Sulindac 200mg 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, feeling faint, 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 symptoms: Flushing, excessive sweating, shortness of breath, significant weight gain, or swelling in the arms or legs.
Cardiovascular symptoms: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological symptoms: Difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
General symptoms: Extreme fatigue or weakness, changes in vision, eye pain, or severe eye irritation, ringing in the ears, fever, chills, or sore throat, severe muscle or joint pain, or flu-like symptoms.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions can be life-threatening and may also affect internal organs. 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
Swollen glands

Other Serious Conditions

Aseptic meningitis: A rare but serious brain condition. Contact your doctor immediately if you experience headache, fever, chills, severe nausea and vomiting, stiff neck, rash, sensitivity to light, sleepiness, or confusion.
Liver problems: This medication can cause liver damage, which can be fatal. Seek medical help right away if you notice dark urine, fatigue, decreased appetite, stomach pain or nausea, light-colored stools, vomiting, or yellow skin and eyes.

Common Side Effects

Most people do not experience severe side effects, but some may encounter mild or moderate symptoms. If you experience any of the following, 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 essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs) like 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 drug like aspirin, or pemetrexed.
If you are having trouble conceiving or undergoing fertility testing.
If you are pregnant, plan 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 has instructed 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 crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Ensure that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.

If you are taking this medication long-term, your doctor may require you to undergo regular blood tests to monitor your condition. It is also crucial to have your blood pressure checked as directed by your doctor, as medications like this one can cause high blood pressure.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, have asthma, or have any other health concerns, consult with your doctor, as these factors may affect your sensitivity to this medication or increase your risk of complications. You may experience easier bleeding while taking this medication, so it is essential to be cautious and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor.

The use of medications like this one can 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. Furthermore, people who have recently experienced a heart attack may have a higher risk of heart attack and heart-related death when taking medications like this one. In fact, studies have shown that individuals taking these medications after a first heart attack were more likely to die within the following year compared to those not taking these medications. Consult with your doctor to understand these risks.

If you are taking aspirin to prevent heart attacks, inform your doctor, as this may affect your treatment plan. Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible, and ovulation typically returns to normal once the medication is discontinued. Discuss any concerns about fertility with your doctor.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and provide guidance on the safe use of this medication.

• Aspirin or other NSAIDs (due to increased risk of serious GI events)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin) - increased bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE Inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment and hyperkalemia

• Beta-blockers - reduced antihypertensive effect
• SSRIs/SNRIs - increased risk of GI bleeding
• Corticosteroids - increased risk of GI ulceration/bleeding
• Digoxin - possible increased digoxin levels
• Pemetrexed - increased pemetrexed toxicity (avoid in patients with renal impairment)

• Antacids - may delay absorption but not significantly affect extent

• Gastrointestinal symptoms (e.g., abdominal pain, dyspepsia, nausea, vomiting, heartburn)
• Signs of bleeding (e.g., unusual bruising, petechiae, black/tarry stools, coffee-ground vomit)
• Fluid retention/edema (e.g., swelling in ankles, feet)
• Skin rash or itching
• Vision changes or blurred vision
• Unexplained weight gain
• Fatigue, lethargy, or flu-like symptoms (may indicate liver issues)
• Signs of allergic reaction (e.g., difficulty breathing, swelling of face/throat)

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. Use with caution; consider potential risks to the infant versus benefits to the mother. Other NSAIDs with better safety profiles in lactation may be preferred.

Safety and effectiveness have not been established for children under 2 years of age. Not generally recommended for routine pediatric use. Limited data for specific conditions (e.g., juvenile idiopathic arthritis) but generally other NSAIDs are preferred.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, 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, especially renal function and GI symptoms.

• Sulindac is a prodrug; its active sulfide metabolite has a longer half-life, allowing for twice-daily dosing.
• Unlike many NSAIDs, sulindac's active metabolite is primarily excreted in bile, which may theoretically lead to less renal toxicity compared to some other NSAIDs, though renal impairment can still occur.
• It has been studied for potential chemopreventive effects in certain cancers (e.g., colorectal polyps), but this is not an FDA-approved indication and carries significant risks.
• Patients with a history of aspirin-exacerbated respiratory disease (AERD) or aspirin triad (asthma, rhinitis with nasal polyps, aspirin sensitivity) should avoid sulindac due to risk of severe, potentially fatal bronchospasm.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, biologics)
• Non-pharmacological therapies (e.g., physical therapy, heat/cold therapy, exercise)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. 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.