Pentosan
Brand names: Elmiron
Drug class:
Antineoplastic Agents
Usage of Pentosan
Interstitial Cystitis
Symptomatic relief of bladder pain or discomfort associated with interstitial cystitis; designated an orphan drug by FDA for this use.
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How to use Pentosan
Administration
Oral Administration
Administer with water ≥1 hour before or 2 hours after meals.
Dosage
Available as Pentosan polysulfate sodium; dosage expressed in terms of the salt.
Adults
Interstitial Cystitis Oral100 mg 3 times daily for 3 months. If after 3 months no improvement and no dose-limiting adverse effects occur, may continue therapy for another 3 months.
Manufacturer states that if no improvement of pain is observed by 6 months, the clinical benefits and risks of continued therapy are unknown. However, data from a long-term clinical study indicate overall continued symptomatic improvement (e.g., pain, urgency, urinary frequency, nocturia) during 1–2 years of therapy.
Some clinicians recommend a dosage of 200 mg twice daily† [off-label]; this dosage appears to be effective and promotes greater patient compliance.
Special Populations
Hepatic Impairment
No specific dosage recommendations. (See Hepatic Impairment under Cautions.)
Renal Impairment
No specific dosage recommendations.
Geriatric Patients
No specific dosage recommendations.
Warnings
Contraindications
Warnings/Precautions
Hematologic Effects
Pentosan polysulfate is weak anticoagulant.
Rectal hemorrhage and bleeding complications of ecchymosis, epistaxis, and gum hemorrhage reported.
Evaluate patients at increased risk for hemorrhage including those undergoing invasive procedures, with signs and symptoms of coagulopathy, or receiving concomitant drugs that affect hemostasis. (See Specific Drugs under Interactions.)
Delayed immunoallergic thrombocytopenia similar to heparin-induced thrombocytopenia with symptoms of thrombosis and hemorrhage reported with sub-Q, IM, or sublingual administration of a different formulation of pentosan polysulfate.
Use with caution in patients with history of heparin-induced thrombocytopenia. Carefully evaluate patients with thrombocytopenia prior to initiation of therapy.
Thrombocytopenia and elevations in PT and partial thromboplastin time (PTT) reported in patients with elevated liver function test results. Such effects not observed in healthy men receiving ≤1.2 g of pentosan polysulfate sodium daily (a dosage greater than the recommended 100 mg 3 times daily) for 8 days.
Concomitant Illnesses
Carefully evaluate patients with diseases such as aneurysms, hemophilia, GI ulcerations, polyps, or diverticula prior to initiation of therapy.
Hepatic Effects
Mild and usually transient elevations (<2.5 times ULN) of serum aminotransferases, alkaline phosphatase, γ-glutamyl transpeptidase, and LDH concentrations reported in about 1.2% of patients. Such abnormalities usually occur 3–12 months after initiation of therapy and generally not associated with jaundice or other clinical signs and symptoms. These elevations may remain unchanged or rarely progress with continued use.
Alopecia
Alopecia, primarily alopecia areata (limited to single area on scalp), reported; may occur within first 4 weeks of initiation of therapy.
Specific Populations
PregnancyCategory B.
LactationNot known whether pentosan polysulfate is distributed into milk. Use with caution in nursing women.
Pediatric UseSafety and efficacy in pediatric patients <16 years of age not established.
Hepatic ImpairmentUse with caution. Not evaluated in patients with hepatic impairment. (See Hepatic Effects under Cautions.)
Hepatic impairment might alter pharmacokinetics; pentosan polysulfate is metabolized in the liver. (See Metabolism under Pharmacokinetics.)
Common Adverse Effects
Rectal hemorrhage, alopecia, diarrhea, nausea, headache, blood in stool, rash, dyspepsia, abdominal pain, abnormal liver function tests, dizziness, bruising.
What other drugs will affect Pentosan
Drugs that Affect Hemostasis
Potential increased risk of hemorrhage with concurrent use of drugs that affect hemostasis.
Monitor for hemorrhage during concurrent administration.
Specific Drugs
Drug
Interaction
Comments
Anticoagulants, oral
Increased risk of bleeding
No effects on pharmacokinetics of R- or S-warfarin or INR
Monitor for hemorrhage
Heparin
Increased risk of bleeding
Monitor for hemorrhage
NSAIAs
Increased risk of bleeding with aspirin (high dosages) and other NSAIAs
Monitor for hemorrhage
Thrombolytic agents (e.g., alteplase)
Increased risk of bleeding
Monitor for hemorrhage
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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