROSI single (Day 1) and after repeated (Day 21) once daily administrations in eight (8) subjects were found to be similar with overlapping ranges. The mean C maxwas 382.83 ng/mL versus 337.74 ng/mL and AUC 0-24was 3549.64 ng*hr/mL versus 3957.62 ng*hr/mL, respectively on Day 1 versus Day 21.

Absorption:In Study 1, the median plasma T maxof minocycline from EMROSI was 1.50 hours (1.00 - 4.17). In Study 2, the median plasma T maxvalues of minocycline from EMROSI on Day 1 and Day 21 were 1.75 and 1.5 hours, respectively.

Effect of Food:Following administration of EMROSI with a high-fat meal (1011 Kcal, 53% fat), T maxwas delayed by approximately 3 hours. The high fat meal did not impact the C maxhowever, the AUC infwas increased by 15.26% ( Table 1) [see Dosage and Administration (2)].

Distribution:Minocycline is lipid soluble and distributes into the skin and sebum. In Study 1, the mean apparent volume of distribution (Vz/F) values of minocycline following oral administration of EMROSI at fasting and fed condition were 229.61 (±67.83) L and 199.83 (±43.71) L, respectively.

Elimination:The mean apparent elimination half-life (t ½) of minocycline from EMROSI was approximately 15 hours independent of fasting and fed dosing condition.

In an oral carcinogenicity study in rats in which minocycline hydrochloride was administered once daily for up to 104 weeks at doses up to 200 mg/kg/day, minocycline hydrochloride increased incidences of follicular cell tumors of the thyroid gland in both sexes, including adenomas, carcinomas, and the combined incidence of adenomas and carcinomas in males and adenomas and the combined incidence of adenomas and carcinomas in females. In an oral carcinogenicity study in mice in which minocycline hydrochloride was administered once daily for up to 104 weeks at doses up to 150 mg/kg/day, minocycline hydrochloride did not increase tumor incidence.

Minocycline hydrochloride was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline hydrochloride was not clastogenic in vitrousing human peripheral blood lymphocytes or in vivoin a mouse micronucleus test.

Male and female reproductive performance in rats was unaffected by oral doses of minocycline hydrochloride up to 300 mg/kg/day (95 times the MRHD based on AUC comparison). However, doses of 100 mg/kg/day (36 times the MRHD based on AUC comparison) and higher to male rats adversely affected spermatogenesis. At 100 mg/kg/day, minocycline increased morphological abnormalities, including absent heads, misshapen heads, and abnormal flagella. At 300 mg/kg/day, minocycline also reduced the number of sperm cells per gram of epididymis and reduced the percentage of motile sperm.

The safety and efficacy of EMROSI in the treatment of inflammatory lesions and erythema of rosacea was assessed in two 16-week, multi-center, randomized, double-blind, active- and placebo-controlled trials (MVOR-1 [NCT05296629] and MVOR-2 [NCT05343455]) in adults. In the two trials, a total of 653 subjects with papulopustular rosacea received EMROSI or doxycycline capsules 40 mg or placebo for up to 16 weeks.

{ "type": "p", "children": [], "text": "The safety and efficacy of EMROSI in the treatment of inflammatory lesions and erythema of rosacea was assessed in two 16-week, multi-center, randomized, double-blind, active- and placebo-controlled trials (MVOR-1 [NCT05296629] and MVOR-2 [NCT05343455]) in adults. In the two trials, a total of 653 subjects with papulopustular rosacea received EMROSI or doxycycline capsules 40 mg or placebo for up to 16 weeks." }

Subjects were required to have an inflammatory lesion count (papules and pustules) in the range 15-60 lesions and an Investigator’s Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline.

{ "type": "p", "children": [], "text": "Subjects were required to have an inflammatory lesion count (papules and pustules) in the range 15-60 lesions and an Investigator’s Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline." }

The mean age of subjects was 49 years and subjects were from the following racial groups: White (93%), Asian (4%), Black or African American (2%), and Other (1%); for ethnicity, 38% of subjects identified as Hispanic or Latino. At baseline, subjects had a mean inflammatory lesion count of 25 (ranged 15 to 58), 88% were scored as moderate (IGA=3), and 12% were scored as severe (IGA=4).

{ "type": "p", "children": [], "text": "The mean age of subjects was 49 years and subjects were from the following racial groups: White (93%), Asian (4%), Black or African American (2%), and Other (1%); for ethnicity, 38% of subjects identified as Hispanic or Latino. At baseline, subjects had a mean inflammatory lesion count of 25 (ranged 15 to 58), 88% were scored as moderate (IGA=3), and 12% were scored as severe (IGA=4)." }

The co-primary efficacy endpoints were the proportion of subjects with IGA ‛treatment success’ at Week 16 (defined as an IGA score of 0 [“clear”] or 1 [“near clear”] with at least a 2-grade reduction from baseline) and the absolute change from baseline in total inflammatory lesion counts at Week 16, in the EMROSI group compared to the placebo group. The efficacy results are presented in Table 2.

{ "type": "p", "children": [], "text": "The co-primary efficacy endpoints were the proportion of subjects with IGA ‛treatment success’ at Week 16 (defined as an IGA score of 0 [“clear”] or 1 [“near clear”] with at least a 2-grade reduction from baseline) and the absolute change from baseline in total inflammatory lesion counts at Week 16, in the EMROSI group compared to the placebo group. The efficacy results are presented in\n \n Table 2.\n\n " }

Table 2: Efficacy Results at Week 16 in Trials MVOR-1 and MVOR-2

{ "type": "p", "children": [], "text": "\nTable 2: Efficacy Results at Week 16 in Trials MVOR-1 and MVOR-2\n" }

<div class="scrollingtable"><table> <thead> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2"> <p class="First"> <span class="Bold">Endpoint</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First"> <span class="Bold">Trial MVOR-1</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First"> <span class="Bold">Trial MVOR-2</span> </p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">EMROSI</span> </p> <p> <span class="Bold">(N=122)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Doxycycline</span> </p> <p> <span class="Bold">(N=121)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N=80)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">EMROSI</span> </p> <p> <span class="Bold">(N=123)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Doxycycline</span> </p> <p> <span class="Bold">(N=125)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Placebo</span> </p> <p> <span class="Bold">(N=82)</span> </p> </td> </tr> </thead> <tbody> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">IGA Treatment</span> </p> <p> <span class="Bold">Success <span class="Sup">1</span></span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">65%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">46%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">31%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">60%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">31%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">27%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">   Difference from</span> </p> <p> <span class="Italics">   Placebo (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">33% (20%, 46%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">34% (21%, 47%)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">   Difference from</span> </p> <p> <span class="Italics">   Doxycycline (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">18% (5%, 31%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">28% (17%, 39%)</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="7"> <p class="First"> <span class="Bold">Inflammatory Lesion Counts</span> </p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First">Mean <span class="Sup">2</span>Absolute Change from Baseline </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-20.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-15.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-11.4</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-18.1</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-14.6</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-11.2</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">   Difference from</span> </p> <p> <span class="Italics">   Placebo (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-9.3 (-11.6, -6.9)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-6.9 (-9.1, -4.6)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">   Difference from</span> </p> <p> <span class="Italics">   Doxycycline (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-5.1 (-7.2, -2.9)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-3.4 (-5.4, -1.5)</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule"> <p class="First">Mean <span class="Sup">2</span> Percent Change from Baseline </p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-79%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-63%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-47%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-75%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-60%</p> </td><td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First">-46%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">   Difference from</span> </p> <p> <span class="Italics">   Placebo (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-33% (-41%, -24%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-30% (-39%, -20%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Italics">   Difference from</span> </p> <p> <span class="Italics">   Doxycycline (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-16% (-24%, -8%)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3"> <p class="First">-15% (-23%, -7%)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table>\n<thead>\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Endpoint</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">Trial MVOR-1</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">\n<span class=\"Bold\">Trial MVOR-2</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">EMROSI</span>\n</p>\n<p>\n<span class=\"Bold\">(N=122)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Doxycycline</span>\n</p>\n<p>\n<span class=\"Bold\">(N=121)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Placebo</span>\n</p>\n<p>\n<span class=\"Bold\">(N=80)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">EMROSI</span>\n</p>\n<p>\n<span class=\"Bold\">(N=123)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Doxycycline</span>\n</p>\n<p>\n<span class=\"Bold\">(N=125)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Placebo</span>\n</p>\n<p>\n<span class=\"Bold\">(N=82)</span>\n</p>\n</td>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">IGA Treatment</span>\n</p>\n<p>\n<span class=\"Bold\">Success\n \n <span class=\"Sup\">1</span></span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">65%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">46%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">31%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">60%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">31%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">27%</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Italics\">   Difference from</span>\n</p>\n<p>\n<span class=\"Italics\">   Placebo (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">33% (20%, 46%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">34% (21%, 47%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Italics\">   Difference from</span>\n</p>\n<p>\n<span class=\"Italics\">   Doxycycline (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">18% (5%, 31%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">28% (17%, 39%)</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"7\">\n<p class=\"First\">\n<span class=\"Bold\">Inflammatory Lesion Counts</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">Mean\n \n <span class=\"Sup\">2</span>Absolute Change from Baseline\n \n </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-20.6</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-15.6</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-11.4</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-18.1</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-14.6</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-11.2</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Italics\">   Difference from</span>\n</p>\n<p>\n<span class=\"Italics\">   Placebo (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-9.3 (-11.6, -6.9)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-6.9 (-9.1, -4.6)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Italics\">   Difference from</span>\n</p>\n<p>\n<span class=\"Italics\">   Doxycycline (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-5.1 (-7.2, -2.9)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-3.4 (-5.4, -1.5)</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">Mean\n \n <span class=\"Sup\">2</span> Percent Change from Baseline\n \n </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-79%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-63%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-47%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-75%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-60%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">-46%</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Italics\">   Difference from</span>\n</p>\n<p>\n<span class=\"Italics\">   Placebo (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-33% (-41%, -24%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-30% (-39%, -20%)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Italics\">   Difference from</span>\n</p>\n<p>\n<span class=\"Italics\">   Doxycycline (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-16% (-24%, -8%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\">\n<p class=\"First\">-15% (-23%, -7%)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

1Investigator’s Global Assessment (IGA) treatment success was defined as an IGA score of 0 or 1 with at least a 2-grade reduction from baseline.

{ "type": "p", "children": [], "text": "\n1Investigator’s Global Assessment (IGA) treatment success was defined as an IGA score of 0 or 1 with at least a 2-grade reduction from baseline.\n\n " }

2Means presented in table are Least Square (LS) means.

{ "type": "p", "children": [], "text": "\n2Means presented in table are Least Square (LS) means.\n\n " }

How Supplied

EMROSI is an opaque, brownish-red colored, hard gelatin capsule, imprinted “MEC” on both cap and body with white ink.

Bottles of 30 capsules with child-resistant closure, NDC 69489-131-30.

Storage and Handling

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

Protect from light, moisture, and excessive heat.

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)." }

Advise patients taking EMROSI extended-release capsules of the following information and instructions:

{ "type": "p", "children": [], "text": "Advise patients taking EMROSI extended-release capsules of the following information and instructions:" }

Administration Instructions

{ "type": "p", "children": [], "text": "\nAdministration Instructions\n" }

{ "type": "ul", "children": [ "EMROSI should be taken exactly as directed.", "Advise patients to swallow EMROSI capsule whole and not to chew or crush the capsule\n \n [see\n \n Dosage and Administration (2)].\n \n \n" ], "text": "" }

Serious Skin/Hypersensitivity Reactions

{ "type": "p", "children": [], "text": "\nSerious Skin/Hypersensitivity Reactions\n" }

{ "type": "ul", "children": [ "Inform patients that serious skin reactions have occurred with minocycline use in patients with acne. Advise patients to discontinue use of EMROSI and contact their healthcare provider immediately at the first evidence of skin erythema\n \n [see\n \n Warnings and Precautions (5.1)].\n \n \n" ], "text": "" }

Tooth Discoloration and Enamel Hypoplasia

{ "type": "p", "children": [], "text": "\nTooth Discoloration and Enamel Hypoplasia\n" }

{ "type": "ul", "children": [ "Advise patients that EMROSI use in pregnancy may cause permanent tooth discoloration of deciduous teeth. Advise patients to discontinue EMROSI during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment\n \n [see\n \n Warnings and Precautions (5.2),\n \n Use in Specific Populations (8.1)].\n \n \n" ], "text": "" }

Inhibition of Bone Growth

{ "type": "p", "children": [], "text": "\nInhibition of Bone Growth\n" }

{ "type": "ul", "children": [ "Advise patients that EMROSI use in pregnancy may cause inhibition of fetal bone growth. Advise patients to discontinue EMROSI during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment\n \n [see\n \n Warnings and Precautions (5.3),\n \n Use in Specific Populations (8.1)].\n \n \n" ], "text": "" }

Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)

{ "type": "p", "children": [], "text": "\nClostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)\n \n \n" }

{ "type": "ul", "children": [ "Advise patients that\n \n Clostridioides difficile-associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including EMROSI. If patients develop watery or bloody stools, advise patients to seek medical attention\n \n [see\n \n Warnings and Precautions (5.4)].\n \n \n" ], "text": "" }

Hepatotoxicity

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

{ "type": "ul", "children": [ "Inform patients about the possibility of hepatotoxicity. Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, bleeding easily, confusion, and sleepiness\n \n [see\n \n Warnings and Precautions (5.5)].\n \n \n" ], "text": "" }

Central Nervous System Effects

{ "type": "p", "children": [], "text": "\nCentral Nervous System Effects\n" }

{ "type": "ul", "children": [ "Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on EMROSI\n \n [see\n \n Warnings and Precautions (5.6)].\n \n \n" ], "text": "" }

Idiopathic Intracranial Hypertension

{ "type": "p", "children": [], "text": "\nIdiopathic Intracranial Hypertension\n" }

{ "type": "ul", "children": [ "Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss\n \n [see\n \n Warnings and Precautions (5.7)].\n \n \n" ], "text": "" }

Autoimmune Syndromes

{ "type": "p", "children": [], "text": "\nAutoimmune Syndromes\n" }

{ "type": "ul", "children": [ "Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash, and malaise. Advise patients who experience such symptoms to immediately discontinue EMROSI and seek medical help\n \n [see\n \n Warnings and Precautions (5.8)].\n \n \n" ], "text": "" }

Photosensitivity

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

{ "type": "ul", "children": [ "Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (i.e., tanning beds or UVA/B treatment) while using EMROSI. Instruct patients to use sunscreen and wear protective clothing (e.g., hat) over treated areas when exposure to sun cannot be avoided\n \n [see\n \n Warnings and Precautions (5.10)].\n \n \n" ], "text": "" }

Tissue Hyperpigmentation

{ "type": "p", "children": [], "text": "\nTissue Hyperpigmentation\n" }

{ "type": "ul", "children": [ "Inform patients that EMROSI may cause discoloration of skin, scars, teeth, or gums\n \n [see\n \n Warnings and Precautions (5.11)]\n \n .\n \n " ], "text": "" }

Lactation

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

{ "type": "ul", "children": [ "Advise patients that EMROSI therapy is not recommended during breast feeding for 4 days after the final dose\n \n [see\n \n Use in Specific Populations (8.2)].\n \n \n" ], "text": "" }

Manufactured for:

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

Journey Medical Corporation Scottsdale, AZ 85258

{ "type": "p", "children": [], "text": "Journey Medical Corporation \n Scottsdale, AZ 85258\n " }

EMR-P01-R01

{ "type": "p", "children": [], "text": "EMR-P01-R01" }

EMROSI is a trademark of Journey Medical Corporation.

