Cleocin Vaginal (Clindamycin Hydrochloride Vaginal) - Indications and Dosage

INDICATIONS AND USAGE

CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules 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, eg, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.

DOSAGE AND ADMINISTRATION

The recommended dose is one CLEOCIN Vaginal Ovule (containing clindamycin phosphate equivalent to 100 mg clindamycin per 2.5 g suppository) intravaginally per day, preferably at bedtime, for 3 consecutive days.

HOW SUPPLIED

CLEOCIN Vaginal Ovules are supplied as follows:

Carton of three suppositories with one applicator

NDC 0009-7667-01

Important Information: Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature].

Caution: Avoid heat over 30°C (86°F). Avoid high humidity. See end of carton for the lot number and expiration date.

Rx only

LAB-0047-2.0

November 2005