Elmiron

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Elmiron uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Patient leaflet
• Elmiron reviews

INDICATIONS AND USAGE

Elmiron^® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

CONTRAINDICATIONS

Elmiron^® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

WARNINGS

None.

PRECAUTIONS

General

Elmiron^® is a weak anticoagulant. At a daily dose of 300 mg (n = 128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage have been reported (see ADVERSE REACTIONS ). Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting Elmiron^®.

A similar product that was given subcutaneously, sublingually, or intramuscularly (and not initially metabolized by the liver) is associated with delayed immunoallergic thrombocytopenia with symptoms of thrombosis and hemorrhage. Caution should be exercised when using Elmiron^® in patients who have a history of heparin induced thrombocytopenia.

Alopecia is associated with pentosan polysulfate and with heparin products. In clinical trials of Elmiron^®, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.

Hepatic Insufficiency

Elmiron^® has not been studied in patients with hepatic insufficiency. Because there is evidence of hepatic contribution to the elimination of Elmiron^®, hepatic impairment may have an impact on the pharmacokinetics of Elmiron^®. Caution should be exercised when using Elmiron^® in this patient population.

Mildly (< 2.5 × normal) elevated transaminase, alkaline phosphatase, γ-glutamyl transpeptidase, and lactic dehydrogenase occurred in 1.2% of patients. The increases usually appeared 3 to 12 months after the start of Elmiron^® therapy, and were not associated with jaundice or other clinical signs or symptoms. These abnormalities are usually transient, may remain essentially unchanged, or may rarely progress with continued use. Increases in PTT and PT (< 1% for both) or thrombocytopenia (0.2%) were noted.

Information for Patients

Patients should take the drug as prescribed, in the dosage prescribed, and no more frequently than prescribed. Patients should be reminded that Elmiron^® has a weak anticoagulant effect. This effect may increase bleeding times.

Laboratory Test Findings

Elmiron did not affect prothrombin time or partial thromboplastin time (PTT) up to 1200 mg per day in 24 healthy male subjects treated for 8 days. Elmiron also inhibits the generation of factor Xa in plasma and inhibits thrombin-induced platelet aggregation in human platelet rich plasma ex vivo. (See PRECAUTIONS-Hepatic Insufficiency Section for additional information.)

Carcinogenicity, Mutagenesis, Impairment of Fertility

Long term carcinogenicity studies of Elmiron^® in F344/N rats and B6C3F1 mice have been conducted. In these studies, Elmiron^® was orally administered once daily via gavage, 5 days per week, for up to 2 years. The dosages administered to mice were 56, 168 or 504 mg/kg. The dosages administered to rats were 14, 42, or 126 mg/kg for males, and 28, 84, or 252 mg/kg for females. The dosages tested were up to 60 times the maximum recommended human dose (MRHD) in rats, and up to 117 times the MRHD in mice, on a mg/kg basis. The results of these studies in rodents showed no clear evidence of drug-related tumorigenesis or carcinogenic risk.

Elmiron was not clastogenic or mutagenic when tested in the mouse micronucleus test or the Ames test (S. typhimurium). The effect of Elmiron on spermatogenesis has not been investigated.

Pregnancy Category B

Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of Elmiron^® when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from Elmiron^®. Direct in vitro bathing of cultured mouse embryos with Elmiron at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Elmiron^® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 16 years have not been established.

ADVERSE REACTIONS

Elmiron^® was evaluated in clinical trials in a total of 2627 patients with a mean age of 47 [range 18 to 88 with 581 (22%) over 60 years of age]. Of the 2627 patients, 128 patients were in a 3–month trial and the remaining 2499 patients were in a long-term, unblinded trial.

Deaths occurred in 6/2627 (0.2%) patients who received the drug over a period of 3 to 75 months. The deaths appear to be related to other concurrent illnesses or procedures, except in one patient for whom the cause was not known.

