Important Safety Information for Clindesse® (clindamycin phosphate) Vaginal Cream, 2%... Read More  

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%).

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Only Clindesse® offers the benefits of our proprietary Bioadhesion Technology for the treatment of BV.2

* Studies show that bioadhesion technology helps reduce leakage by 50%, compared to conventional cream.1

Clindesse® (clindamycin phosphate) Vaginal Cream, 2% is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginitis) in non-pregnant women.

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 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.

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%).

Please see full Prescribing Information

References:

  1. Merabet J, Thompson D, Levinson RS. Advancing vaginal drug delivery. Expert Opin Drug Deliv. 2005;2:769-777.
  2. Clindesse® (clindamycin phosphate) Vaginal Cream, 2% Prescribing Information, Perrigo, November 2014.
  3. Faro S, Skokos CK. The efficacy and safety of a single dose of Clindesse vaginal cream versus a seven-dose regimen of Cleocin® vaginal cream in patients with bacterial vaginosis. Infect Dis Obstet Gynecol. 2005;13:155-160.
  4. Data on file, Perrigo, 2005, 2009. Clindesse patient satisfaction survey.
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