"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
OLUX (clobetasol propionate) Foam is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of OLUX Foam therapy (See ADVERSE REACTIONS). Use in children under 12 years of age is not recommended.
DOSAGE AND ADMINISTRATION
Note: For proper dispensing of foam, hold the can upside down and depress the actuator.
OLUX (clobetasol propionate) Foam should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of OLUX (clobetasol propionate) Foam (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying OLUX (clobetasol propionate) Foam to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.
Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.
OLUX (clobetasol propionate) Foam is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended. Unless directed by a physician, OLUX (clobetasol propionate) Foam should not be used with occlusive dressings.
Instructions for applying OLUX (clobetasol propionate) Foam
Apply OLUX (clobetasol propionate) Foam twice a day, once in the morning and once at night. Apply only enough to cover the affected areas. OLUX (clobetasol propionate) Foam should not be applied to the groin, armpits, or other skin fold areas.
To use OLUX (clobetasol propionate) Foam:
Before applying OLUX (clobetasol propionate) Foam for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.
Turn the can upside down.
Push the button to squirt a small amount of OLUX (clobetasol propionate) Foam into the cap of the can, onto a saucer or other cool surface, or your affected skin area. This amount should be no more than 1 ½ capfuls, about the size of a golf ball.
Do not squirt OLUX (clobetasol propionate) Foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin. If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)
If the can seems warm or the foam seems runny, run the can under cold water.
Using your fingertips, gently massage OLUX (clobetasol propionate) Foam into the affected areas until the foam disappears.
If you are treating areas with hair such as the scalp, move any hair away so that the foam can be applied directly to the affected areas.
Repeat the process until the affected areas are treated.
Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your doctor right away.
Wash your hands after applying OLUX (clobetasol propionate) Foam. Throw away any of the unused medicine that you squirted out of the can.
OLUX (clobetasol propionate) Foam is supplied in 100 g (NDC 63032-031-00) and 50 g (NDC 63032- 031-50) aluminum cans.
Store at controlled room temperature 68-77°F (20-25°C).
FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).
Manufactured for : Connetics Corporation, Palo Alto, CA 94304, USA. For additional information: 1-888-500-DERM or visit, www.olux (clobetasol propionate) .com. VersaFoam-HF is a trademark, and the V logo, the interlocking C design, OLUX (clobetasol propionate) and Connetics are registered trademarks, of Connetics Corporation. January 2006. FDA revision date: 7/11/2006This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/23/2008
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