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| Product NDC Code | 68462-625 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Clobetasol propionate |
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| Type | Generic | ||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | AEROSOL, FOAM | ||||||
| RxCUI drug identifier | 1992273 | ||||||
| Application Number | ANDA211450 | ||||||
| Labeler Name | Glenmark Pharmaceuticals Inc., USA | ||||||
| Packages |
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Overdosage of clobetasol propionate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Topically applied clobetasol propionate emulsion foam can be absorbed in sufficient amounts to produce systemic effects.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Effects on Endocrine System [see Warnings and Precautions (5.1) ] • Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] • The most common adverse reactions (incidence ≥1%) are application site atrophy and application site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 821 subjects exposed to clobetasol propionate emulsion foam and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with clobetasol propionate emulsion foam was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender. 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness. The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate. Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. Ophthalmic adverse reactions may include cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown. 12.2 Pharmacodynamics In a trial evaluating the potential for HPA axis suppression using the cosyntropin stimulation test, clobetasol propionate emulsion foam demonstrated reversible adrenal suppression after two weeks of twice-daily use in subjects with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects aged 12 years and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this trial HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30 minutes post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4)]. 12.3 Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile. Following twice-daily application of clobetasol propionate emulsion foam for one week to 32 adult subjects with mild to moderate plaque-type psoriasis, mean peak plasma concentrations (±SD) of 59 ± 36 pg/mL of clobetasol were observed at around 5 hours post dose on Day 8.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics In a trial evaluating the potential for HPA axis suppression using the cosyntropin stimulation test, clobetasol propionate emulsion foam demonstrated reversible adrenal suppression after two weeks of twice-daily use in subjects with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects aged 12 years and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this trial HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30 minutes post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4)].
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile. Following twice-daily application of clobetasol propionate emulsion foam for one week to 32 adult subjects with mild to moderate plaque-type psoriasis, mean peak plasma concentrations (±SD) of 59 ± 36 pg/mL of clobetasol were observed at around 5 hours post dose on Day 8.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. None. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Clobetasol Propionate Emulsion Foam, 0.05% is a white to off-white emulsion aerosol foam containing the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25 H 32 ClFO 5 , and a molecular weight of 467 g/mol. The following is the chemical structure: Clobetasol Propionate, USP Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Emulsion Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl-20 cetostearyl ether, potassium citrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative. Clobetasol Propionate Emulsion Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant. structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION • Apply a thin layer of clobetasol propionate emulsion foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. • The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. • For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. • Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. • Clobetasol propionate emulsion foam is not for oral, ophthalmic, or intravaginal use. • Avoid contact with the eyes. • Avoid use on face, axillae, and groin, or if skin atrophy is present at the treatment site. • Wash hands after each application. Clobetasol propionate emulsion foam is not for oral, ophthalmic, or intravaginal use. ( 2 ) • Apply clobetasol propionate emulsion foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks. The maximum weekly dose should not exceed 50 g. ( 2 ) • Avoid use on face, axilla, and groin, or if skin atrophy is present at the treatment site. ( 2 )
