CLEOCIN Vaginal Cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

CLEOCIN Vaginal Cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester.

(See CLINICAL STUDIES.)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, eg, 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.

CLEOCIN Vaginal Cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream.

CLEOCIN Vaginal Cream 2%, 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.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening.

Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal) formulations of clindamycin.

Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated" colitis.After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.

Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone.

In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.