
Precautions
Elmiron (pentosan polysulfate sodium) is a prescription drug used to treat a disease called interstitial cystitis (IC). IC is a chronic, painful bladder condition. Elmiron may damage the eye (retina), potentially leading to blindness. Elmiron users may be concerned about this side effect and how to respond to it.
What is Elmiron used for?
Elmiron is used to treat the pain or discomfort of interstitial cystitis (IC). You must take Elmiron as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed. Elmiron is a weak anticoagulant (blood thinner) which may increase bleeding.
How is Elmiron used to treat interstitial cystitis?
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 ADVERSE REACTIONS).
Is Elmiron a good anticoagulant?
Elmiron 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.
Can you take ibuprofen with Elmiron?

What kind of medicine is Elmiron?
ELMIRON® is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis.
How long can you stay on Elmiron?
Dosage & Treatment Plan of Elmiron three times a day, for a total of 300 mg/day. Some patients report symptom relieve in three to four weeks. For others, it may take up to six months to see improvement. Patients are urged to continue therapy for at least six months before discontinuing treatment.
Does Elmiron weaken the immune system?
Elmiron® treatment did not affect the humoral immune response or T cell proliferative response.
Does Elmiron help with pain?
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.
Do you have to take Elmiron forever?
It's important that you continue to take Elmiron (pentosan) every day as prescribed, even if you don't see results immediately. Your provider will monitor you while you're taking Elmiron (pentosan) and if you haven't seen any improvement after 6 months, they might have you stop the medication.
What can I use in place of Elmiron?
What about other Elmiron alternatives?Nonsteroidal anti-inflammatory medications — this class of medications include common pain relievers like ibuprofen (Advil or Motrin) and naproxen sodium (Aleve)Tricyclic antidepressants — medications like Tofranil (imipramine) or amitriptyline can help reduce bladder pain.More items...•
Is interstitial cystitis an inflammatory disease?
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic inflammatory disease characterized by recurrent pain, discomfort, or tenderness in the urinary bladder and pelvic region and can be accompanied by various urinary symptoms, such as urinary frequency, persistent urge to void, and nocturia.
What are the long term effects of Elmiron?
Pigmentary maculopathy has been reported with long-term use of Elmiron. These changes in the retina can cause vision loss or damage. Most of these changes occurred after patients used Elmiron for three years or longer, according to the drug's label. But some people had eye damage after a shorter duration of use.
What autoimmune disease is linked to interstitial cystitis?
The strongest association occurs between interstitial cystitis and Sjögren's syndrome. Increasing evidence suggests a possible role of autoantibodies to the muscarinic M3 receptor in Sjögren's syndrome.
What is the best medication for bladder inflammation?
Amitriptyline is the medication most commonly prescribed for interstitial cystitis. Elmiron is the only oral drug approved by the FDA specifically for interstitial cystitis. It improves the bladder lining, making it less leaky and therefore less inflamed and painful.
Why does interstitial cystitis hurt so much?
Interstitial cystitis is a chronic bladder condition that causes discomfort and/or pain in the bladder or pelvic region. The bladder walls become inflamed and irritated, which causes the bladder to become very sensitive.
How can I reduce inflammation in my bladder?
Lifestyle and home remediesUse a heating pad. A heating pad placed on your lower abdomen may soothe bladder pressure or pain.Stay hydrated. Drink plenty of fluids to keep yourself hydrated. Avoid coffee, alcohol, soft drinks with caffeine and citrus juices. Also avoid spicy foods until your infection clears.
What are the long term effects of Elmiron?
Pigmentary maculopathy has been reported with long-term use of Elmiron. These changes in the retina can cause vision loss or damage. Most of these changes occurred after patients used Elmiron for three years or longer, according to the drug's label. But some people had eye damage after a shorter duration of use.
How long does it take for Elmiron to cause eye damage?
How Long Did It Take to Develop Vision Problems? The median duration of Elmiron use was about 14.5 years among patients in the Hanif and Jain study. But symptoms could occur as early as three years after starting Elmiron treatment.
