Indocin 25mg Capsules

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its primary mechanism of action is believed to be inhibition of prostaglandin synthesis, mainly 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 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 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, 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. (Note: Liver problems can be life-threatening and have occurred with similar medications.)
Severe Skin Reactions: 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. These reactions can be life-threatening and may affect internal organs.

Common Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor if they bother you or persist:

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

Reporting Side Effects

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 or 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 prescribed by your doctor, as taking more than recommended may increase your risk of experiencing severe side effects. Do not exceed the prescribed treatment duration, as this can also lead to adverse effects.

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's 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's vital to inform all your healthcare providers and laboratory personnel that you are taking this drug. If you plan to consume alcohol, discuss this with your doctor first. Similarly, if you smoke, consult with your doctor about the potential risks. Long-term use of this medication may require regular blood tests, so be sure to follow your doctor's recommendations.

There is a 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 can 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 who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking this medication. There is also an increased risk of death in the year following a heart attack compared to those not taking this medication. Talk to your doctor about these risks.

If you are taking aspirin to prevent heart attacks, inform your doctor, as this may affect your treatment plan. Certain conditions, such as depression, mood problems, seizures, and Parkinson's disease, may worsen with this medication. If you have any of these conditions and notice your symptoms worsening, notify your doctor promptly.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age should be aware that NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns with your doctor.

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

• Aspirin (high dose)
• Other NSAIDs (concurrent use increases risk of GI adverse events)
• Ketorolac
• Methotrexate (high-dose)
• Lithium (concurrent use increases lithium levels and toxicity)
• Furosemide (reduced natriuretic effect)
• Thiazide diuretics (reduced natriuretic effect)
• Anticoagulants (e.g., Warfarin, Dabigatran) in patients with active bleeding or high risk of bleeding
• Pemetrexed (in patients with creatinine clearance <45 mL/min)

• Anticoagulants (e.g., Warfarin, Heparin, DOACs): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Diuretics (e.g., Hydrochlorothiazide, Furosemide): Reduced diuretic and antihypertensive effect, increased risk of renal impairment.
• Cyclosporine: Increased nephrotoxicity.
• Digoxin: Increased serum digoxin levels.
• Methotrexate (low-dose): Increased methotrexate toxicity.
• Phenytoin: Increased phenytoin levels.
• Beta-blockers: Reduced antihypertensive effect.
• Corticosteroids: Increased risk of GI ulceration and bleeding.

• Oral hypoglycemics: May alter blood glucose control.
• Probenecid: May increase indomethacin levels.
• Triamterene: Increased risk of renal failure.
• Tacrolimus: Increased nephrotoxicity.
• Cholestyramine: May reduce indomethacin absorption.

• Antacids: May reduce absorption (separate administration).

• 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 liver injury (fatigue, nausea, dark urine, jaundice, right upper quadrant pain, flu-like symptoms)
• Signs of kidney problems (decreased urination, swelling in ankles/feet, unusual fatigue)
• Unusual bruising or bleeding
• Severe headache, dizziness, confusion, or psychiatric disturbances
• Skin rash or allergic reactions

Avoid use during pregnancy, especially in the third trimester. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Indomethacin is excreted in breast milk. Due to potential for serious adverse reactions in nursing infants (e.g., CNS effects, GI bleeding, renal effects), use is generally not recommended. A safer alternative NSAID may be preferred.

Safety and efficacy have not been established for children under 14 years of age for inflammatory conditions. Oral capsules are not indicated for patent ductus arteriosus (PDA) closure in neonates (IV formulation is used for this specific indication).

Use with caution. Elderly patients are at higher risk for serious adverse events, particularly GI bleeding, cardiovascular events, and renal impairment. Start with the lowest effective dose and monitor closely for adverse effects.

• Indomethacin is a potent NSAID with a higher incidence of CNS side effects (e.g., headache, dizziness, confusion) compared to other NSAIDs.
• It is particularly effective for acute gouty arthritis and acute painful shoulder (bursitis/tendinitis).
• Due to its side effect profile, it is often reserved for patients who have not responded to other NSAIDs or for specific indications like gout.
• Always take with food, milk, or antacids to minimize GI irritation.
• Patients should be advised to report any signs of bleeding, severe stomach pain, or unusual headaches immediately.
• Avoid in patients with a history of aspirin-exacerbated respiratory disease (asthma, rhinitis with nasal polyps) due to risk of severe bronchospasm.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• Acetaminophen (for pain/fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, short-term use)
• Colchicine (for acute gout)
• Allopurinol/Febuxostat (for chronic gout prophylaxis)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA or AS.

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 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 reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.