{ "type": "p", "children": [], "text": "EMROSI is a trademark of Journey Medical Corporation." }

All other trademarks are the properties of their respective owners. Copyright © 2024, Journey Medical Corporation. All rights reserved.

{ "type": "p", "children": [], "text": "All other trademarks are the properties of their respective owners. Copyright © 2024, Journey Medical Corporation. All rights reserved." }

<div class="scrollingtable"><table border="1" cellpadding="0" cellspacing="0" width="950px"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> </p> <p> <span class="Bold">EMROSI <span class="Sup">TM</span>(em-ROH-see) </span> </p> <p> <span class="Bold">(minocycline hydrochloride)</span> </p> <p> <span class="Bold">extended-release capsules, for oral use</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First First Paragraph"> <span class="Bold">What is EMROSI?</span> </p> <p>EMROSI is a prescription medicine used to treat adults with pimples and bumps (inflammatory lesions) caused by a condition called rosacea.</p> <p>It is not known if EMROSI is:</p> <ul> <li>safe and effective for the treatment of infections</li> <li>safe and effective in children under the age of 18 years       </li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Who should not take EMROSI?</span> </p> <p> <span class="Bold">Do not take EMROSI</span>if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">Before taking EMROSI, tell your healthcare provider about all of your medical conditions, including if you:</span> </p> <ul> <li>have diarrhea or watery stools</li> <li>have liver problems</li> <li>have kidney problems</li> <li>have had increased pressure around your brain that may have cause vision problems</li> <li>are pregnant or plan to become pregnant. EMROSI may harm your unborn baby. Taking EMROSI while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking EMROSI and call your healthcare provider right away if you become pregnant during treatment with EMROSI</li> <li>are breastfeeding or plan to breastfeed. EMROSI passes into your milk and may harm your baby. Do not breastfeed during treatment with EMROSI and for 4 days after your final dose</li> </ul> <p> <span class="Bold">Tell your healthcare provider about all the other medicines you take,</span>including prescription and over-the counter medicines, vitamins and herbal supplements. </p> <p>EMROSI and other medicines may affect each other and cause serious side effects. EMROSI may affect the way other medicines work, and other medicines may affect how EMROSI works.</p> <p> <span class="Bold">Especially tell your healthcare provider if you take:</span> </p> <ul> <li>a blood thinner medicine</li> <li>penicillin antibiotic medicine</li> <li>antacids that contain aluminum, calcium, or magnesium or iron-containing medicines</li> <li>an acne medicine that contains isotretinoin</li> </ul> <p>Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">How should I take EMROSI?</span> </p> <ul> <li>Take EMROSI exactly as your healthcare provider tells you</li> <li>Take EMROSI 1 time per day with or without food. Taking EMROSI with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach</li> <li>Swallow EMROSI whole. Do not chew or crush the capsules</li> </ul> <p> <span class="Bold">If you take too much EMROSI, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">What should I avoid while taking EMROSI?</span> </p> <ul> <li>You should not drive or operate dangerous machinery until you know how EMROSI affects you. EMROSI may cause you to feel dizzy or lightheaded or have a spinning feeling (vertigo)</li> <li>Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with EMROSI. EMROSI can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment. Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment with EMROSI</li> </ul> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">What are the possible side effects of EMROSI?</span> </p> <span class="Bold">EMROSI may cause serious side effects, including:</span> <br/> <ul> <li> <span class="Bold">Serious skin and allergic reactions</span>have happened during treatment with minocycline. EMROSI may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. Stop taking EMROSI and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following signs or symptoms, including: <ul> <li>skin redness, rash, hives, sores in your mouth, or your skin blisters and peels</li> <li>swelling of your face, eyes, lips, tongue, or throat</li> <li>trouble swallowing or breathing</li> <li>blood in your urine</li> <li>fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine</li> <li>pain on the right side of the stomach area (abdominal pain)</li> <li>chest pain or abnormal heartbeats</li> <li>swelling in your legs, ankles, and feet</li> </ul> </li> <li> <span class="Bold">Permanent tooth discoloration and problems with tooth enamel.</span>EMROSI may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. EMROSI may cause tooth enamel to not develop properly. You should not use EMROSI during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and in children from birth to 8 years of age. See <span class="Bold">“Before taking EMROSI, tell your healthcare provider about all your medical conditions, including if you:”</span> </li> <li> <span class="Bold">Slow bone growth.</span>EMROSI may cause slow bone growth if it is used during the second and third trimesters of pregnancy and if it is used in infants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with EMROSI. </li> <li> <span class="Bold">Diarrhea (antibiotic associated colitis).</span>Antibiotic associated colitis can happen with most antibiotics, including EMROSI. This type of diarrhea may be caused by an infection ( <span class="Italics">Clostridioides difficile</span>) in your intestines and can be severe and lead to death. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. </li> <li> <span class="Bold">Liver problems.</span>EMROSI may cause serious liver problems that can lead to death.Stop taking EMROSI and call your healthcare provider right away if you get any of the following symptoms of liver problems: <ul> <li>loss of appetite</li> <li>tiredness</li> <li>diarrhea</li> <li>yellowing of your skin or the whites of your eyes</li> <li>unexplained bleeding or bleeding easily than normal</li> <li>confusion</li> <li>sleepiness</li> </ul> </li> </ul> <ul> <li> <span class="Bold">Central nervous system effects.</span>See “ <span class="Bold">What should I avoid while taking EMROSI?</span>” Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with EMROSI or if treatment is stopped. </li> <li> <span class="Bold">Increased pressure around the brain (idiopathic intracranial hypertension).</span>This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female who can have children, are overweight, and have already had intracranial hypertension. Stop taking EMROSI and tell your healthcare provider right away if you have unusual headaches, blurred vision, double vision, and vision loss. </li> <li> <span class="Bold">Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis).</span>Using EMROSI for a long time to treat acne may cause immune system reactions. Stop taking EMROSI and tell your healthcare provider right away if you get a fever, rash, joint pain, or body weakness. </li> <li> <span class="Bold">Sensitivity to sunlight (photosensitivity).</span>See “ <span class="Bold">What should I avoid while taking EMROSI?</span>” </li> <li> <span class="Bold">Discoloration (tissue hyperpigmentation).</span>EMROSI may cause darkening of your nails, bone, skin, eyes, teeth, gums, scars, and internal organs. </li> </ul> <p> <span class="Bold">The most common side effects of EMROSI include</span>stomach upset or burning (dyspepsia) after eating or drinking. </p> <br/> <p>Your healthcare provider may do blood tests and check you for side effects during treatment with EMROSI and may stop treatment if you develop certain side effects.</p> <br/> <p>These are not all the side effects with EMROSI.</p> <br/> <p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> <p>You may also report side effects to Journey Medical Corporation at 1-855-531-1859.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">How should I store EMROSI?</span> </p> <ul> <li>Store EMROSI at room temperature between 68°F to 77°F (20°C to 25°C)</li> <li>EMROSI comes in a child-resistant package</li> <li>Keep EMROSI container tightly closed</li> <li>Keep EMROSI away from light, moisture, and excessive heat</li> <li>Do not eat desiccant</li> </ul> <p> <span class="Bold">Keep EMROSI out of the reach of children</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">General information about the safe and effective use of EMROSI.</span> <br/> <br/> Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use EMROSI for a condition for which it was not prescribed. Do not give EMROSI to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EMROSI that is written for health professionals. </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule"> <p class="First"> <span class="Bold">What are the ingredients in EMROSI?</span> </p> <p> <br/> <span class="Bold"><span class="Bold"></span></span> </p> <p> <span class="Bold"><span class="Bold">Active ingredient:</span></span>minocycline hydrochloride </p> <p> <br/> <span class="Bold"></span> </p> <p> <span class="Bold">Inactive ingredients:</span>ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry clear, polyethylene glycol, triethyl citrate, and talc </p> <p> <br/> <br/> <span class="Bold">Manufactured for:</span> </p> <p>Journey Medical Corporation</p> <p>Scottsdale, AZ 85258</p> <p></p> <p> <br/> For more information, go to <a href="http://www.journeymedicalcorp.com/">www.journeymedicalcorp.com</a>or call 1-855-531-1859 </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"950px\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n</p>\n<p>\n<span class=\"Bold\">EMROSI\n \n <span class=\"Sup\">TM</span>(em-ROH-see)\n \n </span>\n</p>\n<p>\n<span class=\"Bold\">(minocycline hydrochloride)</span>\n</p>\n<p>\n<span class=\"Bold\">extended-release capsules, for oral use</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First First Paragraph\">\n<span class=\"Bold\">What is EMROSI?</span>\n</p>\n<p>EMROSI is a prescription medicine used to treat adults with pimples and bumps (inflammatory lesions) caused by a condition called rosacea.</p>\n<p>It is not known if EMROSI is:</p>\n<ul>\n<li>safe and effective for the treatment of infections</li>\n<li>safe and effective in children under the age of 18 years       </li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Who should not take EMROSI?</span>\n</p>\n<p>\n<span class=\"Bold\">Do not take EMROSI</span>if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">Before taking EMROSI, tell your healthcare provider about all of your medical conditions, including if you:</span>\n</p>\n<ul>\n<li>have diarrhea or watery stools</li>\n<li>have liver problems</li>\n<li>have kidney problems</li>\n<li>have had increased pressure around your brain that may have cause vision problems</li>\n<li>are pregnant or plan to become pregnant. EMROSI may harm your unborn baby. Taking EMROSI while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking EMROSI and call your healthcare provider right away if you become pregnant during treatment with EMROSI</li>\n<li>are breastfeeding or plan to breastfeed. EMROSI passes into your milk and may harm your baby. Do not breastfeed during treatment with EMROSI and for 4 days after your final dose</li>\n</ul>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the other medicines you take,</span>including prescription and over-the counter medicines, vitamins and herbal supplements.\n \n </p>\n<p>EMROSI and other medicines may affect each other and cause serious side effects. EMROSI may affect the way other medicines work, and other medicines may affect how EMROSI works.</p>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider if you take:</span>\n</p>\n<ul>\n<li>a blood thinner medicine</li>\n<li>penicillin antibiotic medicine</li>\n<li>antacids that contain aluminum, calcium, or magnesium or iron-containing medicines</li>\n<li>an acne medicine that contains isotretinoin</li>\n</ul>\n<p>Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take EMROSI?</span>\n</p>\n<ul>\n<li>Take EMROSI exactly as your healthcare provider tells you</li>\n<li>Take EMROSI 1 time per day with or without food. Taking EMROSI with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach</li>\n<li>Swallow EMROSI whole. Do not chew or crush the capsules</li>\n</ul>\n<p>\n<span class=\"Bold\">If you take too much EMROSI, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">What should I avoid while taking EMROSI?</span>\n</p>\n<ul>\n<li>You should not drive or operate dangerous machinery until you know how EMROSI affects you. EMROSI may cause you to feel dizzy or lightheaded or have a spinning feeling (vertigo)</li>\n<li>Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with EMROSI. EMROSI can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment. Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment with EMROSI</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of EMROSI?</span>\n</p>\n<span class=\"Bold\">EMROSI may cause serious side effects, including:</span>\n<br/>\n<ul>\n<li>\n<span class=\"Bold\">Serious skin and allergic reactions</span>have happened during treatment with minocycline. EMROSI may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. Stop taking EMROSI and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following signs or symptoms, including:\n \n <ul>\n<li>skin redness, rash, hives, sores in your mouth, or your skin blisters and peels</li>\n<li>swelling of your face, eyes, lips, tongue, or throat</li>\n<li>trouble swallowing or breathing</li>\n<li>blood in your urine</li>\n<li>fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine</li>\n<li>pain on the right side of the stomach area (abdominal pain)</li>\n<li>chest pain or abnormal heartbeats</li>\n<li>swelling in your legs, ankles, and feet</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Permanent tooth discoloration and problems with tooth enamel.</span>EMROSI may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. EMROSI may cause tooth enamel to not develop properly. You should not use EMROSI during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and in children from birth to 8 years of age. See\n \n <span class=\"Bold\">“Before taking EMROSI, tell your healthcare provider about all your medical conditions, including if you:”</span>\n</li>\n<li>\n<span class=\"Bold\">Slow bone growth.</span>EMROSI may cause slow bone growth if it is used during the second and third trimesters of pregnancy and if it is used in infants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with EMROSI.\n \n </li>\n<li>\n<span class=\"Bold\">Diarrhea (antibiotic associated colitis).</span>Antibiotic associated colitis can happen with most antibiotics, including EMROSI. This type of diarrhea may be caused by an infection (\n \n <span class=\"Italics\">Clostridioides difficile</span>) in your intestines and can be severe and lead to death. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.\n \n </li>\n<li>\n<span class=\"Bold\">Liver problems.</span>EMROSI may cause serious liver problems that can lead to death.Stop taking EMROSI and call your healthcare provider right away if you get any of the following symptoms of liver problems:\n \n <ul>\n<li>loss of appetite</li>\n<li>tiredness</li>\n<li>diarrhea</li>\n<li>yellowing of your skin or the whites of your eyes</li>\n<li>unexplained bleeding or bleeding easily than normal</li>\n<li>confusion</li>\n<li>sleepiness</li>\n</ul>\n</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">Central nervous system effects.</span>See “\n \n <span class=\"Bold\">What should I avoid while taking EMROSI?</span>” Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with EMROSI or if treatment is stopped.\n \n </li>\n<li>\n<span class=\"Bold\">Increased pressure around the brain (idiopathic intracranial hypertension).</span>This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female who can have children, are overweight, and have already had intracranial hypertension. Stop taking EMROSI and tell your healthcare provider right away if you have unusual headaches, blurred vision, double vision, and vision loss.\n \n </li>\n<li>\n<span class=\"Bold\">Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis).</span>Using EMROSI for a long time to treat acne may cause immune system reactions. Stop taking EMROSI and tell your healthcare provider right away if you get a fever, rash, joint pain, or body weakness.\n \n </li>\n<li>\n<span class=\"Bold\">Sensitivity to sunlight (photosensitivity).</span>See “\n \n <span class=\"Bold\">What should I avoid while taking EMROSI?</span>”\n \n </li>\n<li>\n<span class=\"Bold\">Discoloration (tissue hyperpigmentation).</span>EMROSI may cause darkening of your nails, bone, skin, eyes, teeth, gums, scars, and internal organs.\n \n </li>\n</ul>\n<p>\n<span class=\"Bold\">The most common side effects of EMROSI include</span>stomach upset or burning (dyspepsia) after eating or drinking.\n \n </p>\n<br/>\n<p>Your healthcare provider may do blood tests and check you for side effects during treatment with EMROSI and may stop treatment if you develop certain side effects.</p>\n<br/>\n<p>These are not all the side effects with EMROSI.</p>\n<br/>\n<p>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n<p>You may also report side effects to Journey Medical Corporation at 1-855-531-1859.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store EMROSI?</span>\n</p>\n<ul>\n<li>Store EMROSI at room temperature between 68°F to 77°F (20°C to 25°C)</li>\n<li>EMROSI comes in a child-resistant package</li>\n<li>Keep EMROSI container tightly closed</li>\n<li>Keep EMROSI away from light, moisture, and excessive heat</li>\n<li>Do not eat desiccant</li>\n</ul>\n<p>\n<span class=\"Bold\">Keep EMROSI out of the reach of children</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of EMROSI.</span>\n<br/>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use EMROSI for a condition for which it was not prescribed. Do not give EMROSI to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EMROSI that is written for health professionals.\n \n </p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in EMROSI?</span>\n</p>\n<p>\n<br/>\n<span class=\"Bold\"><span class=\"Bold\"></span></span>\n</p>\n<p>\n<span class=\"Bold\"><span class=\"Bold\">Active ingredient:</span></span>minocycline hydrochloride\n \n </p>\n<p>\n<br/>\n<span class=\"Bold\"></span>\n</p>\n<p>\n<span class=\"Bold\">Inactive ingredients:</span>ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry clear, polyethylene glycol, triethyl citrate, and talc\n \n </p>\n<p>\n<br/>\n<br/>\n<span class=\"Bold\">Manufactured for:</span>\n</p>\n<p>Journey Medical Corporation</p>\n<p>Scottsdale, AZ 85258</p>\n<p></p>\n<p>\n<br/> For more information, go to\n \n <a href=\"http://www.journeymedicalcorp.com/\">www.journeymedicalcorp.com</a>or call 1-855-531-1859\n \n </p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration.                   Revised: 11/2024

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration.                   Revised: 11/2024" }

EMR-P02-R01

{ "type": "p", "children": [], "text": "EMR-P02-R01" }

EMROSI is a trademark of Journey Medical Corporation.

