(clindamycin)
INDICATIONS AND USAGE
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, e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.
CLEOCIN® VAGINAL OVULES(CLINDAMYCIN PHOSPHATE VAGINAL SUPPOSITORIES)
Cleocin® Vaginal Ovules (clindamycin phosphate vaginal suppositories)
DIRECTIONS FOR USE
How do I use CLEOCIN Vaginal Ovules?
For vaginal use only. Do not take by mouth.
Use one CLEOCIN Vaginal Ovule daily, preferably at bedtime, for 3 days in a row.
Do not use this product if the foiled pouches containing vaginal ovules are torn, opened, or incompletely sealed.
Read the full directions below before using.
Insertion without the applicator:
- 1.
- Remove the vaginal ovule from its packaging (See Figure 1).
- Figure 1
- 2.
- Holding the ovule with your thumb and a finger, insert it into the vagina (See Figure 2).
Figure 2
- 3.
- Using your finger, gently push the ovule into the vagina as far as it will comfortably go (See Figure 3).
Figure 3
- 4.
- Once inside the vagina, the ovule melts. Lie down as soon as possible. This will keep leakage to a minimum.
- 5.
- Repeat steps 1 through 4, before bedtime, for the next 2 days.
STORAGE CONDITIONS:
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.
LAB-0649-4.0
Revised February 2026
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