Sulindac 150mg Tablets

Sulindac is a prodrug that is reversibly metabolized to its active sulfide metabolite. The sulfide metabolite is a non-selective inhibitor of cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Bleeding: Vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
High or low blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Pancreatitis: Severe stomach pain, severe back pain, or severe nausea and vomiting.
Other severe symptoms: Flushing, excessive sweating, shortness of breath, significant weight gain, or swelling in the arms or legs, chest pain or pressure, rapid heartbeat, weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Aseptic meningitis: A severe brain problem that can occur with this medication. Contact your doctor immediately if you experience headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, sleepiness, or confusion.
Liver problems: Although rare, liver problems can occur with this medication and may be fatal. Seek medical help immediately if you experience dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.

Common Side Effects

Most people do not experience severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Heartburn
* Dizziness or headache

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other medications, foods, or substances. Describe the allergic reaction and its symptoms.
If you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.
If you have experienced nasal polyps, swelling of the mouth, face, lips, tongue, or throat, unusual hoarseness, or breathing difficulties after taking aspirin or NSAIDs.
If you have a history of gastrointestinal (GI) bleeding or kidney problems.
If you have heart failure (a weak heart) or have recently had a heart attack.
If you are currently taking another NSAID, a salicylate medication like aspirin, or pemetrexed.
If you are having difficulty conceiving or undergoing fertility testing.
If you are pregnant, planning to become pregnant, or become pregnant while taking this medication. This drug may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor advises you to do so. Do not take this medication if you are more than 30 weeks pregnant.

Additional Considerations:

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing adverse effects. Additionally, do not take this medication for a longer duration than specified by your doctor.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.

There is a risk of developing high blood pressure associated with medications like this one. Follow your doctor's instructions for monitoring your blood pressure.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions. If you smoke, it is also important to discuss this with your doctor, as smoking may affect your condition or treatment.

If you have asthma, inform your doctor, as you may be more sensitive to this medication. Furthermore, this medication may increase your risk of bleeding easily. To minimize this risk, be cautious and avoid injuries. Use a soft toothbrush and an electric razor to reduce the risk of bleeding.

The use of medications like this one may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization due to heart failure, and death may be higher. Discuss these risks with your doctor.

In people who have recently experienced a heart attack, the use of medications like this one may increase the risk of another heart attack and heart-related death. Additionally, research has shown that people taking medications like this one after a first heart attack were more likely to die within the year following the heart attack compared to those not taking these medications. It is crucial to discuss these risks with your doctor.

If you are taking aspirin to prevent heart attacks, inform your doctor, as this may affect your treatment plan.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Medications like this one, which are classified as NSAIDs, may affect ovulation (egg release), potentially impacting fertility. However, this effect is reversible, and ovulation typically returns to normal once the medication is stopped. Discuss any concerns about fertility with your doctor.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Severe renal impairment
• Severe hepatic impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Anticoagulants (e.g., warfarin): Increased risk of bleeding
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding
• Corticosteroids: Increased risk of GI ulceration/bleeding
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced natriuretic and antihypertensive effects, increased risk of renal impairment
• ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment
• Lithium: Increased lithium plasma concentrations and toxicity
• Methotrexate: Increased methotrexate plasma concentrations and toxicity
• Cyclosporine: Increased nephrotoxicity
• Digoxin: Increased digoxin plasma concentrations
• SSRIs/SNRIs: Increased risk of GI bleeding

• Beta-blockers: Reduced antihypertensive effect
• Hydantoins (e.g., phenytoin): Increased hydantoin levels
• Sulfonylureas: Increased hypoglycemic effect
• Probenecid: Increased sulindac plasma levels and half-life
• Quinolone antibiotics: Increased risk of CNS stimulation and seizures

• Not available

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Signs of fluid retention/edema (e.g., swelling in ankles, feet, hands)
• Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of kidney problems (e.g., decreased urine output, swelling, unusual fatigue)
• Unexplained weight gain
• Chest pain, shortness of breath, weakness on one side of the body, slurred speech (signs of cardiovascular events)
• Severe skin reactions (e.g., blistering, peeling rash)

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Sulindac and its metabolites are excreted in breast milk. While the amount is generally low, caution is advised. Monitor the infant for adverse effects, especially GI upset or bleeding.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

Elderly patients are at increased risk for serious adverse reactions, including gastrointestinal bleeding, ulceration, perforation, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Sulindac is a prodrug that requires hepatic activation to its active sulfide metabolite. This unique metabolism may contribute to its relatively lower incidence of renal adverse effects compared to some other NSAIDs, though renal toxicity is still a risk.
• It has been studied off-label for its potential role in reducing the number and size of colorectal polyps in patients with familial adenomatous polyposis (FAP), independent of its COX inhibition.
• Due to its long half-life, twice-daily dosing is sufficient for most indications.
• Patients should be advised to report any signs of GI bleeding immediately, as these can occur without warning.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib, diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) or biologics (for chronic inflammatory conditions like rheumatoid arthritis)
• Opioid analgesics (for severe acute pain, short-term use, with caution)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and avoid taking medication prescribed to someone else. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.