Clindamycin Phosphate and Benzoyl Peroxide
Generic: CLINDAMYCIN AND BENZOYL PEROXIDE GEL
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
3b151c49-d44c-4a24-b7ff-329797a2cda3
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.
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.
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.
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.