(clindamycin)
WARNINGS
WARNINGS
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 and vaginal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of CLEOCIN Vaginal Ovules, because approximately 30% 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 Clostridioides 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 Clostridioides difficile colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
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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