Elmiron (Pentosan Polysulfate Sodium Capsules)
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Elmiron (Pentosan Polysulfate Sodium Capsules)

ELMIRON® - 100 mg
(pentosan polysulfate sodium) Capsules

DRUG DESCRIPTION

Pentosan polysulfate sodium is a semi-synthetically produced heparin-like macro molecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water to 50% at pH 6. It has a molecular weight of 4000 to 6000 Dalton with the following structural formula:

ELMIRON (pentosan polysulfate sodium) structural formula illustration

ELMIRON (pentosan polysulfate sodium capsules) ® is supplied in white opaque hard gelatin capsules containing 100 mg pentosan polysulfate sodium, microcrystalline cellulose, and magnesium stearate. It also contains pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol, SDA-3A alcohol, and titanium dioxide. It is formulated for oral use.

What are the possible side effects of pentosan polysulfate sodium (Elmiron)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • nosebleed;
  • blood in your urine or stools;
  • rectal bleeding;
  • coughing up blood;
  • bleeding gums; or
  • feeling like you might pass out.

Less serious side effects may include:

  • hair loss;
  • nausea, diarrhea, stomach pain;
  • headache;
  • mild...

Read All Potential Side Effects and See Pictures of Elmiron »

What are the precautions when taking pentosan polysulfate sodium capsules (Elmiron)?

Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), blood vessel disorders (e.g., aneurysm), liver disease, spleen disorders, stomach/intestinal disorders (e.g., stomach ulcers, polyps, diverticula).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when...

Read All Potential Precautions of Elmiron »

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

The recommended dose of ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® should be reassessed after 3 months. If improvement has not occurred and if limiting adverse events are not present, ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® is supplied in white opaque hard gelatin capsules imprinted "BNP7600" containing 100 mg pentosan polysulfate sodium. Supplied in bottles of 100 capsules.

NDC NUMBER 0062-9800-01

Storage

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

Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, New Jersey 08869. Manufactured by: Janssen Ortho LLC Gurabo, Puerto Rico 00778. Manufactured for: Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, New Jersey 08869. Revised December 2008. FDA rev date:

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

ELMIRON (pentosan polysulfate sodium capsules) ® was evaluated in clinical trials in a total of 2627 patients (2343 women, 262 men, 22 unknown) 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 (pentosan polysulfate sodium capsules) ® and which events are associated with concurrent illness, medicine, or other factors.

Adverse Experience In Placebo-Controlled Clinical Trials of ELMIRON (pentosan polysulfate sodium capsules) ® 100 mg Three Times a Day for 3 Months

Body System/ Adverse Experience ELMIRON®
n=128
Placebo
n=130
CNS Overall Number of Patients* 3 5
   Insomnia 1 0
   Headache 1 3
   Severe Emotional Lability/Depression 2 1
   Nystagmus/Dizziness 1 1
   Hyperkinesia 1 1
Gl Overall Number of Patients* 7 7
   Nausea 3 3
   Diarrhea 3 6
   Dyspepsia 1 0
   Jaundice 0 1
   Vomiting 0 2
Skin/Allergic Overall Number of Patients* 2 4
   Rash 0 2
   Pruritus 0 2
   Lacrimation 1 1
   Rhinitis 1 1
   Increased Sweating 1 0
Other Overall Number of Patients* 1 3
   Amenorrhea 0 1
   Arthralgia 0 1
   Vaginitis 1 1
Total Events 17 27
Total Number of Patients Reporting Adverse Events 13 19
* Within a body system, the individual events do not sum to equal overall number of patients because a patient may have more than one event.

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

Rectal Hemorrhage: ELMIRON (pentosan polysulfate sodium capsules) ® 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 (n = 128), 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® treated patients and 2% (n = 1) of placebo treated patients.

Read the Elmiron (pentosan polysulfate sodium capsules) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

None.

PRECAUTIONS

General

ELMIRON (pentosan polysulfate sodium capsules) ® is a weak anticoagulant (1/15 the activity of heparin). 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 (pentosan polysulfate sodium capsules) ®.

