Side Effects of Cleocin Vaginal Ovules (clindamycin)

Cleocin Vaginal Ovules (clindamycin) is an antibiotic used to treat bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women. 

Clindamycin in general is an antibiotic used for treating several other infections as well. It is effective against several types of bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, and Staphylococcus epidermidis, and Propionibacterium acnes. It reduces growth of bacteria by interfering with their ability to make proteins.

Common side effects of Cleocin Vaginal Ovules include

• vaginal yeast infection,
• inflammation of the vulva and vagina,
• vulvovaginal disorder,
• trichomonal vaginitis,
• itching,
• abdominal pain,
• nausea,
• diarrhea, and
• vomiting.

Serious side effects of Cleocin Vaginal Ovules include

• severe colitis (inflammation of the colon) with diarrhea or bloody diarrhea (including C. difficile colitis).

Very little clindamycin is absorbed into the bloodstream when given vaginally so the likelihood of drug interactions is low. 

The frequency of congenital abnormalities was not increased when pregnant women used oral clindamycin during the second and third trimesters. Pregnant women who used clindamycin vaginal cream during the second trimester reported abnormal labor more frequently than those who received placebo. 

Cleocin Vaginal Ovules have not been properly evaluated during the first trimester of pregnancy. They should only be used during the first trimester of pregnancy when they are clearly needed. 

Oral clindamycin is excreted in breast milk and should not be used by nursing mothers or nursing should be stopped. It is unknown if Cleocin Vaginal Ovules are excreted in breast milk. Consult your doctor before breastfeeding.

The most common side effects of clindamycin vaginal suppositories are:

• vaginal moniliasis, a fungal infection
• vulvovaginitis
• vulvovaginal disorder
• trichomonal vaginitis
• moniliasis
• itching.

Other side effects that may occur include:

• Abdominal pain
• Nausea
• Diarrhea
• Vomiting

Possible serious side effects of clindamycin include:

• Orally administered and injected clindamycin may cause severe colitis (inflammation of the colon).
• Vaginal formulations of clindamycin may be absorbed into the blood stream, and colitis with diarrhea or bloody diarrhea (including C.difficile colitis) have been reported with the use of clindamycin vaginal suppositories.

Clinical Trials

In clinical trials, 3 (0.5%) of 589 nonpregnant women who received treatment with Cleocin Vaginal Ovules discontinued therapy due to drug-related adverse events. 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%), and vaginal moniliasis (1.5%).
• Body as a whole: Fungal infection (1.0%).
• 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 pruritis, rash, application-site pain, and application-site pruritis.

Other clindamycin formulations

The overall systemic exposure to clindamycin from Cleocin Vaginal Ovules is substantially lower than the systemic exposure from therapeutic doses of oral clindamycin hydrochloride (two-fold to 20-fold lower) or parenteral clindamycin phosphate (40-fold to 50-fold lower).

Although these lower levels of exposure are less likely to produce the common reactions seen with oral or parenteral clindamycin, the possibility of these and other reactions cannot be excluded.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin and may also occur following administration of Cleocin Vaginal Ovules:

• Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea.
• Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports.
• Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.
• Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
• Musculoskeletal: Rare instances of polyarthritis have been reported.
• Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.

• Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
• Therefore, it should be used with caution in patients receiving such agents.