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DOSAGE AND ADMINISTRATION
The recommended dose of ELMIRON® 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® should be reassessed after 3 months. If improvement has not occurred and if limiting adverse events are not present, ELMIRON® 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® is supplied in white opaque hard gelatin capsules imprinted “BNP7600” containing 100 mg pentosan polysulfate sodium. Supplied in bottles of 100 capsules.
NDC NUMBER 50458-098-01
Store at controlled room temperature 15°-30°C (59°-86°F).
Manufactured by: Janssen Ortho LLC, Gurabo, Puerto Rico 00778. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560. Revised August 2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/22/2016
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