No

Analgesic, Urinary

Relief of bladder pain or discomfort due to interstitial cystitis

B

Hypersensitivity to pentosan polysulfate sodium or any component

Pentosan polysulfate is a low-molecular weight heparin-like compound with anticoagulant and fibrinolytic effects, therefore, bleeding complications such as ecchymosis, epistaxis and gum bleeding, may occur; patients with the following diseases should be carefully evaluated before initiating therapy: aneurysm, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, diverticula, or hepatic insufficiency; patients undergoing invasive procedures or having signs or symptoms of underlying coagulopathies or other increased risk of bleeding (eg, receiving heparin, warfarin, thrombolytics, or high dose aspirin) should be evaluated for hemorrhage; elevations in transaminases and alopecia can occur

1% to 10%:

Central nervous system: Headache, dizziness

Dermatologic: Alopecia, rash

Gastrointestinal: Diarrhea, nausea, dyspepsia, abdominal pain

Hepatic: Liver function test abnormalities

<1%: Pruritus, urticaria, photosensitivity, bruising, vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, anorexia, gum bleeding, anemia, prolonged PT, increased partial thromboplastin time, leukopenia, thrombocytopenia, conjunctivitis, optic neuritis, amblyopia, retinal hemorrhage, tinnitus, pharyngitis, rhinitis, epistaxis, dyspnea, allergic reactions

Overdosage has not been reported; based on the pharmacodynamics, toxicity is likely to include anticoagulation, bleeding, thrombocytopenia, liver function abnormalities and gastric distress

Gastric lavage along with symptomatic and supportive therapy is recommended

Although there is no information about potential drug interactions, it is expected that pentosan polysulfate sodium would have at least additive anticoagulant effects when administered with anticoagulant drugs such as warfarin or heparin, and possible similar effects when administered with aspirin or thrombolytics

Although pentosan polysulfate sodium is a low-molecular weight heparinoid, it is not known whether these properties play a role in its mechanism of action in treating interstitial cystitis; the drug appears to adhere to the bladder wall mucosa where it may act as a buffer to protect the tissues from irritating substances in the urine.

Absorption: ~3%

Metabolism: In the liver and spleen

Half-life: 4.8 hours

Elimination: In urine, 3% unchanged drug

Adults: Oral: 100 mg 3 times/day taken with water 1 hour before or 2 hours after meals

May cause dizziness

May cause anemia and leukopenia; use caution with clozapine and carbamazepine

No information available to require special precautions

<1% of patients experience gum bleeding, mouth ulcers

Patients should be advised to take the medication as prescribed and no more frequently; tell patients about the slight anticoagulant effects and the potential for increased bleeding; until more is known about drug interactions, carefully monitor the medication profile of patients receiving pentosan polysulfate sodium for drugs that might increase the anticoagulant effects

Capsule: 100 mg