Clindagel Information
Clindagel ()
Clindagel () Description
Clindagel () (clindamycin 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 the structural formula represented below:
The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl--4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--α-D--octopyranoside 2-(dihydrogen phosphate).
Clindagel () Clinical Pharmacology
Following multiple applications of Clindagel () less than 0.04% of the total dose was excreted in the urine.
Microbiology: Although clindamycin phosphate is inactive , rapid hydrolysis converts this compound to clindamycin which has antibacterial activity. Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. studies indicated that clindamycin inhibited all tested cultures at a minimum inhibitory concentration (MIC) of 0.4 µg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.
Clindagel () Clinical Studies
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 treatment 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:
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.
Clindagel () Indications And Usage
Clindagel () is indicated for topical application 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 , , and .)
Clindagel () Contraindications
Clindagel () 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.
Clindagel () Precautions
The carcinogenicity of a 1% clindamycin phosphate gel similar to Clindagel () was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of Clindagel () , assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.
A 1% clindamycin phosphate gel similar to Clindagel () caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight.
Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.
Clindagel () Adverse Reactions
In the one well-controlled clinical study comparing Clindagel () and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented below:
Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.
Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see ). Abdominal pain and gastrointestinal disturbances, as well as Gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.
Clindagel () Overdosage
Topically applied Clindagel () may be absorbed in sufficient amounts to produce systemic effects (see ).
Clindagel () Dosage And Administration
Apply a thin film of Clindagel () once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly.
Keep container tightly closed.
Clindagel () How Supplied
Clindagel () containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following sizes:
75 mL bottle - NDC 0299-4500-75
40 mL bottle - NDC 0299-4500-40
7.3 mL bottle - NDC 0299-4500-00 (physician’s sample, not for resale)
Store under controlled room temperature 20°C-25°C (68°F to 77°F); excursions permitted between 15°C-30°C (59°F to 86°F). Do not store in direct sunlight.
US Patent No. 6,387,383
Marketed by:
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA
Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
GALDERMA is a registered trademark.
www.Clindagel () .com
325083-0207
Revised: February 2007
Clindagel () Package Label
clindamycin phosphate topical gel equivalent to 1% clindamycin
See package insert for complete product information.
Store at controlled room temperature 15° to 30° C (59° to 86° F). Do not store in direct sunlight. Retain in carton until contents are used.
US Patent No. 6,387,383
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA
Manufactured by:DPT Laboratories, Ltd.San Antonio, Texas 78125 USA
GALDERMA is a registered trademark.
310131-0207
