Side Effects of topical Cleocin (clindamycin)

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 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
• itching.

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.

• The most common side effects of topical clindamycin are:
  • Burning
  • Itching
  • Dryness
  • Skin redness
  • Oily skin

Some clindamycin topical solutions contain an alcohol base which will cause burning and irritation in the eye.

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.

Clinical Trials

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%

Other events occurring in <1% of the clindamycin vaginal cream 2% groups include:

Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain.

Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, headache, bacterial infection, inflammatory swelling, allergic reaction, and fungal infection.

Digestive system: nausea, vomiting, constipation, dyspepsia, flatulence, diarrhea, and gastrointestinal disorder.

Endocrine system: hyperthyroidism.

Central nervous system: dizziness and vertigo.

Respiratory system: epistaxis.

Skin: pruritus (non-application site), moniliasis, rash, maculopapular rash, erythema, and urticaria.

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

Other events occurring in <1% of the clindamycin vaginal cream 2% group include:

Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis.

Body as a whole: upper respiratory infection.

Skin: pruritus (topical application site) and erythema.

Post-Marketing Experience

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:

Gastrointestinal

Abdominal pain, esophagitis, nausea, vomiting, diarrhea and pseudomembranous colitis.

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.

Systemic 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.