is elmiron a prescription drug

Precautions

ELMIRON ® is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis. It is not known if ELMIRON ® is safe and effective in children under 16 years of age. What is the most important information I should know about ELMIRON® (pentosan polysulfate sodium) Capsules?

What is Elmiron® used to treat?

Elmiron Side Effects 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.

What are the side effects of Elmiron?

You and your healthcare provider should decide if you will take ELMIRON ® or breastfeed Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements Store ELMIRON ® at room temperature between 68°F to 77°F (20°C to 25°C).

Can I take Elmiron ® If I am breastfeeding?

Clinical Trials. 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.

What are the clinical trials for Elmiron?

Do doctors still prescribe Elmiron?

Elmiron, a bladder medication used to treat pain and discomfort associated with interstitial cystitis, is widely prescribed in the United States. Elmiron is currently the only FDA-approved medication for treating 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.

How do you get Elmiron?

like to receive an ELMIRON® EarlyAssist™ Savings Card. Download and print the card and present it at a participating retail pharmacy along with a valid prescription. Your eligibility to use this card is dependent upon meeting the program requirements each time you present the card when filling your prescription.

What is the best pain medication for interstitial cystitis?

Nonsteroidal anti-inflammatory drugs, such as ibuprofen (Advil, Motrin IB, others) or naproxen sodium (Aleve), to relieve pain. Tricyclic antidepressants, such as amitriptyline or imipramine (Tofranil), to help relax your bladder and block pain.

Can interstitial cystitis go away?

For about half the cases, interstitial cystitis goes away by itself. Among those who need treatment, most find relief and get their lives back to normal. Treatment is mainly about symptom control.

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.

Is Elmiron expensive?

The most common version of Elmiron is covered by 97% of insurance plans at a co-pay of $40.00-$67.50, however, some pharmacy coupons or cash prices may be lower. The lowest GoodRx price for the most common version of Elmiron is around $887.13, 15% off the average retail price of $1,054.14. Compare glycosaminoglycans.

What happens if interstitial cystitis goes untreated?

Interstitial cystitis can result in a number of complications, including: Reduced bladder capacity. Interstitial cystitis can cause stiffening of the bladder wall, which allows your bladder to hold less urine. Lower quality of life.

Is there a generic version of Elmiron?

No. There is currently no therapeutically equivalent version of Elmiron available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Elmiron. These medications may be counterfeit and potentially unsafe.

How do you calm an interstitial cystitis flare up?

Here are some general self-help techniques to keep your bladder calm and help you reduce the possibility of a flare:Try relaxation techniques.Use meditation tapes and/or visualization.Learn self-hypnosis.Receive massages or learn self-massage.Go to psychotherapy to learn coping skills and stress reduction techniques.More items...•

What foods trigger interstitial cystitis?

Coffee, soda, alcohol, tomatoes, hot and spicy foods, chocolate, caffeinated beverages, citrus juices and drinks, MSG, and high-acid foods can trigger IC symptoms or make them worse.

How serious is interstitial cystitis?

IC is a chronic disease. Patients may find some comfort in the fact that it is not life-threatening and it does not lead to cancer. However, because the symptoms are always present, patients need to develop coping skills to deal with them.

What are the long term side effects of Elmiron?

The primary adverse reactions include changes in vision, alopecia, thrombosis, and hemorrhage. Studies show that the long-term use of Elmiron increases the risk of serious issues.

Can Elmiron stop working?

Symptom improvement may be gradual. Don't stop taking ELMIRON® or reduce your dosage just because you are feeling better or because ELMIRON® is not working right away. Talk to your doctor if symptoms do not improve within 6 months of treatment.

Can you just stop taking Elmiron?

ELMIRON controls your condition but does not cure it. Therefore ELMIRON must be taken every day. Continue taking ELMIRON for as long as your doctor prescribes. If you stop taking ELMIRON, the positive effects may gradually wear off.

Does Elmiron heal the bladder?

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.

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 is Elmiron?

Elmiron is used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).

How should I take Elmiron?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

What are the side effects of Elmiron?

Elmiron side effects. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: nosebleeds, bleeding gums; blood in your urine or stools; rectal bleeding; coughing up blood;

How long after eating can you take Elmiron?

Take on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the delayed-release capsule whole and do not crush, chew, break, or open it. Your doctor will need to check your progress every 3 months to help determine how long to treat you with Elmiron.

Can you take Elmiron if you are allergic to it?

You should not use Elmiron if you are allergic to it. Tell your doctor if you have ever had: a bleeding or blood clotting disorder; eye problems (especially a problem with your retina) in you or a family member; an aneurysm or stroke; a stomach ulcer, intestinal polyps or diverticulitis; or. liver disease.

Can you stop Elmiron for a short time?

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time. Store at room temperature away from moisture and heat. Detailed Elmiron dosage information.

Does Elmiron make you bleed?

Warnings. Taking Elmiron can make it easier for you to bleed. Call your doctor at once if you have any unusual bleeding (nosebleed, blood in your urine or stools, rectal bleeding, coughing up blood, bleeding gums).

What is Elmiron used for?

Elmiron is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis.

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.

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 ).

Is Elmiron contraindicated?

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

How much of a drug is excreted in urine?

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.

What drugs should be used for hemorrhage?

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.

Is Elmiron a carbohydrate?

Elmiron Description. 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.

Does Elmiron cause bleeding?

