ELMIRON®100mg (100 capsules)

ELMIRON® contains pentosan polysulfate sodium, a low molecular weight heparin-like compound. It is available as 100mg capsules for oral administration.

Indications

ELMIRON is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis (IC).

Dosage and Administration

The recommended dosage is 300mg per day taken as one 100mg capsule orally three times daily. Elmiron should be taken on an empty stomach, at least 1 hour before or 2 hours after meals. The dosage can be increased to 600mg/day for patients who do not respond adequately. Treatment for at least 6 months may be needed to achieve efficacy.

Contraindications

ELMIRON is contraindicated in patients with known hypersensitivity to pentosan polysulfate sodium or any components of the formulation.

Warnings and Precautions

– Pigment changes in the retina have been reported with long term use. Eye examinations are recommended at 6 month intervals.

– ELMIRON may increase anticoagulant activity. Patients on anticoagulant therapy require close monitoring.

Adverse Reactions

The most common side effects are hair loss, diarrhea, nausea, headache, rash, upset stomach, abnormal liver function tests, dizziness and bruising.

Drug Interactions

Use caution when administering ELMIRON with other products that affect bleeding. Concurrent use of pentosan polysulfate sodium with anticoagulants, platelet inhibitors, or thrombolytic agents may increase risk of bleeding.

Storage and Handling

Store ELMIRON capsules at controlled room temperature 20°C to 25°C (68°F to 77°F).