Clindesse™ is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.

There are no adequate and well-controlled studies of Clindesse™ in pregnant women.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.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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Bacterial Vaginosis -- Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli.

Vaginitis -- Inflammation of the vagina characterized by pain and a purulent discharge.

Gardnerella vaginitis --

Vulvovaginitis -- Inflammation of the VULVA and the VAGINA, characterized by discharge, burning, and PRURITUS.

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Clindesse™ is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream.

Clindesse™ is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Regional enteritis -- Inflammation of the intestines, but usually only of the small intestine. Regional enteritis increases the risk for developing colon cancer. Also called Crohn's disease.

Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

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.Using the Clindesse™ Prefilled Disposable Applicator3 Easy Steps:One disposable plastic applicator is provided with this package.

It is designed to allow proper vaginal administration of the cream.