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Important Safety Information for Clindesse® (clindamycin phosphate) Vaginal Cream, 2%
Do not administer Clindesse to individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme and anaphylactoid reactions. Do not administer Clindesse to patients with regional enteritis, ulcerative colitis or a history of Clostridium difficile-associated diarrhea.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Vaginal intercourse or use of other vaginal products is not recommended for at least 7 days following treatment with Clindesse.
Most common adverse reactions ( 2%) of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%) and urinary tract infection (2%).