{ "type": "p", "children": [], "text": "\n EMROSI is a trademark of Journey Medical Corporation.\n " }

All other trademarks are the properties of their respective owners.

{ "type": "p", "children": [], "text": "\n All other trademarks are the properties of their respective owners.\n " }

Copyright © 2024, Journey Medical Corporation. All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2024, Journey Medical Corporation. All rights reserved." }

PRINCIPAL DISPLAY PANEL

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL\n" }

NDC 69489-131-30

{ "type": "p", "children": [], "text": "\nNDC 69489-131-30\n" }

emrosi TM

{ "type": "p", "children": [], "text": "\nemrosi\n \n TM\n" }

(minocycline hydrochloride)

{ "type": "p", "children": [], "text": "(minocycline hydrochloride)" }

extended-release capsules

{ "type": "p", "children": [], "text": "extended-release capsules" }

40mg*

{ "type": "p", "children": [], "text": "\n40mg*\n" }

*10mg immediate-release & 30mg extended-release

{ "type": "p", "children": [], "text": "*10mg immediate-release \n & 30mg extended-release\n " }

Rx Only

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

30 Capsules

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

PRINCIPAL DISPLAY PANEL

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL\n" }

NDC 69489-131-07

{ "type": "p", "children": [], "text": "\nNDC 69489-131-07\n" }

PHYSICIAN SAMPLE-NOT FOR SALE

{ "type": "p", "children": [], "text": "\nPHYSICIAN SAMPLE-NOT FOR SALE\n" }

emrosi TM

{ "type": "p", "children": [], "text": "\nemrosi\n \n TM\n" }

(minocycline hydrochloride)

{ "type": "p", "children": [], "text": "(minocycline hydrochloride)" }

extended-release capsules

{ "type": "p", "children": [], "text": "extended-release capsules" }

40mg*

{ "type": "p", "children": [], "text": "\n40mg*\n" }

*10mg immediate-release & 30mg extended-release

{ "type": "p", "children": [], "text": "*10mg immediate-release \n & 30mg extended-release\n " }

Rx Only

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

7 Capsules

{ "type": "p", "children": [], "text": "\n7 Capsules\n" }

Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

{ "type": "p", "children": [], "text": "\nMinocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older." }

Limitations of Use

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

{ "type": "ul", "children": [ "Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions.", "This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)].", "To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]." ], "text": "" }

The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. Table 1 provides the recommended minocycline hydrochloride extended-release tablets dosage based upon weight ranges.

<div class="scrollingtable"><table class="Noautorules" width="306"> <col width="156"/> <col width="150"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold"> Patient's</span> <br/> <span class="Bold"> Weight</span>  <span class="Bold"> (kg)</span> <br/> </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold"> Recommended Dosage</span> <br/> <span class="Bold"> (mg/day)</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 45 to 49<br/> </td><td align="center" class="Botrule Rrule"> 45<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 50 to 59<br/> </td><td align="center" class="Botrule Rrule"> 55<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 60 to 71<br/> </td><td align="center" class="Botrule Rrule"> 65<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 72 to 84<br/> </td><td align="center" class="Botrule Rrule"> 80<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 85 to 96<br/> </td><td align="center" class="Botrule Rrule"> 90<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 97 to 110<br/> </td><td align="center" class="Botrule Rrule"> 105<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 111 to 125<br/> </td><td align="center" class="Botrule Rrule"> 115<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 126 to 136<br/> </td><td align="center" class="Botrule Rrule"> 135<br/> </td> </tr> </tbody> </table></div>

Higher dosages have not shown to be of additional benefit in the treatment of inflammatory lesions of acne and may be associated with more acute vestibular adverse reactions.

Swallow tablets whole. Do not chew, crush, or split the extended-release tablets.

Administer minocycline hydrochloride extended-release tablets with or without food [see Clinical Pharmacology (12.3)]. Ingestion of food along with minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration.

In patients with renal impairment, decrease the daily dosage by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.9)].

Minocycline hydrochloride extended-release tablet is contraindicated in patients with history of a hypersensitivity reaction to any of the tetracyclines [see Warnings and Precautions (5.1)].

Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue minocycline immediately.

The use of tetracycline-class drugs, including minocycline, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray -brown). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of minocycline is not recommended during tooth development.

Advise the patient of the potential risk to the fetus if minocycline is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].

The use of tetracycline-class drugs, including minocycline, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including minocycline, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Advise the patient of the potential risk to the fetus if minocycline is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].

Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, discontinue minocycline.

Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal), have been reported with minocycline use in the treatment of acne. Discontinue minocycline if liver injury is suspected.

Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Caution patients who experience these symptoms about driving vehicles or using hazardous machinery while on minocycline. These symptoms may disappear during therapy and usually rapidly disappear when minocycline is discontinued.

Idiopathic intracranial hypertension has been associated with the use of tetracycline-class drugs, including minocycline. Clinical manifestations of idiopathic intracranial hypertension include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of idiopathic intracranial hypertension are at a greater risk for developing idiopathic intracranial hypertension. Avoid concomitant use of isotretinoin and minocycline because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension.

Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, monitor patients until they stabilize.

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis, and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Evaluate symptomatic patients. If symptoms occur, immediately discontinue use of minocycline.

The anti-anabolic action of the tetracyclines, including minocycline, may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired renal function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, lower the total doses of minocycline, and if therapy is prolonged, monitor serum levels minocycline.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (e.g., tanning beds or UVA/B treatment) while using minocycline. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided.

Tetracycline-class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (e.g., teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

Bacterial resistance to tetracyclines may develop in patients using minocycline hydrochloride extended-release tablets. Because of the potential for drug-resistant bacteria to develop during the use of minocycline hydrochloride extended-release tablets, it should be used only as indicated.

Use of minocycline hydrochloride extended-release tablets may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy.

Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies.

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 following table summarizes selected adverse reactions reported in clinical trials at a rate of >1% for minocycline hydrochloride extended-release tablets and higher than placebo.

<div class="scrollingtable"><table class="Noautorules" width="558"> <col width="197"/> <col width="252"/> <col width="109"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Toprule" valign="top"><span class="Bold"> Adverse</span><span class="Bold"> Reactions</span> <br/> </td><td align="center" class="Botrule Toprule" valign="top"><span class="Bold"> Minocycline</span><span class="Bold"> Hydrochloride</span> <br/> <span class="Bold"> Extended-Release Tablets</span> <br/> <span class="Bold"> (1</span><span class="Bold"> mg/kg)</span> <br/> <span class="Bold"> N</span><span class="Bold"> =</span><span class="Bold"> 674</span><span class="Bold"> (%)</span> <br/> </td><td align="center" class="Botrule Toprule" valign="top"><span class="Bold"> PLACEBO</span> <br/> <span class="Bold"> N</span><span class="Bold"> =</span><span class="Bold"> 364</span><span class="Bold"> (%)</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule" valign="top"> At least one treatment-emergent event<br/> </td><td align="center" class="Botrule" valign="top"> 379 (56)<br/> </td><td align="center" class="Botrule" valign="top"> 197 (54)<br/> </td> </tr> <tr> <td align="center" valign="top"> Fatigue<br/> </td><td align="center" valign="top"> 62 (9)<br/> </td><td align="center" valign="top"> 24 (7)<br/> </td> </tr> <tr> <td align="center" valign="top"> Dizziness<br/> </td><td align="center" valign="top"> 59 (9)<br/> </td><td align="center" valign="top"> 17 (5)<br/> </td> </tr> <tr> <td align="center" valign="top"> Pruritus<br/> </td><td align="center" valign="top"> 31 (5)<br/> </td><td align="center" valign="top"> 16 (4)<br/> </td> </tr> <tr> <td align="center" valign="top"> Malaise<br/> </td><td align="center" valign="top"> 26 (4)<br/> </td><td align="center" valign="top"> 9 (3)<br/> </td> </tr> <tr> <td align="center" valign="top"> Somnolence<br/> </td><td align="center" valign="top"> 13 (2)<br/> </td><td align="center" valign="top"> 3 (1)<br/> </td> </tr> <tr> <td align="center" valign="top"> Urticaria<br/> </td><td align="center" valign="top"> 10 (2)<br/> </td><td align="center" valign="top"> 1 (0)<br/> </td> </tr> <tr> <td align="center" valign="top"> Tinnitus<br/> </td><td align="center" valign="top"> 10 (2)<br/> </td><td align="center" valign="top"> 5 (1)<br/> </td> </tr> <tr> <td align="center" valign="top"> Arthralgia<br/> </td><td align="center" valign="top"> 9 (1)<br/> </td><td align="center" valign="top"> 2 (0)<br/> </td> </tr> <tr> <td align="center" class="Botrule" valign="top"> Vertigo<br/> </td><td align="center" class="Botrule" valign="top"> 8 (1)<br/> </td><td align="center" class="Botrule" valign="top"> 3 (1)<br/> </td> </tr> </tbody> </table></div>

The following adverse reactions have been reported with minocycline hydrochloride use in a variety of indications.

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.

Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet's syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome.

Central nervous system: idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing.

Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function.

Oncology: thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving minocycline hydrochloride in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and iron-containing preparations.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Risk Summary 

Tetracycline class drugs, including minocycline may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.4)]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data).

If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and to discontinue treatment.

The 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Human Data

The use of tetracycline class drugs, including minocycline, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions (5.2)].

Animal Data

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions (5.3)].

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively (3 times the MRHD and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at dosages of 5 mg/kg/day, 10 mg/kg/day, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

Risk Summary

Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during minocycline therapy and for 4 days after the final dose [see Warnings and Precautions (5.2, 5.3)].

The safety and effectiveness of minocycline hydrochloride have been established in pediatric patients 12 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris [see Clinical Studies (14)]. Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precaution (5.2, 5.3)]. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions (5.2)].

Safety and effectiveness of minocycline have not been established in pediatric patients younger than 12 years of age.

Clinical studies of minocycline hydrochloride extended-release tablets 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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue minocycline, treat symptomatically, and institute supportive measures. Call Poison Control Center at 1-800 222-1222 for the latest recommendations.

{ "type": "p", "children": [], "text": "\nMinocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue minocycline, treat symptomatically, and institute supportive measures. Call Poison Control Center at 1-800 222-1222 for the latest recommendations." }

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:

{ "type": "p", "children": [], "text": "\nMinocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:" }

                                     C23H27N3O7•HCl             M. W. 493.95

{ "type": "p", "children": [], "text": "\n                                     C23H27N3O7•HCl             M. W. 493.95" }

Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin.

{ "type": "p", "children": [], "text": "Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin." }

Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake.

{ "type": "p", "children": [], "text": "Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake." }

USP dissolution test-8 used.

{ "type": "p", "children": [], "text": "USP dissolution test-8 used." }

USP organic impurities procedure pending.

{ "type": "p", "children": [], "text": "USP organic impurities procedure pending." }

The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

The pharmacodynamics of minocycline hydrochloride extended-release tablets for the treatment of acne are unknown.

Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, minocycline hydrochloride extended-release tablets produce a delayed Tmax at 3.5 hours to 4 hours as compared to a non-modified release reference minocycline product (Tmax at 2.25 hours to 3 hours). At steady-state (Day 6), the mean AUC(0 to 24) and Cmax were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended-release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively. These parameters are based on dose adjusted to 135 mg/day for both products.

A single-dose, four-way crossover study demonstrated that minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, minocycline hydrochloride extended-release tablets 55 mg, 80 mg, and 105 mg were shown to be dose-proportional to minocycline hydrochloride extended-release tablets 90 mg and 135 mg.

When minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions.

Minocycline is lipid soluble and distributes into the skin and sebum.

In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline hydrochloride was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline hydrochloride did not result in a significantly increased incidence of neoplasms in either males or females.

Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (40 times the MRHD on an AUC comparison basis). However, oral administration of 100 mg/kg/day or 300 mg/kg/day of minocycline to male rats (15 to 40 times the MRHD on an AUC comparison basis) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 mg/kg/day and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

The two primary efficacy endpoints were:

1) Mean percent change in inflammatory lesion counts from Baseline to 12 weeks.

2) Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks.

Efficacy results are presented in Table 4.

