Pentosan polysulfate sodium

Pentosan polysulfate sodium Should be taken on an empty stomach.

Active bleeding. Contraindications may vary among countries and between individual products (refer to specific product guidelines).

Patient with retinal pigment changes due to other causes (e.g. retinitis pigmentosa), signs and symptoms of coagulopathy, bleeding disorders (e.g. haemophilia, thrombocytopenia), history of heparin-induced thrombocytopenia, aneurysm, gastrointestinal disease (e.g. gastrointestinal ulcerations, polyps, diverticula). Patients undergoing surgery or invasive procedures prior to administration. Hepatic impairment. Pregnancy and lactation. Concomitant administration with drugs affecting haemostasis (e.g. anticoagulants, NSAIDs, thrombolytics).

Significant: Bleeding complications (e.g. ecchymosis, epistaxis, gum bleeding), rectal haemorrhage, alopecia, retinal pigment changes, including pigmentary maculopathy.
Gastrointestinal disorders: Nausea, enlarged abdomen, abdominal pain, dyspepsia, diarrhoea.
General disorders and administration site conditions: Asthenia, pelvic pain, peripheral oedema.
Infections and infestations: Infections, influenza.
Investigations: Liver function abnormalities.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: Urinary frequency.

PO: Z (Not recommended by some manufacturers.)

Perform ophthalmologic examination (e.g. retinal examinations) at baseline within 6 months from treatment initiation and periodically during treatment. Monitor CBC, urinalysis, aPTT, prothrombin time, LFTs, renal function tests, and serum calcium periodically during treatment in patients receiving long-term therapy.

Symptoms: Bleeding and/or gastrointestinal disturbances.

Management: Symptomatic and supportive treatment. May perform gastric lavage.

May increase risk of haemorrhage with heparin, anticoagulants, antiplatelets (e.g. aspirin), thrombolytic agents (e.g. alteplase), NSAIDs (e.g. celecoxib).

Description:
Overview: Pentosan polysulfate sodium, a semisynthetic, low-molecular-weight heparinoid, is a uroprotective agent with anticoagulant and fibrinolytic effects.
Mechanism of Action: The exact mechanism of action of pentosan polysulfate sodium in the management of interstitial cystitis has not been fully determined; however, it appears to replenish the defective mucosal glycosaminoglycan layer and restore bladder integrity by adhering to the bladder surface. It also acts as a buffer to control cell permeability, thereby preventing irritating substances in the urine from reaching the cells.
Synonym(s): Pentosan polysulphate sodium.
Onset: Pain relief: 6-8 weeks (mild cases); approx 6 months (moderate to severe cases).
Duration: Pain relief: >29 months.
Pharmacokinetics:
Absorption: Slowly absorbed from the gastrointestinal tract. Bioavailability: <1%. Time to peak plasma concentration: 2 hours (range: 0.6-120 hours).
Metabolism: Metabolised in the liver and spleen via partial desulfation and in the kidney via partial depolymerisation.
Excretion: Mainly via faeces (58-84% as unchanged drug); urine (6% mainly as metabolites). Elimination half-life: 20-27 hours.

Store between 15-30°C.

Other Drugs Acting on the Genito-Urinary System

C05BA04 - pentosan polysulfate sodium ; Belongs to the class of heparins or heparinoids used topically in antivaricose therapy.
G04BX15 - pentosan polysulfate sodium ; Belongs to the class of other urologicals.

Brayfield A, Cadart C (eds). Pentosan Polysulfate Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/01/2026.

Elmiron 100 mg Hard Capsules (bene-Arzneimittel GmbH). MHRA. https://products.mhra.gov.uk. Accessed 02/01/2026.

Elmiron Capsule, Gelatin Coated (Janssen Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/01/2026.

Joint Formulary Committee. Pentosan Polysulfate Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/01/2026.

Pentosan Polysulfate Sodium. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/01/2026.

Pentosan Polysulfate Sodium. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/01/2026.

Pentosan. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 02/01/2026.