Pronunciation:

PEN-toe-san pol-ee-SUL-fate SOE-dee-um

Brand Names:

• Elmiron

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Cystitis Agent

Uses of This Medicine:

Pentosan polysulfate sodium is used to relieve the symptoms (eg, pain, discomfort) of interstitial cystitis (inflammation of the bladder).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pentosan polysulfate sodium in children younger than 16 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of pentosan polysulfate sodium in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anistreplase
• Apixaban
• Argatroban
• Aspirin
• Bemiparin
• Bivalirudin
• Bromfenac
• Bufexamac
• Celecoxib
• Chamomile
• Choline Salicylate
• Citalopram
• Clonixin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Drotrecogin Alfa
• Droxicam
• Enoxaparin
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fondaparinux
• Garlic
• Heparin
• Ibuprofen
• Ibuprofen Lysine
• Indomethacin
• Ketoprofen
• Ketorolac
• Lepirudin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Papaya
• Parecoxib
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Protein C
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sertraline
• Sodium Salicylate
• St John's Wort
• Streptokinase
• Sulindac
• Tan-Shen
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Tinzaparin
• Tolfenamic Acid
• Tolmetin
• Urokinase
• Valdecoxib
• Venlafaxine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chondroitin
• Coenzyme Q10
• Dong Quai
• Ginger
• Vitamin A

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding or blood vessel problems (eg, aneurysm, hemophilia) or
• Eye or vision problems, or history of—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Stomach or bowel problems (eg, ulcer, polyps, diverticulitis) or
• Thrombocytopenia, heparin-induced (low platelet count), history of—Use with caution. May increase risk of bleeding.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with water on an empty stomach at least 1 hour before or 2 hours after meals.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For symptoms of interstitial cystitis:
    • Adults and children 16 years of age and older—100 milligrams (mg) 3 times a day for 3 months. Some patients may continue to take this medicine for another 3 months.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if blurred vision, difficulty with reading, slower adjustment to low or reduced light, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor) and eye tests will be needed, especially within 6 months of starting treatment with this medicine.

This medicine can temporarily lower the number of platelets in your blood, which are necessary for proper blood clotting. Because of this, you may bleed longer than usual or get bruised more easily. If this occurs, there are certain precautions you can take to reduce the risk of bleeding:

• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Black, tarry stools

bleeding of the gums

blindness

blood in the urine or stools

blue-yellow color

blurred, decreased, or other changes in vision

bruising

burning, dry, or itching eyes

burning feeling in the chest or stomach

chest pain or tightness

chills

cough

difficulty breathing or swallowing

discharge, excessive tearing

dizziness

eye pain

fast heartbeat

heartburn

hives, itching, skin rash

indigestion

large, flat, blue or purplish patches in the skin

loss of appetite

nosebleed

painful or difficult urination

pain or burning in the throat

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sores, ulcers, or white spots on the lips or tongue or inside the mouth

stomach cramps, tenderness, or upset

swollen glands

uncontrolled eye movements

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

watery or bloody diarrhea

weight loss

Rare

Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Belching

bloating

body aches or pain

constipation

continuing ringing or buzzing or other unexplained noise in ears

diarrhea

discouragement

dizziness

dryness of the throat

excess air or gas in the stomach or bowels

feeling sad or empty

full feeling

headache

hearing loss

hoarseness

increased body movements

increased sensitivity of skin to sunlight

increased sweating

indigestion

irritability

itching of the vagina or genital area

loss of interest or pleasure

nausea

pain during sexual intercourse

passing gas

redness or other discoloration of the skin

runny or stuffy nose

severe sunburn

sneezing

stomach discomfort, upset, or pain

thick, white vaginal discharge with no odor or with a mild odor

thinning or loss of hair

trouble concentrating

trouble sleeping

voice changes

Rare

Absent, missed, or irregular menstrual periods

difficulty in moving

joint pain

muscle pain or stiffness

stopping of menstrual bleeding

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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