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1.1 Treatment of Bacterial Vaginosis
Clindesse is indication for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerellavaginitis, nonspecific vaginitis, Corynebacteriumvaginitis, or anaerobic vaginosis) in non-pregnant women.
Clindamycin phosphate, a lincosamide, 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 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). It has a molecular weight of 504.95, and the molecular formula is C18H34CIN2O8PS. The structural formula is represented below:
Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, as a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution.
Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream.