Elmiron

DRUG DESCRIPTION

Pentosan polysulfate sodium is a semi-synthetically produced heparin-like macro molecular 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 (pentosan polysulfate sodium) structural formula illustration

ELMIRON (pentosan polysulfate sodium capsules) 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 are the possible side effects of pentosan polysulfate sodium (Elmiron)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any easy bruising or unusual bleeding such as:

  • nosebleed;
  • blood in your urine or stools;
  • rectal bleeding;
  • coughing up blood;
  • bleeding gums; or
  • feeling like you might pass out.

Less serious side effects may include:

  • hair...

Read All Potential Side Effects and See Pictures of Elmiron

What are the precautions when taking pentosan polysulfate sodium capsules (Elmiron)?

Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), blood vessel disorders (e.g., aneurysm), liver disease, spleen disorders, stomach/intestinal disorders (e.g., stomach ulcers, polyps, diverticula).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when...

Read All Potential Precautions of Elmiron


Elmiron Consumer (continued)

SIDE EFFECTS: Diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bruising/bleeding (e.g., blood in stool), mental/mood changes, heartburn, discomfort when swallowing.

Tell your doctor immediately if any of these rare but very serious side effects occur: tiredness, fast/pounding heartbeat, signs of infection (e.g., fever, persistent sore throat), shortness of breath, vision changes, eye pain, dark urine, yellowing eyes/skin, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), blood vessel disorders (e.g., aneurysm), liver disease, spleen disorders, stomach/intestinal disorders (e.g., stomach ulcers, polyps, diverticula).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Elmiron Patient Information Including Side Effects

Brand Names: Elmiron

Generic Name: pentosan polysulfate sodium (Pronunciation: PEN toe san POL ee SUL fate SOE dee um)

  • What is pentosan polysulfate sodium (Elmiron)?
  • What are the possible side effects of pentosan polysulfate sodium (Elmiron)?
  • What is the most important information I should know about pentosan polysulfate sodium (Elmiron)?
  • What should I discuss with my healthcare provider before taking pentosan polysulfate sodium (Elmiron)?
  • How should I take pentosan polysulfate sodium (Elmiron)?
  • What happens if I miss a dose (Elmiron)?
  • What happens if I overdose (Elmiron)?
  • What should I avoid while taking pentosan polysulfate sodium (Elmiron)?
  • What other drugs will affect pentosan polysulfate sodium (Elmiron)?
  • Where can I get more information?

What is pentosan polysulfate sodium (Elmiron)?

Pentosan polysulfate sodium works like an anticoagulant (blood thinner) that prevents the formation of blood clots. However, it is used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).

Pentosan polysulfate sodium may also be used for other purposes not listed in this medication guide.

What are the possible side effects of pentosan polysulfate sodium (Elmiron)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any easy bruising or unusual bleeding such as:

  • nosebleed;
  • blood in your urine or stools;
  • rectal bleeding;
  • coughing up blood;
  • bleeding gums; or
  • feeling like you might pass out.

Less serious side effects may include:

  • hair loss;
  • nausea, diarrhea, stomach pain;
  • headache;
  • mild dizziness;
  • depressed mood; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pentosan polysulfate sodium (Elmiron)?

Before taking pentosan polysulfate sodium, tell your doctor if you have a bleeding or blood clotting disorder, a history of aneurysm or stroke, a stomach ulcer, intestinal polyps, diverticulitis, or liver disease.

Take the medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.

Call your doctor at once if you have any easy bruising or unusual bleeding such as nosebleed, blood in your urine or stools, rectal bleeding, coughing up blood, bleeding gums, or feeling like you might pass out.

To be sure this medication is helping your condition, your doctor will need to check your progress every 3 months. This will help your doctor determine how long to treat you with pentosan polysulfate sodium. You may also need blood tests to check for certain side effects. Do not miss any scheduled appointments.

Tell your doctor if you use any other medications that can increase your risk of bleeding, including blood thinners, medications to treat or prevent blood clots, or an NSAID (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), and others.

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