Miscellaneous urogenital disorders:
Indications for: ELMIRON
Bladder pain/discomfort due to interstitial cystitis.
Two clinical trials evaluated the efficacy and safety of Elmiron for the relief of pain in patients with chronic interstitial cystitis (IC).
Trial 1: The blinded, randomized, placebo-controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years. Patients were randomly assigned 1:1 to receive either placebo or Elmiron 100 mg three times a day for 3 months.
38% of patients treated with Elmiron showed greater than 50% improvement in bladder pain vs 18% of patients treated with placebo (P =.005).
Trial 2: The second clinical trial was a prospectively designed retrospective analysis of 2499 patients (2220 women, 254 men, 25 unknown) with a mean age of 47 years who received Elmiron 300 mg/day without blinding.
At 3 months, 722/2499 (29%) of the patients originally in the study had pain scores that improved by 1 or 2 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.
Take with water 1 hr before or 2 hrs after meals. ≥16yrs: 100mg 3 times daily. Reevaluate at 3 and 6 months.
<16yrs: not established.
Retinal pigmentary changes. Do retinal exam (including OCT, auto-fluorescence imaging) at baseline, within 6 months of initiation, periodically during and after treatment completion. Bleeding or risk of bleeding (eg, surgery, aneurysm, hemophilia, GI ulcers, polyps, diverticula). History of heparin-induced thrombocytopenia. Hepatic insufficiency. Pregnancy. Nursing mothers.
Caution with drugs that increase bleeding risk (eg, anticoagulants, tPA, aspirin, NSAIDs).
Alopecia, diarrhea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities, dizziness, increased prothrombin time, hemorrhage.
Fecal (mean 84% in the 300 mg group; mean 58% in the 450 mg group), renal (mean 6%).
Mean half-life: 27 hours (for 300 mg dose); 20 hours (for 450 mg dose).
Generic Drug Availability: