Important Safety Information
Cleocin Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis
in nonpregnant women. There are no adequate and well-controlled studies of Cleocin
Vaginal Ovules in pregnant women.
Cleocin Vaginal Ovules should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Cleocin Vaginal Ovules are contraindicated in individuals with a history of hypersensitivity
to clindamycin, lincomycin, or any of the components of this vaginal suppository.
Cleocin Vaginal Ovules are also contraindicated in individuals with a history of
regional enteritis, ulcerative colitis, or a history of “antibiotic-associated”
colitis.
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 Cleocin Vaginal Ovules, because approximately
30% of the clindamycin dose is systemically absorbed from the vagina.
Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial
treatment.
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.
Patients who treat with Cleocin Vaginal Ovules should be instructed not to engage
in vaginal intercourse or use other vaginal products (such as tampons or douches)
during treatment with this product.
The patient should also be advised that these suppositories use an oleaginous base
that may weaken latex or rubber products such as condoms or vaginal contraceptive
diaphragms. Therefore, the use of such products within 72 hours following treatment
with Cleocin Vaginal Ovules is not recommended.
Adverse events judged to have a reasonable possibility of having been caused by
clindamycin phosphate vaginal suppositories were reported for 10.5% of patients.
Events reported by 1% or more of patients receiving Cleocin Vaginal Ovules were
as follows:
Urogenital system:
- Vulvovaginal disorder (3.4%)
- Vaginal pain (1.9%)
- Vaginal moniliasis (1.5%)
Body as a whole:
Other events reported by <1% of patients included:
Urogenital system:
- Menstrual disorder, dysuria, pyelonephritis, vaginal discharge, and vaginitis/vaginal
infection
Body as a whole:
- Abdominal cramps, localized abdominal pain, fever, flank pain, generalized pain,
headache, localized edema, and moniliasis
Digestive system:
- Diarrhea, nausea, and vomiting
Skin:
- Nonapplication-site pruritus, rash, application-site pain, and application-site
pruritus