Indocin 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 by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This 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 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, difficulty speaking or thinking, 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 fatal, 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 be life-threatening. Seek medical help right away 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 Side Effects

Most people experience few or no side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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, 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 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 drugs like 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 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, 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 treatments 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 are aware of how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving. Be aware that you may experience easier bleeding, so it is crucial to be careful and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor for shaving.

This medication may influence the results of certain laboratory tests. Therefore, it is vital to inform all your healthcare providers and laboratory personnel that you are taking this medication. Before consuming alcohol, consult with your doctor to discuss any potential risks. If you smoke, it is also important to talk to your doctor, as smoking may interact with the effects of this medication. Long-term use of this medication may require regular blood tests, so be sure to discuss this with your doctor.

There is a potential 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 the effects of this medication.

The use of medications similar to this one has been linked to an increased risk of heart failure. If you already have heart failure, the risk of heart attack, hospitalization due to heart failure, and death may be higher. It is crucial to discuss these risks with your doctor. Furthermore, people who have recently experienced a heart attack may have a higher risk of heart attack and heart-related death when taking medications like this one. In fact, studies have shown that individuals 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. Therefore, it is essential to have an open discussion with your doctor about these risks.

If you are taking aspirin to prevent heart attacks, consult with your doctor, as there may be interactions between these medications. In some cases, medications like this one have been known to exacerbate depression, mood problems, seizures, and conditions like Parkinson's disease. If you have any of these health issues and notice a worsening of symptoms, inform your doctor promptly.

If you are 65 years or older, use this medication with caution, as you 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. If you are trying to conceive, discuss this with your doctor. Finally, if you are breastfeeding, consult with your doctor to assess any potential risks to your baby.

• Aspirin (increased GI toxicity)
• Other NSAIDs (increased GI toxicity, renal dysfunction)
• Ketorolac (increased GI toxicity, renal dysfunction)

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of gastrointestinal bleeding.
• 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 and hyperkalemia.
• Lithium: Increased plasma lithium levels and toxicity.
• Methotrexate: Increased plasma methotrexate levels and toxicity.
• Cyclosporine: Increased nephrotoxicity.
• Digoxin: Increased plasma digoxin levels.
• Corticosteroids: Increased risk of gastrointestinal ulceration and bleeding.

• Beta-blockers: Reduced antihypertensive effect.
• Sulfonylureas: Potentiation of hypoglycemic effect.
• Phenytoin: Increased plasma phenytoin levels.
• Probenecid: Increased indomethacin plasma levels and half-life.
• Triamterene: Increased risk of renal failure.

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

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (e.g., nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Signs of allergic reaction or severe skin reactions (e.g., rash, hives, blistering, peeling skin, swelling of face/lips/tongue/throat, difficulty breathing)
• Unusual weight gain or swelling (fluid retention)
• Persistent headache or dizziness

Avoid use during 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 during 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 the potential for serious adverse reactions in nursing infants, 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.

Generally not recommended for chronic use in children under 14 years of age due to a higher incidence of adverse reactions, including serious ones. Specific IV formulation is used for patent ductus arteriosus (PDA) in neonates, but the oral suspension is not typically used for this indication.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, perforation, renal impairment, 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 agents due to its higher incidence of CNS and GI side effects.
• Take with food, milk, or antacids to minimize GI irritation.
• Patients should be advised to report any signs of GI bleeding (e.g., black, tarry stools) or cardiovascular events (e.g., chest pain, shortness of breath) immediately.
• Monitor renal function, liver function, and blood pressure regularly, especially in long-term therapy or in patients with comorbidities.
• Avoid in patients with a history of aspirin-exacerbated respiratory disease (AERD) due to risk of severe bronchospasm.
• Due to its relatively short half-life, multiple daily dosing is required for sustained effect.

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 is a crucial 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 about the medication taken, including the dosage, timing, and circumstances surrounding the overdose.