Aside from these side effects, some patients have reported experiencing excessive bleeding while on Elmiron. The drug is a weak blood thinner, so you must inform your doctor or surgeon of your dosage and the duration you have been taking it before undergoing any surgeries or treatments. Additionally, a blog at https://drugguardians.com/elmiron-lawsuit/ notes that Elmiron has been linked to Pigmentary Maculopathy after being taken for an extended period. Pigmentary Maculopathy is a degenerative eye disease that affects the macula in the eye, causing vision loss. If you experience vision loss, blurry vision, or difficulty reading, see your doctor immediately.#N#The rare side effects of Elmiron may also include:

Can you take Elmiron while pregnant?

During pregnancy, the doctor can prescribe the medication if it is necessarily needed. Though there is no evidence if Elmiron passes into breast milk, you should consult your doctor on that matter.

Is Elmiron a blood thinner?

Additionally, if there is any unusual bleeding, bruising, blood in the urine or stools, or red patches on your skin, consult your doctor immediately. Since Elmiron is a blood thinner, be careful when using your toothbrush, toothpick, or dental floss, and find alternative ways to clean your teeth with your dentist. Stay away from any activities that may cause injuries or bruises as they can develop complications while you’re on Elmiron.

What is Interstitial Cystitis (IC)?

Interstitial cystitis is a painful, incurable condition that can make daily life impossible to enjoy. In severe cases, sufferers may take 40-60 trips to the bathroom every day. They have trouble sleeping, as the urge to urinate is constant. The exact cause of the disorder is unknown.

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Are There Alternatives to Elmiron?

While Elmiron is the only FDA-approved treatment for interstitial cystitis, some alternatives exist, although they may be less effective for moderate to severe cases.

What is Elmiron used for?

Elmiron is a medication used to treat pain or discomfort associated with a bladder disorder known as interstitial cystitis (IC).

What Company Makes Elmiron?

Elmiron is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The U.S. Food and Drug Administration approved Elmiron for sale in 1996.

Why is Elmiron suing?

A growing number of plaintiffs have been filing Elmiron lawsuits due to serious side effects they have suffered which ultimately resulted in eye damage. Read on to learn more about how Elmiron works and what particular side effects are related ot its use.

What are the dangers of Elmiron?

Plaintiffs who have filed an Elmiron lawsuit also accuse Elmiron’s manufacturer of failing to adequately warn the public of the potential dangers related to the use of the bladder pain medication, including retinal damage, vision damage, and a handful of other eye problems.

What happens if you stop taking Elmiron?

After all, if you immediately stop taking this bladder medication, its positive effects will wear off and the symptoms of pain for which you originally took Elmiron may possibly re-emerge.

Is PPS toxic to the eye?

According to Dr. Nieraj Jain, an Ophthalmology Specialist from the Emory Eye Center, pentosan polysulfate sodium (PPS) can be toxic to the retin a, as Elmiron users for several years who were observed in the study were subsequently diagnosed with toxicity of the retina related to their chronic exposure to the drug.

What to do if you notice changes in your vision while taking Elmiron?

Seek immmediate medical attention if you notice any changes in your vision while taking Elmiron.

Can Prothrombin interfere with lab tests?

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.

Can you take aspirin and ketorolac together?

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 81-162 milligrams a day). Ask your doctor or pharmacist for more details.

Can you take pentosan with heparin?

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.

Are you currently using Elmiron?

This survey is being conducted by the WebMD marketing sciences department.

What is Elmiron used for?

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. Important Safety Information For ELMIRON ®.

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.

Can you take Elmiron more than once?

You must take ELMIRON ® as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed. Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON ®.

Does Elmiron cause bleeding?

Your risk of bleeding may be increased if you take ELMIRON ® along with other medicines such as:

Pharmaceutical drugs come with warnings

Any prescription drug sold and distributed in the United States must first be approved by the US Food and Drug Administration (FDA). The FDA will only approve a prescription drug after the pharmaceutical company has thoroughly tested the product.

The dangers of the prescription drug Elmiron

The prescription drug Elmiron (pentosan polysulfate sodium) is the only FDA-approved medication used to treat interstitial cystitis, or bladder pain syndrome. However, new research indicates the side effects of Elmiron may be more severe than was previously understood.

Let us help with your Elmiron eye disease case

If you or somebody you care about has taken the prescription drug Elmiron, you may need to speak to an attorney as soon as possible. This pharmaceutical drug has been linked too serious and irreversible eye damage. At Colson Hicks Eidson, a nationally recognized firm has a reputation for helping clients who have been injured by defective drugs.

What is Elmiron, and What Is It Used For?

The generic name for Elmiron is pentosan polysulfate sodium. Elmiron was first approved by the Food and Drug Administration (FDA) in 1996. The main manufacturer of Elmiron is Johnson & Johnson.

Possible Elmiron Complications

When you take a medication, you may experience some side effects. Side effects can range from rare and minimal to common and severe. Sometimes the term adverse event is used to refer to more severe side effects.

Elmiron Side Effects and Adverse Effects

Some side effects are minimal and only cause minor discomfort. You should always tell your doctor about any side effects or reactions you experience, particularly if they are severe or continuing.

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History of Elmiron

The FDA first approved Elmiron for use in 1996. Because it has been on the market for several years, many people have taken Elmiron. It is a highly popular treatment for interstitial cystitis.

Our Legal Advocates Are Here to Help You

If you have taken Elmiron and experienced vision problems, there may be legal action you can take.

Elmiron Description

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 …

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Precautions

Adverse Reactions

Overdosage

Elmiron Dosage and Administration