《ELMIRON-100 mg(pentosan polysulfate sodium) Capsules》.pdf

® ELMIRON -100 mg (pentosan polysulfate sodium) Capsules Prescribing Information DESCRIPTION Pentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water to 50% at pH 6. It has a molecular weight of 4000 to 6000 Dalton with the following structural formula: O O O O O O OR O OR O OR O OR O OR O OR OR OR OR COONa O O R = SO Na 3 OR MeO OR ELMIRON® is supplied in white opaque hard gelatin capsules containing 100 mg pentosan polysulfate sodium, microcrystalline cellulose, and magnesium stearate. It also contains pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, FDC Blue No. 2 aluminum lake, FDC Red No. 40 aluminum lake, FDC Blue No. 1 aluminum lake, DC Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol, SDA-3A alcohol, and titanium dioxide. It is formulated for oral use. CLINICAL PHARMACOLOGY General: Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. The mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known