Interstitial Cystitis Association
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Elmiron

General Information
    Brand Name: Elmiron®
    Generic Name: pentosan polysulfate sodium
    Distributor: Ortho McNeil Pharmaceuticals
    http://www.orthoelmiron.com/

Drug Information
Elmiron (pentosan polysulfate sodium) is an oral prescription medication which may work by restoring a damaged, thin, or “leaky” bladder surface. This surface (glycosaminoglycans, or GAG layer) is composed of a coating of mucus, which protects the bladder wall from bacteria and irritating substances in urine. It is believed that Elmiron functions as a synthetic GAG layer, but the drug’s mechanical action in IC is unknown.

Clinical Studies
In In double-blind, placebo controlled clinical trials, 38% of patients treated with Elmiron for 3 months reported improvement of their IC symptoms. In open-label trials, 61% of patients reported improvement.

Treatment Program

  • It is recommended that IC patients take 100 mg. of Elmiron three times a day, for a total of 300 mg./day.
  • It may take up to six months to see improvement. Patients are urged to continue therapy for at least six months before discontinuing this treatment, if they experience no improvement in symptoms.
  • Pain subsides first, but a decrease in frequency often takes six to nine months.
  • It may be necessary to use other medications, such as low-dose tricyclic antidepressants, antihistamines, etc., in conjunction with Elmiron.
Side Effects
The side effects of Elmiron® include minor gastrointestinal disturbances. Some patients have also experienced hair loss that is reversible upon discontinuing the drug. There are no reports that Elmiron has any negative interactions with any other medications. In controlled trials, no adverse effect occurred more frequently with Elmiron than with placebos. Since Elmiron is metabolized by the liver, it is recommended that blood tests be performed periodically to test liver function.
 
Availability In the fall of 1996 the FDA approved Elmiron, which is the first and only oral medication specifically for treating the pain and discomfort of IC. You or your physician can get more information on Elmiron by calling toll-free 1-888-ELMIRON or visiting http://www.orthoelmiron.com/.

Pregnancy
Because studies have not been performed in pregnant women, the manufacturer recommends that the drug not be used in pregnancy. The safety and effectiveness of Elmiron use in children has not been established.
 
Resources and References
  • Sant GR, Propert KJ, Hanno PM, Burks D, Culkin D, Diokno AC, Hardy C, Landis JR, Mayer R, Madigan R, Messing EM, Peters K, Theoharides TC, Warren J, Wein AJ, Steers W, Kusek JW, Nyberg LM; Interstitial Cystitis Clinical Trials Group. A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. J Urol. 2003 Sep;170(3):816-7.
  • AUA Abstracts 2001- Nickel, J C, et al, Randomized, Double- Blind, Dose-Ranging Study of Pentosan Polysulfate Sodium (PPS) for Interstitial Cystitis (IC)
  • Evans RJ. Long-term use of pentosan polysulfate for interstitial cystitis. Urology. 1999 Apr;53(4):863.
  • Hanno, PM, Analysis of Long-Term Elmiron Therapy for Intersitial Cystitis, Urology: Interstitial Cystitis Supplement to May 1997, Alan J. Wein, MD & Philip M Hanno, MD, Editors, pp. 93-99.