Generic
Pentosan Polysulfate Sodium
3 brands available in the market
At a glance
Pentosan Polysulfate Sodium is used for the relief of bladder pain or discomfort associated with interstitial cystitis. It is a polymer of xylose hydrogen sulfate that binds Fibroblast growth factors (FGFs) and other heparin-binding growth factors.
Description
Pentosan Polysulfate Sodium is a polymer of xylose hydrogen sulfate containing two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It interacts with the heparin-binding site of FGFR-1 and inhibits growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.
Indications
- Bladder pain or discomfort associated with interstitial cystitis
Therapeutic class
Other genito-urinary preparations
Pharmacological class
Heparin-like Polymer
Pharmacology
Pentosan Polysulfate Sodium is a heparin-like polymer that binds Fibroblast growth factors (FGFs) and other heparin-binding growth factors. It forms a protective layer on the bladder wall and reduces inflammation.
Mechanism of action
Forms a protective layer on the bladder wall and inhibits tumor growth and angiogenesis by binding to FGF.
Dosage
Adult Dose (Oral):
- Recommended dose: 300 mg/day (100 mg capsule three times daily)
- Take with water at least 1 hour before or 2 hours after meals
- Reassess after 3 months; may continue for another 3 months if no improvement
- Clinical value of continued treatment beyond 6 months in non-responders is unknown
Pediatric Dose: Safety and efficacy not established in children under 16 years.
Administration
- Take with water at least 1 hour before or 2 hours after meals
- Follow the prescribed dose
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Side Effects:
- Rectal hemorrhage (6.3% of patients at 300 mg/day)
- Ecchymosis
- Epistaxis
- Gum hemorrhage
- Alopecia (97% alopecia areata; begins within first 4 weeks of treatment)
- Elevated liver enzymes (at higher doses)
Precautions & warnings
- Weak anticoagulant (1/15 activity of heparin)
- Evaluate patients undergoing invasive procedures or with underlying coagulopathy or increased bleeding risk
- Caution in patients with aneurysms, thrombocytopenia, hemophilia, GI ulcerations, polyps, or diverticula
- Caution in history of heparin-induced thrombocytopenia
- Similar product given subcutaneously/sublingually/IM is associated with delayed immunoallergic thrombocytopenia
Contraindications
- Hypersensitivity to Pentosan Polysulfate Sodium, structurally related compounds, or excipients
Drug interactions
- Warfarin: No significant effect on INR; however, caution required
Food interactions
Take with water at least 1 hour before or 2 hours after meals; food may affect absorption.
Use in pregnancy
Use in Pregnancy: Animal studies showed no evidence of impaired fertility or fetal harm; however, adequate human studies not available; use only if clearly needed.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Unknown if excreted in human milk; caution required.
Pediatric use
Safety and efficacy not established in children under 16 years.
Geriatric use
Caution required in elderly patients; consult your doctor.
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; dose adjustment may be needed; consult your doctor.
Hepatic Impairment: Caution in liver disease; dose adjustment may be needed; consult your doctor.
Overdose effects
Overdose has not been reported; toxicity may manifest as anticoagulation, bleeding, thrombocytopenia, liver function abnormalities, and gastric distress. In acute overdose, gastric lavage and symptomatic/supportive treatment.
Storage conditions
Store below 30°C, away from light and moisture; keep out of reach of children.
Chemical structure
Pentosan Polysulfate Sodium