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What is Cleocin (clindamycin) vaginal cream?
- 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 cream include:
- vaginal yeast infection,
- inflammation of the vulva and vagina,
- vulvovaginal disorder,
- trichomonal vaginitis, and
Drug interactions of Cleocin vaginal cream include neuromuscular blocking drugs because it can increase the action of these drugs. However, very little clindamycin is absorbed into the bloodstream when given vaginally so the likelihood of drug interactions is less.
The frequency of congenital abnormalities was not increased when pregnant women used Cleocin vaginal cream during the second and third trimesters, and Cleocin vaginal cream is approved for use during the second and third trimesters of pregnancy. Cleocin vaginal cream should not be used during the first trimester of pregnancy unless it is clearly needed because it has not been properly evaluated during the first trimester.
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 cream is excreted in breast milk. Consult your doctor before breastfeeding.
What are the important side effects of Cleocin (clindamycin) vaginal cream?
- The most common side effects of topical clindamycin are:
- Skin redness
- Oily skin
Possible serious side effects of clindamycin include:
- Stomach pain and folliculitis (inflammation of the tissue surrounding the base of hairs) may occur during treatment with topical clindamycin.
- Orally administered and injected clindamycin may cause severe colitis. Orally or injected clindamycin have been associated with severe colitis which may result in death. Diarrhea, colitis, and pseudomembranous colitis may begin up to several weeks after stopping oral and parenteral therapy with clindamycin.
- Topical formulations of clindamycin may be absorbed from the skin surface, and diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin.
Cleocin (clindamycin) vaginal cream side effects list for healthcare professionals
Non-pregnant Women: In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with Cleocin vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1.
TABLE 1 – Events Occurring in ≥1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2%
|Event||Cleocin Vaginal Cream|
|Body as a Whole|
Other events occurring in <1% of the clindamycin vaginal cream 2% groups include:
Endocrine system: hyperthyroidism.
Respiratory system: epistaxis.
Special senses: taste perversion.
Pregnant Women: In a clinical trial involving pregnant women during the second trimester, 1.7% of 180 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 22.8% of pregnant patients. Events occurring in ≥1% of patients receiving either clindamycin phosphate vaginal cream 2% or placebo are shown in Table 2.
TABLE 2 -Events Occurring in ≥1% of Pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% or Placebo
|Event||Cleocin Vaginal Cream||Placebo|
|Body as a Whole|
|Pruritus, non-application site||1.1||0|
Other events occurring in <1% of the clindamycin vaginal cream 2% group include:
Body as a whole: upper respiratory infection.
Skin: pruritus (topical application site) and erythema.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In the post-marketing period, there have been case reports of pseudomembranous colitis with the use of clindamycin phosphate vaginal cream.
Other Clindamycin Formulations
Clindamycin vaginal cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral clindamycin, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.
The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:
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.
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.
Rare instances of polyarthritis have been reported.
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.
Cleocin vaginal cream (clindamycin) is an antibiotic used to treat serious infections. It is effective against several types of bacteria such as Staphylococcus aureus, Streptococcus pneumonia, and Staphylococcus epidermidis, and Propionibacterium acnes. Common side effects of Cleocin vaginal cream include vaginal yeast infection, inflammation of the vulva and vagina, vulvovaginal disorder, trichomonal vaginitis, and itching. Cleocin vaginal cream should not be used during the first trimester of pregnancy unless it is clearly needed because it has not been properly evaluated during the first trimester. 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 cream is excreted in breast milk.
Related Disease Conditions
Bacterial vaginosis is an abnormal vaginal condition with signs and symptoms of vaginal discharge, vaginal odor, and vaginal pain. Bacterial vaginosis results from an overgrowth of normal bacteria in the vagina. Although it may cause some disturbing symptoms (discharge and odor), it is not dangerous and cannot be passed by sex. Diagnosis becomes important to exclude serious infections like gonorrhea and Chlamydia. Many treatment options are available such as oral antibiotics and vaginal gels.
Yeast Infection vs. Bacterial Vaginosis (BV)
Yeast infections and bacterial vaginosis (BV) both cause vaginal discharge. Yeast infection discharge is thick, white, and had a cottage cheese consistency. BV discharge is whitish-gray and is thinner. Vaginal odor, irritation, and pain may also be present. Treatment of yeast infections includes over-the-counter and prescription antifungals. BV treatment involves antibiotics.
Treatment & Diagnosis
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.