Pentosan Polysulfate Sodium

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 purposes not listed in this medication guide.

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

Contraindications

• Known hypersensitivity to pentosan polysulfate, structurally related compounds, or any ingredient in formulation.1

Warnings/Precautions

Hematologic Effects

Pentosan polysulfate is weak anticoagulant.1 11

Rectal hemorrhage and bleeding complications of ecchymosis, epistaxis, and gum hemorrhage reported.1

Evaluate patients at increased risk for hemorrhage including those undergoing invasive procedures, with signs and symptoms of coagulopathy, or receiving concomitant drugs that affect hemostasis.1 (See Specific Drugs under Interactions.)

Delayed immunoallergic thrombocytopenia similar to heparin-induced thrombocytopenia with symptoms of thrombosis and hemorrhage reported with sub-Q, IM, or sublingual administration of a different formulation of pentosan polysulfate.1 13

Use with caution in patients with history of heparin-induced thrombocytopenia.1 Carefully evaluate patients with thrombocytopenia prior to initiation of therapy.1

Thrombocytopenia and elevations in PT and partial thromboplastin time (PTT) reported in patients with elevated liver function test results.1 10 Such effects not observed in healthy men receiving ≤1.2 g of pentosan polysulfate sodium daily (a dosage greater than the recommended 100 mg 3 times daily) for 8 days.1

Concomitant Illnesses

Carefully evaluate patients with diseases such as aneurysms, hemophilia, GI ulcerations, polyps, or diverticula prior to initiation of therapy.1

Hepatic Effects

Mild and usually transient elevations (<2.5 times ULN) of serum aminotransferases, alkaline phosphatase, γ-glutamyl transpeptidase, and LDH concentrations reported in about 1.2% of patients.1 Such abnormalities usually occur 3–12 months after initiation of therapy and generally not associated with jaundice or other clinical signs and symptoms.1 These elevations may remain unchanged or rarely progress with continued use.1

Alopecia

Alopecia, primarily alopecia areata (limited to single area on scalp), reported; may occur within first 4 weeks of initiation of therapy.1

Specific Populations

Category B.1

Not known whether pentosan polysulfate is distributed into milk.1 Use with caution in nursing women.1

Safety and efficacy in pediatric patients <16 years of age not established.1

Use with caution.1 Not evaluated in patients with hepatic impairment.1 (See Hepatic Effects under Cautions.)

Hepatic impairment might alter pharmacokinetics; pentosan polysulfate is metabolized in the liver.1 (See Metabolism under Pharmacokinetics.)

Common Adverse Effects

Rectal hemorrhage,1 alopecia,1 7 9 diarrhea,1 7 9 nausea,1 2 7 9 headache,5 7 9 blood in stool,9 rash,1 5 7 9 dyspepsia,1 7 9 abdominal pain,1 7 abnormal liver function tests,1 7 9 dizziness,1 7 9 bruising.9

Drugs that Affect Hemostasis

Potential increased risk of hemorrhage with concurrent use of drugs that affect hemostasis.1 12

Monitor for hemorrhage during concurrent administration.1 5

Specific Drugs

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Chills
• difficulty in breathing
• fever
• skin rash or hives
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision impairment

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal pain
• bleeding gums
• constipation
• diarrhea
• difficulty or pain upon swallowing
• dizziness
• dryness of throat
• hair loss
• headache
• heartburn
• increased sensitivity of skin to sunlight
• irritated or red eyes
• itching
• loss of appetite
• nausea
• nosebleed
• ringing in the ears
• runny nose
• sores in mouth
• stomach gas
• stomach upset
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use pentosan polysulfate sodium as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Take with a full glass of water.
• Follow up with your doctor after using this medicine for 3 months.
• To gain the most benefit, do not miss doses.
• Keep taking pentosan polysulfate sodium as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Relief of bladder pain or discomfort due to interstitial cystitis

Hypersensitivity to pentosan polysulfate sodium, related compounds (LMWHs or heparin), or any component of the formulation

Should be administered with water 1 hour before or 2 hours after meals.

Store at room temperature of 15°C to 30°C (59°F to 86°F).

Data not available