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VANOS (fluocinonide) Cream, 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].
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 VANOS Cream 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.
DOSAGE AND ADMINISTRATION
For topical use only. VANOS Cream is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of VANOS Cream 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 VANOS Cream 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].
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of VANOS Cream once or twice daily to the affected areas as directed by a physician.
Dosage Forms and Strengths
Each gram of VANOS Cream contains 1 mg of fluocinonide in a white to off-white cream base.
VANOS Cream is white to off-white in color and is supplied in tubes as follows:
30 g (NDC 99207-525-30)
60 g (NDC 99207-525-60)
120 g (NDC 99207-525-10)
Store at controlled room temperature: 15° to 30°C (59° to 86°F). Keep the tube tightly closed.
Manufactured for: Medicis, The Dermatology Company, Scottsdale, AZ 85256. Manufactured by: Contract Pharmaceuticals Ltd. Mississauga, Ontario Canada L5N 6L6 Product of Italy. Revised: 03/2012.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2012
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