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Clindagel (Clindamycin Phosphate Topical) - Description and Clinical Pharmacology

 
 



DESCRIPTION

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).

CLINICAL PHARMACOLOGY

Pharmacokinetics: In an open label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3-12 grams/day of Clindagel® for five days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL.

Following multiple applications of C lindagel® less than 0.04% of the total dose was excreted in the urine.

Microbiology: Although clindamycin phosphate is inactive in   vitro , rapid in   vitro hydrolysis converts this compound to clindamycin which has antibacterial activity. Clindamycin inhibits bacteria protien synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium   acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 µg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.

 

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