Pentosan polysulfate sodium


Concise Prescribing Info
Indications/Uses
Interstitial cystitis.
Dosage/Direction for Use
Adult : PO 100 mg tid for 3 months.
Dosage Details
Oral
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.
Administration
Should be taken on an empty stomach. Take at least 1 hr before or 2 hr after meals.
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.
MonitoringParameters
Monitor CBC, aPTT, prothrombin time, serum Ca, LFT, renal function tests.
Overdosage
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.
Action
Description: 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).
Pharmacokinetics:
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.
Storage
Store between 15-30°C.
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.
References
Anon. Pentosan Polysulfate Sodium. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/10/2017.

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

Elmiron Capsule, Gelatin Coated (Janssen Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. 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). https://www.medicinescomplete.com. Accessed 05/10/2017.

Disclaimer: This information is independently developed by MIMS based on Pentosan polysulfate sodium from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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