clindamycin and benzoyl peroxide

INDICATIONS AND USAGE Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION Clindamycin and Benzoyl Peroxide Gel 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 and Benzoyl Peroxide Gel 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 and benzoyl peroxide gel treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide gel and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and Benzoyl Peroxide n=420 Vehicle n=168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 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 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 504.96 g/mol 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 - α -D- galacto -octopyranoside 2-(dihydrogen phosphate). Clindamycin 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 g/mol. Each gram of Clindamycin 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 homopolymer type C, docusate sodium, edetate disodium, sodium hydroxide and purified water. clinidamycin-structure benzoyl-peroxide

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS NDC Number Size (Net Weight) Benzoyl Peroxide Gel (in a jar) *includes pump Active Clindamycin powder (in plastic vial) Purified Water to be added to each vial 68462-486-19 19.7 g (68462-485-19) 0.3 g (68462-484-69) 5 mL 68462-485-24 35 g Carton 27.6 g (68462-485-24) 0.4 g (68462-484-98) 7 mL 68462-486-27 50 g Carton 39.4 g (68462-485-27) 0.6 g (68462-484-86) 10 mL 68462-859-24 35 g Pump Carton 27.6* (68462-858-24) 0.4 g (68462-857-98) 7 mL 68462-859-27 50 g Pump Carton 39.4* (68462-858-27) 0.6 g (68462-857-86) 10 mL Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial 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 (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.