"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
Olux-E (clobetasol propionate foam) Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
Limitations of Use
- Olux-E (clobetasol propionate foam) Foam should not be applied to the face, axillae, or groin.
- Olux-E (clobetasol propionate foam) Foam should not be used if there is skin atrophy at the treatment site.
- Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.
DOSAGE AND ADMINISTRATION
Olux-E (clobetasol propionate foam) Foam is not for oral, ophthalmic, or intravaginal use.
Apply a thin layer of Olux-E (clobetasol propionate foam) Foam to the affected area(s) twice daily, morning and evening for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g. or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.
Dosage Forms And Strengths
White emulsion aerosol foam, 0.05%
Olux-E (clobetasol propionate) Foam, 0.05% is supplied as follows:
- 50 g aluminum can NDC 63032-101-50
- 100 g aluminum can NDC 63032-101-00
Storage and Handling
Store at controlled room temperature 68°F to 77°F (20°C to 25°C).
FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
Keep out of reach of children.
Manufactured for Stiefel Laboratories, Inc. Coral Gables , FL 33134. Revised 11/2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/16/2010
Additional Olux-E Information
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