Prescription Drugs

CLINICAL PHARMACOLOGY The exact method of action of benzoyl peroxide In acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

Brevoxyl-4 Gel (benzoyl peroxide 4%) Brevoxyl-8 Gel (benzoyl peroxide 8%) AQUEOUS BASE ACNE GEL FOR TOPICAL USE DESCRIPTION Brevoxyl-4 Gel (benzoyl peroxide gel) and Brevoxyl-8 Gel are topical preparations containing benzoyl peroxide 4% and 8%, respectively, as the active Ingredient In a gel vehicle containing purified water, cetyl alcohol, dimethyl Isosorblde, fragrance, simethicone, stearyl alcohol and ceteareth-20. The structural formula of benzoyl peroxide is:

INDICATIONS Brevoxyl-4 Gel (benzoyl peroxide gel) and Brevoxyl-8 Gel are indicated for use in the topical treatment of mild to moderate acne vulgaris. Brevoxyl-4 Gel (benzoyl peroxide gel) or Brevoxyl-8 Gel may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations. DOSAGE AND ADMINISTRATION Therapy may be initiated with either Brevoxyl-4 Gel (benzoyl peroxide gel) or Brevoxyl-8 Gel. The medication should be applied once or twice daily to the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas prior to application of Brevoxyl-4 Gel (benzoyl peroxide gel) or Brevoxyl-8 Gel may be beneficial. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response. HOW SUPPLIED Brevoxyl®-4 Gel is supplied in 42.5 g (1.5 oz) tubes NDC 0145-2374-06. Brevoxyl®-8 Gel is supplied in 42.5 g (1.5 oz) tubes NDC 0145-2384-06. Store at controlled room temperature 15°-30°C (59°- 86°F). Stiefel Laboratories, Inc. Coral Gables, FL 33134. Rev. 1007

PATIENT INFORMATION No information provided. Please refer to the PRECAUTIONS section.

OVERDOSE No information provided. CONTRAINDICATIONS Brevoxyl-4 Gel (benzoyl peroxide gel) and Brevoxyl-8 Gel should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

SIDE EFFECTS Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use. DRUG INTERACTIONS No information provided.

WARNINGS No information provided. PRECAUTIONS General - For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING. Carcinogenesis, Mutagenesis, Impairment of Fertility Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known. Pregnancy Category C - Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. Nursing Mothers It is not known whetherthis drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 12 have not been established.