Will I have interstitial cystitis forever?
Most patients need to continue treatment indefinitely or the symptoms return. Some patients have flare-ups of symptoms even while on treatment. In some patients the symptoms gradually improve and even disappear. Some patients do not respond to any IC/BPS therapy.
Will my interstitial cystitis ever go away?
Interstitial cystitis (IC) is a chronic and painful condition of the bladder. People with IC have a bladder wall that is tender and easily irritated, leading to uncomfortable symptoms. Although IC currently has no cure, the symptoms can be managed to help you feel better and live more comfortably.
Before Taking This Medicine
You should not use this medication if you are allergic to Elmiron.To make sure you can safely take Elmiron, tell your doctor if you have any of the...
How Should I Take 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 p...
What Happens If I Miss A Dose?
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...
What Happens If I Overdose?
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 Other Drugs Will Affect Elmiron?
Tell your doctor if you use any other medications that can increase your risk of bleeding, such as: 1. abciximab (ReoPro); 2. alteplase (Activase);...
What Pentosan Polysulfate Sodium?
Pentosan polysulfate sodium (PPS) is the active ingredient in Elmiron.
What Does Elmiron Treat?
Elmiron treats interstitial cystitis (IC). IC is a rare but debilitating bladder condition. It affects approximately 1 million people in the United States. The disease mainly affects women.
What is the most serious side effect of Elmiron?
The most serious adverse event reported for Elmiron is eye damage. The specific form of eye damage Elmiron causes is called pigmentary maculopathy. This side effect is not referenced in the common side effects section of the drug label. However, you can find information about this side effect in the Warnings and Contraindications section below.
How long does it take for Elmiron to work?
It may take three to six months for symptoms to improve. The manufacturer has not determined the value or risk of taking the drug for more than six months in patients who do not achieve pain relief by that point. Elmiron Usage Information PDF.
How long does it take for PPS to build up in the bladder?
Interesting Fact: Scientific studies confirm that PPS does build up in the bladder over a period of months.
When does Elmiron vision loss occur?
The label claims the visual consequences of these pigment abnormalities are unknown. Most cases of Elmiron vision loss occur after three or more years of use.
What are the side effects of stopping Elmiron?
According to these reports, patients experienced the following symptoms: Amnesia. Cystitis.
What is pentosan polysulfate sodium?
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.
How long does it take for Elmiron to improve pain?
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 ®, 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 ).
What is Elmiron used for?
Elmiron is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis.
How often are unblinded pain scores evaluated?
Patients had unblinded evaluations every 3 months for the 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 for the 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.
Where is pentosan metabolized?
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.
What to do if you take too much Elmiron?
If you take too much Elmiron, call your healthcare provider right away or go to the nearest emergency room.
Is Elmiron a weak anticoagulant?
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 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 ®.
What is Elmiron?
Elmiron (pronounced EL ma ron) 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.
What is the most important information I should know about Elmiron?
Elmiron is used to treat the pain or discomfort of interstitial cystitis (IC).
What should I tell my healthcare provider before taking Elmiron?
If you are taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.
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 are the ingredients in Elmiron?
Inactive ingredients: microcrystalline cellulose, magnesium stearate, ferrosoferric oxide, FD&C blue no. 2, aluminum oxide, FD&C red no. 40, FD&C blue no. 1, D&C yellow no. 10, butyl alcohol, propylene glycol, titanium dioxide.
Does Elmiron cause rash?
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.
Is there a generic version of Elmiron?
Unfortunately, there is currently no generic version of Elmiron available in the United States. To date, it is the only FDA-approved medication for treating interstitial cystitis.
What is the FDA approved medication for bladder pain?
Elmiron is the only FDA-approved medication to treat the bladder pain and discomfort associated with IC.
What is Elmiron used for?
Elmiron is a medication prescribed for the treatment of bladder pain and discomfort caused by interstitial cystitis (IC).
