Clobetasol Propionate Cream, 0.05%

Prescription

Nomes comerciais: Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05%

Forma Farmacêutica

Topical

Via de Administração

TOPICAL

Fabricante

Proficient Rx LP

About This Medication

DESCRIPTION: Clobetasol propionate cream USP contains the active compound clobetasol propionate, 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. Chemically, clobetasol propionate is (11β, 16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 ClFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream USP, 0.05% contains clobetasol propionate 0.5 mg/g in a cream base of propylene glycol, mono- and di-glycerides, cetostearyl alcohol, stearoyl macrogolglycerides, white wax, chlorocresol, sodium citrate, anhydrous citric acid, and purified water. structure.jpg

Princípios Ativos

Ingrediente	Concentração
Clobetasol Propionate	-

Indicações e Uso

INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Posologia e Administração

DOSAGE AND ADMINISTRATION: Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE). Clobetasol propionate cream is super- high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g / week should not be used . As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate cream should not be used with occlusive dressings. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Side Effects Overview

ADVERSE REACTIONS: In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindicações

CONTRAINDICATIONS: Clobetasol propionate cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Frequently Asked Questions

INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued …

DOSAGE AND ADMINISTRATION: Apply a thin layer of clobetasol propionate cream to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE). Clobetasol propionate cream is super- high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g / week should not be used . As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within …

CONTRAINDICATIONS: Clobetasol propionate cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Clobetasol Propionate Cream, 0.05% is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Clobetasol Propionate Cream, 0.05% drug label (National Library of Medicine)
• openFDA — Clobetasol Propionate Cream, 0.05% label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 861495 (NLM Normalized Drug Names)
• NDC Directory — Clobetasol Propionate Cream, 0.05% (FDA National Drug Code)

Aviso Médico

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Fontes de dados: DailyMed (NLM), openFDA, MFDS