Betamethasone dipropionate lotion (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate lotion (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older." }

Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin areas once or twice daily and massage lightly until the lotion disappears.

{ "type": "p", "children": [], "text": "Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin areas once or twice daily and massage lightly until the lotion disappears." }

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate lotion (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate lotion (augmented) should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [ see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate lotion (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate lotion (augmented) should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [\n \n see\n \n Warnings and Precautions (5.1)].\n\n " }

Betamethasone dipropionate lotion (augmented) should not be used with occlusive dressings unless directed by a physician.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate lotion (augmented) should not be used with occlusive dressings unless directed by a physician." }

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site." }

Avoid contact with eyes. Wash hands after each application.

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

Betamethasone dipropionate lotion (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate lotion (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use." }

Lotion, 0.05%. Each gram of betamethasone dipropionate lotion (augmented), 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion.

{ "type": "p", "children": [], "text": "Lotion, 0.05%. Each gram of betamethasone dipropionate lotion (augmented), 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion." }

Betamethasone dipropionate lotion (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate lotion (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation." }

Betamethasone dipropionate lotion (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of betamethasone dipropionate lotion (augmented) on the HPA axis, betamethasone dipropionate lotion (augmented) was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in subjects with scalp psoriasis, betamethasone dipropionate lotion (augmented) was shown to lower plasma cortisol levels below normal limits in 2 out of 11 subjects. HPA axis suppression in these subjects was transient and returned to normal within a week. In one of these subjects, plasma cortisol levels returned to normal while treatment continued.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

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

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

Avoid contact of betamethasone dipropionate lotion (augmented) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

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

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

In controlled clinical trials, adverse reactions associated with the use of betamethasone dipropionate lotion (augmented) reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation.

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

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, striae, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

Risk Summary

There are no available data on betamethasone dipropionate lotion (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate lotion (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate lotion (augmented) ( see Data).

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

Data

Animal Data

Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Risk Summary

There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate lotion (augmented) to women who are breastfeeding.

It is possible that topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for betamethasone dipropionate lotion (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate lotion (augmented) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate lotion (augmented) directly to the nipple and areola to avoid direct infant exposure [ see Use in Specific Populations (8.4)].

Use of betamethasone dipropionate lotion (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [ see Warnings and Precautions (5.1)].

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream USP (augmented), 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of betamethasone dipropionate lotion (augmented) in the treatment of diaper dermatitis.

Clinical trials of betamethasone dipropionate lotion (augmented) included 56 subjects who were 65 years of age and over and 9 subjects who were 75 years of age and over. There was a numerical difference for application site reactions (most frequently reported events were burning and stinging) which occurred in 15% (10/65) of geriatric subjects and 11% (38/342) of subjects less than 65 years of age. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

However, greater sensitivity of some older individuals cannot be ruled out.

Betamethasone dipropionate lotion (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate lotion (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone." }

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28H 37FO 7, a molecular weight of 504.6, and the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C\n \n 28H\n \n 37FO\n \n 7, a molecular weight of 504.6, and the following structural formula:\n\n " }

It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

{ "type": "p", "children": [], "text": "It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol." }

Each gram of betamethasone dipropionate lotion (augmented), 0.05% contains 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a colorless, clear to translucent lotion base of hydroxypropylcellulose, isopropyl alcohol (30%), phosphoric acid (used to adjust the pH to 4.5), propylene glycol, purified water, and sodium phosphate monobasic monohydrate.

{ "type": "p", "children": [], "text": "Each gram of betamethasone dipropionate lotion (augmented), 0.05% contains 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a colorless, clear to translucent lotion base of hydroxypropylcellulose, isopropyl alcohol (30%), phosphoric acid (used to adjust the pH to 4.5), propylene glycol, purified water, and sodium phosphate monobasic monohydrate." }

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate lotion (augmented) in corticosteroid responsive dermatoses is unknown.

Vasoconstrictor Assay

Trials performed with betamethasone dipropionate lotion USP (augmented), 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

No pharmacokinetic trials have been conducted with betamethasone dipropionate lotion (augmented).

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [ see Dosage and Administration (2)].

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitrohuman lymphocyte chromosome aberration assay, and equivocal in the in vivomouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

The safety and efficacy of betamethasone dipropionate lotion (augmented) for the treatment of corticosteroid-responsive dermatoses have been evaluated in two randomized vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 263 subjects, of whom 131 received betamethasone dipropionate lotion (augmented), were included in these trials. These trials evaluated betamethasone dipropionate lotion (augmented) applied once daily for 21 days.

{ "type": "p", "children": [], "text": "The safety and efficacy of betamethasone dipropionate lotion (augmented) for the treatment of corticosteroid-responsive dermatoses have been evaluated in two randomized vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 263 subjects, of whom 131 received betamethasone dipropionate lotion (augmented), were included in these trials. These trials evaluated betamethasone dipropionate lotion (augmented) applied once daily for 21 days." }

Betamethasone dipropionate lotion (augmented) was shown to be effective in relieving the signs and symptoms of corticosteroid responsive dermatoses.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate lotion (augmented) was shown to be effective in relieving the signs and symptoms of corticosteroid responsive dermatoses." }

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

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

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

Inform patients of the following:

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

{ "type": "ul", "children": [ "Discontinue therapy when control is achieved, unless directed otherwise by the physician.", "Use no more than 50 mL per week of betamethasone dipropionate lotion (augmented) and for no longer than 2 consecutive weeks.", "Avoid contact with the eyes.", "Advise patients to report any visual symptoms to their healthcare providers.", "Avoid use of betamethasone dipropionate lotion (augmented) on the face, underarms, or groin areas unless directed by the physician.", "Do not occlude the treatment area with bandage or other covering, unless directed by the physician.", "Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.", "Advise a woman to use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate lotion (augmented) directly to the nipple and areola to avoid direct infant exposure." ], "text": "" }

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

{ "type": "p", "children": [], "text": "Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1" }

Dist. by: Taro Pharmaceuticals U.S.A., Inc.,Hawthorne, NY 10532

{ "type": "p", "children": [], "text": "Dist. by:\n \n Taro Pharmaceuticals U.S.A., Inc.,Hawthorne, NY 10532\n\n " }

