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Drug Catalog - Product Detail

FLUOCINONIDE CREAM 0.1% 60GM

NDC Mfr Size Str Form
45802-0151-96 PADAGIS 60 0.1% CREAM
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Description
11 DESCRIPTION Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C 26 H 32 F 2 O 7 and it has a molecular weight of 494.52. It has the following chemical structure: Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fluocinonide Cream USP, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g (NDC 45802-151-94) 60 g (NDC 45802-151-96) 120 g (NDC 45802-151-53) Store at controlled room temperature: 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.
Indications & Usage
1 INDICATIONS AND USAGE Fluocinonide Cream USP, 0.1% 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. Limitation of Use: • Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. • Avoid use on the face, groin, or axillae. • Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [ see Use in Specific Populations (8.4) ]. 1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week. Fluocinonide Cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. For psoriasis, apply a thin layer of Fluocinonide Cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment. For atopic dermatitis, apply a thin layer of Fluocinonide Cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [ see Clinical Studies (14) ]. For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream USP, 0.1% once or twice daily to the affected areas as directed by a physician. For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. Psoriasis: apply a thin layer once or twice daily to the affected skin areas. Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas.