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brand elmiron 100 mg capsule

In stock Manufacturer JANSSEN PHARM. 50458009801
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Uses

Interstitial Cystitis

Pentosan polysulfate sodium is used for the symptomatic relief of bladder pain or discomfort associated with interstitial cystitis; the drug has been designated an orphan drug by FDA for this use.

In a randomized, blinded, placebo-controlled study in 151 patients (approximately 96% women; mean age of 44 years) with chronic interstitial cystitis, greater than 50% improvement in bladder pain was reported by a greater proportion of patients receiving pentosan polysulfate sodium (100 mg 3 times daily for 3 months) compared with those receiving placebo (38 versus 18%).

Pentosan polysulfate sodium also has been evaluated in a prospectively designed retrospective analysis of data for 2499 patients (approximately 89% women, mean age of 47 years, 23% of patients older than 60 years of age) with chronic interstitial cystitis who received pentosan polysulfate sodium (300 mg daily) in an open-label unblinded manner. Unblinded evaluations were performed every 3 months and included the patient's rating of the overall change in pain (based on a 6-point scale assessing the patient's recollection of the difference between current and baseline pain) and the change from baseline in pain/discomfort score (based on a 3-point scale). Baseline pain/discomfort scores indicated the presence of severe or unbearable, moderate, or mild or no pain in 60, 33, or 7%, respectively, of patients in the original treatment group. By 3 months, 52% of patients had withdrawn from the study or were ineligible for evaluation; 48, 36, or 24% of patients in the original treatment group received pentosan polysulfate sodium for 3 months, 6 months, or 1 year, respectively. At 3 months, 29% of patients in the original treatment group had pain/discomfort scores that were improved by 1 or 2 categories. At 6 months, pain/discomfort scores were improved by 1 or 2 categories in an additional 5% of patients in the original treatment group; after 6 months, the proportion of patients in the original treatment group reporting first onset of pain relief was less than 1.5%. The median patient rating of overall change in pain corresponded to slight improvement at 3 months and moderate improvement at 6 months.

Patients enrolled in both of these studies met National Institutes of Health criteria for interstitial cystitis based on cystoscopic, cytologic, and biopsy findings.

Dosage and Administration

Administration

Pentosan polysulfate sodium is administered orally with water at least 1 hour before or 2 hours after meals.

Dosage

Interstitial Cystitis

The recommended adult dosage of pentosan polysulfate sodium for the symptomatic treatment of interstitial cystitis is 100 mg 3 times daily for 3 months. If after 3 months improvement has not occurred and there are no dose-limiting adverse effects, therapy may be continued for another 3 months.

The manufacturer of pentosan polysulfate sodium 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 that overall continued symptomatic improvement (e.g., pain, urgency, urinary frequency, nocturia) has been observed in patients treated with pentosan polysulfate sodium during 1-2 years of therapy.

Some clinicians recommend a pentosan polysulfate sodium dosage of 200 mg twice daily; this dosage appears to be effective and promotes greater patient compliance.

Special Populations

The manufacturer makes no specific dosage recommendations for geriatric patients or patients with renal or hepatic impairment.(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Cautions

Contraindications

Pentosan polysulfate sodium is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or any ingredient in the formulation.

Warnings/Precautions

Hematologic Effects

Pentosan polysulfate sodium is a weak anticoagulant. Rectal hemorrhage and bleeding complications of ecchymosis, epistaxis, and gum hemorrhage have been reported in patients receiving the drug.

Patients at increased risk for hemorrhage, including those undergoing invasive procedures, with signs and symptoms of coagulopathy, or receiving concomitant drugs that affect hemostasis, should be evaluated for hemorrhage during pentosan polysulfate sodium therapy.(See Drug Interactions.)

Delayed immunoallergic thrombocytopenia similar to heparin-induced thrombocytopenia with symptoms of thrombosis and hemorrhage has been reported with subcutaneous, IM, or sublingual administration of a different formulation of pentosan polysulfate. Pentosan polysulfate sodium should be used with caution in patients with a history of heparin-induced thrombocytopenia. Patients with thrombocytopenia should be evaluated carefully prior to initiation of pentosan polysulfate sodium therapy.

Thrombocytopenia and elevations in prothrombin time (PT) and partial thromboplastin time (PTT) have been reported in patients with elevated liver function test results. Such effects were not observed in healthy men receiving 1.2 g or less of pentosan polysulfate sodium daily (a dosage greater than the recommended 100 mg 3 times daily) for 8 days.

