Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)
McKesson Corporation
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate cream USP, 0.05% (emollient) is a super-high potency corticosteroid indicated for: Clobetasol propionate cream USP, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week. Clobetasol propionate cream USP, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended. Clobetasol propionate cream USP, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. The total dosage should not exceed 50 grams per week. Avoid use if skin atrophy is present at the treatment site. None Pregnancy Category C. There are no adeq
How Supplied Clobetasol Propionate Cream USP, 0.05% (emollient), is a white to off-white cream, supplied as follows: NDC 63739-064-65 15 grams tube NDC 63739-064-66 30 grams tube NDC 63739-064-68 60 grams tube Storage and Handling Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM MCKESSON CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOBETASOL PROPIONATE CREAM (EMOLLIENT) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL PROPIONATE CREAM (EMOLLIENT). CLOBETASOL PROPIONATE CREAM, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1994 INDICATIONS AND USAGE Clobetasol propionate cream USP, 0.05% (emollient) is a corticosteroid indicated for: The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1) The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2) Limitations of Use Clobetasol propionate cream USP, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. (1.3) The total dosage should not exceed 50 grams per week. (1.3) Avoid use if skin atrophy is present at the treatment site. (1.3) DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol propionate cream USP, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. (2) Treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used. (2) In moderate to severe plaque-type psoriasis, Clobetasol propionate cream USP, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefit of extending treatment should be weighed against the risk of HPA suppression. (2) DOSAGE FORMS AND STRENGTHS Cream: 0.05% (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis doses as low as 2 grams per day. (5.1) Cushing's syndrome, hyperglycemia, and glucosuria can also res Les hele dokumentet