"(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"...
DOSAGE AND ADMINISTRATION
Apply a thin film of DIPROLENE Ointment to the affected skin areas once or twice daily.
Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DIPROLENE Ointment is a super-high-potency topical corticosteroid. Treatment with DIPROLENE Ointment should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
DIPROLENE Ointment should not be used with occlusive dressings unless directed by a physician.
DIPROLENE Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Dosage Forms And Strengths
Ointment, 0.05%. Each gram of DIPROLENE Ointment, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base.
Storage And Handling
DIPROLENE Ointment 0.05% is a white ointment supplied in 15-g (NDC 0085-0575-02) and 50-g (NDC 0085-0575-05) tubes.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Manufactured for : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Schering Plough Canada, Inc. Pointe Claire, Quebec H9R 1B4, Canada. Revised: Aug 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/27/2014
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