FDA label 7ca216b7-74dd-47e0-b722-fe8a69ee3224

WARNINGS 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. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium 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 Clostridium difficile colitis. Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

ADVERSE REACTIONS 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). (See CLINICAL PHARMACOLOGY .) 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, diarrhea, and pseudomembranous colitis. (See WARNINGS .) 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. There have been reports of pseudomembranous colits following the administration of clindamycin vaginal cream.