<div class="scrollingtable"><table class="Noautorules" width="61%"> <col width="28%"/> <col width="22%"/> <col width="13%"/> <col width="22%"/> <col width="13%"/> <tbody class="Headless"> <tr> <td class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold"> Trial</span><span class="Bold"> 1</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold"> Trial</span><span class="Bold"> 2</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold"> Minocycline</span><span class="Bold"> Hydrochloride</span> <br/> <span class="Bold"> Extended-Release Tablets</span> <br/> <span class="Bold"> (1</span><span class="Bold"> mg/kg)</span> <br/> <span class="Bold"> N</span><span class="Bold"> =</span><span class="Bold"> 300</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold"> Placebo</span> <br/> <span class="Bold"> N</span><span class="Bold"> =</span><span class="Bold"> 151</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold"> Minocycline</span><span class="Bold"> Hydrochloride</span> <br/> <span class="Bold"> Extended-Release Tablets</span> <br/> <span class="Bold"> (1</span><span class="Bold"> mg/kg)</span> <br/> <span class="Bold"> N</span><span class="Bold"> =</span><span class="Bold"> 315</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold"> Placebo</span> <br/> <span class="Bold"> N</span><span class="Bold"> =</span><span class="Bold"> 158</span> <br/> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> Mean Percent Improvement in Inflammatory Lesions<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 43.1%<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 31.7%<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 45.8%<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 30.8%<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> No. (%) of Subjects<br/> Clear or Almost<br/> Clear on the EGSA<span class="Sup">*</span> <br/> </td><td align="center" class="Botrule Rrule" valign="top"> 52<br/> (17.3%)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 12<br/> (7.9%)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 50<br/> (15.9%)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 15<br/> (9.5%)<br/> </td> </tr> </tbody> </table></div>

Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

How Supplied

{ "type": "p", "children": [], "text": "\nHow Supplied\n" }

Minocycline Hydrochloride Extended-release Tablets, USP 45 mg are grey colored, modified capsule shaped, biconvex, coated tablets, debossed with "531" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 45 mg are grey colored, modified capsule shaped, biconvex, coated tablets, debossed with \"531\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-531-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-531-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-531-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-531-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-531-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-531-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-531-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-531-05 in bottles of 500 tablets" }

NDC 68382-531-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-531-10 in bottles of 1000 tablets" }

NDC 68382-531-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-531-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 55 mg are yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "550" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 55 mg are yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with \"550\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-550-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-550-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-550-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-550-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-550-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-550-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-550-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-550-05 in bottles of 500 tablets" }

NDC 68382-550-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-550-10 in bottles of 1000 tablets" }

NDC 68382-550-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-550-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 65 mg are blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "532" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 65 mg are blue colored, modified capsule shaped, biconvex, coated tablets, debossed with \"532\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-532-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-532-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-532-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-532-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-532-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-532-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-532-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-532-05 in bottles of 500 tablets" }

NDC 68382-532-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-532-10 in bottles of 1000 tablets" }

NDC 68382-532-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-532-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 80 mg are whitish blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "551" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 80 mg are whitish blue colored, modified capsule shaped, biconvex, coated tablets, debossed with \"551\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-551-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-551-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-551-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-551-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-551-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-551-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-551-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-551-05 in bottles of 500 tablets" }

NDC 68382-551-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-551-10 in bottles of 1000 tablets" }

NDC 68382-551-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-551-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 90 mg are light yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "533" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 90 mg are light yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with \"533\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-533-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-533-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-533-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-533-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-533-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-533-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-533-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-533-05 in bottles of 500 tablets" }

NDC 68382-533-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-533-10 in bottles of 1000 tablets" }

NDC 68382-533-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-533-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 105 mg are light blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "552" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 105 mg are light blue colored, modified capsule shaped, biconvex, coated tablets, debossed with \"552\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-552-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-552-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-552-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-552-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-552-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-552-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-552-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-552-05 in bottles of 500 tablets" }

NDC 68382-552-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-552-10 in bottles of 1000 tablets" }

NDC 68382-552-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-552-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 115 mg are green colored, modified capsule shaped, biconvex, coated tablets, debossed with "534" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 115 mg are green colored, modified capsule shaped, biconvex, coated tablets, debossed with \"534\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-534-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-534-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-534-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-534-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-534-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-534-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-534-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-534-05 in bottles of 500 tablets" }

NDC 68382-534-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-534-10 in bottles of 1000 tablets" }

NDC 68382-534-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-534-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 135 mg are light pink colored, modified capsule shaped, biconvex, coated tablets, debossed with "535" on one side and plain on other side and are supplied as follows:

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 135 mg are light pink colored, modified capsule shaped, biconvex, coated tablets, debossed with \"535\" on one side and plain on other side and are supplied as follows:" }

NDC 68382-535-06 in bottles of 30 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-535-06 in bottles of 30 tablets with child resistance closure" }

NDC 68382-535-16 in bottles of 90 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-535-16 in bottles of 90 tablets with child resistance closure" }

NDC 68382-535-01 in bottles of 100 tablets with child resistance closure

{ "type": "p", "children": [], "text": "NDC 68382-535-01 in bottles of 100 tablets with child resistance closure" }

NDC 68382-535-05 in bottles of 500 tablets

{ "type": "p", "children": [], "text": "NDC 68382-535-05 in bottles of 500 tablets" }

NDC 68382-535-10 in bottles of 1000 tablets

{ "type": "p", "children": [], "text": "NDC 68382-535-10 in bottles of 1000 tablets" }

NDC 68382-535-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

{ "type": "p", "children": [], "text": "NDC 68382-535-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets" }

Storage

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

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]." }

Handling

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

Keep this and all drugs out of the reach of children.

{ "type": "p", "children": [], "text": "Keep this and all drugs out of the reach of children." }

Protect from light, moisture and excessive heat.

{ "type": "p", "children": [], "text": "Protect from light, moisture and excessive heat." }

Dispense in a tight, light-resistant container as defined in the USP with child-resistant closure.

{ "type": "p", "children": [], "text": "Dispense in a tight, light-resistant container as defined in the USP with child-resistant closure." }

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

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

Patients taking minocycline hydrochloride extended-release tablets should receive the following information and instructions:

{ "type": "p", "children": [], "text": "Patients taking minocycline hydrochloride extended-release tablets should receive the following information and instructions:" }

Administration Instructions

{ "type": "p", "children": [], "text": "\nAdministration Instructions\n" }

{ "type": "ul", "children": [ "Minocycline hydrochloride extended-release tablets should be taken exactly as directed.", "Advise patients to swallow minocycline extended-release tablets whole and not to chew, crush, or split the tablets [see Dosage and Administration (2)].\n" ], "text": "" }

Serious Skin/Hypersensitivity Reactions

{ "type": "p", "children": [], "text": "\nSerious Skin/Hypersensitivity Reactions\n" }

{ "type": "ul", "children": [ "Inform patients that serious skin reactions have occurred with the minocycline use in patients with acne. Advise patients to discontinue use of minocycline extended-release tablets and contact their healthcare provider immediately at the first evidence of skin erythema [see Warnings and Precautions (5.1)].\n" ], "text": "" }

Tooth Discoloration and Enamel Hypoplasia

{ "type": "p", "children": [], "text": "\nTooth Discoloration and Enamel Hypoplasia\n" }

{ "type": "ul", "children": [ "Advise patients that minocycline extended-release tablets use in pregnancy may cause permanent tooth discoloration of deciduous teeth. Advise patients to discontinue minocycline extended-release tablets during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.2), Use in Specific Populations (8.1)].", "Advise caregivers of pediatric patients that minocycline extended-release tablets use may cause permanent discoloration of deciduous and permanent teeth [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)]." ], "text": "" }

Inhibition of Bone Growth

{ "type": "p", "children": [], "text": "\nInhibition of Bone Growth\n" }

{ "type": "ul", "children": [ "Advise patients that minocycline use in pregnancy may cause inhibition of fetal bone growth. Advise patients to discontinue minocycline during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)].\n" ], "text": "" }

Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)

{ "type": "p", "children": [], "text": "\nClostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)\n" }

{ "type": "ul", "children": [ "Advise patients that Clostridioides difficile-associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including minocycline extended-release tablets. If patients develop watery or bloody stools, advise patients to seek medical attention [see Warnings and Precautions (5.4)]." ], "text": "" }

Hepatotoxicity

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

{ "type": "ul", "children": [ "Inform patients about the possibility of hepatotoxicity. Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, bleeding easily, confusion, and sleepiness [see Warnings and Precautions (5.5)]." ], "text": "" }

Central Nervous System Effects

{ "type": "p", "children": [], "text": "\nCentral Nervous System Effects\n" }

{ "type": "ul", "children": [ "Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on minocycline[see Warnings and Precautions (5.6)]." ], "text": "" }

Idiopathic Intracranial Hypertension

{ "type": "p", "children": [], "text": "\nIdiopathic Intracranial Hypertension\n" }

{ "type": "ul", "children": [ "Inform patients that idiopathic intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss [see Warnings and Precautions (5.7)]." ], "text": "" }

Autoimmune Syndromes

{ "type": "p", "children": [], "text": "\nAutoimmune Syndromes\n" }

{ "type": "ul", "children": [ "Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash, and malaise. Advise patients who experience such symptoms to immediately discontinue minocycline and seek medical help [see Warnings and Precautions (5.8)].\n" ], "text": "" }

Photosensitivity

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

{ "type": "ul", "children": [ "Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (i.e., tanning beds or UVA/B treatment) while using minocycline. Instruct patients to use sunscreen and wear protective clothing (e.g., hat) over treated areas when exposure to sun cannot be avoided [see Warnings and Precautions (5.10)]." ], "text": "" }

Tissue Hyperpigmentation

{ "type": "p", "children": [], "text": "\nTissue Hyperpigmentation\n" }

{ "type": "ul", "children": [ "Inform patients that minocycline may cause discoloration of skin, scars, teeth, or gums [see Warnings and Precautions (5.11)]." ], "text": "" }

Lactation

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

{ "type": "ul", "children": [ "Advise patients that minocycline therapy is not recommended during breast feeding for 4 days after the final dose [see Use in Specific Populations (8.2)]." ], "text": "" }

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": "\nCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n" }

Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by:\n" }

Zydus Lifesciences Ltd.,

{ "type": "p", "children": [], "text": "Zydus Lifesciences Ltd.," }

Ahmedabad, India

{ "type": "p", "children": [], "text": "Ahmedabad, India " }

Distributed by:

{ "type": "p", "children": [], "text": "\nDistributed by:\n" }

Zydus Pharmaceuticals (USA) Inc.

{ "type": "p", "children": [], "text": "\nZydus Pharmaceuticals (USA) Inc.\n" }

Pennington, NJ 08534

{ "type": "p", "children": [], "text": "Pennington, NJ 08534" }

Rev.: 06/25

{ "type": "p", "children": [], "text": "Rev.: 06/25" }

Patient Information

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

Minocycline Hydrochloride Extended-release Tablets

{ "type": "p", "children": [], "text": "\nMinocycline Hydrochloride Extended-release Tablets\n" }

What are minocycline hydrochloride extended-release tablets? 

{ "type": "p", "children": [], "text": "\nWhat are minocycline hydrochloride extended-release tablets? " }

Minocycline hydrochloride extended-release tablets are a prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years of age and older. Minocycline hydrochloride extended-release tablets are not effective for acne that is not red-looking (not-inflammatory acne).

{ "type": "p", "children": [], "text": "Minocycline hydrochloride extended-release tablets are a prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years of age and older. Minocycline hydrochloride extended-release tablets are not effective for acne that is not red-looking (not-inflammatory acne). " }

{ "type": "ul", "children": [ "safe and effective for the treatment of infections.", "safe and effective in children under 12 years of age." ], "text": "" }

Who should not take minocycline hydrochloride extended-release tablets?

{ "type": "p", "children": [], "text": "\nWho should not take minocycline hydrochloride extended-release tablets? \n" }

Do not take minocycline hydrochloride extended-release tablets if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

{ "type": "p", "children": [], "text": "\nDo not take minocycline hydrochloride extended-release tablets if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure." }

Before taking minocycline hydrochloride extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:

{ "type": "p", "children": [], "text": "\nBefore taking minocycline hydrochloride extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you: \n" }

{ "type": "ul", "children": [ "have kidney problems.", "have liver problems.", "have diarrhea or watery stools.", "have had increased pressure around your brain that may have caused vision problems.", "are pregnant or plan to become pregnant. Minocycline hydrochloride extended-release tablets may harm your unborn baby. Taking minocycline hydrochloride extended-release tablets while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider right away if you become pregnant during treatment with minocycline hydrochloride extended-release tablets.", "are breastfeeding or plan to breastfeed. Minocycline hydrochloride passes into your breast milk and may harm your baby. Do not breastfeed during treatment with minocycline hydrochloride extended-release tablets and for 4 days after your final dose." ], "text": "" }

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

Minocycline hydrochloride extended-release tablets and other medicines may affect each other and can cause serious side effects. Minocycline may affect the way other medicines work, and other medicines may affect how Minocycline hydrochloride extended-release tablets works.

{ "type": "p", "children": [], "text": "Minocycline hydrochloride extended-release tablets and other medicines may affect each other and can cause serious side effects. Minocycline may affect the way other medicines work, and other medicines may affect how Minocycline hydrochloride extended-release tablets works. " }

Especially tell your healthcare provider if you take:

{ "type": "p", "children": [], "text": "\nEspecially tell your healthcare provider if you take:\n" }

{ "type": "ul", "children": [ "a blood thinner medicine.", "a penicillin antibiotic medicine.", "antacids that contain aluminum, calcium, or magnesium or iron-containing medicines.", "an acne medicine that contains isotretinoin" ], "text": "" }

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

{ "type": "p", "children": [], "text": "\nAsk your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist. " }

How should I take minocycline hydrochloride extended-release tablets?

{ "type": "p", "children": [], "text": "\nHow should I take minocycline hydrochloride extended-release tablets?\n" }

{ "type": "ul", "children": [ "Take minocycline hydrochloride extended-release tablets exactly as your healthcare provider tells you.", "Take minocycline hydrochloride extended-release tablets 1 time per day with or without food. Taking minocycline hydrochloride extended-release tablets with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.", "Swallow minocycline hydrochloride extended-release tablets whole. Do not chew, crush, or split the tablets." ], "text": "" }

If you take too much minocycline hydrochloride extended-release tablets, stop taking minocycline hydrochloride extended-release tablet and call your healthcare provider or go to the nearest hospital emergency room, or contact a poison control center right away at 1-800-222-1222.

{ "type": "p", "children": [], "text": "\nIf you take too much minocycline hydrochloride extended-release tablets, stop taking minocycline hydrochloride extended-release tablet and call your healthcare provider or go to the nearest hospital emergency room, or contact a poison control center right away at 1-800-222-1222." }

What should I avoid while taking minocycline hydrochloride extended-release tablets?

{ "type": "p", "children": [], "text": "\nWhat should I avoid while taking minocycline hydrochloride extended-release tablets? \n" }

{ "type": "ul", "children": [ "You should not drive or operate dangerous machinery until you know how minocycline hydrochloride extended-release tablet affects you. Minocycline hydrochloride extended-release tablets may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).", "Avoid sunlight or artificial sunlight, such as sunlamps and tanning beds during treatment with minocycline hydrochloride extended-release tablet. Minocycline hydrochloride extended-release tablet can make your skin sensitive to the sun and artificial sunlight and you could get severe sunburn during treatment. Use sunscreen and wear a hat and protective clothing that covers your skin while out in the sunlight during treatment with minocycline hydrochloride extended-release tablet." ], "text": "" }

What are possible side effects of minocycline hydrochloride extended-release tablets? 

