Indomethacin 50mg 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, largely through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandins, which are mediators 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 or seek medical attention immediately:

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 that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden 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 weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure.
Neurological Issues: Weakness on one side of the body, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Vision Changes: Changes in eyesight.
Hearing Issues: Ringing in the ears.
Mood Changes: Depression.
Flu-like Symptoms: Flu-like signs.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be fatal and require immediate medical attention.)
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.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or persist, contact your doctor or seek medical attention:

Headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
* Dizziness, drowsiness, fatigue, or weakness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 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, diflunisal), triamterene, or pemetrexed.
Fertility issues or ongoing fertility evaluation.
Pregnancy, planned pregnancy, or suspected pregnancy. This medication may harm an 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, it is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems, to 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 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.

Until you understand how this medication affects you, avoid driving and other activities that require alertness. Be aware that 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 for shaving.

This medication may interfere with certain laboratory tests, so it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug. Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, consult with your doctor about the possible implications. Long-term use of this medication may require regular blood tests, so discuss this with your doctor.

There is a potential risk of developing high blood pressure with medications like this one. Ensure that your blood pressure is monitored as advised by your doctor. If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

The use of drugs 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. Discuss these risks with your doctor. Furthermore, the risk of heart attack and heart-related death may be increased in individuals taking this type of medication after a recent heart attack. In fact, people taking drugs like this one after a first heart attack were more likely to die in the year following the heart attack compared to those not taking these medications. Consult with your doctor about these risks.

If you are taking aspirin to prevent a heart attack, discuss the potential interactions with your doctor. Certain health conditions, such as depression, mood problems, seizures, and Parkinson's disease, may worsen with this medication. Inform your doctor if you have any of these conditions and experience worsening symptoms.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss the potential risks with your doctor.

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

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Other NSAIDs (increased risk of GI bleeding/ulceration)
• Ketorolac (increased risk of GI bleeding/ulceration)

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
• Antiplatelet agents (e.g., Aspirin, Clopidogrel) - increased bleeding risk
• SSRIs/SNRIs - increased bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Digoxin - increased digoxin levels
• 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
• Corticosteroids - increased risk of GI ulceration/bleeding
• Pemetrexed - increased myelosuppression, renal, and GI toxicity

• Beta-blockers - reduced antihypertensive effect
• Hydralazine - reduced antihypertensive effect
• Probenecid - increased indomethacin levels
• Phenytoin - increased phenytoin levels
• Sulfonylureas - altered blood glucose control
• Quinolone antibiotics - increased risk of CNS stimulation/seizures

• Antacids - may delay absorption but not extent

• 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 body, slurred speech)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness)
• Skin reactions (e.g., rash, blisters, peeling skin)
• Unusual weight gain or swelling (fluid retention)
• Vision changes or blurred vision (rare, but reported)
• Severe headache, dizziness, confusion (CNS effects)

Contraindicated after 20 weeks gestation due to risk of fetal renal dysfunction and oligohydramnios, and particularly after 30 weeks gestation due to risk of premature closure of the fetal ductus arteriosus. 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 breastfed infants (e.g., seizures, GI bleeding, renal dysfunction), it is generally not recommended for use during breastfeeding. A safer alternative should be considered.

Oral capsules are generally not recommended for children under 14 years of age due to lack of established safety and efficacy for most indications. IV indomethacin is used in neonates for patent ductus arteriosus (PDA).

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

• 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.
• It is particularly effective for acute gouty arthritis and acute bursitis/tendinitis.
• Always take indomethacin with food, milk, or antacids to minimize GI upset.
• Patients should be advised to report any signs of GI bleeding (e.g., black stools, vomiting blood) immediately.
• Monitor blood pressure regularly, as NSAIDs can elevate BP.
• Due to its relatively short half-life, multiple daily doses are typically required.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain/fever without inflammation)
• Corticosteroids (for severe inflammation, short-term)
• Colchicine (for acute gout)
• Allopurinol/Febuxostat (for chronic gout prophylaxis)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, biologics)

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 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. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.