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Clobetasol Propionate Emulsion Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram in a white to off-white emulsion aerosol foam. Foam, 0.05%. ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Clobetasol propionate emulsion foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. Clobetasol propionate emulsion foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.clobetasol propionate clobetasol propionate CLOBETASOL PROPIONATE CLOBETASOL ANHYDROUS CITRIC ACID CETYL ALCOHOL CYCLOMETHICONE ISOPROPYL MYRISTATE LIGHT MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER POTASSIUM CITRATE PROPYLENE GLYCOL WATER SORBITAN MONOLAURATE PETROLATUM PHENOXYETHANOL PROPANE BUTANE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate emulsion foam or clobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate emulsion foam at dose concentrations from 0.001% to 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol propionate resulted in a toxicity profile consistent with long term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression and opportunistic fungal and bacterial infections. A no observable adverse effect level 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 for carcinogenesis. Clobetasol propionate was non-mutagenic in the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. In the in vivo mouse micronucleus test, a positive finding was observed at 24 hours, but not at 48 hours, following oral administration at a dose of 2,000 mg/kg. Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate emulsion foam or clobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate emulsion foam at dose concentrations from 0.001% to 0.1% or from 0.03 to 0.3 mg/kg/day of clobetasol propionate resulted in a toxicity profile consistent with long term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression and opportunistic fungal and bacterial infections. A no observable adverse effect level 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 for carcinogenesis. Clobetasol propionate was non-mutagenic in the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. In the in vivo mouse micronucleus test, a positive finding was observed at 24 hours, but not at 48 hours, following oral administration at a dose of 2,000 mg/kg. Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Display Panel CTN.jpg
clobetasol propionate: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information) Effects on Endocrine System Clobetasol propionate emulsion foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including clobetasol propionate emulsion foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using clobetasol propionate emulsion foam if surgery is contemplated [see Warnings and Precautions (5.1) ]. Ophthalmic Adverse Reactions Advise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.3) ] . Local Adverse Reactions Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use [see Warnings and Precautions (5.2) ] . Pregnancy Advise a pregnant woman that use of clobetasol propionate emulsion foam may cause fetal harm and to use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1) ]. Lactation Advise a woman to use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate emulsion foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ]. Important Administration Instructions Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician. It is for external use only. Unless directed by the prescriber, it should not be used on the face or in skin-fold areas, such as the underarms or groin. Avoid contact with the eyes or other mucous membranes. Wash hands after use. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Do not use for more than 50 grams per week of clobetasol propionate emulsion foam, or an amount greater than 21 capfuls per week [see Dosage and Administration ( 2 )] . • This medication is flammable; avoid heat, flame, or smoking when applying this product. For additional information, call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115. Manufactured by: Glenmark Pharmaceuticals Limited Aurangabad, Maharashtra 431154, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com January 2022 Logo.jpg
Instructions for use
Information about safe handling and use of the drug product.INSTRUCTIONS FOR USE Clobetasol Propionate (kloe bay’ ta sol proe’ pee oh nate) Foam Important information: Clobetasol propionate emulsion foam is for use on the skin only. Do not get clobetasol propionate emulsion foam in your eyes, mouth, or vagina; if contact happens, rinse well with water. How to apply clobetasol propionate emulsion foam Figure A Step 1 : Before applying clobetasol propionate emulsion foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle. (See Figure A). Figure B Step 2 : Shake the can of clobetasol propionate emulsion foam before use. (See Figure B). Figure C Step 3 : Turn the can of clobetasol propionate emulsion foam upside down and press the nozzle. See Figure C. Figure D Step 4 : Press down on the actuator to dispense a small amount of clobetasol propionate emulsion foam into the palm of your hand. (See Figure D). Figure E Step 5 : Apply a thin layer of clobetasol propionate emulsion foam to cover the affected area. Gently rub the foam into the affected area until the foam disappears. (See Figure E). Step 6 : Wash your hands after applying clobetasol propionate emulsion foam. • Throw away any of the unused medicine that you dispensed out of the can. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Glenmark Pharmaceuticals Limited Aurangabad, Maharashtra 431154, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com January 2022 figureA figureB figureC figureD figureE Logo.jpg
