Pentosan Polysulfate Sodium

Pentosan Polysulfate Sodium is a prescription medication used for the relief of bladder pain associated with interstitial cystitis.

• Pentosan Polysulfate Sodium is available under the following different brand names: Elmiron

Common side effects of Pentosan Polysulfate Sodium include:

• Diarrhea,
• Hair loss,
• Nausea,
• Headache,
• Stomach upset or pain,
• Abdominal pain,
• Dizziness,
• Depressed mood, or
• Itching or skin rash.

Serious side effects of Pentosan Polysulfate Sodium include:

• Unusual bruising or bleeding (e.g., blood in stool),
• Mental/mood changes,
• Heartburn, or
• Discomfort when swallowing.

Rare side effects of Pentosan Polysulfate Sodium include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 100 mg

Interstitial Cystitis

Adult dosage

• 100 mg orally every 8 hours
• Administration: 1 hour before or 2 hours after meals with water
• Reassess every 3 Months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pentosan Polysulfate Sodium has no noted severe interactions with any other drugs.
• Pentosan Polysulfate Sodium has no noted serious interactions with any other drugs.
• Pentosan Polysulfate Sodium has no noted moderate interactions with any other drugs.
• Pentosan Polysulfate Sodium has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pentosan Polysulfate Sodium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pentosan Polysulfate Sodium?”

Cautions

• Alopecia is associated with pentosan polysulfate and with heparin products; alopecia began within the first 4 weeks of treatment in clinical trials; ninety-seven percent (97%) of cases of alopecia reported were alopecia areata, limited to a single area on the scalp
• The drug has not been studied in patients with hepatic insufficiency; because there is evidence of hepatic contribution to the elimination of the drug, hepatic impairment may have an impact on the pharmacokinetics of the drug; exercise caution when using the drug in this patient population
• Retinal pigmentary changes
  • Pigmentary changes in the retina, reported as pigmentary maculopathy, identified with long-term use of the drug
  • Although most 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 reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision
  • Visual consequences of pigmentary changes are not fully characterized
  • Use caution in patients with retinal pigment changes from other causes in which examination findings may confound appropriate diagnosis, follow-up, and treatment
  • Obtain detailed ophthalmologic history in all patients before starting treatment; consider testing if there is a family history of hereditary pattern dystrophy, genetic
  • For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended before starting therapy
  • A baseline retinal examination (including OCT and autofluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment; if pigment try changes in the retina develop, re-evaluate the risks and benefits of continuing treatment, since these changes may be irreversible
  • Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment
• Anticoagulant effects
  • The drug is a weak anticoagulant (1/15 the activity of heparin) At a daily dose of 300 mg (n=128), rectal hemorrhage was reported as an adverse event in 6.3% of patients
  • Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage reported
  • Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, tPA, streptokinase, high-dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage.
  • Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting therapy
  • Exercise caution when administering therapy in patients who have a history of heparin-induced thrombocytopenia

Pregnancy and Lactation

• May be acceptable during pregnancy.
• Lactation
  • Not known if excreted in breast milk, use caution