{ "type": "p", "children": [], "text": "\nWhat are possible side effects of minocycline hydrochloride extended-release tablets? " }

Minocycline hydrochloride extended-release tablets may cause serious side effects, including: 

{ "type": "p", "children": [], "text": "\nMinocycline hydrochloride extended-release tablets may cause serious side effects, including: " }

{ "type": "ul", "children": [ "\nSerious skin and allergic reactions have happened during treatment with minocycline. Minocycline hydrochloride extended-release tablets may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. Stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following signs or symptoms, including:" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="591"> <caption> <span></span> </caption> <col width="47"/> <col width="544"/> <tbody class="Headless"> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> skin redness, rash, hives, sores in your mouth, or your skin blisters and peels<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> swelling of your face, eyes, lips, tongue, or throat<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> trouble swallowing or breathing<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> blood in your urine<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> pain on the right side of the stomach area (abdominal pain)<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> chest pain or abnormal heartbeats<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> swelling in your legs, ankles, and feet<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"591\">\n<caption>\n<span></span>\n</caption>\n<col width=\"47\"/>\n<col width=\"544\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> skin redness, rash, hives, sores in your mouth, or your skin blisters and peels<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> swelling of your face, eyes, lips, tongue, or throat<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> trouble swallowing or breathing<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> blood in your urine<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> pain on the right side of the stomach area (abdominal pain)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> chest pain or abnormal heartbeats<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> swelling in your legs, ankles, and feet<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "\nPermanent tooth discoloration and problems with tooth enamel. Minocycline hydrochloride extended-release tablets may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Minocycline hydrochloride extended-release tablets may also cause tooth enamel to not develop properly. You should not use minocycline hydrochloride extended-release tablets during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and in children from birth to 8 years of age. See \"What should I tell my healthcare provider before taking minocycline hydrochloride extended-release tablets?\"\n", "\nSlow bone growth. Minocycline hydrochloride extended-release tablets may cause slow bone growth if it is used during the second and third trimesters of pregnancy and if it is used in infants and children up to 8 years of age. Slow bone growth is reversible after stopping treatment with minocycline hydrochloride extended-release tablets.", "\nDiarrhea (antibiotic associated colitis). Antibiotic associated colitis can happen with most antibiotics, including minocycline hydrochloride extended-release tablets. This type of diarrhea may be caused by an infection (Clostridioides difficile) in your intestines and can be severe and can lead to death. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.", "\nLiver problems. Minocycline hydrochloride extended-release tablets may cause serious liver problems that can lead to death. Stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider right away if you get any of the following symptoms of liver problems:" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="416"> <caption> <span></span> </caption> <col width="46"/> <col width="370"/> <tbody class="Headless"> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> loss of appetite<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> tiredness<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> diarrhea<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> yellowing of your skin or the whites of your eyes (jaundice)<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> unexplained bleeding or bleeding more easily than normal<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> confusion<br/> </td> </tr> <tr> <td align="right" valign="top"> ○<br/> </td><td align="left" valign="top"> sleepiness<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"416\">\n<caption>\n<span></span>\n</caption>\n<col width=\"46\"/>\n<col width=\"370\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> loss of appetite<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> tiredness<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> diarrhea<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> yellowing of your skin or the whites of your eyes (jaundice)<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> unexplained bleeding or bleeding more easily than normal<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> confusion<br/>\n</td>\n</tr>\n<tr>\n<td align=\"right\" valign=\"top\"> ○<br/>\n</td><td align=\"left\" valign=\"top\"> sleepiness<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "\nCentral nervous system effects. See \"What should I avoid while taking minocycline hydrochloride extended-release tablets?\" Central nervous system effects such as light-headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with minocycline hydrochloride extended-release tablets or if treatment is stopped.", "\nIncreased pressure around the brain (idiopathic intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female who can have children, are overweight, and have already had intracranial hypertension. Stop taking minocycline hydrochloride extended-release tablets and tell your healthcare provider right away if you have blurred vision, double vision, vision loss, or unusual headaches.", "\nImmune system reactions including a lupus-like syndrome, hepatitis, and inflammationof blood or lymph vessels (vasculitis).Using minocycline hydrochloride extended-release tablets for a long time to treat acne may cause immune system reactions. Stop taking m       inocycline hydrochloride extended-release tablets and tell your healthcare provider right away if you get a fever, rash, joint pain, or body weakness.", "\nSensitivity to sunlight (photosensitivity). See\"What should I avoid while taking minocycline hydrochloride extended-release tablets?\"\n", "\nDiscoloration (tissue hyperpigmentation). Minocycline hydrochloride extended-release tablets may cause darkening of your nails, skin, eyes, teeth, gums, scars, and internal organs." ], "text": "" }

The most common side effects of minocycline hydrochloride extended-release tablets include:

{ "type": "p", "children": [], "text": "\nThe most common side effects of minocycline hydrochloride extended-release tablets include:\n" }

{ "type": "ul", "children": [ "headache", "tiredness", "dizziness or spinning feeling", "itching" ], "text": "" }

Your healthcare provider may do blood tests and check you for side effects during treatment with minocycline hydrochloride extended-release tablets and may lower your dose or stop treatment if you develop certain side effects.

{ "type": "p", "children": [], "text": "\nYour healthcare provider may do blood tests and check you for side effects during treatment with minocycline hydrochloride extended-release tablets and may lower your dose or stop treatment if you develop certain side effects." }

These are not all of the possible side effects of minocycline hydrochloride extended-release tablets.

{ "type": "p", "children": [], "text": "These are not all of the possible side effects of minocycline hydrochloride extended-release tablets." }

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to MedicalAffairs@ zydususa.com at 1-877-993-8779.

{ "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. You may also report side effects to MedicalAffairs@ zydususa.com at 1-877-993-8779." }

How should I store minocycline hydrochloride extended-release tablets?

{ "type": "p", "children": [], "text": "\nHow should I store minocycline hydrochloride extended-release tablets?\n" }

{ "type": "ul", "children": [ "Store minocycline hydrochloride extended-release tablets between 59ºF to 86ºF (15ºC to 30ºC).", "Keep minocycline hydrochloride extended-release tablets in the container that it comes in and keep the container tightly closed.", "Keep minocycline hydrochloride extended-release tablets dry." ], "text": "" }

Keep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children.\n" }

General information about the safe and effective use of minocycline hydrochloride extended-release tablets 

{ "type": "p", "children": [], "text": "\nGeneral information about the safe and effective use of minocycline hydrochloride extended-release tablets " }

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

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

Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

{ "type": "p", "children": [], "text": "Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779. " }

What are the ingredients in minocycline hydrochloride extended-release tablets?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in minocycline hydrochloride extended-release tablets? \n" }

Active ingredient: minocycline hydrochloride, USP

{ "type": "p", "children": [], "text": "\nActive ingredient: minocycline hydrochloride, USP " }

Inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin.

{ "type": "p", "children": [], "text": "\nInactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin." }

Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake.

{ "type": "p", "children": [], "text": "Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. " }

Brands mentioned are trademarks of their respective owners.

{ "type": "p", "children": [], "text": "Brands mentioned are trademarks of their respective owners." }

Manufactured by:

{ "type": "p", "children": [], "text": "\nManufactured by:\n" }

Zydus Lifesciences Ltd.,

{ "type": "p", "children": [], "text": "Zydus Lifesciences Ltd.," }

Ahmedabad, India

{ "type": "p", "children": [], "text": "Ahmedabad, India " }

Distributed by:

{ "type": "p", "children": [], "text": "\nDistributed by:\n" }

Zydus Pharmaceuticals (USA) Inc.

{ "type": "p", "children": [], "text": "\nZydus Pharmaceuticals (USA) Inc.\n" }

Pennington, NJ 08534

{ "type": "p", "children": [], "text": "Pennington, NJ 08534" }

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 " }

Rev.: 06/25

{ "type": "p", "children": [], "text": "Rev.: 06/25" }

NDC 68382-531-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-531-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 45 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 45 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-550-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-550-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 55 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 55 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-532-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-532-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 65 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 65 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-551-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-551-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 80 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 80 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-533-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-533-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 90 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 90 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-552-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-552-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 105 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 105 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-534-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-534-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 115 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 115 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

NDC 68382-535-01 in bottle of 100 Tablets

{ "type": "p", "children": [], "text": "\nNDC 68382-535-01 in bottle of 100 Tablets" }

Minocycline Hydrochloride Extended-release Tablets, USP 135 mg

{ "type": "p", "children": [], "text": "Minocycline Hydrochloride Extended-release Tablets, USP 135 mg" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 TABLETS

{ "type": "p", "children": [], "text": "100 TABLETS" }

ZYDUS

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

AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [ see Clinical Studies ( 14) ].

{ "type": "p", "children": [], "text": "AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [\n \n see Clinical Studies (\n \n 14)\n \n ].\n\n " }

Limitations of Use

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

This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [ see Warnings and Precautions ( 5.14) ].

{ "type": "p", "children": [], "text": "This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [\n \n see Warnings and Precautions (\n \n 5.14)\n \n ].\n\n " }

For topical use only, not for oral, ophthalmic or intravaginal use [ see Clinical Studies ( 14) ].

{ "type": "p", "children": [], "text": "For topical use only, not for oral, ophthalmic or intravaginal use [\n \n see Clinical Studies (\n \n 14)\n \n ].\n\n " }

After shaking the can well, a small amount of topical foam (e.g. a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then rubbed into acne-affected parts of the face. This should be repeated as needed until all acne-affected parts of the face are treated. If acne is present on other parts of the patient’s body (neck, shoulders, arms, back or chest), additional amounts of topical foam should also be applied to these areas. The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime. The patient should not bathe, shower or swim for at least 1 hour after application of the product.

{ "type": "p", "children": [], "text": "After shaking the can well, a small amount of topical foam (e.g. a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then rubbed into acne-affected parts of the face. This should be repeated as needed until all acne-affected parts of the face are treated. If acne is present on other parts of the patient’s body (neck, shoulders, arms, back or chest), additional amounts of topical foam should also be applied to these areas. The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime. The patient should not bathe, shower or swim for at least 1 hour after application of the product." }

Topical foam, 4%

{ "type": "p", "children": [], "text": "Topical foam, 4%" }

Each gram of AMZEEQ contains 40 mg of minocycline equivalent to 43 mg of minocycline hydrochloride and is supplied as a yellow suspension in a pressurized aluminum aerosol container (can).

{ "type": "p", "children": [], "text": "Each gram of AMZEEQ contains 40 mg of minocycline equivalent to 43 mg of minocycline hydrochloride and is supplied as a yellow suspension in a pressurized aluminum aerosol container (can)." }

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients within AMZEEQ.

{ "type": "p", "children": [], "text": "This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients within AMZEEQ." }

The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Minocycline, like other tetracycline-class drugs, may inhibit bone growth when administered orally during pregnancy. Based on animal data, when administered orally, tetracyclines cross the placenta, are found in fetal tissues, and can cause skeletal malformation and retardation of skeletal development on the developing fetus [see Use in Specific Populations ( 8.1) and Nonclinical Toxicology ( 13)] .

The use of tetracycline class drugs orally during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term oral use of the tetracycline but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with oral tetracycline drugs. Use of tetracycline drugs is not recommended during tooth development.

The safety and effectiveness of AMZEEQ have not been established in pediatric patients less than 9 years of age.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. The safety and effectiveness of AMZEEQ have not been established in patients less than 9 years of age [see Use in Specific Populations ( 8.1, 8.4)].

Results of animal studies indicate that oral tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated orally early in pregnancy [see Use in Specific Populations ( 8.1)].

Clostridioides difficileassociated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including oral minocycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficilecause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibiotic use not directed against C. difficilemay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with oral minocycline use in the treatment of acne.

The anti-anabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, recommended oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, adjust the dose downward, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with oral minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and may disappear when the drug is discontinued.

Intracranial hypertension has been associated with the use of tetracycline-class drugs. Clinical manifestations of intracranial hypertension include headache, blurred vision, diplopia and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of IH are at a greater risk for developing intracranial hypertension. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines. Concomitant use of isotretinoin and tetracycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension.

Although intracranial hypertension typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize.

Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of oral minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis. Sporadic cases of serum sickness have presented shortly after oral minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, immediately discontinue the use of all tetracycline-class drugs, including AMZEEQ.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking oral tetracyclines; this reaction has been reported less frequently with minocycline. Although AMZEEQ did not induce phototoxicity or photoallergic responses in human dermal safety studies, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using AMZEEQ, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.

Cases of anaphylaxis, serious skin reactions (e.g. Stevens Johnson syndrome), erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with oral minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported with oral minocycline use. If this syndrome is recognized, discontinue AMZEEQ immediately.

Oral tetracyclines are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as pigmentation over sites of scars or injury.

AMZEEQ has not been evaluated in the treatment of infections. Bacterial resistance to the tetracyclines may develop in patients using AMZEEQ, therefore, the susceptibility of bacteria associated with infection should be considered in selecting antimicrobial therapy. Because of the potential for drug-resistant bacteria to develop during the use of AMZEEQ, it should be used only as indicated.

Use of AMZEEQ may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.

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.

In 3 randomized, double-blind, vehicle-controlled trials, subjects age 9 years and older applied AMZEEQ or vehicle once daily for 12 weeks. A total of 1,356 subjects were treated with AMZEEQ and 1,058 with vehicle. The majority of subjects were White (74%) and female (60%). Approximately 34% were Hispanic/Latino and 49% were younger than 18 years of age.

The most common adverse reaction reported by ≥1% of subjects treated with AMZEEQ and more frequently than in subjects treated with vehicle was headache, which was reported in 3% of subjects treated with AMZEEQ and 2% of subjects treated with vehicle.

Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, dryness, hyperpigmentation, skin peeling and itching. Table 1presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with AMZEEQ.

Local tolerability signs and symptoms occurred in similar frequency and severity as subjects treated with the vehicle component of AMZEEQ.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1: Facial Cutaneous Tolerability Assessment</span> </caption> <col width="27%"/> <col width="22%"/> <col width="22%"/> <col width="22%"/> <tfoot> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with acne.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First">AMZEEQ, %</p> <p>(N=1,377)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Symptom/Severity</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Mild</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Moderate</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Severe</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Erythema</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">14.2</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1.5</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Dryness</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6.8</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.6</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Hyperpigmentation <a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a> </p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">12.4</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2.8</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.1</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Skin Peeling</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3.2</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.2</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">Itching</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">5.1</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.8</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0.1</p> </td> </tr> </tbody> </table></div>

In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment), frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Risk Summary

Available data with AMZEEQ 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. Systemic absorption of AMZEEQ in humans is low following once daily topical administration of AMZEEQ for 21 days  [see Clinical Pharmacology ( 12.3)] . Because of low systemic exposure, it is not expected that maternal use of AMZEEQ will result in significant fetal exposure to the drug.

Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy [see Warnings and Precautions ( 5.2, 5.3, 5.4) and Use in Specific Populations ( 8.4)] .

Animal reproduction studies were not conducted with AMZEEQ. In animal reproduction studies, oral administration of minocycline administered to pregnant rats and rabbits during the period of organogenesis induced skeletal malformations in fetuses at systemic exposures of 750 and 500 times, respectively, the maximum recommended human dose (MRHD; based on AUC comparison) of AMZEEQ ( see Data).

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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus [ see Warnings and Precautions ( 5.2) ].

Minocycline induced skeletal malformations (bent limb bones) in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (750 and 500 times, respectively, the systemic exposure at the MRHD based on AUC comparison). Reduced mean fetal body weight was observed when minocycline was orally administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (250 times the systemic exposure at the MRHD based on AUC comparison).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation, at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (650 times the systemic exposure at the MRHD based on AUC comparison). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received oral minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

Risk Summary

Tetracycline-class drugs, including minocycline, are present in breast milk following oral administration. It is not known whether minocycline is present in human milk after topical administration to the nursing mother. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with AMZEEQ [see Warnings and Precautions ( 5.2)].

The safety and effectiveness of AMZEEQ have been established in pediatric patients 9 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. Use of AMZEEQ for this indication is supported by three adequate and well controlled 12-week trials in patients 9 years of age and older; two of the trials included a 40-week open-label extension. Additional data was obtained from a 7-day open-label safety and pharmacokinetics study conducted in 20 patients 10 years to less than 17 years of age with acne vulgaris [see Clinical Pharmacology ( 12.3) and Clinical Studies ( 14)] . A total of 686 subjects 9 years of age and older received AMZEEQ in these clinical trials.

Safety and effectiveness for this indication have not been established in pediatric patients less than 9 years of age. The use of oral tetracycline drugs during tooth development below the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and inhibition of bone growth [see Warnings and Precautions ( 5.2, 5.3)] .

Clinical studies of AMZEEQ did not include sufficient numbers of subjects aged 65 years 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.

Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑ (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑ tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:

{ "type": "p", "children": [], "text": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑ (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑ tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:" }

C 23H 27N 3O 7•HCl   M. W. 493.94

{ "type": "p", "children": [], "text": "C\n \n 23H\n \n 27N\n \n 3O\n \n 7•HCl   M. W. 493.94\n\n " }

Each gram of AMZEEQ contains micronized minocycline 40 mg equivalent to 43 mg minocycline hydrochloride in a yellow suspension foam.