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.PATIENT INFORMATION Clobetasol Propionate (kloe bay’ ta sol proe’ pee oh nate) Foam Important: For skin use only. Do not get clobetasol propionate emulsion foam in your eyes, mouth, or vagina. What is clobetasol propionate emulsion foam? Clobetasol propionate emulsion foam is a prescription corticosteroid medicine used on the skin (topical) to treat people 12 years of age and older with certain skin conditions that cause red, flaky, and itchy skin. Clobetasol propionate emulsion foam is not recommended for use in children under 12 years of age. Clobetasol propionate emulsion foam should not be used: • on your face, underarms, or groin area • if you have skin thinning (atrophy) at the treatment area You should not use clobetasol propionate emulsion foam for longer than 2 weeks in a row. You should not use more than 50 grams or 21 capfuls of clobetasol propionate emulsion foam in 1 week. Before using clobetasol propionate emulsion foam, tell your healthcare provider about all of your medical conditions, including if you: • have had irritation or other skin reaction to a steroid medicine in the past. • have a skin infection. You may need medicine to treat the skin infection before using clobetasol propionate emulsion foam. • have diabetes. • have adrenal gland problems. • have liver problems. • plan to have surgery. • are pregnant or plan to become pregnant. It is not known if clobetasol propionate emulsion foam will harm your unborn baby. If you use clobetasol propionate emulsion foam during pregnancy, use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest time needed. • are breastfeeding or plan to breastfeed. It is not known if clobetasol propionate passes into your breast milk. If you use clobetasol propionate emulsion foam while breastfeeding, use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest time needed. Do not apply clobetasol propionate emulsion foam directly to the nipple and areola to avoid getting clobetasol propionate emulsion foam into your baby’s mouth. Tell your healthcare provider about all the medicine you take including prescription and over-the‑counter medicines, vitamins, and herbal supplements. Do not use other products containing a corticosteroid medicine during treatment with clobetasol propionate emulsion foam without talking to your healthcare provider first. How should I use clobetasol propionate emulsion foam? See the“Instructions for Use” for detailed information about the right way to apply clobetasol propionate emulsion foam . • Use clobetasol propionate emulsion foam exactly as your healthcare provider tells you to use it. • Apply a thin layer of clobetasol propionate emulsion foam to the affected area 2 times each day, 1 time in the morning and 1 time at night, or as directed by your healthcare provider. • Do not bandage, wrap or cover your treated area unless your healthcare provider tells you to. • Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with clobetasol propionate emulsion foam. • Wash your hands after using clobetasol propionate emulsion foam. What should I avoid while using clobetasol propionate emulsion foam? Clobetasol propionate emulsion foam is flammable . Avoid heat, flame, or smoking during and right after you apply clobetasol propionate emulsion foam to your skin. What are the possible side effects of clobetasol propionate emulsion foam? Clobetasol propionate emulsion foam may cause serious side effects, including: • Clobetasol propionate emulsion foam can pass through your skin. Too much clobetasol propionate emulsion foam passing through your skin can cause adrenal glands to stop working. • Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol. • High blood sugar (hyperglycemia) • Vision problems. Clobetasol propionate emulsion foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during your treatment with clobetasol propionate emulsion foam. • Skin reactions at the treated site. Tell your healthcare provider if you get any skin reactions or skin infections. • Effects on growth and weight in children. Your healthcare provider may do certain blood tests to check for side effects. The most common side effects of clobetasol propionate emulsion foam include: • thinning of skin • itching • burning • dryness • redness These are not all the side effects of clobetasol propionate emulsion foam. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store clobetasol propionate emulsion foam? • Store clobetasol propionate emulsion foam at room temperature between 68°F to 77°F (20°C to 25°C). • Do not break through (puncture) clobetasol propionate emulsion foam can. • Never throw the can into a fire, even if the can is empty. • Do not store clobetasol propionate emulsion foam near heat or at temperatures above 120°F (49°C). Keep clobetasol propionate emulsion foam and all medicines out of the reach of children . General information about the safe and effective use of clobetasol propionate emulsion foam Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clobetasol propionate emulsion foam for a condition for which it was not prescribed. Do not give clobetasol propionate emulsion foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about clobetasol propionate emulsion foam that is written for health professionals. What are the ingredients in clobetasol propionate emulsion foam? Active ingredient : clobetasol propionate Inactive ingredients : anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl-20 cetostearyl ether, potassium citrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative; pressurized with a hydrocarbon (propane/butane) propellant. Manufactured by: Glenmark Pharmaceuticals Limited Aurangabad, Maharashtra 431154, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com January 2022 This Patient Information has been approved by the U.S. Food and Drug Administration. Logo.jpg