Revised: August 2019 PPK-5026-4 37

{ "type": "p", "children": [], "text": "Revised: August 2019 \n PPK-5026-4 \n 37\n " }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr class="Botrule"> <td align="center" class="Lrule Rrule Toprule"><span class="Bold">Patient Information <br/> Betamethasone Dipropionate <br/> (bay'' ta meth' a sone dye proe' pee oh nate) <br/> Lotion (Augmented) </span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Important information: Betamethasone Dipropionate Lotion (Augmented) is for use on skin only</span>. Do not use betamethasone dipropionate lotion (augmented) in your eyes, mouth, or vagina. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">What is Betamethasone Dipropionate Lotion (Augmented)?</span> <br/> Betamethasone dipropionate lotion (augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older. <ul> <li>Betamethasone dipropionate lotion (augmented) should not be used in children under 13 years of age.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Do not use Betamethasone Dipropionate Lotion (Augmented) if you</span>are allergic to betamethasone dipropionate or any of the ingredients in betamethasone dipropionate lotion (augmented). See the end of this leaflet for a complete list of ingredients in betamethasone dipropionate lotion (augmented). </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">Before using Betamethasone Dipropionate Lotion (Augmented), tell your healthcare provider about all of your medical conditions, including if you:</span> <ul> <li>have had irritation or other skin reaction to a steroid medicine in the past.</li> <li>have thinning of the skin (atrophy) at the treatment site.</li> <li>have diabetes.</li> <li>have adrenal gland problems.</li> <li>have liver problems.</li> <li>have cataracts or glaucoma.</li> <li>are pregnant or plan to become pregnant. It is not known if betamethasone dipropionate lotion (augmented) will harm your unborn baby. If you use betamethasone dipropionate lotion (augmented) during pregnancy, use betamethasone dipropionate lotion (augmented) on the smallest area of the skin and for the shortest time needed.</li> <li>are breastfeeding or plan to breastfeed. It is not known if betamethasone dipropionate lotion (augmented) passes into your breast milk. Breastfeeding women should use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply betamethasone dipropionate lotion (augmented) directly to the nipple and areola to avoid contact with your baby.</li> </ul> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. <br/> <span class="Bold">Especially</span>tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection or use other products on your skin or scalp that contain corticosteroids. <br/> Do not use other products containing a steroid medicine with betamethasone dipropionate lotion (augmented) without talking to your healthcare provider first. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">How should I use Betamethasone Dipropionate Lotion (Augmented)?</span> <ul> <li>Use betamethasone dipropionate lotion (augmented) exactly as your healthcare provider tells you to use it.</li> <li>Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin area 1 or 2 times each day and massage lightly until the lotion disappears. Do not use more than 50 mL of betamethasone dipropionate lotion (augmented) in 1 week.</li> <li>Do not use betamethasone dipropionate lotion (augmented) for longer than 2 weeks in a row unless your healthcare provider tells you to.</li> <li>Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with betamethasone dipropionate lotion (augmented).</li> <li>Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.</li> <li>Betamethasone dipropionate lotion (augmented) should not be used to treat diaper rash or redness.</li> <li>Avoid using betamethasone dipropionate lotion (augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.</li> <li>Wash your hands after applying betamethasone dipropionate lotion (augmented) unless you are using the medicine to treat your hands.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">What are the possible side effects of Betamethasone Dipropionate Lotion (Augmented)? <br/> Betamethasone Dipropionate Lotion (Augmented) may cause serious side effects, including: </span> <ul> <li> <span class="Bold">Betamethasone dipropionate lotion (augmented) can pass through your skin.</span>Too much betamethasone dipropionate lotion (augmented) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. </li> <li> <span class="Bold">Cushing's syndrome</span>, a condition that happens when your body is exposed to too much of the hormone cortisol. </li> <li> <span class="Bold">High blood sugar</span>(hyperglycemia). </li> <li> <span class="Bold">Effects on growth and weight in children.</span> </li> <li> <span class="Bold">Vision problems.</span>Topical corticosteroids including betamethasone dipropionate lotion (augmented) may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with betamethasone dipropionate lotion (augmented). </li> <li> <span class="Bold">Skin problems.</span>Skin problems including, allergic reactions (contact dermatitis) may happen during treatment with betamethasone dipropionate lotion (augmented). Stop using betamethasone dipropionate lotion (augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with betamethasone dipropionate lotion (augmented). </li> </ul> <span class="Bold">The most common side effects of betamethasone dipropionate lotion (augmented) include:</span>redness of the skin, inflamed hair follicles, itching and blistering. <br/> These are not all of the possible side effects of betamethasone dipropionate lotion (augmented). <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">How should I store Betamethasone Dipropionate Lotion (Augmented)?</span> <ul> <li>Store betamethasone dipropionate lotion (augmented) at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li> <span class="Bold">Keep betamethasone dipropionate lotion (augmented) and all medicines out of the reach of children.</span> </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">General information about the safe and effective use of Betamethasone Dipropionate Lotion (Augmented). <br/> </span>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use betamethasone dipropionate lotion (augmented) for a condition for which it was not prescribed. Do not give betamethasone dipropionate lotion (augmented) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about betamethasone dipropionate lotion (augmented) that is written for health professionals. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule"><span class="Bold">What are the ingredients in Betamethasone Dipropionate Lotion (Augmented)? <br/> Active ingredient: </span>betamethasone dipropionate <br/> <span class="Bold">Inactive ingredients:</span>hydroxypropylcellulose, isopropyl alcohol (30%), phosphoric acid (used to adjust the pH to 4.5), propylene glycol, purified water, and sodium phosphate monobasic monohydrate. <br/> Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 <br/> Distributed by: <span class="Bold">Taro Pharmaceuticals U.S.A., Inc.,</span>Hawthorne, NY 10532 <br/> Revised: August 2019    PPK-5026-4    37 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule Toprule\"><span class=\"Bold\">Patient Information \n <br/> Betamethasone Dipropionate \n <br/> (bay'' ta meth' a sone dye proe' pee oh nate) \n <br/> Lotion (Augmented)\n </span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Important information: Betamethasone Dipropionate Lotion (Augmented) is for use on skin only</span>. Do not use betamethasone dipropionate lotion (augmented) in your eyes, mouth, or vagina.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What is Betamethasone Dipropionate Lotion (Augmented)?</span>\n<br/> Betamethasone dipropionate lotion (augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older.\n \n <ul>\n<li>Betamethasone dipropionate lotion (augmented) should not be used in children under 13 years of age.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Do not use Betamethasone Dipropionate Lotion (Augmented) if you</span>are allergic to betamethasone dipropionate or any of the ingredients in betamethasone dipropionate lotion (augmented). See the end of this leaflet for a complete list of ingredients in betamethasone dipropionate lotion (augmented).\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">Before using Betamethasone Dipropionate Lotion (Augmented), tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul>\n<li>have had irritation or other skin reaction to a steroid medicine in the past.</li>\n<li>have thinning of the skin (atrophy) at the treatment site.</li>\n<li>have diabetes.</li>\n<li>have adrenal gland problems.</li>\n<li>have liver problems.</li>\n<li>have cataracts or glaucoma.</li>\n<li>are pregnant or plan to become pregnant. It is not known if betamethasone dipropionate lotion (augmented) will harm your unborn baby. If you use betamethasone dipropionate lotion (augmented) during pregnancy, use betamethasone dipropionate lotion (augmented) on the smallest area of the skin and for the shortest time needed.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if betamethasone dipropionate lotion (augmented) passes into your breast milk. Breastfeeding women should use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply betamethasone dipropionate lotion (augmented) directly to the nipple and areola to avoid contact with your baby.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span>including prescription and over-the-counter medicines, vitamins, and herbal supplements. \n <br/>\n<span class=\"Bold\">Especially</span>tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection or use other products on your skin or scalp that contain corticosteroids. \n <br/> Do not use other products containing a steroid medicine with betamethasone dipropionate lotion (augmented) without talking to your healthcare provider first.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">How should I use Betamethasone Dipropionate Lotion (Augmented)?</span>\n<ul>\n<li>Use betamethasone dipropionate lotion (augmented) exactly as your healthcare provider tells you to use it.</li>\n<li>Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin area 1 or 2 times each day and massage lightly until the lotion disappears. Do not use more than 50 mL of betamethasone dipropionate lotion (augmented) in 1 week.</li>\n<li>Do not use betamethasone dipropionate lotion (augmented) for longer than 2 weeks in a row unless your healthcare provider tells you to.</li>\n<li>Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with betamethasone dipropionate lotion (augmented).</li>\n<li>Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.</li>\n<li>Betamethasone dipropionate lotion (augmented) should not be used to treat diaper rash or redness.</li>\n<li>Avoid using betamethasone dipropionate lotion (augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.</li>\n<li>Wash your hands after applying betamethasone dipropionate lotion (augmented) unless you are using the medicine to treat your hands.</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What are the possible side effects of Betamethasone Dipropionate Lotion (Augmented)? \n <br/> Betamethasone Dipropionate Lotion (Augmented) may cause serious side effects, including:\n </span>\n<ul>\n<li>\n<span class=\"Bold\">Betamethasone dipropionate lotion (augmented) can pass through your skin.</span>Too much betamethasone dipropionate lotion (augmented) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.\n \n </li>\n<li>\n<span class=\"Bold\">Cushing's syndrome</span>, a condition that happens when your body is exposed to too much of the hormone cortisol.\n \n </li>\n<li>\n<span class=\"Bold\">High blood sugar</span>(hyperglycemia).\n \n </li>\n<li>\n<span class=\"Bold\">Effects on growth and weight in children.</span>\n</li>\n<li>\n<span class=\"Bold\">Vision problems.</span>Topical corticosteroids including betamethasone dipropionate lotion (augmented) may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with betamethasone dipropionate lotion (augmented).\n \n </li>\n<li>\n<span class=\"Bold\">Skin problems.</span>Skin problems including, allergic reactions (contact dermatitis) may happen during treatment with betamethasone dipropionate lotion (augmented). Stop using betamethasone dipropionate lotion (augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with betamethasone dipropionate lotion (augmented).\n \n </li>\n</ul>\n<span class=\"Bold\">The most common side effects of betamethasone dipropionate lotion (augmented) include:</span>redness of the skin, inflamed hair follicles, itching and blistering. \n <br/> These are not all of the possible side effects of betamethasone dipropionate lotion (augmented). \n <br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">How should I store Betamethasone Dipropionate Lotion (Augmented)?</span>\n<ul>\n<li>Store betamethasone dipropionate lotion (augmented) at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>\n<span class=\"Bold\">Keep betamethasone dipropionate lotion (augmented) and all medicines out of the reach of children.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">General information about the safe and effective use of Betamethasone Dipropionate Lotion (Augmented). \n <br/>\n</span>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use betamethasone dipropionate lotion (augmented) for a condition for which it was not prescribed. Do not give betamethasone dipropionate lotion (augmented) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about betamethasone dipropionate lotion (augmented) that is written for health professionals.\n \n </td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\"><span class=\"Bold\">What are the ingredients in Betamethasone Dipropionate Lotion (Augmented)? \n <br/> Active ingredient:\n </span>betamethasone dipropionate \n <br/>\n<span class=\"Bold\">Inactive ingredients:</span>hydroxypropylcellulose, isopropyl alcohol (30%), phosphoric acid (used to adjust the pH to 4.5), propylene glycol, purified water, and sodium phosphate monobasic monohydrate. \n <br/> Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 \n <br/> Distributed by:\n \n <span class=\"Bold\">Taro Pharmaceuticals U.S.A., Inc.,</span>Hawthorne, NY 10532 \n <br/> Revised: August 2019    PPK-5026-4    37\n \n </td>\n</tr>\n</tbody>\n</table></div>" }

