Elmiron (Pentosan Polysulfate Sodium)

Prescription Required
Brand
Dose Size & Price Qty
100mg
Generic
Dose Size & Price Qty
100mg
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Fact Table

Fact Table
Formula (C5H8O5S)n · xNa
License FDA approved (1996); EMA approved
Bioavailability ~3–6% (oral)
Legal status Prescription only (Rx)
Chemical Name Pentosan polysulfate sodium (semi-synthetic sulfated polysaccharide)
Elimination half-life ~20–27 hours
Dosage (Strength) 100 mg oral capsules (typically 100 mg three times daily)
Pregnancy Category B – Use only if clearly needed
Brands Elmiron®
Protein binding Low (minimal plasma protein binding)
PubChem CID 161324
MedlinePlus a601098
ChEBI 28088
ATC code G04BX01
DrugBank DB00686
KEGG D00560
Routes of administration By mouth (oral capsules)

Elmiron is a semi-synthetic medicine similar in structure to natural sugars found in the body called glycosaminoglycans. The exact way in which Elmiron works isn’t fully known, but it’s been shown to have blood-thinning and clot-dissolving effects. Elmiron is used to reduce pain and discomfort in people with interstitial cystitis, a condition that causes chronic bladder irritation and inflammation.

Directions

Take Elmiron with a full glass of water on an empty stomach, at least 1 hour before or 2 hours after eating a meal. The standard dosage is 300 mg daily, taken as one 100 mg capsule 3 times per day.

Swallow the capsules whole and not crush, chew, or break them open. Treatment may need to continue for up to 6 months before symptoms improve, though some patients may see relief earlier.

If a dose is missed, patients should take it as soon as they remember unless it's nearly time for the next scheduled dose. In that case, they should skip the missed dose and continue with the regular dosing schedule. Patients shouldn't take 2 doses at once to make up for a missed one.

Ingredients

The active ingredient in this drug is pentosan polysulfate sodium.

Cautions

  • Before using this medication, you may want to consult a healthcare provider about the following:
    • Any existing health conditions
    • Any allergies
    • A list of all medications currently being taken
  • Elmiron has been linked to pigment changes in the back of the eye, which may affect vision. These changes tend to happen with long-term use, so doctors usually check your eyes before you start treatment and periodically after.
  • Some people develop symptoms like trouble seeing in low light, blurred vision, or difficulty reading. If any vision changes appear, your doctor may reconsider whether you should keep taking the medication.
  • Elmiron has a mild blood-thinning effect, so it can increase the chance of bleeding or bruising. People with bleeding risks or who take other blood-thinning medicines may need extra monitoring.
  • Hair thinning (usually in a small patch) has been reported, often within the first month of treatment. This side effect is usually mild but should be reported if it's concerning.
  • Elmiron hasn't been well-studied in people with liver problems, and liver tests may occasionally rise during treatment. Your doctor may monitor liver function if needed.
  • Tell your doctor if you notice unusual bleeding, bruising, or any vision changes. Regular eye exams, including retinal imaging, are recommended during long-term use.
  • Elmiron hasn't been shown to cause cancer in animal studies and doesn't appear to damage DNA. Its effects on male fertility haven't been fully studied.
  • Use during pregnancy or breastfeeding should only occur if clearly needed because safety is not fully known. Elmiron is not recommended for children under 16.

Contraindications

Avoid taking or using this medication if any of the following apply:

  • Known hypersensitivity to pentosan polysulfate sodium
  • Sensitivity to any of the excipients or other ingredients in the drug

Side Effects

Common side effects of Elmiron include:

  • Hair loss
  • Diarrhea
  • Nausea
  • Stomach pain or upset stomach
  • Headache
  • Dizziness
  • Rash
  • Abnormal liver function tests

These side effects are usually mild and may improve as the body gets used to the medication. Digestive side effects like nausea or stomach discomfort are among the most frequently reported, with some people noticing temporary hair thinning. Let your healthcare provider know if any symptoms become bothersome or do not go away.

More serious reactions can occur, including changes in the retina that may affect vision and an increased risk of bleeding. Because these effects can develop gradually, regular eye exams and monitoring are important while taking Elmiron. Seek medical attention right away if you notice vision changes, unusual bruising or bleeding, or any symptoms that concern you.

Frequently Asked Questions about Elmiron (Pentosan Polysulfate Sodium)


What is Elmiron used for?

Elmiron is primarily prescribed to treat bladder pain or discomfort associated with interstitial cystitis (IC), a chronic condition affecting the bladder lining. It helps relieve symptoms like urinary urgency, frequency, and pelvic pain by forming a protective layer on the bladder wall.


How does Elmiron work?

Elmiron is thought to act as a synthetic substitute for the bladder’s protective mucous lining. By coating the bladder wall, it may prevent irritating substances in urine from reaching and damaging the bladder tissue, thus reducing pain and inflammation over time.


How long does it take for Elmiron to work?

Elmiron does not provide immediate relief. It may take several weeks to a few months of consistent use (often 3 to 6 months) before noticeable improvement occurs. Patients are usually advised to continue the medication for at least six months before assessing its full effect.


What is the typical dosage for Elmiron?

The usual adult dose is 100 mg taken orally three times daily. It should be taken on an empty stomach, at least one hour before or two hours after meals, unless otherwise directed by a healthcare provider.


What are the common side effects of Elmiron?

Common side effects may include nausea, diarrhea, headache, abdominal pain, and hair loss. These symptoms are typically mild, but patients should report any unusual or persistent issues to their doctor.


Can Elmiron cause serious side effects?

Yes, although rare, serious side effects have been reported. The most concerning is pigmentary maculopathy, a type of eye damage that may affect vision. Long-term use of Elmiron has been associated with changes in the retina, so regular eye exams are recommended.


Is vision loss from Elmiron permanent?

In some cases, retinal changes linked to Elmiron use may be irreversible, even after stopping the medication. Early detection through routine eye exams can help manage risks. Patients should promptly report symptoms like blurry vision, difficulty reading, or dark spots in vision.


Who should not take Elmiron?

Elmiron should not be used by individuals with known hypersensitivity to pentosan polysulfate sodium. Caution is also advised in patients with bleeding disorders, liver dysfunction, or a history of eye conditions, as the drug may increase bleeding risk and affect vision.


Can Elmiron interact with other medications?

Yes, Elmiron has mild anticoagulant (blood-thinning) properties and may interact with medications that affect blood clotting, such as aspirin, NSAIDs, warfarin, or heparin. Always inform your healthcare provider of all medications and supplements you are taking.


Is Elmiron safe during pregnancy or breastfeeding?

The safety of Elmiron during pregnancy or breastfeeding has not been fully established. It should be used during pregnancy only if clearly needed and prescribed by a healthcare provider. Nursing mothers should consult their doctor to weigh potential risks and benefits.

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