Dailymed – elmiron- pentosan polysulfate sodium capsule, gelatin coated gas vs diesel engine

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ELMIRON ® was evaluated in two clinical trials for the relief of pain in patients with chronic interstitial cystitis (IC). All patients met the NIH definition of IC based upon the results of cystoscopy, cytology, and biopsy. One blinded, randomized, placebo-controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years (range 18 to 81). Approximately equal numbers of patients received either placebo or ELMIRON ® 100 mg three times a day for 3 months. Clinical improvement in bladder pain was based upon the patient’s own assessment. In this study, 28/74 (38%) of patients who received ELMIRON ® and 13/74 (18%) of patients who received placebo showed greater than 50% improvement in bladder pain (p = 0.005).

A second clinical trial, the physician’s usage study, was a prospectively designed retrospective analysis of 2499 patients who received ELMIRON ® 300 mg a day without blinding. Of the 2499 patients, 2220 were women, 254 were men, and 25 were of unknown sex. The patients had a mean age of 47 years and 23% were over 60 years of age. By 3 months, 1307 (52%) of the patients had dropped out or were ineligible for analysis, overall, 1192 (48%) received ELMIRON ® for 3 months; 892 (36%) received ELMIRON ® for 6 months; and 598 (24%) received ELMIRON ® for one year.

Patients had unblinded evaluations every 3 months for the patient’s rating of overall change in pain in comparison to baseline and for the difference calculated in "pain/discomfort" scores. At baseline, pain/discomfort scores for the original 2499 patients were severe or unbearable in 60%, moderate in 33% and mild or none in 7% of patients. The extent of the patients’ pain improvement is shown in Table 1.

At 3 months, 722/2499 (29%) of the patients originally in the study had pain scores that improved by one or two categories. By 6 months, in the 892 patients who continued taking ELMIRON ®, an additional 116/2499 (5%) of patients had improved pain scores. After 6 months, the percent of patients who reported the first onset of pain relief was less than 1.5% of patients who originally entered in the study (see Table 2).

ELMIRON ® is a weak anticoagulant (1/15 the activity of heparin). At a daily dose of 300 mg (n = 128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage have been reported (see ADVERSE REACTIONS). Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting ELMIRON ®.

A similar product that was given subcutaneously, sublingually, or intramuscularly (and not initially metabolized by the liver) is associated with delayed immunoallergic thrombocytopenia with symptoms of thrombosis and hemorrhage. Caution should be exercised when using ELMIRON ® in patients who have a history of heparin induced thrombocytopenia.

Alopecia is associated with pentosan polysulfate and with heparin products. In clinical trials of ELMIRON ®, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.

ELMIRON ® is used to treat the pain or discomfort of interstitial cystitis (IC). It is not known exactly how ELMIRON ® works, but it is not a pain medication like aspirin or acetaminophen and therefore must be taken continuously for relief as prescribed.

The most common side effects are hair loss, diarrhea, nausea, blood in the stool, headache, rash, upset stomach, abnormal liver function tests, dizziness and bruising. Weight gain and swelling caused by fluid build up in the body have also been reported in patients taking ELMIRON ®.

If you suspect that someone may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

This leaflet provides a summary of information about ELMIRON ®. Medicines are sometimes prescribed for uses other than those listed in a Patient Leaflet. If you have any questions or concerns, or want more information about ELMIRON ®, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about ELMIRON ® that is written for health professionals that you can ask to read.