Indomethacin 25mg/5ml Suspension

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 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, or 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 fatal, so seek medical attention immediately if you experience any of these symptoms.
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 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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have ever experienced asthma triggered by a salicylate drug, such as aspirin, or an NSAID.
If you have any of the following health conditions:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
If you have recently had a heart attack.
If you are currently taking any other NSAID, a salicylate drug like aspirin or diflunisal, triamterene, or pemetrexed.
If you are having difficulty getting pregnant or are undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. It is crucial to note that this medication may harm an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is vital to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help you verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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. Additionally, do not take this drug for a longer duration than specified by your doctor.

Until you understand how this medication affects you, avoid driving and other activities that require alertness. Be aware that you may bleed more easily while on this drug, 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 drugs 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 similar to this one has been associated with an increased risk of heart failure. In individuals who already have heart failure, the risk of heart attack, hospitalization for heart failure, and death is elevated. Discuss these risks with your doctor. Furthermore, people taking drugs like this one after a recent heart attack have a higher risk of heart attack and heart-related death. There is also an increased likelihood of death in the year following a heart attack compared to those not taking this type of medication. Talk to your doctor about these risks.

If you are taking aspirin to prevent heart attacks, consult with your doctor about the potential interactions. In some cases, this medication has been known to worsen depression, mood problems, seizures, and conditions like Parkinson's disease. If you have any of these health issues and experience worsening symptoms, inform your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Nonsteroidal anti-inflammatory drugs (NSAIDs) like this one may affect ovulation, potentially impacting fertility. However, this effect is reversible upon stopping the medication. Discuss this with your doctor if you are concerned about fertility.

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)
• Severe renal impairment
• Severe hepatic impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• 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.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium levels and toxicity.
• Methotrexate: Increased methotrexate levels and toxicity.
• Cyclosporine: 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 and hyperkalemia.
• Beta-blockers: Reduced antihypertensive effect.

• Phenytoin: Increased phenytoin levels.
• Probenecid: Increased indomethacin levels.
• Quinolone antibiotics: Increased risk of CNS stimulation and seizures.
• Sulfonylureas: Potentiation of hypoglycemic effect.
• Potassium-sparing diuretics: Increased risk of hyperkalemia.

• Not available

• 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, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat)
• Unusual weight gain or swelling (edema)
• Severe headache, dizziness, confusion, or mental changes
• Vision changes (blurred vision, double vision)
• Hearing changes (tinnitus)

Indomethacin is generally not recommended 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 into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., CNS effects, GI bleeding, renal effects), it is generally not recommended during breastfeeding. Other NSAIDs with shorter half-lives or lower milk transfer may be preferred.

Oral indomethacin suspension is generally not recommended for children under 14 years of age due to a higher risk of adverse effects, particularly CNS effects (e.g., headache, dizziness, confusion) and GI issues, compared to other NSAIDs. Its use in pediatrics is primarily for specific conditions like patent ductus arteriosus (PDA) in neonates, for which an intravenous formulation is used.

Elderly patients are at a greater 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 renal function, GI symptoms, and blood pressure closely.

• Indomethacin is a potent NSAID often reserved for conditions unresponsive to less toxic NSAIDs due to its higher incidence of CNS and GI side effects.
• Always take with food, milk, or antacids to minimize gastrointestinal irritation.
• Patients should be advised to report any signs of GI bleeding (black stools, coffee-ground vomit) immediately.
• Monitor blood pressure regularly, as NSAIDs can cause or worsen hypertension.
• Due to its potential for CNS side effects (headache, dizziness, confusion), caution patients about driving or operating machinery until they know how the medication affects them.
• Avoid concomitant use with other NSAIDs, including aspirin (unless low-dose aspirin for cardiac protection, in which case timing may be important).
• Consider a proton pump inhibitor (PPI) or H2 blocker for patients at high risk of GI complications.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib, diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, but with different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., methotrexate, biologics)
• Colchicine (for acute gouty arthritis)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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, 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 details about the medication taken, the quantity, and the time it occurred.