ABOUT

 

OLUX® (clobetasol propionate) Foam, 0.05% is a super-potent corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic symptoms of moderate to severe corticosteroid-responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis on non-scalp regions excluding the face and intertriginous areas.

 

The foam is applied for no more than 2 consecutive weeks; patients should use no more than 50 grams per week.

 

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 grams 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 therapy.

 

 


IMPORTANT SAFETY INFORMATION


Full Prescribing Information


  • OLUX® (clobetasol propionate) Foam, 0.05% is for topical use only. Avoid contact with eyes.

  • OLUX Foam is a super-potent topical corticosteroid that has been shown to suppress the adrenals at 7.0 g of OLUX Foam per day. Lesser amounts of OLUX Foam were not studied.

  • Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Evaluate patients periodically for evidence of HPA axis suppression.

  • Cushing's Syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. Use of OLUX Foam for longer than 2 weeks may suppress the immune system.

  • Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Use in children under 12 years of age is not recommended.

  • OLUX Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

  • Caution should be exercised when OLUX Foam is administered to a nursing woman.

  • In clinical trials, the most common adverse events associated with the use of OLUX Foam were burning, dryness, and other reactions at the application site.

  • The propellant in this foam is flammable; patients should avoid fire, flame, and/or smoking during and immediately following application.








OLUX Foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.