NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Sulindac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: NSAID
Chemical Class: Acetic Acid (class)
Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis) or acute gout, such as inflammation, swelling, stiffness, and joint pain. sulindac does not cure arthritis and will help you only as long as you continue to take it.
Sulindac is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. sulindac may also be used to treat painful shoulder (bursitis or tendinitis).
sulindac is available only with your doctor's prescription.
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 sulindac, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to sulindac 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.
Appropriate studies have not been performed on the relationship of age to the effects of sulindac in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulindac in the elderly. However, elderly patients may be more sensitive to the effects of sulindac than younger adults, and are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving sulindac.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
Using sulindac with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using sulindac 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.
Using sulindac 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.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of sulindac. Make sure you tell your doctor if you have any other medical problems, especially:
For safe and effective use of sulindac, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of sulindac may increase the chance of unwanted effects, especially in elderly patients.
sulindac should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
When used for severe or continuing arthritis, sulindac must be taken regularly as ordered by your doctor in order for it to help you. sulindac usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of sulindac.
It is best to take sulindac with food. Also drink extra fluids so you will pass more urine while you are using sulindac. This will keep your kidneys working well and help prevent kidney problems.
The dose of sulindac 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 sulindac. 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.
If you miss a dose of sulindac, 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.
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.
It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
sulindac may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use sulindac for a long time might also have a higher risk.
sulindac may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or if you are using certain other medicines (such as a steroid medicine or a blood thinner).
Serious skin reactions can occur during treatment with sulindac. Check with your doctor right away if you have any of the following symptoms while taking sulindac: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.
Some possible warning signs of serious side effects that can occur during treatment with sulindac may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. . Also, signs of serious heart problems could occur such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking sulindac and check with your doctor right away if you notice any of these warning signs.
sulindac may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include a color change of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.
Using sulindac during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
sulindac may cause problems with your pancreas. Check with your doctor right away if you have any of the following symptoms while taking sulindac: bloating; chills; constipation; darkened urine; fast heartbeat; fever; indigestion; loss of appetite; nausea; pains in the stomach, side, or abdomen, possibly radiating to the back; vomiting; or yellow eyes or skin.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Call your doctor right away if you have confusion, drowsiness, a fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of meningitis.
Before having any kind of surgery or medical tests, tell your doctor that you are taking sulindac. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:More common
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
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
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.
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