sulindac

What is the most important information I should know about sulindac?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use sulindac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking sulindac, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What is sulindac?

Sulindac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Sulindac works by reducing hormones that cause inflammation and pain in the body.

Sulindac is used to treat pain or inflammation caused by arthritis, ankylosing spondylitis, tendinitis, bursitis, or gout.

Sulindac may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sulindac?

Do not use sulindac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking sulindac, especially in older adults.

Do not use this medication if you are allergic to sulindac, or to aspirin or other NSAIDs.

To make sure you can safely take sulindac, tell your doctor if you have any of these other conditions:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding, bowel problems, diverticulosis;
• liver or kidney disease;
• asthma;
• polyps in your nose; or
• if you smoke.

FDA pregnancy category C. It is not known whether sulindac will harm an unborn baby. Taking sulindac during the last 3 months of pregnancy may result in birth defects. Do not take sulindac during pregnancy unless your doctor has told you to.

It is not known whether sulindac passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without the advice of a doctor.

How should I take sulindac?

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 prescription label.

The maximum amount of sulindac for adults is 400 milligrams (mg) per day. Know the amount of sulindac in the specific product you are taking.

If you take sulindac for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Visit your doctor regularly.

Store at room temperature, away from moisture, heat, and light.

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 make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, dizziness, drowsiness, black or bloody stools, coughing up blood, fever, urinating less than usual or not at all, shallow breathing, and fainting.

What should I avoid while taking sulindac?

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain type of drug. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

What are the possible side effects of sulindac?

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

Stop using sulindac and call your doctor at once if you have a serious side effect such as:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
• dizziness, headache, nervousness;
• skin itching or rash;
• dry mouth;
• increased sweating, runny nose;
• blurred vision; or
• ringing in your ears.

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.

What other drugs will affect sulindac?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with sulindac may cause you to bruise or bleed easily.

Tell your doctor about all other medicines you use, especially:

• cyclosporine (Gengraf, Neoral, Sandimmune);
• a diuretic (water pill) such as furosemide (Lasix);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall);
• a blood thinner such as warfarin (Coumadin);
• steroids (prednisone and others);
• heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Benicar), telmisartan (Micardis), or valsartan (Diovan);
• oral diabetes medications such as glipizide (Glucotrol), glimepiride (Amaryl, Duetact, Avandaryl), and others;
• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with sulindac. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sulindac.