{ "type": "p", "children": [], "text": "Each gram of AMZEEQ contains micronized minocycline 40 mg equivalent to 43 mg minocycline hydrochloride in a yellow suspension foam." }

In addition, the 4% AMZEEQ topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. AMZEEQ topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane).

{ "type": "p", "children": [], "text": "In addition, the 4% AMZEEQ topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol. AMZEEQ topical foam is dispensed from an aluminum container (can) pressurized with propellant (butane + isobutane + propane)." }

The mechanism of action of AMZEEQ for the treatment of acne is unknown.

The pharmacodynamics of AMZEEQ for the treatment of acne are unknown.

In a pharmacokinetic study, male and female subjects 18 years of age or older with acne vulgaris (N=30) applied approximately 4 grams of AMZEEQ topically to the face, neck, upper chest, upper back, shoulder and upper arms once daily for 21 days. The mean ± SD C maxand AUC 0-24hwere 1.3 ± 0.6 ng/mL and 23.0 ± 10.8 ng·h/mL, respectively at Day 21 for AMZEEQ. After daily application of AMZEEQ in subjects with acne for 21 days, steady-state was reached by Day 6 and systemic accumulation of minocycline was not evident.

Specific Populations

Age: Pediatric Population

Pharmacokinetics of minocycline was evaluated in 20 subjects 10 years to less than 17 years of age with acne vulgaris following application of approximately 4 grams of AMZEEQ topically to the face, neck, upper chest, upper back, shoulder and upper arms once daily for 7 days. Minocycline was detected in all samples obtained on Day 7. Pharmacokinetic results are presented by age group in Table 2. The overall pediatric population showed 2.4-fold and 2.7-fold higher C maxand AUC 0-24hcompared to the adult population.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2: Clinical Pharmacokinetics of Minocycline when treated with AMZEEQ (~4 g) in Pediatric Subjects Aged 10 to &lt;17 years with Acne Vulgaris</span> </caption> <col width="33%"/> <col width="33%"/> <col width="33%"/> <thead> <tr class="First First Last Last"> <th align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Age Group (years)</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Mean ± SD C <span class="Sub">max</span></span> <br/> <span class="Bold">(ng/mL)</span></th><th align="center" class="Botrule Lrule Rrule Toprule" valign="middle"><span class="Bold">Mean ± SD AUC <span class="Sub">0-24h</span>(ng·h/mL) </span></th> </tr> </thead> <tbody> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">10 - 11</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4.5 ± 4.0</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">90.9 ± 90.2</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">12 - 14</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2.8 ± 2.2</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">54.0 ± 46.2</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">15 - &lt;17</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2.0 ± 1.2</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">40.8 ± 23.8</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">10 - &lt;17</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3.1 ± 2.7</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">61.1 ± 59.2</p> </td> </tr> </tbody> </table></div>

Resistance

Propionibacterium acnesstrains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies being <10 −8at 2 to 16 × MIC.

Antimicrobial Activity

Minocycline is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.

In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline hydrochloride was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline hydrochloride did not result in a significantly increased incidence of neoplasms in either males or females.

Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (10,000 times the systemic exposure at the MRHD based on AUC comparison). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (3,800 or 10,000 times, respectively, the systemic exposure at the MRHD based on AUC comparison), adversely affected spermatogenesis.

Effects observed at 300 mg/kg/day of oral minocycline included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

The safety and efficacy of AMZEEQ was assessed in three 12-week, multicenter, randomized, double-blind, vehicle-controlled studies (Study 1 [NCT02815267], Study 2 [NCT02815280], and Study 3 [NCT03271021]) in subjects with moderate to severe acne vulgaris. Efficacy was assessed in a total of 2,418 subjects 9 years of age and older. AMZEEQ or its vehicle were applied once daily for 12 weeks; no other topical or systemic medication affecting the course of acne vulgaris was permitted for use during these studies.

{ "type": "p", "children": [], "text": "The safety and efficacy of AMZEEQ was assessed in three 12-week, multicenter, randomized, double-blind, vehicle-controlled studies (Study 1 [NCT02815267], Study 2 [NCT02815280], and Study 3 [NCT03271021]) in subjects with moderate to severe acne vulgaris. Efficacy was assessed in a total of 2,418 subjects 9 years of age and older. AMZEEQ or its vehicle were applied once daily for 12 weeks; no other topical or systemic medication affecting the course of acne vulgaris was permitted for use during these studies." }

Subjects were required to have an inflammatory and non-inflammatory lesion count in the range 20-50 lesions and 25-100 lesions respectively, and an Investigator Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline.

{ "type": "p", "children": [], "text": "Subjects were required to have an inflammatory and non-inflammatory lesion count in the range 20-50 lesions and 25-100 lesions respectively, and an Investigator Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline." }

Overall, 74% were Caucasian and 61% were female. Forty-two (2%) subjects were 9 to 11 years of age, 1,139 (47%) subjects were 12 to 17 years of age, and 1,237 (51%) subjects were 18 years or older. At baseline, subjects had a mean inflammatory lesion count of 31.2 and a mean non-inflammatory lesion count of 49.3. Additionally, approximately 85% of subjects had an IGA score of 3 (“moderate”).

{ "type": "p", "children": [], "text": "Overall, 74% were Caucasian and 61% were female. Forty-two (2%) subjects were 9 to 11 years of age, 1,139 (47%) subjects were 12 to 17 years of age, and 1,237 (51%) subjects were 18 years or older. At baseline, subjects had a mean inflammatory lesion count of 31.2 and a mean non-inflammatory lesion count of 49.3. Additionally, approximately 85% of subjects had an IGA score of 3 (“moderate”)." }

The co-primary efficacy endpoints were the absolute change from baseline in inflammatory lesion counts at Week 12 and the proportion of subjects with treatment success at Week 12, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12. The efficacy results are presented in Table 3.

{ "type": "p", "children": [], "text": "The co-primary efficacy endpoints were the absolute change from baseline in inflammatory lesion counts at Week 12 and the proportion of subjects with treatment success at Week 12, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12. The efficacy results are presented in\n \n Table 3.\n\n " }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: Clinical Efficacy of AMZEEQ in Subjects with Acne Vulgaris at Week 12</span> </caption> <col width="29%"/> <col width="12%"/> <col width="12%"/> <col width="12%"/> <col width="12%"/> <col width="12%"/> <col width="12%"/> <tfoot> <tr class="First First Last Last"> <td align="left" class="Botrule" colspan="7" valign="top"><span class="Sup">a</span>Treatment success is defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline. <br/> <span class="Sup">b</span>Means presented in table are Least Square (LS) means. </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Lrule Rrule Toprule" valign="bottom"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">Study 1</span> </p> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">Study 2</span> </p> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">Study 3</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="bottom"></td><td align="center" class="Botrule" valign="bottom"> <p class="First"> <span class="Bold">AMZEEQ (N=307)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">Vehicle (N=159)</span> </p> </td><td align="center" class="Botrule" valign="bottom"> <p class="First"> <span class="Bold">AMZEEQ</span> </p> <p> <span class="Bold">(N=312)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">Vehicle</span> </p> <p> <span class="Bold">(N=152)</span> </p> </td><td align="center" class="Botrule" valign="bottom"> <p class="First"> <span class="Bold">AMZEEQ</span> </p> <p> <span class="Bold">(N=738)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">Vehicle</span> </p> <p> <span class="Bold">(N=750)</span> </p> </td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First"> <span class="Bold">IGA</span> </p> </td><td class="Lrule" valign="bottom"></td><td class="Rrule" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" class="Rrule" valign="bottom"></td><td valign="bottom"></td><td align="center" class="Rrule" valign="bottom"></td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First">Treatment Success <span class="Sup">a</span> </p> </td><td align="center" class="Lrule" valign="bottom"> <p class="First">8.1%</p> </td><td align="center" class="Rrule" valign="bottom"> <p class="First">4.8%</p> </td><td align="center" valign="bottom"> <p class="First">15.8%</p> </td><td align="center" class="Rrule" valign="bottom"> <p class="First">8.4%</p> </td><td align="center" valign="bottom"> <p class="First">30.8%</p> </td><td align="center" class="Rrule" valign="bottom"> <p class="First">19.6%</p> </td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First"> <span class="Italics">    Difference from Vehicle</span> </p> <p> <span class="Italics">    (95% CI)</span> </p> </td><td align="center" class="Lrule Rrule" colspan="2" valign="top"> <p class="First">3.3%</p> <p>(-1.5%, 8.2%)</p> </td><td align="center" class="Rrule" colspan="2" valign="top"> <p class="First">7.4%</p> <p>(0%, 13.7%)</p> </td><td align="center" class="Rrule" colspan="2" valign="top"> <p class="First">11.2%</p> <p>(6.6%, 15.8%)</p> </td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First"> <span class="Bold">Inflammatory Lesion Count</span> </p> </td><td class="Lrule" valign="bottom"></td><td class="Rrule" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" class="Rrule" valign="bottom"></td><td align="center" valign="bottom"></td><td align="center" class="Rrule" valign="bottom"></td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First">Mean <span class="Sup">b</span>Absolute Change from Baseline </p> </td><td align="center" class="Lrule" valign="middle"> <p class="First">-14.0</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">-11.2</p> </td><td align="center" valign="middle"> <p class="First">-13.7</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">-10.5</p> </td><td align="center" valign="middle"> <p class="First">-16.4</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">-12.7</p> </td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First"> <span class="Italics">    Difference from Vehicle</span> </p> <p> <span class="Italics">    (95% CI)</span> </p> </td><td align="center" class="Lrule Rrule" colspan="2" valign="top"> <p class="First">-2.8</p> <p>(-4.9, -0.7)</p> </td><td align="center" class="Rrule" colspan="2" valign="top"> <p class="First">-3.2</p> <p>(-5.6, -0.9)</p> </td><td align="center" class="Rrule" colspan="2" valign="top"> <p class="First">-3.7</p> <p>(-4.8, -2.5)</p> </td> </tr> <tr> <td class="Lrule" valign="bottom"> <p class="First">Mean <span class="Sup">b</span>Percent Change from Baseline </p> </td><td align="center" class="Lrule" valign="middle"> <p class="First">-44%</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">-34%</p> </td><td align="center" valign="middle"> <p class="First">-43%</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">-34%</p> </td><td align="center" valign="middle"> <p class="First">-54%</p> </td><td align="center" class="Rrule" valign="middle"> <p class="First">-42%</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="bottom"> <p class="First"> <span class="Italics">    Difference from Vehicle</span> </p> <p> <span class="Italics">    (95% CI)</span> </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First">-10%</p> <p>(-17%, -3%)</p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">-10%</p> <p>(-17%, -2%)</p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">-12%</p> <p>(-16%, -8%)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 3: Clinical Efficacy of AMZEEQ in Subjects with Acne Vulgaris at Week 12</span>\n</caption>\n<col width=\"29%\"/>\n<col width=\"12%\"/>\n<col width=\"12%\"/>\n<col width=\"12%\"/>\n<col width=\"12%\"/>\n<col width=\"12%\"/>\n<col width=\"12%\"/>\n<tfoot>\n<tr class=\"First First Last Last\">\n<td align=\"left\" class=\"Botrule\" colspan=\"7\" valign=\"top\"><span class=\"Sup\">a</span>Treatment success is defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline. \n <br/>\n<span class=\"Sup\">b</span>Means presented in table are Least Square (LS) means.\n \n </td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Lrule Rrule Toprule\" valign=\"bottom\"></td><td align=\"center\" class=\"Botrule Rrule Toprule\" colspan=\"2\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Study 1</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" colspan=\"2\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Study 2</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" colspan=\"2\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Study 3</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"bottom\"></td><td align=\"center\" class=\"Botrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">AMZEEQ (N=307)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle (N=159)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">AMZEEQ</span>\n</p>\n<p>\n<span class=\"Bold\">(N=312)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle</span>\n</p>\n<p>\n<span class=\"Bold\">(N=152)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">AMZEEQ</span>\n</p>\n<p>\n<span class=\"Bold\">(N=738)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle</span>\n</p>\n<p>\n<span class=\"Bold\">(N=750)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">IGA</span>\n</p>\n</td><td class=\"Lrule\" valign=\"bottom\"></td><td class=\"Rrule\" valign=\"bottom\"></td><td align=\"center\" valign=\"bottom\"></td><td align=\"center\" class=\"Rrule\" valign=\"bottom\"></td><td valign=\"bottom\"></td><td align=\"center\" class=\"Rrule\" valign=\"bottom\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">Treatment Success\n \n <span class=\"Sup\">a</span>\n</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">8.1%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"bottom\">\n<p class=\"First\">4.8%</p>\n</td><td align=\"center\" valign=\"bottom\">\n<p class=\"First\">15.8%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"bottom\">\n<p class=\"First\">8.4%</p>\n</td><td align=\"center\" valign=\"bottom\">\n<p class=\"First\">30.8%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"bottom\">\n<p class=\"First\">19.6%</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Italics\">    Difference from Vehicle</span>\n</p>\n<p>\n<span class=\"Italics\">    (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">3.3%</p>\n<p>(-1.5%, 8.2%)</p>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">7.4%</p>\n<p>(0%, 13.7%)</p>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">11.2%</p>\n<p>(6.6%, 15.8%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Bold\">Inflammatory Lesion Count</span>\n</p>\n</td><td class=\"Lrule\" valign=\"bottom\"></td><td class=\"Rrule\" valign=\"bottom\"></td><td align=\"center\" valign=\"bottom\"></td><td align=\"center\" class=\"Rrule\" valign=\"bottom\"></td><td align=\"center\" valign=\"bottom\"></td><td align=\"center\" class=\"Rrule\" valign=\"bottom\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">Mean\n \n <span class=\"Sup\">b</span>Absolute Change from Baseline\n \n </p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"middle\">\n<p class=\"First\">-14.0</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">-11.2</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">-13.7</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">-10.5</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">-16.4</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">-12.7</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Italics\">    Difference from Vehicle</span>\n</p>\n<p>\n<span class=\"Italics\">    (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">-2.8</p>\n<p>(-4.9, -0.7)</p>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">-3.2</p>\n<p>(-5.6, -0.9)</p>\n</td><td align=\"center\" class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">-3.7</p>\n<p>(-4.8, -2.5)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"bottom\">\n<p class=\"First\">Mean\n \n <span class=\"Sup\">b</span>Percent Change from Baseline\n \n </p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"middle\">\n<p class=\"First\">-44%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">-34%</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">-43%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">-34%</p>\n</td><td align=\"center\" valign=\"middle\">\n<p class=\"First\">-54%</p>\n</td><td align=\"center\" class=\"Rrule\" valign=\"middle\">\n<p class=\"First\">-42%</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"bottom\">\n<p class=\"First\">\n<span class=\"Italics\">    Difference from Vehicle</span>\n</p>\n<p>\n<span class=\"Italics\">    (95% CI)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">-10%</p>\n<p>(-17%, -3%)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">-10%</p>\n<p>(-17%, -2%)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">-12%</p>\n<p>(-16%, -8%)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

How Supplied

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AMZEEQ ®(minocycline) topical foam, 4% is a yellow suspension supplied in a pressurized aluminum aerosol container (can). Each gram of AMZEEQ contains 40 mg of minocycline equivalent to 43 mg of minocycline hydrochloride, and is supplied as follows:

{ "type": "p", "children": [], "text": "AMZEEQ\n \n ®(minocycline) topical foam, 4% is a yellow suspension supplied in a pressurized aluminum aerosol container (can). Each gram of AMZEEQ contains 40 mg of minocycline equivalent to 43 mg of minocycline hydrochloride, and is supplied as follows:\n\n " }

NDC 69489-201-30    30 g Can

{ "type": "p", "children": [], "text": "NDC 69489-201-30    30 g Can" }

Storage

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

AMZEEQ must be stored at 2ºC - 8ºC (36ºF - 46ºF) until dispensed to the patient.

