Clindamycin Phosphate and Benzoyl Peroxide

INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% and vehicle groups. Local Adverse Events - all causalities in >/= 1% of patients Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% n = 420 Vehicle n = 168 Application Site Reaction 13 (3%) 1 (< 1%) Dry Skin 50 (12%) 10 (6%) Pruritis 8 (2%) 1 (< 1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (< 1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

DESCRIPTION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, propylene glycol, potassium hydroxide, and purified water. Clindamycin Phosphate Structural Formula Benzoyl Peroxide Structural Formula

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS Size (Net Weight) NDC # Benzoyl Peroxide Gel Clindamycin Phosphate Solution (in plastic bottle) 25 grams 51672-1381-2 20 g 5 g 35 grams (PUMP) 51672-1381-5 28 g 7 g 50 grams 51672-1381-4 40 g 10 g 50 grams (PUMP) 51672-1381-6 40 g 10 g Prior to dispensing, add the solution in the bottle to the gel and stir until homogenous in appearance (1 to 11⁄2 minutes). For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] for 3 months. Place a 3 month expiration date on the label immediately following mixing. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Keep tightly closed. Keep out of the reach of children.