"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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.
Last reviewed on RxList: 4/4/2012
This monograph has been modified to include the generic and brand name in many instances.
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