Drug Facts
Composition & Profile
Identifiers & Packaging
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 1½ 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.; PRINCIPAL DISPLAY PANEL - Kit Carton NDC 51672-1381-6 One 50 gram Pump (after admixing) Clindamycin and Benzoyl Peroxide Gel 1%/5% For Topical Use Only Reconstitute with clindamycin phosphate solution. Rx only TARO PRINCIPAL DISPLAY PANEL - Kit Carton
- 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 1½ 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.
- PRINCIPAL DISPLAY PANEL - Kit Carton NDC 51672-1381-6 One 50 gram Pump (after admixing) Clindamycin and Benzoyl Peroxide Gel 1%/5% For Topical Use Only Reconstitute with clindamycin phosphate solution. Rx only TARO PRINCIPAL DISPLAY PANEL - Kit Carton
Overview
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 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 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 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, potassium hydroxide, propylene glycol, and purified water. Chemical Structure Chemical Structure
Indications & Usage
Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
Clindamycin 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.
Warnings & Precautions
WARNINGS ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN. STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Contraindications
Clindamycin 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 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 and Benzoyl Peroxide Gel, 1%/5% and vehicle groups. Local Adverse Events - all causalities in >/= 1% of patients Clindamycin and Benzoyl Peroxide Gel, 1%/5% 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.
Storage & Handling
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.
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