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 08/2019

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration. \n Revised: 08/2019\n " }

30 mL

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

NDC 51672-1340-3

{ "type": "p", "children": [], "text": "\nNDC 51672-1340-3\n" }

Betamethasone Dipropionate

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

Lotion

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

(Augmented*) USP, 0.05%

{ "type": "p", "children": [], "text": "\n(Augmented*) \n USP, 0.05%\n \n" }

(Potency expressed as betamethasone) *Vehicle augments the penetration of the steroid.

{ "type": "p", "children": [], "text": "\n(Potency expressed as betamethasone)\n *Vehicle augments the penetration of \n the steroid.\n\n " }

FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

{ "type": "p", "children": [], "text": "FOR DERMATOLOGIC USE ONLY. \n NOT FOR OPHTHALMIC USE.\n " }

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

{ "type": "p", "children": [], "text": "\nKeep this and all \n medications out of the \n reach of children.\n \n" }

DO NOT USE IN EYES

{ "type": "p", "children": [], "text": "\nDO NOT USE IN EYES\n" }

Rx only

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

TARO

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

Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older." }

Apply a thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily.

{ "type": "p", "children": [], "text": "Apply a thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily." }

Therapy should be discontinued when control is achieved. Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid. Treatment with betamethasone dipropionate cream (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

{ "type": "p", "children": [], "text": "Therapy should be discontinued when control is achieved. Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid. Treatment with betamethasone dipropionate cream (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis." }

Betamethasone dipropionate cream (augmented) should not be used with occlusive dressings unless directed by a physician.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate cream (augmented) should not be used with occlusive dressings unless directed by a physician." }

Betamethasone dipropionate cream (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate cream (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use." }

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site." }

Cream, 0.05%. Each gram of betamethasone dipropionate cream USP (augmented), 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white cream base.

{ "type": "p", "children": [], "text": "Cream, 0.05%. Each gram of betamethasone dipropionate cream USP (augmented), 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white cream base." }

Betamethasone dipropionate cream (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate cream (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation." }

Betamethasone dipropionate cream (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

Betamethasone dipropionate cream (augmented), 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the HPA axis. The results suggested that the drug lowered adrenal corticosteroid secretion, although plasma cortisol levels did not go below the lower limit of the normal range.

In an open-label pediatric trial of 60 evaluable subjects (3 months to 12 years of age), 19 subjects showed evidence of HPA axis suppression. Four (4) subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

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

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

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

In controlled clinical trials, involving 242 adult subjects, the adverse reaction associated with the use of betamethasone dipropionate cream (augmented) reported at a frequency of 0.4% was stinging. It occurred in 1 subject.

In a controlled clinical trial involving 67 pediatric subjects from 3 months to 12 years of age, the adverse reactions associated with the use of betamethasone dipropionate cream (augmented) occurred in 7 of 67 (10%) subjects. Reported reactions included signs of skin atrophy (telangiectasia, bruising, shininess).

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

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, skin atrophy, striae, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Betamethasone dipropionate cream (augmented) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

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

Use of betamethasone dipropionate cream (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [ see Warnings and Precautions (5.1)].

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group [ see Warnings and Precautions (5.1)].

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of betamethasone dipropionate cream (augmented) in the treatment of diaper dermatitis.

Clinical trials of betamethasone dipropionate cream (augmented) included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Betamethasone dipropionate cream USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate cream USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone." }

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28H 37FO 7, a molecular weight of 504.6, and the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C\n \n \n 28H\n \n \n 37FO\n \n \n 7, a molecular weight of 504.6, and the following structural formula:\n \n\n " }

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water." }

Each gram of betamethasone dipropionate cream USP (augmented), 0.05% contains: 0.64 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer homopolymer type C, ceteareth-30, chlorocresol, cyclomethicone, glyceryl oleate, propylene glycol, purified water, sodium hydroxide, sorbitol solution, white petrolatum and white wax.

{ "type": "p", "children": [], "text": "Each gram of betamethasone dipropionate cream USP (augmented), 0.05% contains: 0.64 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer homopolymer type C, ceteareth-30, chlorocresol, cyclomethicone, glyceryl oleate, propylene glycol, purified water, sodium hydroxide, sorbitol solution, white petrolatum and white wax." }

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate cream (augmented) in corticosteroid responsive dermatoses is unknown.

Vasoconstrictor Assay

Trials performed with betamethasone dipropionate cream (augmented), 0.05% indicate that it is in the high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

No pharmacokinetics trials have been conducted with betamethasone dipropionate cream (augmented), 0.05%. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings [ see Dosage and Administration (2)].

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [ see Dosage and Administration (2)].

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Betamethasone was negative in the bacterial mutagenicity assay ( Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

The safety and efficacy of betamethasone dipropionate cream (augmented) for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque psoriasis. A total of 81 subjects who received betamethasone dipropionate cream (augmented) were included in these trials. These trials evaluated betamethasone dipropionate cream (augmented) applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. Betamethasone dipropionate cream (augmented) was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis.

{ "type": "p", "children": [], "text": "The safety and efficacy of betamethasone dipropionate cream (augmented) for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque psoriasis. A total of 81 subjects who received betamethasone dipropionate cream (augmented) were included in these trials. These trials evaluated betamethasone dipropionate cream (augmented) applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. Betamethasone dipropionate cream (augmented) was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis. " }

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

Inform patients of the following:

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

{ "type": "ul", "children": [ "Discontinue therapy when control is achieved, unless directed otherwise by the physician. ", "Use no more than 50 grams per week. ", "Avoid contact with the eyes. ", "Avoid use of betamethasone dipropionate cream (augmented) on the face, underarms, or groin areas unless directed by the physician. ", "Do not occlude the treatment area with bandage or other covering, unless directed by the physician. ", "Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. " ], "text": "" }

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

{ "type": "p", "children": [], "text": "Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1" }

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

{ "type": "p", "children": [], "text": "Dist. by: \n \n \n Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532\n \n\n " }

Revised: April, 2016 LPK-4705-6    20

{ "type": "p", "children": [], "text": "Revised: April, 2016\n \n \n LPK-4705-6    20\n \n\n " }

SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

{ "type": "p", "children": [], "text": "SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older." }

Shake well before use.

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

Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently.

{ "type": "p", "children": [], "text": "Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently." }

Use SERNIVO Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

{ "type": "p", "children": [], "text": "Use SERNIVO Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended." }

Discontinue SERNIVO Spray when control is achieved.

{ "type": "p", "children": [], "text": "Discontinue SERNIVO Spray when control is achieved." }

Do not use if atrophy is present at the treatment site.

{ "type": "p", "children": [], "text": "Do not use if atrophy is present at the treatment site. " }

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

{ "type": "p", "children": [], "text": "Do not bandage, cover, or wrap the treated skin area unless directed by a physician." }

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

{ "type": "p", "children": [], "text": "Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. " }

SERNIVO Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

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

Spray, 0.05% for topical use. Each gram of SERNIVO Spray contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white oil-in-water emulsion.

{ "type": "p", "children": [], "text": "Spray, 0.05% for topical use. Each gram of SERNIVO Spray contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white oil-in-water emulsion." }

None.

{ "type": "p", "children": [], "text": "None." }

SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with SERNIVO Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with SERNIVO Spray twice daily for 29 days [see Clinical Pharmacology (12.2)].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration (2)].

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of SERNIVO Spray is not recommended in pediatric patients [see Use in Specific Populations (8.4)].

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

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

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid 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 clinical practice.

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1.

