Pentosan polysulfate sodium

Pentosan polysulfate sodium is used to treat bladder pain and discomfort caused by cystitis (which is inflammation or irritation of the bladder).

Pentosan polysulfate sodium is for adults and children who are at least 16 years old.

Pentosan polysulfate sodium may also be used for reasons not mentioned in this medication guide.

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

Take pentosan polysulfate sodium with a full glass of water. Take it 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 decide how long you should be treated with pentosan polysulfate sodium. You may also need blood tests and eye exams to check for certain side effects.

If you need surgery, tell your surgeon that you are currently using this medicine. You may need to stop using it for a short time.

Store at room temperature, away from moisture and heat.

Taking pentosan polysulfate sodium can increase your risk of bleeding. Call your doctor immediately if you notice any unusual bleeding (such as a nosebleed, blood in your urine or stools, rectal bleeding, coughing up blood, or bleeding gums).

You should not use pentosan polysulfate sodium 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.

Tell your doctor if you are pregnant or breastfeeding.

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

Pentosan polysulfate sodium may cause serious side effects. Call your doctor right away if you have:

• nosebleeds, bleeding gums;
• blood in your urine or stools;
• rectal bleeding;
• coughing up blood;
• feeling light-headed, like you might pass out; or
• vision problems (blurred vision, trouble reading, trouble seeing in low light).

Common side effects of pentosan polysulfate sodium may include:

• bruising, blood in your stools;
• hair loss;
• nausea, diarrhea, upset stomach;
• headache;
• swelling, weight gain;
• dizziness;
• rash; or
• abnormal liver function tests.

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.

Usual Adult Dose for Cystitis:

100 mg orally 3 times a dayUse: For the relief of bladder pain or discomfort associated with interstitial cystitis

Usual Pediatric Dose for Cystitis:

16 years or older: 100 mg orally 3 times a dayUse: For the relief of bladder pain or discomfort associated with interstitial cystitis

Take the medicine as soon as you can, but if it is nearly time for your next dose, skip the missed dose. Do not take two doses at the same time.

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

Ask a doctor or pharmacist before using any medicine that contains aspirin, ibuprofen, or similar ingredients. This includes medicine for pain, fever, swelling, or cold/flu symptoms.

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven;
• medication used to prevent blood clots--apixaban, heparin, rivaroxaban, Eliquis, Xarelto, and others; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect pentosan polysulfate sodium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.