{ "type": "p", "children": [], "text": "AMZEEQ must be stored at 2ºC - 8ºC (36ºF - 46ºF) until dispensed to the patient." }

Once dispensed, the patient is to store AMZEEQ at room temperature below 25ºC (77ºF) for 90 days. Do not store in the refrigerator.

{ "type": "p", "children": [], "text": "Once dispensed, the patient is to store AMZEEQ at room temperature below 25ºC (77ºF) for 90 days. Do not store in the refrigerator." }

Handling

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

Allow the can to warm to room temperature before first use.

{ "type": "p", "children": [], "text": "Allow the can to warm to room temperature before first use." }

Shake can well before use.

{ "type": "p", "children": [], "text": "Shake can well before use." }

WARNING: Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or temperatures above 49 oC (120 oF).

{ "type": "p", "children": [], "text": "WARNING: Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or temperatures above 49\n \n oC (120\n \n oF).\n\n " }

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)." }

Inform patients using AMZEEQ (minocycline) topical foam, 4% of the following information and instructions:

{ "type": "p", "children": [], "text": "Inform patients using AMZEEQ (minocycline) topical foam, 4% of the following information and instructions:" }

Flammability

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

The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

{ "type": "p", "children": [], "text": "The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application." }

Tooth Discoloration

{ "type": "p", "children": [], "text": "\nTooth Discoloration\n" }

Advise caregivers of pediatric patients that AMZEEQ may cause permanent discoloration of deciduous and permanent teeth during tooth development (generally up to the age of 8 years) based on observations with oral tetracycline.

{ "type": "p", "children": [], "text": "Advise caregivers of pediatric patients that AMZEEQ may cause permanent discoloration of deciduous and permanent teeth during tooth development (generally up to the age of 8 years) based on observations with oral tetracycline." }

Lactation

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

Advise women that breastfeeding is not recommended during AMZEEQ therapy.

{ "type": "p", "children": [], "text": "Advise women that breastfeeding is not recommended during AMZEEQ therapy." }

Tissue Hyperpigmentation

{ "type": "p", "children": [], "text": "\nTissue Hyperpigmentation\n" }

Inform patients that AMZEEQ may cause discoloration of skin, scars, teeth or gums based on observations with oral minocycline.

{ "type": "p", "children": [], "text": "Inform patients that AMZEEQ may cause discoloration of skin, scars, teeth or gums based on observations with oral minocycline." }

Clostridioides difficileAssociated Diarrhea

{ "type": "p", "children": [], "text": "\nClostridioides difficileAssociated Diarrhea\n \n \n" }

Advise patients that Clostridioides difficileassociated diarrhea can occur with oral minocycline therapy. Advise patients to seek medical attention if they develop watery or bloody stools while using AMZEEQ.

{ "type": "p", "children": [], "text": "Advise patients that\n \n Clostridioides difficileassociated diarrhea can occur with oral minocycline therapy. Advise patients to seek medical attention if they develop watery or bloody stools while using AMZEEQ.\n\n " }

Hepatotoxicity

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

Inform patients about the possibility of hepatotoxicity reported with oral minocycline. Advise patients to seek medical advice if they experience symptoms or signs of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, increased bleeding tendencies, confusion, and sleepiness.

{ "type": "p", "children": [], "text": "Inform patients about the possibility of hepatotoxicity reported with oral minocycline. Advise patients to seek medical advice if they experience symptoms or signs of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, increased bleeding tendencies, confusion, and sleepiness." }

Central Nervous System Effects

{ "type": "p", "children": [], "text": "\nCentral Nervous System Effects\n" }

Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on AMZEEQ.

{ "type": "p", "children": [], "text": "Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on AMZEEQ." }

Intracranial Hypertension

{ "type": "p", "children": [], "text": "\nIntracranial Hypertension\n" }

Inform patients that intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss.

{ "type": "p", "children": [], "text": "Inform patients that intracranial hypertension can occur with minocycline therapy. Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss." }

Photosensitivity

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

Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking oral tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial UV light (tanning beds or UVA/B treatment) while using AMZEEQ. Discuss other sun protection measures, if patients need to be outdoors while using AMZEEQ. Advise patients to discontinue treatment at the first evidence of sunburn.

{ "type": "p", "children": [], "text": "Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking oral tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial UV light (tanning beds or UVA/B treatment) while using AMZEEQ. Discuss other sun protection measures, if patients need to be outdoors while using AMZEEQ. Advise patients to discontinue treatment at the first evidence of sunburn." }

Autoimmune Syndromes

{ "type": "p", "children": [], "text": "\nAutoimmune Syndromes\n" }

Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with oral tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Advise patients who experience such symptoms to stop the drug immediately and seek medical help.

{ "type": "p", "children": [], "text": "Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with oral tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Advise patients who experience such symptoms to stop the drug immediately and seek medical help." }

Other Information

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

AMZEEQ should be applied exactly as directed.

{ "type": "p", "children": [], "text": "AMZEEQ should be applied exactly as directed." }

AMZEEQ may stain fabric.

{ "type": "p", "children": [], "text": "AMZEEQ may stain fabric." }

Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258 Product of Portugal or Italy

{ "type": "p", "children": [], "text": "Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland \n Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258 \n Product of Portugal or Italy\n " }

AMZ-P01-R01

{ "type": "p", "children": [], "text": "AMZ-P01-R01" }

AMZEEQ is a registered trademark of Journey Medical Corporation All other trademarks are the properties of their respective owners. Copyright © 2023 Journey Medical Corporation. All rights reserved.

{ "type": "p", "children": [], "text": "AMZEEQ is a registered trademark of Journey Medical Corporation \n All other trademarks are the properties of their respective owners. \n Copyright © 2023 Journey Medical Corporation. All rights reserved.\n " }

<div class="scrollingtable"><table width="100%"> <col width="3%"/> <col width="47%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> </p> <p> <span class="Bold">AMZEEQ <span class="Sup">®</span>(am-Zeek) </span> </p> <p> <span class="Bold">(minocycline)</span> </p> <p> <span class="Bold">topical foam</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Important Information: AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">What is AMZEEQ?</span> </p> <p>AMZEEQ is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in adults and children 9 years of age and older.</p> <p>AMZEEQ should not be used for the treatment of infections.</p> <p>It is not known if AMZEEQ is safe and effective in children under 9 years of age.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Do not use AMZEEQ</span>if you are allergic to any tetracycline medicines or to any of the ingredients in AMZEEQ. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">What should I tell my healthcare provider before using AMZEEQ?</span> </p> <p> <span class="Bold">Before using AMZEEQ, tell your healthcare provider about all of your medical conditions, including if you:</span> </p> <p>• have diarrhea or watery stools</p> <p>• have liver problems</p> <p>• have kidney problems</p> <p>• are pregnant or plan to become pregnant. Taking tetracycline medicines by mouth during pregnancy may cause serious side effects on the growth of bone and teeth of your baby. AMZEEQ topical foam is used on your skin and it is not known if it will harm your unborn baby.•are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with AMZEEQ.</p> <p></p> <p> <span class="Bold">Tell your healthcare provider about all the other medicines you take,</span>including prescription and over-the-counter medicines, vitamins and herbal supplements. Tetracycline medicines taken by mouth may affect the way other medicines work, and may increase your risk of certain side effects. </p> <p> <span class="Bold">Especially tell your healthcare provider if you take:</span> </p> <p>• a blood thinner medicine.</p> <p>• a penicillin antibiotic medicine</p> <p>• isotretinoin</p> <p>Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">How should I use AMZEEQ?</span> </p> <p>• See the detailed <span class="Bold">“Instructions for Use”</span>included with this leaflet for directions about how to apply AMZEEQ the right way. </p> <p>• Use AMZEEQ exactly as your healthcare provider tells you.</p> <p>• Apply AMZEEQ to the affected skin area(s) at about the same time each day, at least 1 hour before bedtime.</p> <p>• Do not bathe, shower, or swim for at least 1 hour after applying AMZEEQ.</p> <p>• Wash your hands after applying AMZEEQ.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">What should I avoid while using AMZEEQ?</span> </p> <p>• AMZEEQ is flammable. Avoid fire, flame, and smoking when applying and right after you apply AMZEEQ.</p> <p>• Limit your time in sunlight. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using AMZEEQ if you get sunburn.</p> <p>• Minocycline taken by mouth may cause feelings of light-headedness, dizziness, or spinning (vertigo). You should not drive or operate dangerous machinery if you have these symptoms during treatment with AMZEEQ.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">What are possible side effects of AMZEEQ?</span> </p> <p> <span class="Bold">AMZEEQ contains minocycline, a tetracycline medicine. Tetracyclines, when taken by mouth, may cause serious side effects, including:</span> </p> <p>•  <span class="Bold">Harm to an unborn baby.</span>See <span class="Bold">“What should I tell my</span><span class="Bold">healthcare provider before using AMZEEQ?”</span> </p> <p>•  <span class="Bold">Permanent tooth discoloration.</span>Tetracycline medicine when taken by mouth may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use AMZEEQ during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth up to 8 years of age. </p> <p>•  <span class="Bold">Slow bone growth.</span>Tetracycline medicine taken by mouth may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment. </p> <p>•  <span class="Bold">Diarrhea.</span>Diarrhea can happen with most antibiotics, including minocycline taken by mouth. This diarrhea may be caused by an infection ( <span class="Italics">Clostridioides difficile)</span>in your intestines. Call your healthcare provider right away if you get watery or bloody stools while using AMZEEQ. </p> <p>•  <span class="Bold">Liver problems.</span>Minocycline taken by mouth to treat acne can cause serious liver problems that may lead to death. Stop using AMZEEQ and call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: </p> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td valign="top"> <p class="First">o loss of appetite</p> <p>o tiredness</p> <p>o diarrhea</p> <p>o yellowing of your skin or the white of your eyes (jaundice)</p> </td><td class="Rrule" valign="top"> <p class="First">o bleeding more easily than normal</p> <p>o confusion</p> <p>o sleepiness</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"></p> <p>•  <span class="Bold">Central nervous system effects.</span>See “ <span class="Bold">What should I avoid while using AMZEEQ?</span>” </p> <p>•  <span class="Bold">Increased pressure in the brain (intracranial hypertension)</span>. This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female of childbearing potential and are overweight or have a history of intracranial hypertension. Stop using AMZEEQ and tell your healthcare provider right away if you have blurred vision, double vision, vision loss, or unusual headaches. </p> <p>•  <span class="Bold">Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis)</span>have happened during treatment with minocycline taken by mouth <span class="Bold">.</span>Call your healthcare provider right away if you get a fever, rash, joint pain, or body weakness. </p> <p>•  <span class="Bold">Sensitivity to sunlight (photosensitivity).</span>See <span class="Bold">“What should I avoid while using AMZEEQ?”</span> </p> <p>•  <span class="Bold">Serious skin or allergic reactions</span>have happened during treatment with minocycline taken by mouth that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death. Stop using AMZEEQ and go to the nearest hospital emergency room right away if you have any of the following signs or symptoms: </p> <p>  o skin rash, hives, sores in your mouth, or your skin blisters and peels</p> <p>  o swelling of your face, eyes, lips, tongue, or throat</p> <p>  o trouble swallowing or breathing</p> <p>  o blood in your urine</p> <p>  o fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine</p> <p>  o pain on the right side of the stomach area (abdominal pain)</p> <p>  o chest pain or abnormal heartbeats</p> <p>  o swelling in your legs, ankles, and feet</p> <p>•  <span class="Bold">Discoloration (hyperpigmentation).</span>Minocycline taken by mouth may cause darkening of your skin, scars, teeth, or gums. </p> <p> <span class="Bold">The most common side effect of AMZEEQ is</span>headache. </p> <p>Your healthcare provider may stop your treatment with AMZEEQ if you develop certain side effects.</p> <p>These are not all the possible side effects with AMZEEQ.</p> <p>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="3" valign="top"> <p class="First"> <span class="Bold">How should I store AMZEEQ?</span> </p> <p>• Store AMZEEQ at room temperature below 77ºF (25ºC) for 90 days.</p> <p>• Do not store AMZEEQ in the refrigerator.</p> <p>• Do not puncture or burn the AMZEEQ can.</p> <p>• Do not expose to heat or temperatures above 120ºF (49ºC)</p> <p> <span class="Bold">Keep AMZEEQ and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of AMZEEQ.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AMZEEQ for a condition for which it was not prescribed. Do not give AMZEEQ 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 AMZEEQ that is written for health professionals.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in AMZEEQ?</span> </p> <p> <span class="Bold">Active ingredient:</span>minocycline </p> <p> <span class="Bold">Inactive ingredients:</span>soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol and propellant (butane + isobutane + propane). <br/> <br/> Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland </p> <p>Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258</p> <p>Product of Portugal or Italy <br/> <br/> AMZ-P02-R01 <br/> <br/> AMZEEQ is a registered trademark of Journey Medical Corporation. <br/> All other trademarks are the properties of their respective owners. <br/> Copyright © 2023, Journey Medical Corporation. All rights reserved. <br/> <br/> For more information, go to www.AMZEEQ.com or call Journey Medical Corporation at 1-855-531-1859. </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"3%\"/>\n<col width=\"47%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n</p>\n<p>\n<span class=\"Bold\">AMZEEQ\n \n <span class=\"Sup\">®</span>(am-Zeek)\n \n </span>\n</p>\n<p>\n<span class=\"Bold\">(minocycline)</span>\n</p>\n<p>\n<span class=\"Bold\">topical foam</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Important Information: AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is AMZEEQ?</span>\n</p>\n<p>AMZEEQ is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in adults and children 9 years of age and older.</p>\n<p>AMZEEQ should not be used for the treatment of infections.</p>\n<p>It is not known if AMZEEQ is safe and effective in children under 9 years of age.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Do not use AMZEEQ</span>if you are allergic to any tetracycline medicines or to any of the ingredients in AMZEEQ. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I tell my healthcare provider before using AMZEEQ?</span>\n</p>\n<p>\n<span class=\"Bold\">Before using AMZEEQ, tell your healthcare provider about all of your medical conditions, including if you:</span>\n</p>\n<p>• have diarrhea or watery stools</p>\n<p>• have liver problems</p>\n<p>• have kidney problems</p>\n<p>• are pregnant or plan to become pregnant. Taking tetracycline medicines by mouth during pregnancy may cause serious side effects on the growth of bone and teeth of your baby. AMZEEQ topical foam is used on your skin and it is not known if it will harm your unborn baby.•are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with AMZEEQ.</p>\n<p></p>\n<p>\n<span class=\"Bold\">Tell your healthcare provider about all the other medicines you take,</span>including prescription and over-the-counter medicines, vitamins and herbal supplements. Tetracycline medicines taken by mouth may affect the way other medicines work, and may increase your risk of certain side effects.\n \n </p>\n<p>\n<span class=\"Bold\">Especially tell your healthcare provider if you take:</span>\n</p>\n<p>• a blood thinner medicine.</p>\n<p>• a penicillin antibiotic medicine</p>\n<p>• isotretinoin</p>\n<p>Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use AMZEEQ?</span>\n</p>\n<p>• See the detailed\n \n <span class=\"Bold\">“Instructions for Use”</span>included with this leaflet for directions about how to apply AMZEEQ the right way.\n \n </p>\n<p>• Use AMZEEQ exactly as your healthcare provider tells you.</p>\n<p>• Apply AMZEEQ to the affected skin area(s) at about the same time each day, at least 1 hour before bedtime.</p>\n<p>• Do not bathe, shower, or swim for at least 1 hour after applying AMZEEQ.</p>\n<p>• Wash your hands after applying AMZEEQ.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I avoid while using AMZEEQ?</span>\n</p>\n<p>• AMZEEQ is flammable. Avoid fire, flame, and smoking when applying and right after you apply AMZEEQ.</p>\n<p>• Limit your time in sunlight. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use sun protection measures such as sunscreen and wear loose-fitting clothes that cover your skin while out in sunlight. Stop using AMZEEQ if you get sunburn.</p>\n<p>• Minocycline taken by mouth may cause feelings of light-headedness, dizziness, or spinning (vertigo). You should not drive or operate dangerous machinery if you have these symptoms during treatment with AMZEEQ.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are possible side effects of AMZEEQ?</span>\n</p>\n<p>\n<span class=\"Bold\">AMZEEQ contains minocycline, a tetracycline medicine. Tetracyclines, when taken by mouth, may cause serious side effects, including:</span>\n</p>\n<p>• \n \n <span class=\"Bold\">Harm to an unborn baby.</span>See\n \n <span class=\"Bold\">“What should I tell my</span><span class=\"Bold\">healthcare provider before using AMZEEQ?”</span>\n</p>\n<p>• \n \n <span class=\"Bold\">Permanent tooth discoloration.</span>Tetracycline medicine when taken by mouth may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use AMZEEQ during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth up to 8 years of age.\n \n </p>\n<p>• \n \n <span class=\"Bold\">Slow bone growth.</span>Tetracycline medicine taken by mouth may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment.\n \n </p>\n<p>• \n \n <span class=\"Bold\">Diarrhea.</span>Diarrhea can happen with most antibiotics, including minocycline taken by mouth. This diarrhea may be caused by an infection (\n \n <span class=\"Italics\">Clostridioides difficile)</span>in your intestines. Call your healthcare provider right away if you get watery or bloody stools while using AMZEEQ.\n \n </p>\n<p>• \n \n <span class=\"Bold\">Liver problems.</span>Minocycline taken by mouth to treat acne can cause serious liver problems that may lead to death. Stop using AMZEEQ and call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:\n \n </p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td valign=\"top\">\n<p class=\"First\">o loss of appetite</p>\n<p>o tiredness</p>\n<p>o diarrhea</p>\n<p>o yellowing of your skin or the white of your eyes (jaundice)</p>\n</td><td class=\"Rrule\" valign=\"top\">\n<p class=\"First\">o bleeding more easily than normal</p>\n<p>o confusion</p>\n<p>o sleepiness</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\"></p>\n<p>• \n \n <span class=\"Bold\">Central nervous system effects.</span>See “\n \n <span class=\"Bold\">What should I avoid while using AMZEEQ?</span>”\n \n </p>\n<p>• \n \n <span class=\"Bold\">Increased pressure in the brain (intracranial hypertension)</span>. This condition may lead to vision changes and permanent vision loss. You are more likely to get intracranial hypertension if you are a female of childbearing potential and are overweight or have a history of intracranial hypertension. Stop using AMZEEQ and tell your healthcare provider right away if you have blurred vision, double vision, vision loss, or unusual headaches.\n \n </p>\n<p>• \n \n <span class=\"Bold\">Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis)</span>have happened during treatment with minocycline taken by mouth\n \n <span class=\"Bold\">.</span>Call your healthcare provider right away if you get a fever, rash, joint pain, or body weakness.\n \n </p>\n<p>• \n \n <span class=\"Bold\">Sensitivity to sunlight (photosensitivity).</span>See\n \n <span class=\"Bold\">“What should I avoid while using AMZEEQ?”</span>\n</p>\n<p>• \n \n <span class=\"Bold\">Serious skin or allergic reactions</span>have happened during treatment with minocycline taken by mouth that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death. Stop using AMZEEQ and go to the nearest hospital emergency room right away if you have any of the following signs or symptoms:\n \n </p>\n<p>  o skin rash, hives, sores in your mouth, or your skin blisters and peels</p>\n<p>  o swelling of your face, eyes, lips, tongue, or throat</p>\n<p>  o trouble swallowing or breathing</p>\n<p>  o blood in your urine</p>\n<p>  o fever, yellowing of the skin or the whites of your eyes (jaundice), dark colored urine</p>\n<p>  o pain on the right side of the stomach area (abdominal pain)</p>\n<p>  o chest pain or abnormal heartbeats</p>\n<p>  o swelling in your legs, ankles, and feet</p>\n<p>• \n \n <span class=\"Bold\">Discoloration (hyperpigmentation).</span>Minocycline taken by mouth may cause darkening of your skin, scars, teeth, or gums.\n \n </p>\n<p>\n<span class=\"Bold\">The most common side effect of AMZEEQ is</span>headache.\n \n </p>\n<p>Your healthcare provider may stop your treatment with AMZEEQ if you develop certain side effects.</p>\n<p>These are not all the possible side effects with AMZEEQ.</p>\n<p>Call 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=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store AMZEEQ?</span>\n</p>\n<p>• Store AMZEEQ at room temperature below 77ºF (25ºC) for 90 days.</p>\n<p>• Do not store AMZEEQ in the refrigerator.</p>\n<p>• Do not puncture or burn the AMZEEQ can.</p>\n<p>• Do not expose to heat or temperatures above 120ºF (49ºC)</p>\n<p>\n<span class=\"Bold\">Keep AMZEEQ and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of AMZEEQ.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AMZEEQ for a condition for which it was not prescribed. Do not give AMZEEQ 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 AMZEEQ that is written for health professionals.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" colspan=\"3\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in AMZEEQ?</span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span>minocycline\n \n </p>\n<p>\n<span class=\"Bold\">Inactive ingredients:</span>soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol and propellant (butane + isobutane + propane). \n <br/>\n<br/> Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland\n \n </p>\n<p>Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258</p>\n<p>Product of Portugal or Italy \n <br/>\n<br/> AMZ-P02-R01 \n <br/>\n<br/> AMZEEQ is a registered trademark of Journey Medical Corporation. \n <br/> All other trademarks are the properties of their respective owners. \n <br/> Copyright © 2023, Journey Medical Corporation. All rights reserved. \n <br/>\n<br/> For more information, go to www.AMZEEQ.com or call Journey Medical Corporation at 1-855-531-1859.\n </p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration.                           Issued: 10/2023