<div class="scrollingtable"><table class="Noautorules" width="550"> <caption> <span>Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks</span> </caption> <col align="left" width="40%"/> <col align="center" width="30%"/> <col align="center" width="30%"/> <tbody class="Headless"> <tr valign="top"> <td align="left" class="Botrule Lrule Rrule Toprule"></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">SERNIVO Spray <span class="Italics">b.i.d.</span> <br/>(N=352)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Vehicle Spray <span class="Italics">b.i.d.</span> <br/>(N=180)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Application site pruritus</td><td align="center" class="Botrule Lrule Rrule Toprule">6.0%</td><td align="center" class="Botrule Lrule Rrule Toprule">9.4%</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Application site burning and/or stinging </td><td align="center" class="Botrule Lrule Rrule Toprule">4.5%</td><td align="center" class="Botrule Lrule Rrule Toprule">10.0%</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Application site pain </td><td align="center" class="Botrule Lrule Rrule Toprule">2.3%</td><td align="center" class="Botrule Lrule Rrule Toprule">3.9%</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Application site atrophy</td><td align="center" class="Botrule Lrule Rrule Toprule">1.1%</td><td align="center" class="Botrule Lrule Rrule Toprule">1.7%</td> </tr> </tbody> </table></div>

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with SERNIVO Spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

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

Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure have been reported with the use of topical corticosteroids, including topical betamethasone products.

There are no available data on SERNIVO Spray use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that SERNIVO Spray may increase the risk of having a low birthweight infant and to use SERNIVO Spray on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits during the period of organogenesis (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of SERNIVO Spray.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Risk Summary

There are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of SERNIVO Spray to women who are breastfeeding.

It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SERNIVO Spray and any potential adverse effects on the breastfed infant from SERNIVO Spray or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use SERNIVO Spray on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply SERNIVO Spray directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied, therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1)]

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Clinical studies of SERNIVO Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use.

{ "type": "p", "children": [], "text": "SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use." }

The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below.

{ "type": "p", "children": [], "text": "The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below." }

Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

{ "type": "p", "children": [], "text": "Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients." }

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of SERNIVO Spray in psoriasis is unknown.

Vasoconstrictor studies performed with SERNIVO Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by SERNIVO Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. SERNIVO Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with SERNIVO Spray for 15 days. No subjects (0 out of 24) treated with SERNIVO Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of betamethasone dipropionate, betamethasone-17-propionate, and betamethasone were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of betamethasone dipropionate, while the metabolites, betamethasone-17-propionate and betamethasone, were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

<div class="scrollingtable"><table class="Noautorules" width="550"> <caption> <span>Table 2: Mean (±SD) Maximum Plasma Concentrations (pg/mL) of Betamethasone Dipropionate Metabolites after 15 or 29 Days of Treatment with SERNIVO Spray </span> </caption> <col align="left" width="40%"/> <col align="center" width="30%"/> <col align="center" width="30%"/> <tbody class="Headless"> <tr valign="bottom"> <td align="left" class="Botrule Lrule Rrule Toprule"><span class="Bold">Analyte (pg/mL)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">SERNIVO Spray <span class="Italics">b.i.d.</span> <br/>(15 days)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">SERNIVO Spray <span class="Italics">b.i.d.</span> <br/>(29 days)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Betamethasone-17-propionate </td><td align="center" class="Botrule Lrule Rrule Toprule">120 ± 127</td><td align="center" class="Botrule Lrule Rrule Toprule">63.9 ± 52.6</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Betamethasone</td><td align="center" class="Botrule Lrule Rrule Toprule">119 ± 176</td><td align="center" class="Botrule Lrule Rrule Toprule">57.6 ± 55.9</td> </tr> </tbody> </table></div>

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of betamethasone dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied SERNIVO Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

{ "type": "p", "children": [], "text": "Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied SERNIVO Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate)." }

Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29.

{ "type": "p", "children": [], "text": "Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29." }

<div class="scrollingtable"><table class="Noautorules" width="650"> <caption> <span>Table 3: Proportion of Subjects with Plaque Psoriasis with Treatment Success<span class="Sup">a</span> after 14 Days and 28 Days of Treatment</span> </caption> <col align="left" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> <col align="center" width="20%"/> <tfoot> <tr> <td align="left" colspan="5"><span class="Sup">a</span> Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.</td> </tr> </tfoot> <tbody class="Headless"> <tr valign="top"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2"></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2"><span class="Bold">Study 1</span></td><td align="center" class="Botrule Lrule Rrule Toprule" colspan="2"><span class="Bold">Study 2</span></td> </tr> <tr valign="top"> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">SERNIVO Spray <span class="Italics">b.i.d.</span> <br/>(N=182)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Vehicle Spray <br/> <span class="Italics">b.i.d.</span> <br/>(N=95)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">SERNIVO Spray <span class="Italics">b.i.d.</span> <br/>(N=174)</span></td><td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold">Vehicle Spray <br/> <span class="Italics">b.i.d.</span> <br/>(N=87)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Treatment Success at Day 15</td><td align="center" class="Botrule Lrule Rrule Toprule">21.5%</td><td align="center" class="Botrule Lrule Rrule Toprule">7.4%</td><td align="center" class="Botrule Lrule Rrule Toprule">19.0%</td><td align="center" class="Botrule Lrule Rrule Toprule">2.3%</td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule">Treatment Success at Day 29</td><td align="center" class="Botrule Lrule Rrule Toprule">42.7%</td><td align="center" class="Botrule Lrule Rrule Toprule">11.7%</td><td align="center" class="Botrule Lrule Rrule Toprule">34.5%</td><td align="center" class="Botrule Lrule Rrule Toprule">13.6%</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"650\">\n<caption>\n<span>Table 3:\tProportion of Subjects with Plaque Psoriasis with Treatment Success<span class=\"Sup\">a</span> after 14 Days and 28 Days of Treatment</span>\n</caption>\n<col align=\"left\" width=\"20%\"/>\n<col align=\"center\" width=\"20%\"/>\n<col align=\"center\" width=\"20%\"/>\n<col align=\"center\" width=\"20%\"/>\n<col align=\"center\" width=\"20%\"/>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"5\"><span class=\"Sup\">a</span> Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr valign=\"top\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Study 1</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\"><span class=\"Bold\">Study 2</span></td>\n</tr>\n<tr valign=\"top\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">SERNIVO Spray <span class=\"Italics\">b.i.d.</span>\n<br/>(N=182)</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Vehicle Spray <br/>\n<span class=\"Italics\">b.i.d.</span>\n<br/>(N=95)</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">SERNIVO Spray <span class=\"Italics\">b.i.d.</span>\n<br/>(N=174)</span></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\">Vehicle Spray <br/>\n<span class=\"Italics\">b.i.d.</span>\n<br/>(N=87)</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Treatment Success at Day 15</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">21.5%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">7.4%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">19.0%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">2.3%</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\">Treatment Success at Day 29</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">42.7%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">11.7%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">34.5%</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">13.6%</td>\n</tr>\n</tbody>\n</table></div>" }

SERNIVO Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes:

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

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

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 of the following:

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

{ "type": "ul", "children": [ "Discontinue therapy when control is achieved, unless directed otherwise by the physician.", "Do not use for longer than 4 consecutive weeks.", "Avoid contact with the eyes.", "Avoid use of SERNIVO Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.", "Do not occlude the treatment area with bandage or other covering, unless directed by the physician.", "Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.", "Advise a woman to use SERNIVO Spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply SERNIVO Spray directly to the nipple and areola to avoid direct infant exposure." ], "text": "" }

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

{ "type": "p", "children": [], "text": "Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215" }

For Encore Dermatology, Inc. Scottsdale, AZ 85254

{ "type": "p", "children": [], "text": "For Encore Dermatology, Inc. Scottsdale, AZ 85254" }

Sernivo is a registered trademark of Encore Dermatology, Inc.