A similar product that was given subcutaneously, sublingualis 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®, 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 (pentosan polysulfate sodium capsules) ® has not been studied in patients with hepatic insufficiency. Because there is evidence of hepatic contribution to the elimination of ELMIRON (pentosan polysulfate sodium capsules) ®, hepatic impairment may have an impact on the pharmacokinetics of ELMIRON (pentosan polysulfate sodium capsules) ®. Caution should be exercised when using ELMIRON (pentosan polysulfate sodium capsules) ® in this patient population.

Mildly ( < 2.5 x normal) elevated transaminase, alkaline phosphatase, Y-glutamyl transpeptidase, and lactic dehydrogenase occurred in 1.2% of patients. The increases usually appeared 3 to 12 months after the start of ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® has a weak anticoagulant effect. This effect may increase bleeding times.

Laboratory Test Findings

Pentosan polysulfate sodium did not affect prothrombin time (PT) or partial thromboplastin time (PTT) up to 1200 mg per day in 24 healthy male subjects treated for 8 days. Pentosan polysulfate sodium 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 (pentosan polysulfate sodium capsules) ® in F344/N rats and B6C3F1 mice have been conducted. In these studies, ELMIRON (pentosan polysulfate sodium capsules) ® 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.

Pentosan polysulfate sodium was not clastogenic or mutagenic when tested in the mouse micronucleus test orthe Ames test (S. typhimuhum). The effect of pentosan polysulfate sodium 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 (pentosan polysulfate sodium capsules) ® when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from ELMIRON (pentosan polysulfate sodium capsules) ®. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) 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 (pentosan polysulfate sodium capsules) ® is administered to a nursing woman.

Pediatric Use

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

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 (pentosan polysulfate sodium capsules) ® 900 mg for 16 weeks in a clinical trial that enrolled 51 patients in the ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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.

CONTRAINDICATIONS

ELMIRON (pentosan polysulfate sodium capsules) ® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

General

Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. The mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known.

Pharmacokinetics

Absorption: In a clinical pharmacology study in which healthy female volunteers received a single oral 300 or 450 mg dose of pentosan polysulfate sodium containing radiolabeled drug as a solution under fasted conditions, maximal levels of plasma radioactivity were seen approximately at a median of 2 hours (range 0.6-120 hours) after dosing. Based on urinary excretion of radioactivity, a mean of approximately 6% of a radiolabeled oral dose of pentosan polysulfate sodium is absorbed and reaches the systemic circulation.

Food Effects: In clinical trials, ELMIRON (pentosan polysulfate sodium capsules) ® was administered with water 1 hour before or 2 hours after meals; the effect of food on absorption of pentosan polysulfate sodium is not known.

Distribution: Preclinical studies with parenterally administered radiolabeled pentosan polysulfate sodium showed distribution to the uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow. Erythrocyte penetration is low in animals.

Metabolism: The fraction of pentosan polysulfate sodium that is absorbed is metabolized by partial desulfation in the liver and spleen, and by partial depolymerization in the kidney to a large number of metabolites. Both the desulfation and depolymerization can be saturated with continued dosing.

Excretion: Following administration of an oral solution of a 300 or 450 mg dose of pentosan polysulfate sodium containing radiolabeled drug to groups of healthy subjects, plasma radioactivity declined with mean half-lives of 27 and 20 hours, respectively. A large proportion of the orally administered dose of pentosan polysulfate sodium (mean 84% in the 300 mg group and 58% in the 450 mg group) is excreted in feces as unchanged drug. A mean of 6% of an oral dose is excreted in the urine, mostly as desulfated and depolymerized metabolites. Only a small fraction of the administered dose (mean 0.14%) is recovered as intact drug in urine.

Special Populations

The pharmacokinetics of pentosan polysulfate sodium has not been studied in geriatric patients or in patients with hepatic or renal impairment. See also PRECAUTIONS - Hepatic Insufficiency.

Drug-Drug Interactions

In a study in which healthy subjects received pentosan polysulfate sodium 100 mg capsule or placebo every 8 hours for 7 days, and were titrated with warfarin to an INR of 1.4 to 1.8, the pharmacokinetic parameters of R-warfarin and S-warfarin were similar in the absence and presence of pentosan polysulfate sodium. INR for warfarin + placebo and warfarin + pentosan polysulfate sodium were comparable. See also PRECAUTIONS on the use of ELMIRON (pentosan polysulfate sodium capsules) ® in patients receiving other therapies with anticoagulant effects.