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration.                           Issued: 10/2023" }

INSTRUCTIONS FOR USE AMZEEQ ®(am-Zeek) (minocycline) topical foam

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n\nAMZEEQ\n \n ®(am-Zeek)\n \n \n\n(minocycline)\n\ntopical foam\n" }

Important Information:AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.

{ "type": "p", "children": [], "text": "\nImportant Information:AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.\n\n " }

Read this Instructions for Use before you start using AMZEEQ and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Use AMZEEQ exactly as your healthcare provider tells you.

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

Before applying AMZEEQ:

{ "type": "p", "children": [], "text": "\nBefore applying AMZEEQ:\n" }

• Allow the AMZEEQ can to warm to room temperature before first use.

{ "type": "p", "children": [], "text": "• Allow the AMZEEQ can to warm to room temperature before first use." }

• Wash your face gently with mild cleanser, rinse with water, and pat your skin dry.

{ "type": "p", "children": [], "text": "• Wash your face gently with mild cleanser, rinse with water, and pat your skin dry." }

<div class="scrollingtable"><table width="100%"> <col width="53%"/> <col width="47%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"></p> <p></p> <p> <img alt="Step 1" src="/dailymed/image.cfm?name=image-02.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad"/></p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <br/> <br/> <span class="Bold">Step 1:</span>Shake the can well. Place thumb under tab above nozzle and lift up to remove the cap from the AMZEEQ foam can. </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"></p> <p> <img alt="Step 2" src="/dailymed/image.cfm?name=image-03.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad"/></p> <p></p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <br/> <span class="Bold">Step 2:</span>Press the top of the can to dispense a small amount of AMZEEQ foam onto your fingertips. </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"></p> <p> <img alt="Step 3" src="/dailymed/image.cfm?name=image-04.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad"/></p> <p></p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <br/> <br/> <span class="Bold">Step 3:</span>Apply and gently rub AMZEEQ foam into the affected areas. </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"></p> <p> <img alt="Step 4" src="/dailymed/image.cfm?name=image-05.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad"/></p> <p></p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <br/> <br/> <span class="Bold">Step 4:</span>If acne is present on other parts of your body (neck, shoulders, arms, back or chest), additional amounts of AMZEEQ foam should also be applied to these affected areas as directed by your healthcare provider. </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" colspan="2" valign="top">•Wash your hands after applying AMZEEQ.•AMZEEQ can stain fabric.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"53%\"/>\n<col width=\"47%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\"></p>\n<p></p>\n<p>\n<img alt=\"Step 1\" src=\"/dailymed/image.cfm?name=image-02.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad\"/></p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<br/>\n<br/>\n<span class=\"Bold\">Step 1:</span>Shake the can well. Place thumb under tab above nozzle and lift up to remove the cap from the AMZEEQ foam can.\n \n </p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\"></p>\n<p>\n<img alt=\"Step 2\" src=\"/dailymed/image.cfm?name=image-03.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad\"/></p>\n<p></p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<br/>\n<span class=\"Bold\">Step 2:</span>Press the top of the can to dispense a small amount of AMZEEQ foam onto your fingertips.\n \n </p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\"></p>\n<p>\n<img alt=\"Step 3\" src=\"/dailymed/image.cfm?name=image-04.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad\"/></p>\n<p></p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<br/>\n<br/>\n<span class=\"Bold\">Step 3:</span>Apply and gently rub AMZEEQ foam into the affected areas.\n \n </p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\"></p>\n<p>\n<img alt=\"Step 4\" src=\"/dailymed/image.cfm?name=image-05.jpg&amp;setid=cc251492-977b-4eb1-a088-a90831324bad\"/></p>\n<p></p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<br/>\n<br/>\n<span class=\"Bold\">Step 4:</span>If acne is present on other parts of your body (neck, shoulders, arms, back or chest), additional amounts of AMZEEQ foam should also be applied to these affected areas as directed by your healthcare provider.\n \n </p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">•Wash your hands after applying AMZEEQ.•AMZEEQ can stain fabric.</td>\n</tr>\n</tbody>\n</table></div>" }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.                       Issued: 10/2023

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration.                       Issued: 10/2023" }

Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258 Product of Portugal or Italy AMZ-P03-R01

{ "type": "p", "children": [], "text": "Manufactured by: ASM Aerosol-Service AG, Mohlin, Switzerland \n Manufactured for: Journey Medical Corporation, Scottsdale, AZ 85258 \n Product of Portugal or Italy \n \n AMZ-P03-R01\n " }

AMZEEQ is a registered trademark of Journey Medical Corporation. All other trademarks are the properties of their respective owners.

{ "type": "p", "children": [], "text": "AMZEEQ is a registered trademark of Journey Medical Corporation. \n All other trademarks are the properties of their respective owners.\n " }

Copyright © 2023, Journey Medical Corporation. All rights reserved.

{ "type": "p", "children": [], "text": "Copyright © 2023, Journey Medical Corporation. All rights reserved." }

AMZEEQ Trade Label

{ "type": "p", "children": [], "text": "\nAMZEEQ Trade Label\n" }

NDC 69489- 201-30 - Label

{ "type": "p", "children": [], "text": "NDC 69489-\n \n 201-30 - Label\n\n " }

amzeeq ®

{ "type": "p", "children": [], "text": "\namzeeq\n \n ®\n" }

(minocycline) topical foam, 4%

{ "type": "p", "children": [], "text": "(minocycline) \n topical foam, 4%\n " }

For topical use only, not for oral, ophthalmic or intravaginal use

{ "type": "p", "children": [], "text": "For topical use only, not for oral, ophthalmic or intravaginal use" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

[logo -Journey Medical Corporation]

{ "type": "p", "children": [], "text": "[logo -Journey Medical Corporation]" }

30 g

{ "type": "p", "children": [], "text": "30 g" }

NDC 69489- 201-30 - Carton

{ "type": "p", "children": [], "text": "NDC 69489-\n \n 201-30 - Carton\n\n " }

amzeeq ®

{ "type": "p", "children": [], "text": "\namzeeq\n \n ®\n" }

(minocycline) topical foam, 4%

{ "type": "p", "children": [], "text": "(minocycline) \n topical foam, 4%\n " }

For topical use only,

{ "type": "p", "children": [], "text": "For topical use only," }

not for oral, ophthalmic

{ "type": "p", "children": [], "text": "not for oral, ophthalmic" }

or intravaginal use

{ "type": "p", "children": [], "text": "or intravaginal use" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

[logo -Journey Medical Corporation]

{ "type": "p", "children": [], "text": "[logo -Journey Medical Corporation]" }

30 g

{ "type": "p", "children": [], "text": "30 g" }

AMZEEQ Sample Labels

{ "type": "p", "children": [], "text": "\nAMZEEQ Sample Labels\n" }

NDC 69489- 201-03 - Label

{ "type": "p", "children": [], "text": "NDC 69489-\n \n 201-03 - Label\n\n " }

Physician Sample Not for Sale

{ "type": "p", "children": [], "text": "\nPhysician Sample Not for Sale\n" }

amzeeq ®

{ "type": "p", "children": [], "text": "\namzeeq\n \n ®\n" }

(minocycline) topical foam, 4%

{ "type": "p", "children": [], "text": "(minocycline) \n topical foam, 4%\n " }

For topical use only, not for oral,

{ "type": "p", "children": [], "text": "For topical use only, not for oral," }

ophthalmic or intravaginal use

{ "type": "p", "children": [], "text": "ophthalmic or intravaginal use" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

[logo -Journey Medical Corporation]

{ "type": "p", "children": [], "text": "[logo -Journey Medical Corporation]" }

3 g

{ "type": "p", "children": [], "text": "3 g" }

NDC 69489- 201-03 - Carton

{ "type": "p", "children": [], "text": "NDC 69489-\n \n 201-03 - Carton\n\n " }

Physician Sample

{ "type": "p", "children": [], "text": "\nPhysician Sample\n" }

Not for Sale

{ "type": "p", "children": [], "text": "\nNot for Sale\n" }

amzeeq ®

{ "type": "p", "children": [], "text": "\namzeeq\n \n ®\n" }

(minocycline) topical foam, 4%

{ "type": "p", "children": [], "text": "(minocycline) \n topical foam, 4%\n " }

For topical use only,

{ "type": "p", "children": [], "text": "For topical use only," }

not for oral, ophthalmic

{ "type": "p", "children": [], "text": "not for oral, ophthalmic" }

or intravaginal use

{ "type": "p", "children": [], "text": "or intravaginal use" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

[logo -Journey Medical Corporation]

{ "type": "p", "children": [], "text": "[logo -Journey Medical Corporation]" }

3 g

{ "type": "p", "children": [], "text": "3 g" }