{ "type": "p", "children": [], "text": "Sernivo is a registered trademark of Encore Dermatology, Inc." }

Revised: 2021-04

{ "type": "p", "children": [], "text": "Revised: 2021-04" }

Product Insert Item Number SER1325 03/20

{ "type": "p", "children": [], "text": "Product Insert Item Number SER1325 03/20" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" width="80%"/> <col align="left" width="20%"/> <tfoot> <tr valign="top"> <td align="left">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align="right">Revised: 04/2019</td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">PATIENT INFORMATION</span> </p> <p> <span class="Bold">SERNIVO™ (ser-ne-vo) <br/>(betamethasone dipropionate) <br/>Spray, 0.05%</span> </p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Important: SERNIVO Spray is for use on the skin only. </span>Do not get SERNIVO Spray near or in your eyes, mouth, or vagina.</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What is SERNIVO Spray?</span> </p> <ul class="Disc"> <li>SERNIVO Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.</li> </ul> <p>It is not known if SERNIVO Spray is safe and effective in children under 18 years of age. SERNIVO Spray is not recommended for use in patients under 18 years of age.</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">Before you use SERNIVO Spray, tell your doctor about all of your medical conditions, including if you:</span> </p> <ul class="Disc"> <li>are allergic to any of the ingredients in SERNIVO Spray. See the end of this leaflet for a list of the ingredients in SERNIVO Spray.</li> <li>have thinning of the skin (atrophy) at the treatment site</li> <li>are pregnant or plan to become pregnant. It is not known if SERNIVO Spray will harm your unborn baby.</li> <li>are breastfeeding or plan to breastfeed. It is not known if SERNIVO Spray passes into breast milk.</li> </ul> <p> <span class="Bold">Tell your doctor about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">How should I use SERNIVO Spray?</span> </p> <p> <span class="Bold">See the “<a href="#s_ifu">Instructions for Use</a>” for detailed information about the right way to apply SERNIVO Spray.</span> </p> <ul class="Disc"> <li>Use SERNIVO Spray exactly as your doctor tells you to use it.</li> <li>Your doctor should tell you how much SERNIVO Spray to use and where to apply it.</li> <li>Apply SERNIVO Spray 2 times a day.</li> <li>Use SERNIVO Spray for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 4 weeks of using SERNIVO Spray. Do not use SERNIVO Spray for longer than 4 weeks.</li> <li>Wash your hands after applying SERNIVO Spray.</li> <li>Do not use SERNIVO Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.</li> <li>Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.</li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What are the possible side effects of SERNIVO Spray? </span> </p> <ul class="Disc"> <li> <span class="Bold">SERNIVO Spray can pass through your skin.</span> Too much SERNIVO Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.</li> </ul> <p> <span class="Bold">The most common side effects of SERNIVO Spray include</span> itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.</p> <p>These are not all the possible side effects of SERNIVO Spray. </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 align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">How should I store SERNIVO Spray?</span> </p> <ul class="Disc"> <li>Store SERNIVO Spray at room temperature between 68°F to 77°F (20°C to 25°C).</li> <li>Throw away (discard) any unused SERNIVO Spray after 4 weeks</li> </ul> <p> <span class="Bold">Keep SERNIVO Spray and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">General information about the safe and effective use of SERNIVO Spray.</span> </p> <p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SERNIVO Spray for a condition for which it was not prescribed. Do not give SERNIVO Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about SERNIVO Spray that is written for health professionals.</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2"> <p class="First"> <span class="Bold">What are the ingredients in SERNIVO Spray? </span> </p> <p> <span class="Bold">Active ingredient:</span> betamethasone dipropionate</p> <p> <span class="Bold">Inactive ingredients:</span> butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate</p> <p>Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215</p> <p>Distributed by: Encore Dermatology, Inc. Scottsdale, AZ 85254<br/> SER 1288<br/> 4/19</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" width=\"80%\"/>\n<col align=\"left\" width=\"20%\"/>\n<tfoot>\n<tr valign=\"top\">\n<td align=\"left\">This Patient Information has been approved by the U.S. Food and Drug Administration.</td><td align=\"right\">Revised: 04/2019</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">PATIENT INFORMATION</span>\n</p>\n<p>\n<span class=\"Bold\">SERNIVO™ (ser-ne-vo) \n\t\t\t\t\t\t\t\t\t\t\t<br/>(betamethasone dipropionate) \n\t\t\t\t\t\t\t\t\t\t\t<br/>Spray, 0.05%</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Important: SERNIVO Spray is for use on the skin only. </span>Do not get SERNIVO Spray near or in your eyes, mouth, or vagina.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What is SERNIVO Spray?</span>\n</p>\n<ul class=\"Disc\">\n<li>SERNIVO Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.</li>\n</ul>\n<p>It is not known if SERNIVO Spray is safe and effective in children under 18 years of age. SERNIVO Spray is not recommended for use in patients under 18 years of age.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">Before you use SERNIVO Spray, tell your doctor about all of your medical conditions, including if you:</span>\n</p>\n<ul class=\"Disc\">\n<li>are allergic to any of the ingredients in SERNIVO Spray. See the end of this leaflet for a list of the ingredients in SERNIVO Spray.</li>\n<li>have thinning of the skin (atrophy) at the treatment site</li>\n<li>are pregnant or plan to become pregnant. It is not known if SERNIVO Spray will harm your unborn baby.</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if SERNIVO Spray passes into breast milk.</li>\n</ul>\n<p>\n<span class=\"Bold\">Tell your doctor about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">How should I use SERNIVO Spray?</span>\n</p>\n<p>\n<span class=\"Bold\">See the “<a href=\"#s_ifu\">Instructions for Use</a>” for detailed information about the right way to apply SERNIVO Spray.</span>\n</p>\n<ul class=\"Disc\">\n<li>Use SERNIVO Spray exactly as your doctor tells you to use it.</li>\n<li>Your doctor should tell you how much SERNIVO Spray to use and where to apply it.</li>\n<li>Apply SERNIVO Spray 2 times a day.</li>\n<li>Use SERNIVO Spray for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 4 weeks of using SERNIVO Spray. Do not use SERNIVO Spray for longer than 4 weeks.</li>\n<li>Wash your hands after applying SERNIVO Spray.</li>\n<li>Do not use SERNIVO Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.</li>\n<li>Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of SERNIVO Spray? </span>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">SERNIVO Spray can pass through your skin.</span> Too much SERNIVO Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.</li>\n</ul>\n<p>\n<span class=\"Bold\">The most common side effects of SERNIVO Spray include</span> itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.</p>\n<p>These are not all the possible side effects of SERNIVO Spray. </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 align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store SERNIVO Spray?</span>\n</p>\n<ul class=\"Disc\">\n<li>Store SERNIVO Spray at room temperature between 68°F to 77°F (20°C to 25°C).</li>\n<li>Throw away (discard) any unused SERNIVO Spray after 4 weeks</li>\n</ul>\n<p>\n<span class=\"Bold\">Keep SERNIVO Spray and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of SERNIVO Spray.</span>\n</p>\n<p>Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SERNIVO Spray for a condition for which it was not prescribed. Do not give SERNIVO Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about SERNIVO Spray that is written for health professionals.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in SERNIVO Spray? </span>\n</p>\n<p>\n<span class=\"Bold\">Active ingredient:</span> betamethasone dipropionate</p>\n<p>\n<span class=\"Bold\">Inactive ingredients:</span> butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate</p>\n<p>Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215</p>\n<p>Distributed by: Encore Dermatology, Inc. Scottsdale, AZ 85254<br/>\n\t\t\t\t\t\t\t\t\t\t\tSER 1288<br/>\n\t\t\t\t\t\t\t\t\t\t\t4/19</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Instructions for Use

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SERNIVO™ (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05%

{ "type": "p", "children": [], "text": "\nSERNIVO™ (ser-ne-vo) \n\t\t\t\t\t\t\t(betamethasone dipropionate) \n\t\t\t\t\t\t\tSpray, 0.05%\n" }

Important: SERNIVO Spray is for use on the skin only. Do not get SERNIVO Spray near or in your eyes, mouth, or vagina.

{ "type": "p", "children": [], "text": "\nImportant: SERNIVO Spray is for use on the skin only. Do not get SERNIVO Spray near or in your eyes, mouth, or vagina." }

Read this “Instructions for Use” before you start using SERNIVO Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

{ "type": "p", "children": [], "text": "\nRead this “Instructions for Use” before you start using SERNIVO Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment." }

Parts of the SERNIVO Spray bottle. (See Figure A)

{ "type": "p", "children": [], "text": "\nParts of the SERNIVO Spray bottle. (See Figure A)\n" }

Figure A

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

How to apply SERNIVO Spray:

{ "type": "p", "children": [], "text": "\nHow to apply SERNIVO Spray: \n" }

Step 1: Shake the SERNIVO Spray bottle well. Remove the cap from the pump top.

{ "type": "p", "children": [], "text": "\nStep 1: Shake the SERNIVO Spray bottle well. Remove the cap from the pump top. " }

Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply SERNIVO Spray to the affected area as instructed by your doctor. (See Figure B)

{ "type": "p", "children": [], "text": "\nStep 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply SERNIVO Spray to the affected area as instructed by your doctor. (See Figure B)\n" }

Figure B

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

Step 3: Spray only enough SERNIVO Spray to cover the affected area, for example, the elbow (See Figure C). Rub in SERNIVO Spray gently.