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES In a randomized trial of subjects 12 years and older with moderate to severe atopic dermatitis, 251 subjects were treated with clobetasol propionate emulsion foam and 126 subjects were treated with vehicle foam. Subjects were treated twice daily for 2 weeks. At the end of treatment, 131 of 251 subjects (52%) treated with clobetasol propionate emulsion foam compared with 18 of 126 subjects (14%) treated with vehicle foam achieved treatment success. Treatment success was defined by an Investigator’s Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, and scores of absent or minimal (0 or 1) for erythema and induration/papulation. In an additional randomized trial of subjects 12 years and older with mild to moderate plaque-type psoriasis, 253 subjects were treated with clobetasol propionate emulsion foam and 123 subjects were treated with vehicle foam. Subjects were treated twice daily for 2 weeks. At the end of treatment, 41 of 253 subjects (16%) treated with clobetasol propionate emulsion foam compared with 5 of 123 subjects (4%) treated with vehicle foam achieved treatment success. Treatment success was defined by an ISGA score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, scores of none or faint/minimal (0 or 1) for erythema and scaling, and a score of none (0) for plaque thickness.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use A limited number of subjects aged 65 years or older have been treated with clobetasol propionate emulsion foam (n = 58) in U.S. clinical trials. While the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger subjects. Based on available data, no adjustment of dosage of clobetasol propionate emulsion foam in geriatric patients is warranted.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Use in pediatric patients younger than 12 years is not recommended because of the risk of HPA axis suppression. After two weeks of twice-daily treatment with clobetasol propionate emulsion foam, 7 of 15 subjects (47%) aged 6 to 11 years demonstrated HPA axis suppression. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post-treatment. In 92 subjects aged 12 to 17 years, safety was similar to that observed in the adult population. Based on these data, no adjustment of dosage of clobetasol propionate emulsion foam in adolescent patients aged 12 to 17 years is warranted [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 HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles (in infants), headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary There are no available data on clobetasol propionate emulsion foam use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible ( see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants (adjusted RR, 7.74 [95% CI, 1.49 to 40.11]). In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12 to 170 g]) over long periods of time. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on clobetasol propionate emulsion foam use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible ( see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was computed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants (adjusted RR, 7.74 [95% CI, 1.49 to 40.11]). In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12 to 170 g]) over long periods of time. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities. 8.2 Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate 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 clobetasol propionate emulsion foam and any potential adverse effects on the breastfed infant from clobetasol propionate emulsion foam or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use clobetasol propionate emulsion foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate emulsion foam directly to the nipple and areola to avoid direct infant exposure. 8.4 Pediatric Use Use in pediatric patients younger than 12 years is not recommended because of the risk of HPA axis suppression. After two weeks of twice-daily treatment with clobetasol propionate emulsion foam, 7 of 15 subjects (47%) aged 6 to 11 years demonstrated HPA axis suppression. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post-treatment. In 92 subjects aged 12 to 17 years, safety was similar to that observed in the adult population. Based on these data, no adjustment of dosage of clobetasol propionate emulsion foam in adolescent patients aged 12 to 17 years is warranted [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 HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles (in infants), headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children. 8.5 Geriatric Use A limited number of subjects aged 65 years or older have been treated with clobetasol propionate emulsion foam (n = 58) in U.S. clinical trials. While the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger subjects. Based on available data, no adjustment of dosage of clobetasol propionate emulsion foam in geriatric patients is warranted.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clobetasol Propionate Emulsion Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white to off-white emulsion aerosol foam is available as follows • 50 g aluminum can NDC 68462-625-27 • 100 g aluminum can NDC 68462-625-94 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API