Elmiron (Pentosan Polysulfate Sodium Capsules) Drug Information: Overdosage and Contraindications

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May 27, 2012

Elmiron

Interstitial Cystitis »

Overview of urinary function

The urinary system consists of the kidneys, ureters, bladder, and urethra. The kidneys, a pair of purplish-brown organs, are located below the ribs toward the middle of the back. The kidneys remove water and waste from the blood in the form of urine, keeping a stable balance of salts and other substances in the blood. The kidneys also produce erythropoietin, a hormone that stimulates the formation of red blood cells. Narrow tubes called ureters carry urine from the kidneys to the bladder, a triangle-shaped, muscular chamber in the lower abdomen. Like a balloon, the bladder's muscular, elastic walls relax and expand to store urine and contract and flatten when urine is emptied through the urethra. The typical adult bladder can store about 1 ½ cups of urine.

Adults urinate about 1 ½ quarts of urine each day. The amount of urine varies depending on the fluids and foods a person consumes. The volume...

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OVERDOSE

Overdose has not been reported. Based upon the pharmacodynamics of the drug, toxicity is likely to be reflected as anticoagulation, bleeding, thrombocytopenia, liver function abnormalities, and gastric distress. (See CLINICAL PHARMACOLOGY and PRECAUTIONS sections.) At a daily dose of 900 mg for 32 weeks (n = 127) in a clinical trial, rectal hemorrhage was reported as an adverse event in 15% of patients. At a daily dose of ELMIRON (pentosan polysulfate sodium capsules) ® 900 mg for 16 weeks in a clinical trial that enrolled 51 patients in the ELMIRON (pentosan polysulfate sodium capsules) ® group and 49 in the placebo group, elevated liver function tests were reported as an adverse event in 11.8% of patients in the ELMIRON (pentosan polysulfate sodium capsules) ® group and 2% of patients in the placebo group. In the event of acute overdosage, the patient should be given gastric lavage if possible, carefully observed and given symptomatic and supportive treatment.

CONTRAINDICATIONS

ELMIRON (pentosan polysulfate sodium capsules) ® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.