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Elmiron

Generic name: pentosan polysulfate sodium
Drug class: Miscellaneous genitourinary tract agents

Medically reviewed by  A Ras MD.

What is Elmiron?

Elmiron is used to treat the pain or discomfort of interstitial cystitis (IC). It is not known exactly how Elmiron works, but it is not a pain medication like aspirin or acetaminophen and therefore must be taken continuously for relief as prescribed.

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:

Chemical Structure

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.

What is the most important information I should know about Elmiron?

Elmiron is used to treat the pain or discomfort of interstitial cystitis (IC).

You must take Elmiron as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed.

Elmiron is a weak anticoagulant (blood thinner) which may increase bleeding.

Call your doctor if you will be undergoing surgery or will begin taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.

Who should not take Elmiron?

  • Patients undergoing surgery should speak with their doctor about when to discontinue Elmiron prior to surgery.
  • Elmiron should be used during pregnancy only if clearly needed.

What should I tell my healthcare provider before taking Elmiron?

  • If you are taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.
  • If you are pregnant.
  • If you have any liver problems.

How should I take Elmiron?

You should take 1 capsule of Elmiron by mouth three times a day, with water at least 1 hour before meals or 2 hours after meals. Each capsule contains 100 mg of Elmiron.

What should I avoid while taking Elmiron?

Anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin or anti-inflammatory drugs such as ibuprofen until you speak with your doctor.

What are the possible side effects of Elmiron?

The most common side effects are hair loss, diarrhea, nausea, blood in the stool, headache, rash, upset stomach, abnormal liver function tests, dizziness and bruising. Weight gain and swelling caused by fluid build up in the body have also been reported in patients taking Elmiron.

Call your doctor if these side effects persist or are bothersome or if there is blood in your stool.If you suspect that someone may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately.

General information about the safe and effective use of Elmiron

This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

This leaflet provides a summary of information about Elmiron. Medicines are sometimes prescribed for uses other than those listed in a Patient Leaflet. If you have any questions or concerns, or want more information about Elmiron, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Elmiron that is written for health professionals that you can ask to read.

How should I store Elmiron?

Store at controlled room temperature 15°–30°C (59°–86°F).

Keep out of reach of children.

What are the ingredients in Elmiron?

Active ingredient: pentosan polysulfate sodium

Inactive ingredients: microcrystalline cellulose, magnesium stearate, ferrosoferric oxide, FD&C blue no. 2, aluminum oxide, FD&C red no. 40, FD&C blue no. 1, D&C yellow no. 10, butyl alcohol, propylene glycol, titanium dioxide

Label

PRINCIPAL DISPLAY PANEL – 100 MG CAPSULE BOTTLE LABEL

  • NDC 50458-098-01
  • pentosan polysulfate sodium)
  • CELMIRON®
    (APSULES
  • 100 mg
  • Attention: Dispense the enclosed
    Medication Guide to each patient.
  • Each capsule contains 100 mg
    pentosan polysulfate sodium.
  • Rx only
  • 100 Capsules
  • janssen
  • PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

 

Imprint BNP 7600 BNP 7600 - Elmiron 100 mg

SRC: NLM .

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