Indocin 50mg Rectal Suppositories

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, mainly through the non-selective 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 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 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, rectal bleeding or pain.
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: These can include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be fatal. 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 Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor:

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

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 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 existing treatments and health issues. 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 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.

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, and if you are taking this medication long-term, have your blood work monitored regularly.

There is a potential risk of developing high blood pressure with medications like this one. Ensure that your blood pressure is checked as directed by your doctor. If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

The use of medications like this one may 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. Furthermore, the risk of heart attack and heart-related death may be 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 in the following year compared to those not taking these medications. It is essential to discuss these risks with your doctor.

If you are taking aspirin to prevent a heart attack, consult with your doctor. In some cases, medications like this one may worsen depression, mood problems, seizures, and conditions like Parkinson's disease. If you have any of these conditions 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 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.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Active gastrointestinal bleeding or ulceration
• 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): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and 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 methotrexate plasma levels and toxicity.
• Cyclosporine: Increased nephrotoxicity.
• Digoxin: Increased serum digoxin levels.
• Other NSAIDs (including COX-2 inhibitors): Increased risk of adverse effects without increased efficacy.

• SSRIs/SNRIs: Increased risk of GI bleeding.
• Sulfonylureas: Potentiation of hypoglycemic effect.
• Phenytoin: Increased phenytoin plasma levels.
• Probenecid: Increased indomethacin plasma levels and half-life.
• Beta-blockers: Reduced antihypertensive effect.

• Antacids: May reduce absorption (less relevant for rectal route).

• 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., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Unusual weight gain or swelling (edema)
• Severe or persistent headache, dizziness, confusion, or mental changes
• Vision changes (e.g., blurred vision, double vision)
• Hearing changes (e.g., tinnitus, hearing loss)

Indomethacin is classified as Pregnancy Category C during the first and second trimesters and Category D during the third trimester. It should be avoided in late pregnancy (after 30 weeks gestation) due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. Use during early pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Indomethacin is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but some sources suggest caution due to potential for adverse effects in the infant (e.g., seizures, GI bleeding). Use with caution, monitor infant for adverse effects.

Safety and efficacy of indomethacin rectal suppositories have not been established in pediatric patients for musculoskeletal conditions. Its use in neonates for patent ductus arteriosus (PDA) closure is via intravenous formulation and specific dosing protocols.

Elderly patients are at increased risk for serious adverse effects from NSAIDs, including gastrointestinal bleeding, ulceration, perforation, renal impairment, 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 potent agents due to its higher incidence of certain side effects, particularly CNS effects (e.g., frontal headache, dizziness).
• The rectal suppository form can be useful for patients who cannot tolerate oral medication, for nocturnal pain, or for morning stiffness in inflammatory arthritis.
• Despite being a rectal formulation, indomethacin suppositories still exert systemic effects and carry the same systemic risks (GI, CV, renal) as oral NSAIDs.
• Patients should be advised to lie down for a short period after inserting the suppository to ensure retention.
• Headache is a common side effect, especially at the beginning of therapy. It may be dose-related and can sometimes be managed by starting with a lower dose and titrating up.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Corticosteroids (for acute inflammatory conditions, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) or biologics (for chronic inflammatory conditions like rheumatoid arthritis, ankylosing spondylitis)
• Colchicine or corticosteroids (for acute gouty arthritis)

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 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 amount, and the time it occurred.