Pharmacodynamics

The mechanism by which pentosan polysulfate sodium achieves its effects in patients is unknown. In preliminary clinical models, pentosan polysulfate sodium adhered to the bladder wall mucosal membrane. The drug may act as a buffer to control cell permeability preventing irritating solutes in the urine from reaching the cells.

Clinical Trials

ELMIRON (pentosan polysulfate sodium capsules) ® was evaluated in two clinical trials for the relief of pain in patients with chronic interstitial cystitis (IC). All patients met the NIH definition of IC based upon the results of cystoscopy, cytology, and biopsy. One blinded, randomized, placebo controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years (range 18 to 81). Approximately equal numbers of patients received either placebo or ELMIRON (pentosan polysulfate sodium capsules) ® 100 mg three times a day for 3 months. Clinical improvement in bladder pain was based upon the patient's own assessment. In this study, 28/74 (38%) of patients who received ELMIRON (pentosan polysulfate sodium capsules) ® and 13/74 (18%) of patients who received placebo, showed greater than 50% improvement in bladder pain (p=0.005).

A second clinical trial, the physician's usage study, was a prospectively designed retrospective analysis of 2499 patients who received ELMIRON (pentosan polysulfate sodium capsules) ® 300 mg a day without blinding. Of the 2499 patients, 2220 were women, 254 were men, and 25 were of unknown sex. The patients had a mean age of 47 years and 23% were over 60 years of age. By 3 months, 1307 (52%) of the patients had dropped out or were ineligible for analysis, overall, 1192 (48%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 3 months; 892 (36%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 6 months; and 598 (24%) received ELMIRON (pentosan polysulfate sodium capsules) ® for one year.

Patients had unblinded evaluations every 3 months forthe patient's rating of overall change in pain in comparison to baseline and for the difference calculated in "pain/discomfort" scores. At baseline, pain/discomfort scores forthe original 2499 patients were severe or unbearable in 60%. moderate in 33% and mild or none in 7% of patients. The extent of the patients' pain improvement is shown in Table 1.

At 3 months, 722/2499 (29%) of the patients originally in the study had pain scores that improved by one or two categories. By 6 months, in the 892 patients who continued taking ELMIRON (pentosan polysulfate sodium capsules) ®, an additional 116/2499 (5%) of patients had improved pain scores. After 6 months, the percent of patients who reported the first onset of pain relief was less than 1.5% of patients who originally entered in the study (see Table 2).

Table 1: Pain Scores in Reference to Baseline in Open Label Physician's Usage Study (N=2499)1

Efficacy Parameter 3 months2 6 months2
Patient Rating of Overall Change in Pain (Recollection of difference between current pain and baseline pain)3 N=1161
Median=3
Mean=3.44
CI: (3.37, 3.51)
N=724
Median=4
Mean=3.91
CI: (3.83, 3.99)
Change in Pain/Discomfort Score (Calculated difference in scores at the time point and baseline)4 N=1440
Median=1
Mean=0.51
CI: (0.45, 0.57)
N=904
Median=1
Mean=0.66
CI: (0.61, 0.71)
1Trial not designed to detect onset of pain relief
2
CI = 95% confidence interval
36-point scale: 1 = worse, 2 = no better; 3 = slightly improved, 4 = moderately improved. 5 = greatly improved, 6 = symptom gone
43-point scale: 1 = none or mild, 2 = moderate, 3 = severe or unbearable

Table 2: Number (%) of Patients with New Relief of Pain/Discomfort1 in the Open-Label Physician's Usage Study (N=2499)

  at 3 months2 (n=1192) at 6 months3 (n=892)
Considering only the patients who continued treatment 722/1192 (61%) 116/892 (13%)
Considering all the patients originally enrolled in the study 722/2499 (29%) 116/2499 (5%)
1First-time Improvement in pain/discomfort score by 1 or 2 categories
2
Number (%) of patients with improvement of pain/discomfort score at 3 months when compared to baseline
3
Number (%) of patients without pain/discomfort improvement at 3 months who had improvement at 6 months

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

ELMIRON®
(Generic name = pentosan polysulfate sodium) Capsules

What is the most important information I should know about ELMIRON (pentosan polysulfate sodium capsules) ®?

