Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clobetasol Propionate Cream, 0.025% is a white to off-white cream, supplied as follows: 100g aluminum tube NDC 74157-710-10 16.2 Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature] Do not freeze.; Product label image description image description
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clobetasol Propionate Cream, 0.025% is a white to off-white cream, supplied as follows: 100g aluminum tube NDC 74157-710-10 16.2 Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature] Do not freeze.
- Product label image description image description
Overview
Clobetasol propionate Cream, 0.025% for topical use contains clobetasol propionate, a synthetic and fluorinated corticosteroid. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β-hydroxy-16 β-methyl-3,20-dioxopregna-1,4-dien-17-yl propanoate, and it has the following structural formula. Clobetasol propionate has a molecular formula of C 25 H 32 CIFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder practically insoluble in water. Each gram of Clobetasol propionate Cream contains 0.25 mg clobetasol propionate. It is an oil-in-water emulsion intended for topical application and contains the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, cyclomethicone, diethylene glycol monoethyl ether, glyceryl stearate and PEG 100 stearate, isopropyl myristate, methyl paraben, propyl paraben. purified water and white wax. Chemical Structure
Indications & Usage
Clobetasol Propionate Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. (1)
Dosage & Administration
Apply a thin layer of Clobetasol Propionate Cream to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application. Use Clobetasol Propionate Cream for up to 2 consecutive weeks of treatment. (2) • Discontinue Clobetasol Propionate Cream when control is achieved. (2) • The total dosage should not exceed 50 g per week. (2) • Do not use if atrophy is present at the treatment site. (2) • Do not bandage, cover, or wrap the treated skin area unless directed by a physician. (2) • Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2) • Clobetasol Propionate Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. (2)
Warnings & Precautions
• Clobetasol propionate has been shown to suppress the HPA axis at the dose tested. (5.1) • Cushing’s syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. (5.1) • Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. (5.1) • Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (5.1, 8.4) • Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of higher potency corticosteroids, including clobetasol propionate. These reactions include: irritation, dryness, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. (5.1, 6.2) 5.1 Effects on the Endocrine System Clobetasol Propionate Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential for systemic absorption, use of topical corticosteroids, including Clobetasol Propionate Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient 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 Clobetasol Propionate Cream on the HPA axis, subjects with plaque psoriasis applied Clobetasol Propionate Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days. Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on Clobetasol Propionate Cream [see Clinical Pharmacology (12.2)]. In another trial to evaluate the effects of Clobetasol Propionate Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied Clobetasol Propionate Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on Clobetasol Propionate Cream. 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. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids. Minimize the unwanted risks from endocrine effects by mitigating 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 because of their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)]. 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Clobetasol Propionate Cream. Some local adverse reactions may be irreversible. 5.3 Concomitant Skin Infections Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Clobetasol Propionate Cream until the infection has been adequately treated. 5.4 Allergic Contact Dermatitis 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, discontinue the topical corticosteroid and institute appropriate therapy.
Contraindications
None. None ( 4 )
Adverse Reactions
The most common adverse reaction (incidence ≥ 1%) is application site discoloration. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact INA Pharmaceutics, Inc. at 1-866-835-0469 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 practice. Clobetasol Propionate Cream was evaluated in two randomized, multicenter, prospective, vehicle-controlled clinical trials in subjects with moderate to severe plaque psoriasis. Subjects applied Clobetasol Propionate Cream or vehicle cream twice daily for 14 days. A total of 354 subjects applied Clobetasol Propionate Cream and 178 subjects applied vehicle. The adverse reaction that occurred in at least 1% of subjects treated with Clobetasol Propionate Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with Clobetasol Propionate Cream were application site atrophy, telangiectasia and rash. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of clobetasol propionate: striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis and miliaria. 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.
Storage & Handling
16.2 Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature] Do not freeze.
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