Concomitant Illnesses

Patients with diseases such as aneurysms, hemophilia, GI ulcerations, polyps, or diverticula should be evaluated carefully prior to initiation of pentosan polysulfate sodium therapy.

Hepatic Effects

Mild and usually transient elevations (less than 2.5 times the upper limit of normal [ULN]) of serum aminotransferase, alkaline phosphatase, γ-glutamyl transpeptidase (γ-glutamyl transpeptidase, GGTP), and LDH concentrations have been reported in about 1.2% of patients receiving pentosan polysulfate sodium. Such abnormalities usually occur 3-12 months after the initiation of therapy and generally are not associated with jaundice or other clinical signs and symptoms. These elevations may remain unchanged or rarely may progress with continued use.

Alopecia

Alopecia, primarily alopecia areata (limited to a single area on the scalp), has been reported in patients receiving pentosan polysulfate sodium, and may occur within the first 4 weeks of initiation of therapy.

Specific Populations

Pregnancy

Category B.

Lactation

It is not known whether pentosan polysulfate sodium is distributed into milk. The drug should be used with caution in nursing women.

Pediatric Use

Safety and efficacy of pentosan polysulfate sodium in pediatric patients younger than 16 years of age have not been established.

Hepatic Impairment

Pentosan polysulfate sodium should be used with caution in patients with hepatic impairment. The drug has not been evaluated in this patient population. Because pentosan polysulfate sodium undergoes hepatic metabolism, hepatic impairment might alter the pharmacokinetics of the drug.(See Hepatic Effects under Cautions: Warnings/Precautions.)

Common Adverse Effects

The most common adverse effects of pentosan polysulfate sodium include rectal hemorrhage, alopecia, diarrhea, nausea, headache, blood in stool, rash, dyspepsia, abdominal pain, abnormal liver function tests, dizziness, and bruising.

Drug Interactions

Drugs that Affect Hemostasis

The risk of hemorrhage may be increased when pentosan polysulfate sodium is used concurrently with drugs that affect hemostasis (e.g., oral anticoagulants, heparin, nonsteroidal anti-inflammatory agents [NSAIAs], thrombolytic agents [e.g., alteplase]). Patients receiving such concomitant therapy should be monitored for hemorrhage.

In healthy individuals, concomitant administration of pentosan polysulfate sodium (100 mg every 8 hours for 7 days) with warfarin sodium (international normalized ratio [INR] of 1.4-1.8) did not alter the pharmacokinetics of R- or S-warfarin or the INR.

Pharmacokinetics

Absorption

Bioavailability

Following oral administration of a radiolabeled dose of pentosan polysulfate sodium solution, approximately 6% of the dose was absorbed into the systemic circulation, with peak levels of plasma radioactivity achieved at a median of 2 hours (range, 0.6-120 hours) after the dose.

Onset

In patients with early or mild interstitial cystitis, pain relief may occur within 6-8 weeks. In a majority of those with moderate to severe interstitial cystitis, pain relief occurs in approximately 6 months.

Duration

Pain relief may persist for longer than 29 months in some patients.

Food

The effect of food on absorption of pentosan polysulfate sodium is unknown. In clinical trials, pentosan polysulfate sodium was administered with water 1 hour before or 2 hours after meals.

Distribution

Extent

In animals, pentosan polysulfate sodium is distributed into uroepithelium of the genitourinary tract, with smaller amounts distributed into liver, spleen, lung, skin, periosteum, and bone marrow. Small amounts are distributed into erythrocytes in animals.

It is not known whether pentosan polysulfate sodium is distributed into milk.

Elimination

Metabolism

Orally absorbed pentosan polysulfate sodium undergoes partial desulfation in the liver and spleen and partial depolymerization in the kidneys to form a large number of metabolites. Desulfation and depolymerization pathways can become saturated with continued dosing.

Elimination Route

Following oral administration of a radiolabeled 300- or 450-mg dose of pentosan polysulfate sodium solution, 84 or 58%, respectively, of the dose was excreted in feces as unchanged drug; about 6% of the dose was excreted in urine, principally as desulfated and depolymerized metabolites.

Half-life

Following oral administration of a radiolabeled 300- or 450-mg dose of pentosan polysulfate sodium solution, the mean half-life for plasma radioactivity was 27 or 20 hours, respectively.

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