Indomethacin 75mg ER Capsules

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its primary mechanism of action is the inhibition of prostaglandin synthesis by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. This inhibition reduces the formation of prostaglandin precursors, which are involved in the mediation of inflammation, pain, and fever.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately or seek emergency medical attention:

Allergic Reaction: 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.
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 Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden significant weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure.
Neurological Issues: Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Vision Changes: Changes in eyesight.
Other Symptoms: Ringing in the ears, depression, flu-like symptoms.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. Liver problems can be life-threatening, so seek medical help immediately if you experience any of these symptoms.
Severe Skin Reactions: These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can affect body organs and be life-threatening. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following:

Headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
* Feeling dizzy, sleepy, tired, or weak

If you experience any of these side effects or any other symptoms that concern you or do not go away, contact your doctor for advice.

Reporting Side Effects

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

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

It is essential to inform your doctor about the following conditions to ensure safe treatment:

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.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Presence of certain health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack.
Concurrent use of other NSAIDs, salicylate drugs (e.g., aspirin or diflunisal), triamterene, or pemetrexed.
Difficulty conceiving or ongoing fertility evaluation.
Pregnancy, planned pregnancy, or pregnancy occurrence during treatment. This medication may harm the unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

Verify with your doctor that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.

Important Warnings and Cautions

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 period than specified by your doctor.

Until you understand how this medication affects you, avoid driving and other activities that require alertness. You may experience easier bleeding, so it is crucial to be cautious and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor.

This medication may interfere with certain laboratory tests. Therefore, it is vital to inform all your healthcare providers and laboratory personnel that you are taking this medication.

Before consuming alcohol, consult with your doctor to discuss any potential risks. If you smoke, talk to your doctor about the potential effects on your health. Long-term use of this medication may require regular blood tests, so consult with your doctor to determine the best course of action.

There is a risk of developing high blood pressure with medications like this one. Follow your doctor's instructions for monitoring your blood pressure. If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.

The use of medications like this one may increase the risk of heart failure. If you already have heart failure, the risk of heart attack, hospitalization for heart failure, and death may be higher. Consult with your doctor to discuss these risks. Additionally, the risk of heart attack and heart-related death may be higher in people taking medications like this one after a recent heart attack. In fact, people taking these medications after a first heart attack were more likely to die in the year following the heart attack compared to those not taking these medications.

If you are taking aspirin to prevent a heart attack, consult with your doctor to discuss any potential interactions.

In some cases, medications like this one may worsen depression or other mood problems, seizures, and health conditions like Parkinson's disease. If you have any of these conditions and experience worsening symptoms, inform your doctor.

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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this medication may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Consult with your doctor to discuss any concerns.

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Ketorolac (concurrent use with other NSAIDs)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Dabigatran): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Lithium: Increased plasma lithium levels and toxicity.
• Methotrexate: Increased methotrexate levels and toxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
• ACE Inhibitors (e.g., Lisinopril) / Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan): Reduced antihypertensive effect, increased risk of renal impairment and hyperkalemia.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Cyclosporine, Tacrolimus: Increased nephrotoxicity.
• Digoxin: Increased serum digoxin levels.

• Beta-blockers: Reduced antihypertensive effect.
• Hydralazine: Reduced antihypertensive effect.
• Probenecid: Increased indomethacin plasma levels.
• Triamterene: Increased risk of renal failure.
• Potassium-sparing diuretics: Increased risk of hyperkalemia.

• Antacids: May delay absorption but generally not clinically significant.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., nausea, fatigue, dark urine, yellowing of skin/eyes, flu-like symptoms)
• Signs of hypersensitivity reactions (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unusual bruising or bleeding
• Persistent headache, dizziness, or confusion
• Vision changes

Use of NSAIDs, including Indomethacin, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Therefore, Indomethacin is contraindicated in the third trimester. Use during the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus.

Indomethacin is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., CNS effects, seizures), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Other NSAIDs with shorter half-lives or lower excretion into milk may be preferred.

Safety and effectiveness of Indomethacin extended-release capsules have not been established in pediatric patients. Use is generally not recommended in children due to potential for serious adverse effects and lack of specific dosing guidelines for this formulation.

Elderly patients are at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events with NSAID use. Use the lowest effective dose for the shortest duration possible. Monitor closely for signs of GI bleeding, renal impairment, and cardiovascular events. Concomitant medications and comorbidities should be carefully considered.

• Indomethacin is a potent NSAID, often reserved for conditions unresponsive to less potent NSAIDs due to its higher incidence of CNS and GI side effects.
• The extended-release formulation is designed for once-daily dosing, improving patient adherence.
• Always advise patients to take Indomethacin with food, milk, or antacids to minimize GI upset.
• Due to its potential for CNS side effects (e.g., headache, dizziness, confusion), caution patients about driving or operating machinery until they know how the drug affects them.
• Closely monitor blood pressure, especially in patients with pre-existing hypertension, as NSAIDs can elevate blood pressure.
• Educate patients on the signs and symptoms of serious adverse events, particularly GI bleeding and cardiovascular events, and when to seek immediate medical attention.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, different mechanism and side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, biologics)
• Physical therapy, occupational therapy, heat/cold therapy (non-pharmacological)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which is a valuable resource 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, we encourage you to discuss them with 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.