Cleocin®(clindamycin)

CLEOCIN Vaginal Cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). CLEOCIN Vaginal Cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

CLEOCIN Vaginal Cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. CLEOCIN Vaginal Cream 2%, is 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 and vaginal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% 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. PRECAUTIONS: General - CLEOCIN Vaginal Cream 2%, contains ingredients that will cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water. The use of CLEOCIN Vaginal Cream may result in the overgrowth of nonsusceptible organisms in the vagina. In clinical studies involving 600 non-pregnant women who received treatment for 3 days, Candida albicans was detected, either symptomatically or by culture, in 8.8% of patients. In 1325 non-pregnant women who received treatment for 7 days, C. albicans was detected in 10.5% of patients. In 180 pregnant women who received treatment for 7 days, C. albicans was detected in 13.3% of patients. Information for the Patient - The patient 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 this cream contains mineral oil 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 Cream 2% is not recommended. Drug Interactions - 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. Carcinogenesis, Mutagenesis, Impairment of Fertility - Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative. Fertility studies in rats treated orally with up to 300 mg/kg/day revealed no effects on fertility or mating ability. Pregnancy - Teratogenic effects: Pregnancy Category B - Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day and have revealed no evidence of harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. CLEOCIN Vaginal Cream 2% should be used during the first trimester of pregnancy only if clearly needed. Nursing Mothers - It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin phosphate. Clindamycin has been reported to appear in breast milk in ranges from <0.5 to 3.8 mcg/mL following oral or parenteral clindamycin administration. Pediatric Use - Safety and effectiveness in pediatric patients have not been established.

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. Events occurring in ≥1% of patients: Vaginal moniliasis (7.7% for 3-day, 10.4% for 7-day), Vulvovaginitis (6.0% for 3-day, 4.4% for 7-day), Vulvovaginal disorder (3.2% for 3-day, 5.3% for 7-day). Events <1%: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, localized/generalized abdominal pain, headache, nausea, vomiting, constipation, diarrhea, pruritus, rash, erythema, urticaria, back pain. Pregnant Women: 1.7% of 180 patients discontinued therapy. Events ≥1%: Vaginal moniliasis (13.3%), Vulvovaginal disorder (6.7%), Abnormal labor (1.1%), Fungal infection (1.7%). Other clindamycin formulations may also cause: Clostridioides difficile colitis, transient neutropenia, eosinophilia, agranulocytosis, thrombocytopenia, maculopapular rash, urticaria, AGEP, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid reactions, jaundice, polyarthritis, acute kidney injury, DRESS.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). The molecular formula is C18H34ClN2O8PS and the molecular weight is 504.96. CLEOCIN Vaginal Cream 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The inactive ingredients are benzyl alcohol, cetostearyl alcohol, cetostearyl alcohol/cetosteareth-20, mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, and stearic acid. Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.