ELMIRON 100 mg/1
PENTOSAN POLYSULFATE SODIUM · CAPSULE, GELATIN COATED · Janssen Pharmaceuticals, Inc.
Elmiron (pentosan polysulfate sodium) is an oral medication taken by mouth as a 100 mg capsule to treat bladder pain syndrome, a condition characterized by chronic pain, pressure, or tenderness in the bladder and surrounding areas. It works by coating the bladder lining to help reduce pain and urinary symptoms associated with this condition.
Key Facts
- Brand Name
- ELMIRON
- Generic Name
- PENTOSAN POLYSULFATE SODIUM
- NDC Code (Product)
50458-098- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA020193
- Marketing Start
- 09/26/1996
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Dosage & Administration
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.
Warnings
WARNINGS Retinal Pigmentary Changes Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON ® (see ADVERSE REACTIONS ). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON ® . If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and au…
Contraindications
CONTRAINDICATIONS ELMIRON ® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
Drug Interactions
Drug-Drug Interactions In a study in which healthy subjects received pentosan polysulfate sodium 100 mg capsule or placebo every 8 hours for 7 days, and were titrated with warfarin to an INR of 1.4 to 1.8, the pharmacokinetic parameters of R-warfarin and S-warfarin were similar in the absence and presence of pentosan polysulfate sodium. INR for warfarin + placebo and warfarin + pentosan polysulfate sodium were comparable. See also PRECAUTIONS on the use of ELMIRON ® in patients receiving other therapies with anticoagulant effects.
Adverse Reactions
ADVERSE REACTIONS ELMIRON ® was evaluated in clinical trials in a total of 2627 patients (2343 women, 262 men, 22 unknown) with a mean age of 47 [range 18 to 88 with 581 (22%) over 60 years of age]. Of the 2627 patients, 128 patients were in a 3-month trial and the remaining 2499 patients were in a long-term, unblinded trial. Deaths occurred in 6/2627 (0.2%) patients who received the drug over a period of 3 to 75 months. The deaths appear to be related to other concurrent illnesses or procedures, except in one patient for whom the cause was not known. Serious adverse events occurred in 33/2627 (1.3%) patients. Two patients had severe abdominal pain or diarrhea and dehydration that required hospitalization. Because there was not a control group of patients with interstitial cystitis who were concurrently evaluated, it is difficult to determine which events are associated with ELMIRON ® and which events are associated with concurrent illness, medicine, or other factors. Adverse Experience in Placebo-Controlled Clinical Trials of ELMIRON ® 100 mg Three Times a Day for 3 Months Body System/Adverse Experience ELMIRON ® n=128 Placebo n=130 CNS Overall Number of Patients Within a body sys…
Frequently Asked Questions
What is ELMIRON used for?
Elmiron (pentosan polysulfate sodium) is an oral medication taken by mouth as a 100 mg capsule to treat bladder pain syndrome, a condition characterized by chronic pain, pressure, or tenderness in the bladder and surrounding areas. It works by coating the bladder lining to help reduce pain and urinary symptoms associated with this condition.
Is ELMIRON a controlled substance?
ELMIRON is not classified as a controlled substance by the DEA.
What is the generic name for ELMIRON?
The generic name for ELMIRON is PENTOSAN POLYSULFATE SODIUM. There are no other listed brand versions of PENTOSAN POLYSULFATE SODIUM.
What is the NDC code for ELMIRON 100 mg/1?
The NDC (National Drug Code) for ELMIRON 100 mg/1 is 50458-098, listed by Janssen Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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