Indocin SR 75mg 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 inhibition reduces the formation of prostaglandin precursors from arachidonic acid, thereby decreasing 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 immediate 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, 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. (Note: Liver problems can be life-threatening and have occurred with similar medications.)
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek immediate medical help 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 potential 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 medications like aspirin or diflunisal, triamterene, or pemetrexed
Fertility issues or ongoing fertility evaluation
Pregnancy, planned pregnancy, or potential 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 (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. Additionally, do not take this medication for a longer duration than recommended by your doctor.

Until you are aware of how this medication affects you, avoid driving and other activities that require alertness. Be cautious, as this medication may increase your risk of bleeding easily. To minimize this risk, use a soft toothbrush and an electric razor, and avoid injuries.

This medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication. Before consuming alcohol, consult with your doctor. If you smoke, discuss this with your doctor, as it may be necessary to monitor your blood work, especially if you are taking this medication long-term.

There is a risk of developing high blood pressure associated 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. Additionally, if you are allergic to tartrazine (FD&C Yellow No. 5), a component found in some products, inform your doctor.

The use of medications similar to this one has been linked to an increased risk of heart failure. In individuals with pre-existing heart failure, the risk of heart attack, hospitalization due to heart failure, and death is elevated. Discuss this with your doctor. Furthermore, the risk of heart attack and heart-related death is increased in individuals 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 within the year following the heart attack compared to those not taking these medications. Consult with your doctor to understand these risks.

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

Individuals aged 65 and older should exercise caution when using this medication, as they may be more susceptible to side effects. It is also important to note that NSAIDs, like this medication, may affect ovulation, potentially impacting fertility. However, this effect is reversible upon discontinuation of the medication. Discuss this with your doctor if you are planning to conceive.

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

• Aspirin (high dose)
• Other NSAIDs (concurrent use)
• Ketorolac
• Anticoagulants (e.g., warfarin) in patients with high bleeding risk
• Diuretics (in patients with severe heart failure or renal impairment)
• ACE inhibitors/ARBs (in patients with severe heart failure or renal impairment)

• Anticoagulants (e.g., warfarin, heparin, DOACs) - increased bleeding risk
• Antiplatelet agents (e.g., clopidogrel, aspirin) - increased bleeding risk
• Corticosteroids - increased GI ulceration/bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Tacrolimus - increased nephrotoxicity
• Digoxin - increased digoxin levels
• Diuretics (e.g., furosemide, hydrochlorothiazide) - reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Beta-blockers - reduced antihypertensive effect
• Pemetrexed - increased pemetrexed toxicity (avoid in renal impairment)

• Phenytoin - increased phenytoin levels
• Sulfonylureas - altered glycemic control
• Probenecid - increased indomethacin levels
• Quinolone antibiotics - increased risk of CNS stimulation/seizures
• Potassium-sparing diuretics - increased risk of hyperkalemia

• Antacids - may reduce absorption (separate administration)

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs 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, difficulty breathing)
• Unusual bruising or bleeding
• Severe headache, dizziness, confusion, or psychiatric disturbances (more common with indomethacin)

Contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use in the first and second trimesters should only be 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., CNS effects, GI bleeding), 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.

Safety and effectiveness have not been established for chronic use in children under 14 years of age. Oral indomethacin is generally not recommended for pediatric use in the same indications as adults. IV indomethacin is used in neonates for patent ductus arteriosus (PDA).

Elderly patients are at a greater risk for serious adverse events from 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 bleeding.

• Indomethacin is a potent NSAID, often associated 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 ankylosing spondylitis.
• Extended-release formulation allows for once or twice daily dosing, improving adherence.
• Always take with food, milk, or antacids to minimize GI upset.
• Due to its potential for significant side effects, it is generally not considered a first-line NSAID for chronic pain conditions unless other NSAIDs have failed or are contraindicated.
• Closely monitor blood pressure, renal function, and signs of GI bleeding, especially in elderly patients or those with comorbidities.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib, diclofenac, meloxicam)
• Acetaminophen (for pain/fever, no anti-inflammatory effect)
• Corticosteroids (for acute inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., methotrexate, biologics)
• Colchicine (for acute gout)
• Allopurinol/Febuxostat (for chronic gout prophylaxis)

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.