{ "type": "p", "children": [], "text": "\nStep 3: Spray only enough SERNIVO Spray to cover the affected area, for example, the elbow (See Figure C). Rub in SERNIVO Spray gently. " }

Figure C

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

Repeat Steps 2 and 3 to apply SERNIVO Spray to other affected areas as instructed by your doctor.

{ "type": "p", "children": [], "text": "Repeat Steps 2 and 3 to apply SERNIVO Spray to other affected areas as instructed by your doctor." }

Step 4: After applying SERNIVO Spray, place the cap back onto the pump top. (See Figure D)

{ "type": "p", "children": [], "text": "\nStep 4: After applying SERNIVO Spray, place the cap back onto the pump top. (See Figure D)\n" }

Figure D

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

How should I store SERNIVO Spray?

{ "type": "p", "children": [], "text": "\nHow should I store SERNIVO Spray?\n" }

{ "type": "ul", "children": [ "Store SERNIVO Spray at room temperature between 68°F to 77°FF (20°FC to 25°C).", "Throw away (discard) any unused SERNIVO Spray after 28 days." ], "text": "" }

Keep SERNIVO Spray and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep SERNIVO Spray and all medicines out of the reach of children.\n" }

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

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

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Encore Dermatology, Inc., Scottsdale AZ 85254

{ "type": "p", "children": [], "text": "Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215\n\t\t\t\t\t\t\tDistributed by: Encore Dermatology, Inc., Scottsdale AZ 85254" }

SERNIVO is a registered trademark of Encore Dermatology, Inc

{ "type": "p", "children": [], "text": "SERNIVO is a registered trademark of Encore Dermatology, Inc " }

Issued: 02/2016 Revised: 04/2019 SER1289 4/19

{ "type": "p", "children": [], "text": "Issued: 02/2016\n\t\t\t\t\t\t\tRevised: 04/2019\n\t\t\t\t\t\t\tSER1289\n\t\t\t\t\t\t\t4/19" }

NDC 68040-714-28

{ "type": "p", "children": [], "text": "NDC 68040-714-28" }

120 mL

{ "type": "p", "children": [], "text": "120 mL" }

Rx Only

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

Sernivo®

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

(betamethasone dipropionate) Spray, 0.05%

{ "type": "p", "children": [], "text": "\n(betamethasone dipropionate) Spray, 0.05%\n" }

Potency expressed as betamethasone

{ "type": "p", "children": [], "text": "Potency expressed as betamethasone" }

For Topical Use Only

{ "type": "p", "children": [], "text": "\nFor Topical Use Only\n" }

Not for oral, ophthalmic or intravaginal use

{ "type": "p", "children": [], "text": "Not for oral, ophthalmic or intravaginal use" }

NDC 68040-714-28

{ "type": "p", "children": [], "text": "NDC 68040-714-28" }

120 mL

{ "type": "p", "children": [], "text": "120 mL" }

Rx Only

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

Sernivo®

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

(betamethasone dipropionate) Spray, 0.05%

{ "type": "p", "children": [], "text": "\n(betamethasone dipropionate) Spray, 0.05%\n" }

Potency expressed as betamethasone

{ "type": "p", "children": [], "text": "Potency expressed as betamethasone" }

For Topical Use Only

{ "type": "p", "children": [], "text": "\nFor Topical Use Only\n" }

Not for oral, ophthalmic or intravaginal use

{ "type": "p", "children": [], "text": "Not for oral, ophthalmic or intravaginal use" }

NDC 68040-714-08

{ "type": "p", "children": [], "text": "NDC 68040-714-08" }

Sample - Not for individual sale

{ "type": "p", "children": [], "text": "Sample - Not for individual sale" }

10 mL

{ "type": "p", "children": [], "text": "10 mL" }

Rx Only

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

Sernivo®

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

(betamethasone dipropionate) Spray, 0.05%

{ "type": "p", "children": [], "text": "\n(betamethasone dipropionate) Spray, 0.05%\n" }

Potency expressed as betamethasone

{ "type": "p", "children": [], "text": "Potency expressed as betamethasone" }

For Topical Use Only

{ "type": "p", "children": [], "text": "\nFor Topical Use Only\n" }

Not for oral, ophthalmic or intravaginal use

{ "type": "p", "children": [], "text": "Not for oral, ophthalmic or intravaginal use" }

NDC 68040-714-08

{ "type": "p", "children": [], "text": "NDC 68040-714-08" }

Sample - Not for individual sale

{ "type": "p", "children": [], "text": "Sample - Not for individual sale" }

10 mL

{ "type": "p", "children": [], "text": "10 mL" }

Rx Only

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

Sernivo®

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

(betamethasone dipropionate) Spray, 0.05%

{ "type": "p", "children": [], "text": "\n(betamethasone dipropionate) Spray, 0.05%\n" }

Potency expressed as betamethasone

{ "type": "p", "children": [], "text": "Potency expressed as betamethasone" }

For Topical Use Only

{ "type": "p", "children": [], "text": "\nFor Topical Use Only\n" }

Not for oral, ophthalmic or intravaginal use

{ "type": "p", "children": [], "text": "Not for oral, ophthalmic or intravaginal use" }

Betamethasone dipropionate ointment USP (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.

{ "type": "p", "children": [], "text": "\nBetamethasone dipropionate ointment USP (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older." }

Apply a thin film of betamethasone dipropionate ointment USP (augmented) to the affected skin areas once or twice daily.

{ "type": "p", "children": [], "text": "\nApply a thin film of betamethasone dipropionate ointment USP (augmented) to the affected skin areas once or twice daily." }

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate ointment USP (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate ointment USP (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see WARNINGS AND PRECAUTIONS (5.1)].

{ "type": "p", "children": [], "text": "Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate ointment USP (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate ointment USP (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see WARNINGS AND PRECAUTIONS (5.1)].\n" }

Betamethasone dipropionate ointment USP (augmented) should not be used with occlusive dressings unless directed by a physician.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate ointment USP (augmented) should not be used with occlusive dressings unless directed by a physician. " }

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

{ "type": "p", "children": [], "text": "Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site." }

Avoid contact with eyes. Wash hands after each application.

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

Betamethasone dipropionate ointment USP (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

{ "type": "p", "children": [], "text": "Betamethasone dipropionate ointment USP (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use." }

Ointment, 0.05%. Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white to off-white opaque ointment base.

{ "type": "p", "children": [], "text": "\nOintment, 0.05%. Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white to off-white opaque ointment base." }

Betamethasone dipropionate ointment (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

{ "type": "p", "children": [], "text": "\nBetamethasone dipropionate ointment (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation." }

Betamethasone dipropionate ointment (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of betamethasone dipropionate ointment (augmented) on the HPA axis, at 14 g per day, betamethasone dipropionate ointment (augmented) was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day, betamethasone dipropionate ointment (augmented) was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders.

With 6 g to 7 g of betamethasone dipropionate ointment (augmented) applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see USE IN SPECIFIC POPULATIONS (8.4)].

Use of topical corticosteroids, including betamethasone dipropionate ointment (augmented), may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate ointment (augmented) [see ADVERSE REACTIONS (6.2)].

Avoid contact of betamethasone dipropionate ointment (augmented) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

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

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

In controlled clinical trials, adverse reactions associated with the use of betamethasone dipropionate ointment (augmented) reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation.

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

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, striae, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

Risk Summary

There are no available data on betamethasone dipropionate ointment (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate ointment (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate ointment (augmented) (see Data).

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

Data

Animal Data

Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

Risk Summary

There are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate ointment (augmented) to women who are breastfeeding.

It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for betamethasone dipropionate ointment (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate ointment (augmented) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

Use of betamethasone dipropionate ointment (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see WARNINGS AND PRECAUTIONS (5.1)].

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, DIPROLENE AF® Cream 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of DIPROLENE AF® Cream, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of betamethasone dipropionate ointment (augmented) in the treatment of diaper dermatitis.

Clinical trials of betamethasone dipropionate ointment (augmented) included 225 subjects who were 65 years of age and over and 46 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Betamethasone dipropionate ointment USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

{ "type": "p", "children": [], "text": "\nBetamethasone dipropionate ointment USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone." }

Chemically, betamethasone    dipropionate   is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6 and the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, betamethasone    dipropionate   is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6 and the following structural formula:" }

It is a white to cream-white, odorless powder practically insoluble in water, freely soluble in acetone, in methylene chloride and in chloroform, sparingly soluble in ethanol (96%).

{ "type": "p", "children": [], "text": "\nIt is a white to cream-white, odorless powder practically insoluble in water, freely soluble in acetone, in methylene chloride and in chloroform, sparingly soluble in ethanol (96%). " }

Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white to off-white opaque ointment base of propylene glycol, propylene glycol monopalmitostearate, white petrolatum and white wax.