What is the active ingredient in Elmiron?
Pentosan polysulfate sodium ( PPS), the active ingredient in Elmiron, is believed to be responsible for the retinal damage in patients who use the drug. However, more evidence is still needed to support this claim.
What is bladder distention?
Bladder distention. In this procedure, a physician stretches the bladder with the use of water. It’s a potential treatment for patients with urinary frequency and bladder pain.
What antidepressants help with bladder pain?
Tricyclic antide pressants (TCAs). Certain tricyclic antidepressants like Tofranil (imipramine) or amitriptyline can help soothe the bladder, therefore reducing pain.
Can you take Elmiron after quitting?
Some studies suggest that the eye damage potentially caused by Elmiron can continue to progress even after years of quitting the medicine. If you are concerned about any side effects or symptoms while taking Elmiron, consult with your doctor.
How long does Elmiron last?
If improvement has not occurred and if limiting adverse events are not present, ELMIRON ® may be continued for another 3 months.
How many patients were in the Elmiron trial?
Of the 2627 patients, 128 patients were in a 3-month trial and the remaining 2499 patients were in a long-term, unblinded trial.
What is pentosan polysulfate sodium?
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.
How long does it take for Elmiron to improve pain?
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 ®, 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 ).
What is Elmiron used for?
ELMIRON is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis.
How often are unblinded pain scores evaluated?
Patients had unblinded evaluations every 3 months for the 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 for the 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.
Where is pentosan metabolized?
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.
What is Elmiron used for?
Elmiron is used to treat the pain associated with interstitial cystitis—a urinary tract system condition that causes abdominal and pelvic pain. This condition mostly affects women and can be chronic or intermittent.
What happens if you take Elmiron?
If you’ve taken Elmiron and have developed a damaging eye condition, you may be able to take legal action for your injuries and losses. At Thomas Law Offices, our dangerous drug attorneys are dedicated to helping injury victims and ensuring their rights are upheld.
What is bladder distention?
Bladder instillation. A bladder instillation is a procedure that delivers medications like Rimso-50 or dimethyl sulfoxide directly by a catheter in the bladder.
How to reduce bladder pain?
Nerve stimulation. Nerve stimulation procedures like transcutaneous electric nerve stimulation (TENS) or sacral nerve stimulation can reduce bladder pain by increasing blood flow to the bladder. As a result, the muscles that control the bladder can strengthen.
What is the best medication for urination?
Antihistamines. Allergy medications like loratadine (Claritin) can reduce the urgency to urinate and reduce discomfort and pain.
What is Thomas Law Offices?
At Thomas Law Offices, our personal injury attorneys recognize that our potential clients are likely going through some of the most difficult times of their lives. We don't want you to have to worry about paying out-of-pocket for legal advice when you're just starting to learn your legal rights and options. That's why we provide free case evaluations. We'll offer our expert advice about your potential case and walk you through how we can help you.
Can you stop taking Elmiron for interstitial cystitis?
If you’ve been diagnosed with interstitial cystitis and are taking Elmiron, it’s important to understand the risks of doing so, as well as what your options are in the event you want to stop taking the medication for your pain management. Elmiron, the only drug used to treat pain associated with the bladder condition mentioned above, ...

Elmiron Description
This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis).
May Treat: Bladder pain · Interstitial cystitis · Urinary tract irritation
Drug Class: Interstitial Cystitis Agents
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
May Treat: Bladder pain · Interstitial cystitis · Urinary tract irritation
Drug Class: Interstitial Cystitis Agents
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: JANSSEN PHARM.
Elmiron - Clinical Pharmacology
Clinical Trials
Indications and Usage For Elmiron
Contraindications
Warnings
- 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
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 …
Precautions
- Elmiron® 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). App…
Adverse Reactions
- Elmiron®(pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Overdosage
- Elmiron®is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
Elmiron Dosage and Administration
- Retinal Pigmentary Changes Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears …