Pentosan polysulfate sodium

Generic Medicine Info
Indications and Dosage
Interstitial cystitis
Adult: 100 mg tid for 3 months. If no improvement and dose-limiting adverse effect after 3rd months, continue for another 3 months.
Should be taken on an empty stomach.
Special Precautions
Patient w/ signs/symptoms of coagulopathy, bleeding disorder (e.g. haemophilia, thrombocytopenia), aneurysm, GI disease (e.g. GI ulcerations, diverticula, polyps), heparin-induced thrombocytopenia; to undergo invasive procedures. Hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Rectal haemorrhage, bleeding complications (e.g. ecchymosis, epistaxis, gum haemorrhage), alopecia; abnormal LFT.
Nervous: Headache, dizziness, insomnia, depression, hyperkinesia.
GI: Diarrhoea, nausea, abdominal pain, dyspepsia, vomiting, mouth ulcer, colitis, esophagitis, flatulence, constipation, anorexia.
Resp: Pharyngitis, rhinitis, dyspnoea.
Dermatologic: Skin rash, pruritus, urticaria.
Monitoring Parameters
Monitor CBC, aPTT, prothrombin time, serum Ca, LFT, renal function tests.
Symptoms: Anticoagulation, bleeding, thrombocytopenia, liver function abnormalities and gastric distress. Management: Symptomatic and supportive therapy. Perform gastric lavage.
Drug Interactions
Increased risk of bleeding w/ oral anticoagulants, heparin, NSAIDs, streptokinase, tissue plasminogen activator.
Mechanism of Action: Pentosan polysulfate sodium, a semisynthetic low molecular wt heparinoid, has anticoagulant activity by inhibiting formation of activated factor Xa and fibrinolytic properties by mobilising plasminogen activator (tPA). It acts as a uroprotective agent by binding to and coating the transitional epithelium of the bladder and by acting as a buffer to protect the epithelium from irritating substances in the urine. It also has a hypolipidaemic and anti-inflammatory effect.
Onset: W/in 6-8 wk (pain relief in mild cases); approx 6 mth (pain relief in moderate to severe cases).
Duration: >29 mth (pain relief).
Absorption: Absorbed from the GI tract. Time to peak plasma concentration: 2 hr. Bioavailability: Approx 6%.
Metabolism: Metabolised in the liver and spleen by partial desulfation and in the kidney by partial depolymerisation.
Excretion: Mainly via faeces (58-84%, as unchanged drug); urine (6%, mainly as desulfated and depolymerised metabolites). Elimination half-life: 20-27 hr.
Store between 15-30°C.
MIMS Class
Other Drugs Acting on the Genito-Urinary System
ATC Classification
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.
Anon. Pentosan Polysulfate Sodium. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 05/10/2017.

Buckingham R (ed). Pentosan Polysulfate Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 05/10/2017.

Elmiron Capsule, Gelatin Coated (Janssen Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. Accessed 05/10/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Pentosan Polysulfate Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). Accessed 05/10/2017.

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