Serious adverse events occurred in 33/2627 (1.3%) patients. Two patients had severe abdominal pain or diarrhea and dehydration that required hospitalization. Because there was not a control group of patients with interstitial cystitis who were concurrently evaluated, it is difficult to determine which events are associated with Elmiron^® and which events are associated with concurrent illness, medicine, or other factors.

The adverse events described below were reported in an unblinded clinical trial of 2499 interstitial cystitis patients treated with Elmiron^®. Of the original 2499 patients, 1192 (48%) received Elmiron^® for 3 months; 892 (36%) received Elmiron^® for 6 months; and 598 (24%) received Elmiron^® for one year, 355 (14%) received Elmiron^® for 2 years, and 145 (6%) for 4 years.

Frequency (1 to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%).

Frequency (≤ 1%):

Digestive: Vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, anorexia, gum hemorrhage.

Hematologic: Anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, leukopenia, thrombocytopenia.

Hypersensitive Reactions: Allergic reaction, photosensitivity.

Respiratory System: Pharyngitis, rhinitis, epistaxis, dyspnea.

Skin and Appendages: Pruritus, urticaria.

Special Senses: Conjunctivitis, tinnitus, optic neuritis, amblyopia, retinal hemorrhage.

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of Elmiron; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: weight gain and edema.

Rectal Hemorrhage

Elmiron^® was evaluated in a randomized, double-blind, parallel group, Phase 4 study conducted in 380 patients with interstitial cystitis dosed for 32 weeks. At a daily dose of 300 mg, rectal hemorrhage was reported as an adverse event in 6.3% of patients. The severity of the events was described as "mild" in most patients. Patients in that study who were administered Elmiron^® 900 mg daily, a dose higher than the approved dose, experienced a higher incidence of rectal hemorrhage, 15%.

Liver Function Abnormality

A randomized, double-blind, parallel group, Phase 2 study was conducted in 100 men (51 Elmiron^® and 49 placebo) dosed for 16 weeks. At a daily dose of 900 mg, a dose higher than the approved dose, elevated liver function tests were reported as an adverse event in 11.8% (n = 6) of Elmiron^®-treated patients and 2% (n = 1) of placebo-treated patients.

OVERDOSAGE

Overdose has not been reported. Based upon the pharmacodynamics of the drug, toxicity is likely to be reflected as anticoagulation, bleeding, thrombocytopenia, liver function abnormalities, and gastric distress. (See CLINICAL PHARMACOLOGY and PRECAUTIONS sections.) At a daily dose of 900 mg for 32 weeks (n = 127) in a clinical trial, rectal hemorrhage was reported as an adverse event in 15% of patients. At a daily dose of Elmiron^® 900 mg for 16 weeks in a clinical trial that enrolled 51 patients in the Elmiron^® group and 49 in the placebo group, elevated liver function tests were reported as an adverse event in 11.8% of patients in the Elmiron^® group and 2% of patients in the placebo group. In the event of acute overdosage, the patient should be given gastric lavage if possible, carefully observed and given symptomatic and supportive treatment.

DOSAGE AND ADMINISTRATION

The recommended dose of Elmiron^® is 300 mg/day taken as one 100 mg capsule orally three times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.

Patients receiving Elmiron^® should be reassessed after 3 months. If improvement has not occurred and if limiting adverse events are not present, Elmiron^® may be continued for another 3 months.

The clinical value and risks of continued treatment in patients whose pain has not improved by 6 months is not known.

HOW SUPPLIED

Elmiron^® is supplied in white opaque hard gelatin capsules imprinted "BNP7600" containing 100 mg Elmiron. Supplied in bottles of 100 capsules.

NDC NUMBER 50458-098-01

Storage

Store at controlled room temperature 15°–30°C (59°–86°F).

Keep out of reach of children.

Elmiron^® is a Registered Trademark of Teva Branded Pharmaceutical Products R&D, Inc. under license to Janssen Pharmaceuticals, Inc.

