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pentosan polysulfate sodium
Overview
What is Elmiron?
Pentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular 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 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 does Elmiron look like?
What are the available doses of Elmiron?
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What should I talk to my health care provider before I take Elmiron?
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How should I use Elmiron?
ELMIRON (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
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.
What interacts with Elmiron?
ELMIRON is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
What are the warnings of Elmiron?
The concomitant use of leucovorin with trimethoprim-sulfamethoxazole for the
acute treatment of pneumonia in
patients with HIV infection was associated with increased rates of treatment
failure and mortality in a placebo-controlled study.
What are the precautions of Elmiron?
General
ELMIRON 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 ). 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
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 . (See 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.
Pentosan polysulfate sodium was not clastogenic or mutagenic when tested in the mouse micronucleus test or the Ames test (). 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 when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from ELMIRON. Direct 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 is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 16 years have not been established.
What are the side effects of Elmiron?
ELMIRON 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 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:
Hematologic:
Hypersensitive Reactions:
Respiratory System:
Skin and Appendages:
Special Senses:
| Body System/Adverse Experience | ELMIRON n=128 | Placebon=130 | |
|---|---|---|---|
| CNS | 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. | 3 | 5 |
| Insomnia | 1 | 0 | |
| Headache | 1 | 3 | |
| Severe Emotional Lability/Depression | 2 | 1 | |
| Nystagmus/Dizziness | 1 | 1 | |
| Hyperkinesia | 1 | 1 | |
| GI | 7 | 7 | |
| Nausea | 3 | 3 | |
| Diarrhea | 3 | 6 | |
| Dyspepsia | 1 | 0 | |
| Jaundice | 0 | 1 | |
| Vomiting | 0 | 2 | |
| Skin/Allergic | 2 | 4 | |
| Rash | 0 | 2 | |
| Pruritus | 0 | 2 | |
| Lacrimation | 1 | 1 | |
| Rhinitis | 1 | 1 | |
| Increased Sweating | 1 | 0 | |
| Other | 1 | 3 | |
| Amenorrhea | 0 | 1 | |
| Arthralgia | 0 | 1 | |
| Vaginitis | 1 | 1 | |
| Total Events | 17 | 27 | |
| Total Number of Patients | |||
| Reporting Adverse Events | 13 | 19 |
What should I look out for while using Elmiron?
ELMIRON is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
None.
What might happen if I take too much Elmiron?
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 and 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.
How should I store and handle Elmiron?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.ELMIRON is supplied in white opaque hard gelatin capsules imprinted "BNP7600" containing 100 mg pentosan polysulfate sodium. Supplied in:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
ELMIRON is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.None.
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including non-steroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving glyburide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for loss of control.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glyburide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for hypoglycemia.
A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism of action for this interaction is not known.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known.
ELMIRON 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 ). 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.
ELMIRON 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 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:
Hematologic:
Hypersensitive Reactions:
Respiratory System:
Skin and Appendages:
Special Senses:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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