Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
clobetasol propionate (UNII: 779619577M) (clobetasol - UNII:ADN79D536H)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
clobetasol propionate
clobetasol propionate 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for: Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-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, 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, 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 adequate and well-controlled
How Supplied Clobetasol Propionate Cream USP, 0.05% (emollient), is a white to off-white cream, supplied as follows: NDC 0168-0301-15 15 g tube NDC 0168-0301-30 30 g tube NDC 0168-0301-60 60 g tube Storage and Handling Store between 15°C and 30°C (59°F and 86°F) Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.
Abbreviated New Drug Application
CLOBETASOL PROPIONATE (EMOLLIENT)- CLOBETASOL PROPIONATE CREAM E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT), FOR TOPICAL USE INITIAL U.S. APPROVAL: 1994 INDICATIONS AND USAGE Clobetasol propionate cream, 0.05% (emollient) is a corticosteroid indicated for: • • Limitations of Use • • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Cream: 0.05% (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS • 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) Clobetasol propionate cream, 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) Apply a thin layer of Clobetasol propionate cream, 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, 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) Clobetasol propionate is a highly potent topical corticosteroid that ha Pročitajte cijeli dokument