Pentosan Polysulfate Sodium

Pentosan polysulfate sodium (Elmiron) is the only oral medicine that is FDA approved for treating the pain and discomfort of IC/BPS.

Pentosan Polysulfate Sodium (Elmiron) and IC/BPS

In double-blind, placebo controlled clinical trials, 38 percent of patients treated with Elmiron for three months reported improvement of their IC/BPS symptoms. In open-label trials, 61 percent of patients reported improvement.

Elmiron is thought to 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.

Dosage & Treatment Plan

A usual dosage for IC/BPS patients is 100 mg. of Elmiron three times a day, for a total of 300 mg/day.

Some patients report symptom relieve in three to four weeks. For others, it may take up to six months to see improvement. Patients are urged to continue therapy for at least six months before discontinuing treatment. Pain subsides first, but a decrease in urinary frequency may take six to nine months. It may also be necessary to use other medicines, such as low-dose tricyclic antidepressants, antihistamines, etc., along with Elmiron.

Potential 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 medicines. 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.

Pregnancy & Children

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.

You can get more information on Elmiron by calling toll-free 888-ELMIRON or visiting Ortho McNeil or the Elmiron healthcare provider portal.

Talk to Your Provider About Elmiron and Vision Changes

The ICA is aware of recent studies appearing in peer-reviewed medical journals that show an association between the use of pentosan polysulfate sodium (Elmiron) and retinal abnormalities (called “pigmentary maculopathy”). The relatively rare patient who develops this condition may suffer vision changes or loss.  Other research is showing different results.  It is important to note that, the US Food and Drug Administration (FDA), has not taken any action or issued any alerts regarding the toxicity of the medication, but has added Elmiron to their watch list of drugs or drug classes for which there is a potential sign of serious risk or new safety information. As more data regarding this medical issue is accrued and analyzed, the ICA recommends that patients taking Elmiron discuss these reports with their healthcare professional. Continuance or discontinuance of the medication based upon risks versus benefits can be discussed. In the appropriate setting an ophthalmologic exam may be suggested.