ELMIRON (pentosan polysulfate sodium capsules) ® (pronounced EL ma ran) is used to treat the pain or discomfort of interstitial cystitis (IC).

You must take ELMIRON (pentosan polysulfate sodium capsules) ® as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed.

ELMIRON (pentosan polysulfate sodium capsules) ® is a weak anticoagulant (blood thinner) which may increase bleeding.

Call your doctor if you will be undergoing surgery or will begin taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.

What is ELMIRON (pentosan polysulfate sodium capsules) ®?

ELMIRON (pentosan polysulfate sodium capsules) ® is used to treat the pain or discomfort of interstitial cystitis (IC). It is not known exactly how ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®?

  • Patients undergoing surgery should speak with their doctor about when to discontinue ELMIRON (pentosan polysulfate sodium capsules) ® prior to surgery.
  • ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®?

You should take 1 capsule of ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®.

What should I avoid while taking ELMIRON (pentosan polysulfate sodium capsules) ®?

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 (pentosan polysulfate sodium capsules) ®?

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.

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 (pentosan polysulfate sodium capsules) ®. 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 (pentosan polysulfate sodium capsules) ®, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about ELMIRON (pentosan polysulfate sodium capsules) ® that is written for health professionals that you can ask to read.

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

ELMIRON®
(Generic name = pentosan polysulfate sodium) Capsules

What is the most important information I should know about ELMIRON (pentosan polysulfate sodium capsules) ®?

ELMIRON (pentosan polysulfate sodium capsules) ® (pronounced EL ma ran) is used to treat the pain or discomfort of interstitial cystitis (IC).

You must take ELMIRON (pentosan polysulfate sodium capsules) ® as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed.

ELMIRON (pentosan polysulfate sodium capsules) ® is a weak anticoagulant (blood thinner) which may increase bleeding.

Call your doctor if you will be undergoing surgery or will begin taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.

What is ELMIRON (pentosan polysulfate sodium capsules) ®?

ELMIRON (pentosan polysulfate sodium capsules) ® is used to treat the pain or discomfort of interstitial cystitis (IC). It is not known exactly how ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®?

  • Patients undergoing surgery should speak with their doctor about when to discontinue ELMIRON (pentosan polysulfate sodium capsules) ® prior to surgery.
  • ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®?

You should take 1 capsule of ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ®.

What should I avoid while taking ELMIRON (pentosan polysulfate sodium capsules) ®?

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 (pentosan polysulfate sodium capsules) ®?

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.

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 (pentosan polysulfate sodium capsules) ®. 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 (pentosan polysulfate sodium capsules) ®, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about ELMIRON (pentosan polysulfate sodium capsules) ® that is written for health professionals that you can ask to read.

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Elmiron Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PENTOSAN POLYSULFATE SODIUM - ORAL

(PEN-toe-san paw-lee-SULL-fate SO-dee-um)

COMMON BRAND NAME(S): Elmiron

USES: This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (e.g., bleeding from the nose/gums).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth at least 1 hour before or 2 hours after meals, usually 3 times daily or as directed by your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Inform your doctor if your condition worsens or does not improve after 3 months.

Disclaimer

Elmiron Consumer (continued)

SIDE EFFECTS: Diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bruising/bleeding (e.g., blood in stool), mental/mood changes, heartburn, discomfort when swallowing.

Tell your doctor immediately if any of these rare but very serious side effects occur: tiredness, fast/pounding heartbeat, signs of infection (e.g., fever, persistent sore throat), shortness of breath, vision changes, eye pain, dark urine, yellowing eyes/skin, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Elmiron (pentosan polysulfate sodium capsules) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), blood vessel disorders (e.g., aneurysm), liver disease, spleen disorders, stomach/intestinal disorders (e.g., stomach ulcers, polyps, diverticula).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Elmiron Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: mifepristone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin, heparin, tenecteplase, abciximab, clopidogrel, ticlopidine), sulfinpyrazone.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen, ketorolac) that may increase your risk for side effects if taken together with this medication. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Ask your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests (including prothrombin time/INR, factor Xa levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: unusual bruising/bleeding, nausea/vomiting.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Elmiron Patient Information Including Side Effects

Brand Names: Elmiron

Generic Name: pentosan polysulfate sodium (Pronunciation: PEN toe san POL ee SUL fate SOE dee um)

What is pentosan polysulfate sodium (Elmiron)?

