CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE TOPICAL GEL, 1% 5% 25 G
Generic: Clindamycin and Benzoyl Peroxide Gel
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE TOPICAL GEL, 1% 5% 25 G
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Identification
Clindamycin and Benzoyl Peroxide Gel
Clindamycin Phosphate and Benzoyl Peroxide
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
KIT
ANDA208776
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.
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
Warnings
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.
Dosage & Administration
DOSAGE AND 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.
Adverse Reactions
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.
Information for Patients
Information for Patients Patients using Clindamycin and Benzoyl Peroxide Gel, 1%/5% should receive the following information and instructions: Clindamycin and Benzoyl Peroxide Gel, 1%/5% is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating. This medication should not be used for any disorder other than that for which it was prescribed. Patients should not use any other topical acne preparation unless otherwise directed by physician. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Clindamycin and Benzoyl Peroxide Gel, 1%/5%. To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue Clindamycin and Benzoyl Peroxide Gel, 1%/5% and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician. Clindamycin and Benzoyl Peroxide Gel, 1%/5% may bleach hair or colored fabric. Clindamycin and Benzoyl Peroxide Gel, 1%/5% can be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] for 3 months. Do not freeze. Discard any unused product after 3 months. Before applying Clindamycin and Benzoyl Peroxide Gel, 1%/5% to affected areas wash the skin gently, then rinse with warm water and pat dry.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.