Sulindac Treatment Report

Precautions

Instructions

Side Effects

Interactions

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

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

Before taking sulindac, tell your doctor if you are allergic to any drugs, or if you have:

• 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.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take sulindac.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. 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.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain medicines similar to sulindac (such as aspirin, ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking sulindac. Alcohol can increase the risk of stomach bleeding.

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Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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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 taking sulindac and seek medical attention or call your doctor at once if you have any of these serious side effects:

• 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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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.

Before taking sulindac, tell your doctor if you are taking any of the following drugs:

• 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); or
• heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), 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 there may be other drugs that can interact with sulindac. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Clinoril and sulindac

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