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Basic Drug Info
Drug Name:Clindamycin Phosphate
Manufacturer:E. FOUGERA & CO.
Other Info:Rx only For External Use



Clinical Trials:


Indications and Usage

Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris.

In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.

(See CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS.)
Acne Vulgaris -- A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.

Diarrhea -- An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.

BLOODY DIARRHEA --

pseudomembranous colitis --

Contraindications
Clindamycin Phosphate Topical Solution USP, 1% is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Regional enteritis -- Inflammation of the intestines, but usually only of the small intestine. Regional enteritis increases the risk for developing colon cancer. Also called Crohn's disease.

Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

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.

Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile.The usual adult dosage is 500 mg to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.

Cholestyramine or colestipol resins bind vancomycin in vitro.If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
Branded Drugs
The following US Branded drugs contain Clindamycin Phosphate


ACANYA -- DOW PHARMACEUTICAL SCIENCES

BENZACLIN -- SANOFI AVENTIS US LLC

DUAC -- STIEFEL LABORATORIES INC

EVOCLIN -- STIEFEL LABORATORIES INC

CLEOCIN -- PHARMACIA AND UPJOHN CO

CLINDESSE -- KV PHARMACEUTICAL CO

CLEOCIN T -- PHARMACIA AND UPJOHN CO

CLINDAGEL -- GALDERMA LABORATORIES LP

CLEOCIN PHOSPHATE -- PHARMACIA AND UPJOHN CO

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER -- PHARMACIA AND UPJOHN CO

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% -- ABRAXIS PHARMACEUTICAL PRODUCTS

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER -- ABBOTT LABORATORIES

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

CLINDA-DERM -- PADDOCK LABORATORIES INC

CLINDETS -- PERRIGO CO

ZIANA -- MEDICIS PHARMACEUTICAL CORP


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