{ "type": "p", "children": [], "text": "Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white to off-white opaque ointment base of propylene glycol, propylene glycol monopalmitostearate, white petrolatum and white wax." }

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate ointment (augmented) in corticosteroid responsive dermatoses is unknown.

Vasoconstrictor Assay

Trials performed with betamethasone dipropionate ointment (augmented), 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

No pharmacokinetics trials have been conducted with betamethasone dipropionate ointment (augmented).

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see DOSAGE AND ADMINISTRATION (2)].

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the  in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

The safety and efficacy of betamethasone dipropionate ointment (augmented) for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis. A total of 378 subjects, of whom 152 received betamethasone dipropionate ointment (augmented), were included in these trials. These trials evaluated betamethasone dipropionate ointment (augmented) applied twice daily, for 14 days. Betamethasone dipropionate ointment (augmented) was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.

{ "type": "p", "children": [], "text": "\nThe safety and efficacy of betamethasone dipropionate ointment (augmented) for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis. A total of 378 subjects, of whom 152 received betamethasone dipropionate ointment (augmented), were included in these trials. These trials evaluated betamethasone dipropionate ointment (augmented) applied twice daily, for 14 days. Betamethasone dipropionate ointment (augmented) was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis." }

Betamethasone dipropionate ointment USP (augmented), 0.05% is a white to off-white opaque ointment supplied in 15-g (NDC 68180-947-01) and 50-g (NDC 68180-947-02) tubes.

{ "type": "p", "children": [], "text": "\nBetamethasone dipropionate ointment USP (augmented), 0.05% is a white to off-white opaque ointment supplied in 15-g (NDC 68180-947-01) and 50-g (NDC 68180-947-02) tubes." }

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

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

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

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

Inform patients of the following:

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

   •   Discontinue therapy when control is achieved, unless directed otherwise by the physician.

{ "type": "p", "children": [], "text": "   •   Discontinue therapy when control is achieved, unless directed otherwise by the physician." }

   •   Use no more than 50 grams per week of betamethasone dipropionate ointment (augmented) and no longer than 2 consecutive weeks.

{ "type": "p", "children": [], "text": "   •   Use no more than 50 grams per week of betamethasone dipropionate ointment (augmented) and no longer than 2 consecutive weeks." }

   •   Avoid contact with the eyes.

{ "type": "p", "children": [], "text": "   •   Avoid contact with the eyes." }

   •   Advise patients to report any visual symptoms to their healthcare providers.

{ "type": "p", "children": [], "text": "   •   Advise patients to report any visual symptoms to their healthcare providers." }

   •   Avoid use of betamethasone dipropionate ointment (augmented) on the face, underarms, or groin areas unless directed by the physician.

{ "type": "p", "children": [], "text": "   •   Avoid use of betamethasone dipropionate ointment (augmented) on the face, underarms, or groin areas unless directed by the physician." }

   •   Do not occlude the treatment area with bandage or other covering, unless directed by the physician.

{ "type": "p", "children": [], "text": "   •   Do not occlude the treatment area with bandage or other covering, unless directed by the physician." }

   •   Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.

{ "type": "p", "children": [], "text": "   •   Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids." }

   •   Advise a woman to use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid direct infant exposure.

{ "type": "p", "children": [], "text": "   •   Advise a woman to use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid direct infant exposure." }

LUPIN and the   are registered trademarks of Lupin Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "LUPIN and the   are registered trademarks of Lupin Pharmaceuticals, Inc." }

Manufactured for:

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

Lupin Pharmaceuticals, Inc.

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

Naples, FL 34108

{ "type": "p", "children": [], "text": "Naples, FL 34108 " }

United States

{ "type": "p", "children": [], "text": "United States" }

Manufactured by:

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

Lupin Limited

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

Pithampur (M.P.) - 454 775

{ "type": "p", "children": [], "text": "Pithampur (M.P.) - 454 775" }

India

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

December 2024                                                                                              

{ "type": "p", "children": [], "text": "December 2024                                                                                               " }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span></span> </caption> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold"> Patient Information</span> <br/> <span class="Bold"> Betamethasone Dipropionate Ointment (Augmented)</span> <br/> <span class="Bold"> (bay″ ta meth′ a sone dye proe′ pee oh nate)</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Important information: Betamethasone Dipropionate Ointment (Augmented) is for use on skin only.</span> Do not use betamethasone dipropionate ointment (augmented) in your eyes, mouth, or vagina.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What is Betamethasone Dipropionate Ointment (Augmented)?</span> <br/> Betamethasone dipropionate ointment (augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older.<br/>    •   Betamethasone dipropionate ointment (augmented) should not be used in children under 13 years of age.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Do not use Betamethasone Dipropionate Ointment (Augmented) if you</span> are allergic to betamethasone dipropionate or any of the ingredients in betamethasone dipropionate ointment (augmented). See the end of this leaflet for a complete list of ingredients in betamethasone dipropionate ointment (augmented).<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> Before using Betamethasone Dipropionate Ointment (Augmented), tell your healthcare provider about all of your medical conditions, including if you:</span> <br/>    •   have had irritation or other skin reaction to a steroid medicine in the past.<br/>    •   have thinning of the skin (atrophy) at the treatment site.<br/>    •   have diabetes.<br/>    •   have adrenal gland problems.<br/>    •   have liver problems.<br/>    •   have cataracts or glaucoma.<br/>    •   are pregnant or plan to become pregnant. It is not known if betamethasone dipropionate ointment (augmented) will harm your unborn baby. If you use betamethasone dipropionate ointment (augmented) during pregnancy, use betamethasone dipropionate ointment (augmented) on the smallest area of the skin and for the shortest time needed.<br/>    •   are breastfeeding or plan to breastfeed. It is not known if betamethasone dipropionate ointment (augmented) passes into your breast milk. Breastfeeding women should use betamethasone dipropionate ointment (augmented)  on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid contact with your baby.<br/> <br/> <span class="Bold"> Tell your healthcare provider about all the medicines you take</span> , including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/> <span class="Bold"> Especially</span> tell your healthcare provider if you take other corticosteroid medicines by mouth or injection or use other products on your skin or scalp that contain corticosteroids.<br/> Do not use other products containing a steroid medicine with betamethasone dipropionate ointment (augmented) without talking to your healthcare provider first.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> How should I use Betamethasone Dipropionate Ointment (Augmented)?</span> <br/>    •   Use betamethasone dipropionate ointment (augmented) exactly as your healthcare provider tells you to use it.<br/>    •   Apply a thin layer (film) of betamethasone dipropionate ointment (augmented) to the affected skin area 1 or 2 times each day. Do not use more than 50 grams of betamethasone dipropionate ointment (augmented) in 1 week.<br/>    •   Do not use betamethasone dipropionate ointment (augmented) for longer than 2 weeks in a row unless your healthcare provider tells you to.<br/>    •   Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with betamethasone dipropionate ointment (augmented).<br/>    •   Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.<br/>    •   Betamethasone dipropionate ointment (augmented) should not be used to treat diaper rash or redness.<br/>    •   Avoid using betamethasone dipropionate ointment (augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.<br/>    •   Wash your hands after applying betamethasone dipropionate ointment (augmented) unless you are using the medicine to treat your hands.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What are the possible side effects of Betamethasone Dipropionate Ointment (Augmented)?</span> <br/> <span class="Bold"> Betamethasone dipropionate ointment (augmented) may cause serious side effects, including:</span> <br/>    •   <span class="Bold"> Betamethasone dipropionate can pass through your skin.</span> Too much betamethasone dipropionate ointment (augmented) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.<br/>    •   <span class="Bold"> Cushing's syndrome,</span> a condition that happens when your body is exposed to too much of the hormone cortisol.<br/>    •   <span class="Bold"> High blood sugar</span> (hyperglycemia).<br/>    •   <span class="Bold"> Effects on growth and weight in children.</span> <br/>    •   <span class="Bold"> Vision problems.</span> Topical corticosteroids including betamethasone dipropionate ointment (augmented) may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems   during treatment with betamethasone dipropionate ointment (augmented).<br/>    •   <span class="Bold"> Skin problems.</span><span class="Bold"> Skin problems</span> including, allergic reactions (contact dermatitis) may happen during treatment with betamethasone dipropionate ointment (augmented). Stop using betamethasone dipropionate ointment (augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with betamethasone dipropionate ointment (augmented).<br/> Your healthcare provider may do certain blood tests to check for side effects.<br/> <span class="Bold"> The most common side effects of betamethasone dipropionate ointment (augmented)</span><span class="Bold"> include</span> redness of the skin, inflamed hair follicles, itching and blistering.<br/> These are not all of the possible side effects of betamethasone dipropionate ointment (augmented).<br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or contact Lupin Pharmaceuticals Inc. at 1-800-399-2561.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> How should I store Betamethasone Dipropionate Ointment (Augmented)?</span> <br/>    •   Store betamethasone dipropionate ointment (augmented) at room temperature between 68°F to 77°F (20°C to 25°C).<br/>    •   <span class="Bold"> Keep betamethasone dipropionate ointment (augmented) and all medicines out of the reach of children.</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> General information about the safe and effective use of Betamethasone Dipropionate Ointment (Augmented).</span> <br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use betamethasone dipropionate ointment (augmented) for a condition for which it was not prescribed. Do not give betamethasone dipropionate ointment (augmented) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about betamethasone dipropionate ointment (augmented) that is written for health professionals.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold"> What are the ingredients in Betamethasone Dipropionate Ointment (Augmented)?</span> <br/> <span class="Bold"> Active ingredient:</span> betamethasone dipropionate USP<br/> <span class="Bold"> Inactive ingredients:</span> propylene glycol, propylene glycol monopalmitostearate, white petrolatum and white wax <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Sup">®</span> The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. <br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<caption>\n<span></span>\n</caption>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Patient Information</span>\n<br/>\n<span class=\"Bold\"> Betamethasone Dipropionate Ointment (Augmented)</span>\n<br/>\n<span class=\"Bold\"> (bay″ ta meth′ a sone dye proe′ pee oh nate)</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Important information: Betamethasone Dipropionate Ointment (Augmented) is for use on skin only.</span> Do not use betamethasone dipropionate ointment (augmented) in your eyes, mouth, or vagina.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What is Betamethasone Dipropionate Ointment (Augmented)?</span>\n<br/> Betamethasone dipropionate ointment (augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older.<br/>    •   Betamethasone dipropionate ointment (augmented) should not be used in children under 13 years of age.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Do not use Betamethasone Dipropionate Ointment (Augmented) if you</span> are allergic to betamethasone dipropionate or any of the ingredients in betamethasone dipropionate ointment (augmented). See the end of this leaflet for a complete list of ingredients in betamethasone dipropionate ointment (augmented).<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> Before using Betamethasone Dipropionate Ointment (Augmented), tell your healthcare provider about all of your medical conditions, including if you:</span>\n<br/>    •   have had irritation or other skin reaction to a steroid medicine in the past.<br/>    •   have thinning of the skin (atrophy) at the treatment site.<br/>    •   have diabetes.<br/>    •   have adrenal gland problems.<br/>    •   have liver problems.<br/>    •   have cataracts or glaucoma.<br/>    •   are pregnant or plan to become pregnant. It is not known if betamethasone dipropionate ointment (augmented) will harm your unborn baby. If you use betamethasone dipropionate ointment (augmented) during pregnancy, use betamethasone dipropionate ointment (augmented) on the smallest area of the skin and for the shortest time needed.<br/>    •   are breastfeeding or plan to breastfeed. It is not known if betamethasone dipropionate ointment (augmented) passes into your breast milk. Breastfeeding women should use betamethasone dipropionate ointment (augmented)  on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid contact with your baby.<br/>\n<br/>\n<span class=\"Bold\"> Tell your healthcare provider about all the medicines you take</span> , including prescription and over-the-counter medicines, vitamins, and herbal supplements.<br/>\n<span class=\"Bold\"> Especially</span> tell your healthcare provider if you take other corticosteroid medicines by mouth or injection or use other products on your skin or scalp that contain corticosteroids.<br/> Do not use other products containing a steroid medicine with betamethasone dipropionate ointment (augmented) without talking to your healthcare provider first.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> How should I use Betamethasone Dipropionate Ointment (Augmented)?</span>\n<br/>    •   Use betamethasone dipropionate ointment (augmented) exactly as your healthcare provider tells you to use it.<br/>    •   Apply a thin layer (film) of betamethasone dipropionate ointment (augmented) to the affected skin area 1 or 2 times each day. Do not use more than 50 grams of betamethasone dipropionate ointment (augmented) in 1 week.<br/>    •   Do not use betamethasone dipropionate ointment (augmented) for longer than 2 weeks in a row unless your healthcare provider tells you to.<br/>    •   Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with betamethasone dipropionate ointment (augmented).<br/>    •   Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.<br/>    •   Betamethasone dipropionate ointment (augmented) should not be used to treat diaper rash or redness.<br/>    •   Avoid using betamethasone dipropionate ointment (augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site.<br/>    •   Wash your hands after applying betamethasone dipropionate ointment (augmented) unless you are using the medicine to treat your hands.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What are the possible side effects of Betamethasone Dipropionate Ointment (Augmented)?</span>\n<br/>\n<span class=\"Bold\"> Betamethasone dipropionate ointment (augmented) may cause serious side effects, including:</span>\n<br/>    •   <span class=\"Bold\"> Betamethasone dipropionate can pass through your skin.</span> Too much betamethasone dipropionate ointment (augmented) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.<br/>    •   <span class=\"Bold\"> Cushing's syndrome,</span> a condition that happens when your body is exposed to too much of the hormone cortisol.<br/>    •   <span class=\"Bold\"> High blood sugar</span> (hyperglycemia).<br/>    •   <span class=\"Bold\"> Effects on growth and weight in children.</span>\n<br/>    •   <span class=\"Bold\"> Vision problems.</span> Topical corticosteroids including betamethasone dipropionate ointment (augmented) may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems   during treatment with betamethasone dipropionate ointment (augmented).<br/>    •   <span class=\"Bold\"> Skin problems.</span><span class=\"Bold\"> Skin problems</span> including, allergic reactions (contact dermatitis) may happen during treatment with betamethasone dipropionate ointment (augmented). Stop using betamethasone dipropionate ointment (augmented) and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with betamethasone dipropionate ointment (augmented).<br/> Your healthcare provider may do certain blood tests to check for side effects.<br/>\n<span class=\"Bold\"> The most common side effects of betamethasone dipropionate ointment (augmented)</span><span class=\"Bold\"> include</span> redness of the skin, inflamed hair follicles, itching and blistering.<br/> These are not all of the possible side effects of betamethasone dipropionate ointment (augmented).<br/> Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or contact Lupin Pharmaceuticals Inc. at 1-800-399-2561.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> How should I store Betamethasone Dipropionate Ointment (Augmented)?</span>\n<br/>    •   Store betamethasone dipropionate ointment (augmented) at room temperature between 68°F to 77°F (20°C to 25°C).<br/>    •   <span class=\"Bold\"> Keep betamethasone dipropionate ointment (augmented) and all medicines out of the reach of children.</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> General information about the safe and effective use of Betamethasone Dipropionate Ointment (Augmented).</span>\n<br/> Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use betamethasone dipropionate ointment (augmented) for a condition for which it was not prescribed. Do not give betamethasone dipropionate ointment (augmented) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about betamethasone dipropionate ointment (augmented) that is written for health professionals.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Bold\"> What are the ingredients in Betamethasone Dipropionate Ointment (Augmented)?</span>\n<br/>\n<span class=\"Bold\"> Active ingredient:</span> betamethasone dipropionate USP<br/>\n<span class=\"Bold\"> Inactive ingredients:</span> propylene glycol, propylene glycol monopalmitostearate, white petrolatum and white wax <br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"><span class=\"Sup\">®</span> The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. <br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

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

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LUPIN and the  are registered trademarks of Lupin Pharmaceuticals, Inc.

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Manufactured for:

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Lupin Pharmaceuticals, Inc.

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Naples, FL 34108

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United States

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Manufactured by:

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Lupin Limited

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Pithampur (M.P.) - 454 775

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India

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December 2024                                                                                               ID#: 278390

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PRINCIPAL DISPLAY PANEL - 50 g Carton

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NDC 68180-947-02

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Betamethasone Dipropionate Ointment USP (Augmented*), 0.05%

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(*Strength expressed as betamethasone)

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For topical use only

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Not for oral, ophthalmic, or intravaginal use

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Rx only

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Keep out of reach of children.

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NET WT 50 g

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PRINCIPAL DISPLAY PANEL - 50 g Container (tube) label

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NDC 68180-947-02

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Betamethasone Dipropionate Ointment USP (Augmented*), 0.05%

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(*Strength expressed as betamethasone)

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For topical use only

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Not for oral, ophthalmic, or intravaginal use

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Rx only

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Keep out of reach of children.

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NET WT 50 g

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