Pentosan polysulfate sodium works like an anticoagulant (blood thinner) that prevents the formation of blood clots. However, it is used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).

Pentosan polysulfate sodium may also be used for purposes not listed in this medication guide.

Elmiron 100mg

white, imprinted with BNP 7600

What are the possible side effects of pentosan polysulfate sodium (Elmiron)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • nosebleed;
  • blood in your urine or stools;
  • rectal bleeding;
  • coughing up blood;
  • bleeding gums; or
  • feeling like you might pass out.

Less serious side effects may include:

  • hair loss;
  • nausea, diarrhea, stomach pain;
  • headache;
  • mild dizziness;
  • depressed mood; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Elmiron (pentosan polysulfate sodium capsules) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pentosan polysulfate sodium (Elmiron)?

Before taking pentosan polysulfate sodium, tell your doctor if you have a bleeding or blood clotting disorder, a history of aneurysm or stroke, a stomach ulcer, intestinal polyps, diverticulitis, or liver disease.

Take the medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.

Call your doctor at once if you have any easy bruising or unusual bleeding such as nosebleed, blood in your urine or stools, rectal bleeding, coughing up blood, bleeding gums, or feeling like you might pass out.

To be sure this medication is helping your condition, your doctor will need to check your progress every 3 months. This will help your doctor determine how long to treat you with pentosan polysulfate sodium. You may also need blood tests to check for certain side effects. Visit your doctor regularly.

Tell your doctor if you use any other medications that can increase your risk of bleeding, including blood thinners, medications to treat or prevent blood clots, or an NSAID (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), and others.

Side Effects Centers

Elmiron Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking pentosan polysulfate sodium (Elmiron)?

You should not use this medication if you are allergic to pentosan polysulfate sodium.

To make sure you can safely take pentosan polysulfate sodium, tell your doctor if you have any of these other conditions:

  • a bleeding or blood clotting disorder;
  • a history of aneurysm or stroke;
  • a stomach ulcer, intestinal polyps or diverticulitis; or
  • liver disease.

FDA pregnancy category B. Pentosan polysulfate sodium is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether pentosan polysulfate sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pentosan polysulfate sodium (Elmiron)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take the medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.

To be sure this medication is helping your condition, your doctor will need to check your progress every 3 months. This will help your doctor determine how long to treat you with pentosan polysulfate sodium. You may also need blood tests to check for certain side effects. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using pentosan polysulfate sodium. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Side Effects Centers

Elmiron Patient Information including If I Miss a Dose

What happens if I miss a dose (Elmiron)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Elmiron)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include easy bruising or unusual bleeding.

What should I avoid while taking pentosan polysulfate sodium (Elmiron)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect pentosan polysulfate sodium (Elmiron)?

Tell your doctor if you use any other medications that can increase your risk of bleeding, such as:

  • abciximab (ReoPro);
  • alteplase (Activase);
  • anagrelide (Agrylin);
  • argatroban (Acova);
  • aspirin;
  • bivalirudin (Angiomax);
  • cilostazol (Pletal);
  • clopidogrel (Plavix);
  • dalteparin (Fragmin);
  • dipyridamole (Persantine, Aggrenox);
  • enoxaparin (Lovenox);
  • eptifibatide (Integrelin);
  • fondaparinux (Arixtra);
  • heparin or warfarin (Coumadin);
  • lepirudin (Refludan);
  • prasugrel (Effient);
  • ticlopidine (Ticlid);
  • tirofiban (Aggrastat);
  • tenecteplase (TNKase);
  • urokinase (Abbokinase); or
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with pentosan polysulfate sodium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pentosan polysulfate sodium.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum'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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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