Indomethacin 50mg Rectal Suppos

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 immediate medical attention:

Signs of an 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.
Signs of 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.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Changes in vision.
Ringing in the ears.
Depression.
Flu-like symptoms.
Rectal bleeding or pain.
Liver problems (which can be life-threatening): dark urine, fatigue, decreased appetite, nausea or stomach pain, pale stools, vomiting, or yellow skin and eyes.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening and affect internal organs. 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
Swollen glands

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Headache
Constipation, diarrhea, stomach pain, nausea, or vomiting
Heartburn
Gas
Dizziness, drowsiness, fatigue, or weakness
Rectal irritation

This is not an exhaustive list of possible side effects. If you have 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 drugs, 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 pregnancy during treatment. 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.
* History of rectal or anal swelling, or recent rectal bleeding.

To ensure your safety, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with 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 prescribed by your doctor, as taking more than recommended may increase your risk of experiencing severe side effects. Do not exceed the duration of treatment 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 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 notify 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 consult with your doctor about the necessary monitoring.

There is a potential risk of developing high blood pressure with this type of medication, so ensure your blood pressure is checked as directed by your doctor. If you have asthma, consult with your doctor about the potential increased sensitivity to this medication.

The use of drugs like this one may increase the risk of heart failure, and in individuals with pre-existing heart failure, the risk of heart attack, hospitalization for heart failure, and death may also be elevated. 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, as well as an increased risk of death within the year following the heart attack compared to those not taking this medication. Consult with your doctor about these potential risks.

If you are taking aspirin to prevent heart attacks, discuss the potential interactions with your doctor. In some cases, this medication may worsen depression, mood problems, seizures, and conditions like Parkinson's disease. If you experience any of these conditions and notice a deterioration in symptoms, inform your doctor promptly.

Individuals 65 years or older should exercise caution when using this medication, as they may be more susceptible to side effects. NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible upon discontinuation of the medication. Discuss the potential risks with your doctor. If you are breastfeeding, consult with your doctor to assess any potential risks to your baby.

• Aspirin (high dose) or other NSAIDs (increased risk of GI bleeding/ulceration)
• Ketorolac (increased risk of GI bleeding/ulceration)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban, Apixaban): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium levels and toxicity.
• Methotrexate: Increased methotrexate levels 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.
• Digoxin: Increased digoxin levels.
• Potassium-sparing diuretics: Increased risk of hyperkalemia.

• Beta-blockers: Reduced antihypertensive effect.
• Hydralazine: Reduced antihypertensive effect.
• Phenytoin: Increased phenytoin levels.
• Probenecid: Increased indomethacin levels.
• Quinolone antibiotics: Increased risk of CNS stimulation/seizures.
• Corticosteroids: Increased risk of GI ulceration/bleeding.

• Cholestyramine: May reduce indomethacin 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)
• Unexplained weight gain or edema
• Severe skin reactions (rash, blistering, peeling)
• Vision changes (blurred vision, double vision)
• Hearing changes (tinnitus, hearing loss)
• Headache, dizziness, confusion, or other CNS effects
• Rectal irritation, pain, bleeding, or proctitis (specific to rectal suppositories)

Avoid use during pregnancy, especially in the third trimester. NSAIDs can cause premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. Use in early pregnancy should be weighed against potential risks.

Indomethacin is excreted into breast milk. Due to potential for serious adverse reactions in the infant (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.

Safety and efficacy have not been established for general use in pediatric patients. Indomethacin IV is used for patent ductus arteriosus (PDA) closure in neonates, but the rectal form is not indicated for this use or for general pain/inflammation in children.

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

• Indomethacin is a potent NSAID with a higher incidence of CNS side effects (e.g., headache, dizziness, confusion) compared to other NSAIDs, especially at higher doses.
• Rectal suppositories are useful for patients who cannot tolerate oral NSAIDs due to GI upset, or for specific conditions like nocturnal pain/stiffness in arthritis.
• However, rectal administration can cause local irritation, proctitis, or bleeding. Patients should be advised to report any rectal discomfort.
• Due to its potency and side effect profile, indomethacin is often reserved for acute conditions or when other NSAIDs are ineffective.
• Always use the lowest effective dose for the shortest possible duration to minimize risks.
• Patients should be advised to avoid lying down for at least 15-30 minutes after inserting the suppository to ensure proper absorption and prevent expulsion.

• 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)
• Disease-modifying antirheumatic drugs (DMARDs) or biologics (for chronic inflammatory conditions like RA, 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 crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.