Indomethacin 25mg 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 prostaglandin precursors, which are involved in 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 experience 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 or 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.
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 internal organs and be life-threatening. Seek medical help immediately 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
* Dizziness, drowsiness, fatigue, or weakness

If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical attention.

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 substances, such as foods or medications. 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 drugs, such as aspirin, or NSAIDs.
Existing health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack.
Current use of other NSAIDs, salicylate drugs (e.g., aspirin or diflunisal), triamterene, or pemetrexed.
Fertility issues or ongoing fertility evaluation.
Pregnancy, planned pregnancy, or pregnancy during treatment with 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure safe treatment, it is essential to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. Verify that it is safe to take this medication with your other 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. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration without consulting 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 this type of medication. 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. Additionally, people taking this type of medication after a recent heart attack may have a higher risk of heart attack and heart-related death. There is also an increased risk of death in the year following a first heart attack compared to those not taking this medication. Consult with your doctor about these risks.

If you are taking aspirin to prevent heart attacks, discuss the potential interactions with your doctor. This medication may worsen depression, mood problems, seizures, and conditions like Parkinson's disease. Inform your doctor if you have any of these conditions and if your symptoms deteriorate.

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 this with your doctor if you are planning to conceive.

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

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• History of asthma, urticaria, or other allergic-type reactions after aspirin or other NSAIDs
• Severe renal impairment (CrCl < 30 mL/min)
• Active gastrointestinal bleeding or ulceration
• Late pregnancy (third trimester)

• Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations 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.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Digoxin: Increased digoxin plasma concentrations.

• Beta-blockers: Reduced antihypertensive effect.
• Hydralazine: Reduced antihypertensive effect.
• Probenecid: Increased indomethacin plasma concentrations and half-life.
• Triamterene: Increased risk of renal failure.
• Potassium-sparing diuretics: Increased risk of hyperkalemia.
• Phenytoin: Possible increased phenytoin levels.
• Oral hypoglycemics: Possible potentiation of hypoglycemic effect.

• Antacids: May delay absorption but not significantly affect extent.
• Cholestyramine: May reduce absorption.

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
• Unusual bruising or bleeding
• Severe or persistent headache, dizziness, confusion

Avoid use in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest possible duration.

Indomethacin is excreted into breast milk in small amounts. While the amount is generally low, there is a potential for adverse effects in the infant (e.g., CNS effects, GI bleeding). Other NSAIDs with shorter half-lives or lower milk transfer may be preferred. Use with caution, monitor infant for adverse effects.

Safety and efficacy for general pain and inflammation in pediatric patients (other than for PDA closure in neonates with IV formulation) have not been established. Use is generally not recommended due to potential for serious adverse effects, including CNS effects and GI bleeding. If used, it should be under strict specialist supervision.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, and perforation, as well as 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.

• 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 due to its rapid onset and potent anti-inflammatory action.
• Always advise patients to take indomethacin with food, milk, or antacids to minimize GI irritation.
• Patients should be advised to remain upright for at least 10-15 minutes after taking the capsule to prevent esophageal irritation.
• 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.
• Regular monitoring of blood pressure, renal function, and liver function is crucial, especially in elderly patients or those on long-term therapy.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib, diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, short-term use)
• Colchicine (for acute gout)
• Allopurinol/Febuxostat (for chronic gout management)
• 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.