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Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Immunology | Obstetrics/Gynecology (Women’s Health)

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Cleocin (clindamycin phosphate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Pharmacia & Upjohn
Approval Status: Approved August 1999
Treatment Area: Immunology; Ob/Gyn

General Information

Cleocin (clindamycin phosphate) vaginal ovules have been approved as a three-day treatment for bacterial vaginosis in nonpregnant women. Bacterial vaginosis is the most common type of vaginitis among women in the U.S. Administered once-daily, Cleocin vaginal ovules are formulated as vaginal suppositories and had similar efficacy in treating bacterial vaginosis as seven day, twice daily oral metronidazole in one controlled study. This new ovule formulation is a convenient three-day treatment option for nonpregnant women with bacterial vaginosis. Each Cleocin ovule is a solid, oval-shaped suppository.

Clinical Results

The FDA approval of Cleocin vaginal ovules for bacterial vaginosis was based on results of three clinical studies that showed use of once-daily Cleocin vaginal ovules are effective in treating bacterial vaginosis. Studies involved non-pregnant women 16 to 60 years old who were free of other vaginal infections.

Side Effects

During the trials, frequencies of side effects, as reported by one percent or more of patients treated with Cleocin included: vulvovaginal disorder, vaginal pain, vaginal moniliasis, and fungal infection.