© 2002 Janssen Pharmaceutical Companies

(logo)

Product of Germany

Manufactured by:

Janssen Ortho LLC

Gurabo, Puerto Rico 00778

Manufactured for:

Janssen Pharmaceuticals, Inc.

Titusville, New Jersey 08560

Revised July 2017

PHARMACIST: PLEASE DISPENSE ONE PATIENT LEAFLET PER PRESCRIPTION

Patient Leaflet

Questions and Answers About

Elmiron^®

(Generic name = Elmiron)

Capsules

What is Elmiron^®?

Elmiron^® is used to treat the pain or discomfort of interstitial cystitis (IC). It is not known exactly how Elmiron^® works, but it is not a pain medication like aspirin or acetaminophen and therefore must be taken continuously for relief as prescribed.

Who should not take Elmiron^®?

• Patients undergoing surgery should speak with their doctor about when to discontinue Elmiron^® prior to surgery.
• Elmiron^® should be used during pregnancy only if clearly needed.

What does your doctor need to know?

• If you are taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.
• If you are pregnant.
• If you have any liver problems.

How should I take Elmiron^®?

You should take 1 capsule of Elmiron^® by mouth three times a day, with water at least 1 hour before meals or 2 hours after meals. Each capsule contains 100 mg of Elmiron^®.

What should I avoid while taking Elmiron^®?

Anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin or anti-inflammatory drugs such as ibuprofen until you speak with your doctor.

What are the most common side effects of Elmiron^®?

The most common side effects are hair loss, diarrhea, nausea, blood in the stool, headache, rash, upset stomach, abnormal liver function tests, dizziness and bruising. Weight gain and swelling caused by fluid build up in the body have also been reported in patients taking Elmiron^®.

Call your doctor if these side effects persist or are bothersome or if there is blood in your stool.

If you suspect that someone may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

This leaflet provides a summary of information about Elmiron^®. Medicines are sometimes prescribed for uses other than those listed in a Patient Leaflet. If you have any questions or concerns, or want more information about Elmiron^®, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Elmiron^® that is written for health professionals that you can ask to read.

Keep out of reach of children.

Elmiron^® is a Registered Trademark of Teva Branded Pharmaceutical Products R&D, Inc. under license to Janssen Pharmaceuticals, Inc.

© 2002 Janssen Pharmaceutical Companies

(logo)

Product of Germany

Manufactured by:

Janssen Ortho LLC

Gurabo, Puerto Rico 00778

Manufactured for:

Janssen Pharmaceuticals, Inc.

Titusville, New Jersey 08560

Revised July 2017

NDC 50458-098-01

Elmiron ^®

(pentosan polysulfate sodium)

CAPSULES

Content: 100 Capsules

Each capsule contains 100 mg pentosan

polysulfate sodium.

Rx only

100 mg

Elmiron^® is a registered trademark

of Teva Branded Pharmaceutical

Products R&D, Inc. under license to

Janssen Pharmaceuticals, Inc.

Revised August 2012

Elmiron pharmaceutical active ingredients containing related brand and generic drugs:

• Pentosan Polysulfate Sodium

Elmiron available forms, composition, doses:

• Capsules; Oral; Pentosan Polysulfate Sodium 100 mg

Elmiron destination | category:

• Human:
• Interstitial cystitis treatment medications

Elmiron Anatomical Therapeutic Chemical codes:

• C05BA04 - Pentosan Polysulfate Sodium
• G04BX15 - Pentosan Polysulfate Sodium

Elmiron pharmaceutical companies:

• ALZA
• Agencia Lei Va Hong
• Arthropharm
• Baker Norton Pharmaceuticals
• Hong Kong Medical Supplies
• IVAX
• International Medical, Hong Kong
• Janssen
• Ortho McNeil Pharmaceuticals

References

1. Dailymed."ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."PENTOSAN POLYSULFATE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "pentosan polysulfate". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Elmiron after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Elmiron not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology