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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (C's) » Clindamycin (topical)



Sterile Solution and IV Solution

Clindamycin therapy has been associated with severe colitis which may end fatally. Therefore, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in INDICATIONS AND USAGE. It should not be used in patients with nonbacterial infections, such as most upper respiratory tract infections. Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. Cholestyramine and colestipol resins have been shown to bind the toxin in vitro. See WARNINGS section. 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 or, if necessary, continued only with close observation of the patient. Large bowel endoscopy has been recommended.

Antiperistaltic agents such as opiates and diphenoxylate with atropine (Lomotil) 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 dose is 500 milligrams 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 therapy with clindamycin.

Clindamycin phosphate sterile solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each ml contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each ml. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

The chemical name of clindamycin phosphate is L-threo-alpha-D-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-.

The molecular formula is C18H34CIN2O8PS and the molecular weight is 504.96.

Sterile Solution and IV Solution

Clindamycin phosphate in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution.

Clindamycin phosphate IV solution in the Galaxy plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/ml. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid.

The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

Vaginal Cream


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.

Clindamycin phosphate vaginal cream, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, and stearic acid.

Each applicator of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.

Topical Solution, Gel and Lotion

Clindamycin phosphate topical solution, gel and lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Topical Solution pledget applicator contains approximately 1 ml of topical solution.

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.

The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water.

The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water.

Vaginal Cream, Topical Solution, Gel and Lotion

The chemical name for clindamycin phosphate 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).


CATEGORIES: Abscess, Abdominal; Abscess, Lung; Abscess, Pulmonary; Acne; Cellulitis; Endometritis; Infection, Bone; Infection, Gynecologic; Infection, Intra-abdominal; Infection, Joint; Infection, Respiratory Tract; Infection, Skin; Osteomyelitis; Peritonitis; Pneumonia; Septicemia; Trichomoniasis; Vaginitis; Vaginosis, Bacterial; FDA Approved 1987 Jan; Pregnancy Category B; Orphan Drugs

FDA Drug Class: Acne Products; Dermatologics; Lincosamides/Macrolides

BRAND NAMES: Basocin Akne Gel; Basocin Akne Losung; Cleocin; Cleocin T; Cleocin Phosphate; Cleocin Vaginal; Cleorin; Cindala; Clicinin; Clinac; Dalacin; Dalacin 2% Vaginal Cream; Dalacin T; Dalacin T Lotion; Dalacin T Topical Solution; Dalacin V; Dalacin VC 2%; Dalacine T; Dalagis T; Euroclin; Sobelin Vaginal Creme
(Foreign brand names outside U.S. in italics)


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