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Clindets (Clindamycin Phosphate Pledgets) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Clindets® (Clindamycin Phosphate Pledgets) contain clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per milliliter in a vehicle of isopropyl alcohol 52% v/v, propylene glycol and water. Each Clindets® pledget applicator contains approximately 1 mL of Clindamycin Phosphate Topical Solution. Clindamycin Phosphate Topical Solution has a pH range between 4.0 and 7.0.

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. It occurs as a white to off-white, hygroscopic, crystalline powder. It is freely soluble in water, slightly soluble in dehydrated alcohol, very slightly soluble in acetone and practically insoluble in chloroform, benzene, and ether. Clindamycin phosphate is odorless or practically odorless, and has a bitter taste.

Chemically, clindamycin phosphate is C18 H34 ClN2 O8 PS. It has the following structural formula:

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). (MW=504.97)

CLINICAL PHARMACOLOGY

Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Cross resistance has been demonstrated between clindamycin and lincomycin.

Antagonism has been demonstrated between clindamycin and erythromycin.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0-3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of a Clindamycin Phosphate Pledget for 4 weeks was 597 mcg/g of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

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