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Clindesse® (clindamycin phosphate) Vaginal Cream, 2%, is indicated for the treatment of bacterial
vaginosis in non-pregnant women. Clindesse is Pregnancy Category B, which means there are no
adequate and well-controlled studies in pregnant women. Therefore, Clindesse should be used
during pregnancy only if clearly needed.
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Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined
by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
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Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus, should be ruled out.
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| Important Safety Information |
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Clindesse is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream, and in individuals with a history of regional enteritis, ulcerative colitis, or a history of “antibiotic-associated” colitis.
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This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases.
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Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin. Orally and parenterally administered clindamycin has been associated with severe colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of Clindesse, even though there is minimal systemic absorption of clindamycin from the vagina with administration of Clindesse Vaginal Cream.
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In clinical trials (n=368), 1.6% of patients discontinued therapy due to adverse events. The most frequently reported adverse events were vaginosis fungal (14.1%), vulvovaginal pruritus (3.3%), and headache (2.7%).
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