Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
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 tocin(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 discountinued. Large bowel endoscopy should be consideres to establicha definitive diagnosis in cases of severe diarrhea. Antipreistaltic agents, such as opiates and diphenooxylate 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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindagel® (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatement of acne vulgaris of mild to moderate severity, Clindagel® applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:
|Lesions|| Clindagel® QD|
| Vehicle Gel |
There was a trend in the investigator's global assessment of the results which favored Clindagel® QD over the vehicle QD.
In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindagel®. There was no signal for contact sensitization in the clinical trials under normal use conditions.
There is currently no drug history available for this drug.
Clindagel® (Clidamycin phosphate gel) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. Chemically, 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, and has a structural formula represented below:
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-∝-D-galacto-octopyranoside 2-(dihydrogen phosphate).