DOSAGE AND ADMINISTRATION
The recommended dose of ELMIRON (pentosan polysulfate sodium capsules) ® is 300 mg/day taken as one 100 mg capsule orally three times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.
Patients receiving ELMIRON (pentosan polysulfate sodium capsules) ® should be reassessed after 3 months. If improvement has not occurred and if limiting adverse events are not present, ELMIRON (pentosan polysulfate sodium capsules) ® may be continued for another 3 months.
The clinical value and risks of continued treatment in patients whose pain has not improved by 6 months is not known.
ELMIRON (pentosan polysulfate sodium capsules) ® is supplied in white opaque hard gelatin capsules imprinted "BNP7600" containing 100 mg pentosan polysulfate sodium. Supplied in bottles of 100 capsules.
NDC NUMBER 0062-9800-01
Store at controlled room temperature 15°-30°C (59°-86°F).
Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, New Jersey 08869. Manufactured by: Janssen Ortho LLC Gurabo, Puerto Rico 00778. Manufactured for: Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, New Jersey 08869. Revised December 2008. FDA rev date:This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/4/2009
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