Elmiron
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Questions & Answers
Side Effects & Adverse Reactions
None.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ELMIRON® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
History
There is currently no drug history available for this drug.
Other Information
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:
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, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol, SDA-3A alcohol, and titanium dioxide. It is formulated for oral use.
Sources
Elmiron Manufacturers
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Janssen Pharmaceuticals, Inc.
![Elmiron (Pentosan Polysulfate Sodium) Capsule, Gelatin Coated [Janssen Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Elmiron | Janssen Pharmaceuticals, Inc.
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.
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Cardinal Health
Elmiron | Cardinal Health
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 (Pentosan Polysulfate Sodium) Capsule, Gelatin Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3b172ad2-074f-4534-af1f-89d951647ee9&name=image-02.jpg)
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