pentosan polysulfate sodium (Rx)

1-10%

Alopecia (4%)

Diarrhea (4%)

Nausea (4%)

Headache (3%)

Abdominal pain (2%)

Indigestion (2%)

Postmarketing Reports

Rectal hemorrhage

Elevated LFTs

Anemia

Leukopenia

Partial thromboplastin time increased

Prothrombin time increased

Thrombocytopenia

Optic neuritis

Retinal hemorrhage

Contraindications

Hypersensitivity

Cautions

Hepatic or splenic disorders

Bleeding diathesis

Risk of alopecia

Pregnancy Category: B

Lactation: not known if excreted in breast milk, use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Low molecular weight heparin-like compound; elicits weak anticoagulant (1/15 activity of heparin) and fibrinolytic effects

MOA in cystitis unknown; drug appears to attach to the bladder wall mucosa where it may act as a buffer to protect tissues from irritating substances in the urine

Pharmacokinetics

Absorption: 6%

Half-Life, Elimination: 4.8 hr

Distribution: Uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow

Metabolism: Spleen and liver; partial depolymerization in the kidney to a large number of metabolites

Excretion: Feces (58% as unchanged drug) Urine (6% primarily as metabolites)