Elmiron (Pentosan Polysulfate Sodium)

ELMIRON™

Alza

Pentosan Polysulfate Sodium

Glycosaminoglycan Substitute

Action And Clinical Pharmacology: Pentosan is intended for the treatment of interstitial cystitis. In interstitial cystitis patients, a deficient or defective bladder protective glycosaminoglycan layer allows diffusion of irritating components in urine through to the underlying bladder wall. The resultant inflammatory response in the bladder wall produces the symptoms of interstitial cystitis. Definitive proof for this is not available.

Elmiron is orally bioavailable pentosan polysulfate sodium. Its mechanism of action is thought to be adherence to the bladder surface supplementing the defective natural glycosaminoglycan layer. It is hypothesized that this action ameliorates the symptoms of interstitial cystitis. Orally administered pentosan has a urinary excretion half-life of 4.4 hours for the unchanged drug. A single dose is completely eliminated in 144 hours.

Indications And Clinical Uses: For the initial and maintenance treatment of interstitial cystitis.

Contra-Indications: In patients with known hypersensitivity to the drug, and related compounds or excipients.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Therefore, this drug should be used during pregnancy only if the potential benefit clearly exceeds the potential risk.

Lactation: It is not known if pentosan is excreted in human milk. Many drugs are excreted in human milk and, therefore, caution should be exercised when pentosan is administered to a nursing mother.

Children: Safety and effectiveness in children and adolescents below the age of 18 years have not been established. This drug should be kept out of the reach of children.

Adverse Reactions: Pentosan is usually well tolerated. Reported adverse reactions are infrequent and usually do not require discontinuation of treatment. The most common reactions are gastrointestinal, hematologic or dermatologic (see Precautions).

Low Frequency (£3%): alopecia, gastrointestinal discomfort, diarrhea, rash, headache, nausea.

Uncommon (£1%): Digestive: liver function abnormalities, vomiting, mouth ulcer, colitis, esophagitis, gastritis.

Hematologic: anemia, ecchymosis, prothrombin decrease, thrombocytopenia, retinal hemorrhage.

Neurologic: dizziness, paresthesia, insomnia, nervousness.

Metabolic: weight gain, weight loss.

Musculoskeletal: myalgia, arthralgia.

Urogenital: urgency, urinary tract infection, urethritis.

Hypersensitivity Reactions: allergic reaction, photosensitivity.

Other: edema, pelvic pain, malaise, sinusitis, sweating.

Rare Events (single occurrence only in over 1 000 patients with interstitial cystitis): gastritis, leukopenia, depression, rhinitis, lacrimation, angina pectoris, chronic myelogenous leukemia, prostate cancer, loss of appetite, subarachnoid hemorrhage, epistaxis, gum hemorrhage, menorrhagia, hematuria.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have been no reported overdosage events and therefore symptoms cannot be described. In human studies, pentosan has been administered i.v. in single bolus doses of 150 mg, in oral doses of 400 mg daily for 3 weeks and orally in total daily doses of 900 mg for up to 3 months without untoward effects. In the event of overdosage, symptomatic treatment is recommended.

Dosage And Administration: The recommended dose is 300 mg/day taken as one 100 mg capsule orally 3 times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.

Some patients with interstitial cystitis may require 6 to 8 weeks of therapy with pentosan to achieve relief of symptoms. Long-term continuation of pentosan therapy is necessary for persistent therapeutic effect.

Availability And Storage: Each white, opaque, hard gelatin capsule, imprinted with “BNP 7600”, contains: pentosan polysulfate sodium 100 mg. Nonmedicinal ingredients: magnesium stearate and microcrystalline cellulose. Bottles of 100. Store at controlled room temperature 15 to 30°C.

ELMIRON™ Alza Pentosan Polysulfate Sodium Glycosaminoglycan Substitute

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