Indomethacin

Selected products treat moderate to severe rheumatoid arthritis, including chronic-disease flares; ankylosing spondylitis; osteoarthritis; and acute painful shoulder from bursitis or tendinitis. IR capsules, suspension and suppositories also include acute gouty arthritis. The ER label specifically excludes acute gout from its substitution indications.

These are prescription anti-inflammatory products. Neonatal IV indomethacin for patent ductus arteriosus is a distinct hospital formulation and population; its indications, contraindications and weight-based courses are excluded here. Off-label headache, tocolysis and other protocols are not supplied. Label presence does not establish local stock or a universal first-choice arthritis or gout regimen.

Selected 75 mg ER: arthritis dose is one capsule daily; painful shoulder one capsule once or twice daily. Label permits substituting 75 mg once daily for IR 25 mg three times daily, or 75 mg twice daily for IR 50 mg three times daily, with different blood levels especially after twelve hours. ER is not for acute gout. The full ER section reproduces IR titration to 200 mg as guidance; that does not authorize three 75 mg ER capsules or arbitrary crushing/conversion.

Selected 50 mg is rectal only, never oral or intravaginal. The label uses oral capsule regimens as guidance and allows 50 mg suppository substitution, but notes different absorption and blood levels. Combined oral/rectal total must not exceed 200 mg daily; bedtime portion up to 100 mg is within that total. Do not construct a 25 mg rectal starting dose or cut suppositories from the oral table without a specific verified plan.

Safety and effectiveness at age fourteen or younger are unestablished, and use is discouraged unless other-drug toxicity or ineffectiveness warrants the risk. The label describes closely monitored exceptional use at age two or older: start 1–2 mg / kg / day divided; usual maximum 3 mg / kg / day or 150–200 mg / day, whichever is less. Evidence for 4 mg / kg / day is limited and is not a routine ceiling. Experience was confined to capsules; do not extrapolate to ER, suppositories or neonatal IV. Monitor liver function. Measure suspension with a calibrated device; follow actual dispensing instructions for preparation and handling.

All selected labels exclude indomethacin/ingredient hypersensitivity, prior aspirin/NSAID-related asthma, urticaria or other allergic reactions, and CABG surgery setting. Prior serious NSAID skin reactions are also excluded in warnings. Suppositories additionally contraindicate history of proctitis or recent rectal bleeding.

Serious cardiovascular thrombotic events, including fatal MI/stroke, may begin early and increase with duration; CABG use is contraindicated. GI bleeding, ulceration and perforation can be fatal at any time without warning; older adults and patients with prior ulcers/GI bleeding are at greater risk.

Headache, dizziness, dyspepsia and nausea are common; vomiting, diarrhea, abdominal discomfort, constipation, tinnitus, somnolence and edema also occur. Serious reactions include the boxed harms, kidney/liver injury, severe skin/allergic reactions and blood disorders. Suppositories can cause rectal irritation and tenesmus; trials did not establish freedom from upper-GI toxicity by this route.

Warfarin/other anticoagulants, aspirin/antiplatelets and SSRIs/SNRIs increase bleeding risk; monitor. Other NSAIDs or salicylates are not recommended; diflunisal particularly increases exposure and has been associated with fatal GI hemorrhage. Analgesic-dose aspirin adds GI risk without greater therapeutic effect; indomethacin does not substitute for low-dose cardioprotective aspirin.

ACE inhibitors, ARBs and beta-blockers may lose BP effect; ACE/ARB combinations in older, dehydrated or renally impaired patients may precipitate AKI. Diuretic effect may diminish. Do not combine triamterene; monitor potassium with other potassium-sparing diuretics. Monitor digoxin concentrations, lithium toxicity, methotrexate toxicity and cyclosporine-related kidney injury. Probenecid raises indomethacin levels; a lower dose may suffice and increases should be cautious.

Pemetrexed interaction increases marrow, renal and GI toxicity risk. Label advises avoiding short-half-life NSAIDs such as indomethacin two days before, the day of and two days after pemetrexed; CLcr 45–79 mL / min needs specific toxicity monitoring. Oncology teams should arrange the actual plan. Plasma-renin activity may be lowered and dexamethasone-suppression tests can be falsely negative; tell the testing clinician.

Fetal kidney dysfunction/oligohydramnios may occur from about twenty weeks; premature ductus closure is a further risk around thirty weeks. Earlier-pregnancy human data are inconclusive. NSAIDs can reversibly delay ovulation; consider stopping during infertility evaluation. Human milk transfer is documented, so weigh maternal need, infant effects and breastfeeding benefits rather than claiming no exposure.

Age fourteen and younger safety/effectiveness are unestablished; exceptional capsule-derived regimens require close clinical/liver monitoring. Pediatric fatal hepatotoxicity has been reported. Older adults have more serious CV/GI/renal risk and can develop confusion or psychosis; start low and reassess regularly.

Selected labels do not supply a creatinine-clearance dosing table or hepatic percentage adjustment; PK was not investigated in those impairment groups. Advanced renal disease generally warrants avoidance unless a documented benefit outweighs risk with monitoring. Liver disease, volume depletion, heart failure and interacting medicines increase kidney injury risk. Stop/evaluate clinically significant liver symptoms or persistent/worsening abnormalities rather than merely reducing dose.

Indomethacin inhibits COX-1/COX-2 and prostaglandin production, contributing to analgesic, anti-inflammatory and antipyretic effects. Its full mechanism is not completely understood.

IR peak occurs around two hours; protein binding is about 99%, mean half-life about 4.5 hours, with metabolism, renal/biliary elimination and enterohepatic recycling. A single 50 mg suspension dose was bioequivalent to capsule when both were given with food. ER releases 25 mg initially and the remaining 50 mg over about twelve hours; selected substitutions still differ in time-course. Rectal absorption is faster but studied total absorption was about 80–90% of capsule exposure, partly related to retention. No universal mg-for-mg exposure assumption or home dialysis treatment follows.

Review pain/function, dose and course length; check BP, volume status, kidney function and potassium when indicated. Consider periodic CBC/chemistry during extended therapy, liver testing with symptoms and eye examinations with prolonged exposure or blurred vision. Seek urgent care for chest pain, weakness/slurred speech, breathing difficulty, black stools/vomiting blood, significant rash or jaundice. Avoid driving while drowsy; review all OTC medicines, pregnancy plans and the prescribed route. Supply/read the NSAID Medication Guide.

Contact emergency services or Poison Control for suspected excess dosing. GI bleeding, kidney failure, hypertension, respiratory depression or coma can occur. There is no specific antidote; high protein binding limits benefit of dialysis. Treatment is medical supportive care; historical label decontamination instructions are not a home emesis or charcoal protocol.

IR capsule example

25 mg light green; H / 103; bottle 30 · NDC 68788-8092-3

ER capsule example

75 mg dark yellow cap / clear body; H / 105; bottle 30 · NDC 85766-034-30

Suspension example

25 mg per 5 mL · 237 mL · NDC 69344-101-01

Suppository example

50 mg white opaque · box 30 · NDC 69344-102-33

IR full label describes 25 and 50 mg capsules, although the selected repack supplies the 25 mg example. ER is 75 mg. Indocin suspension is off-white pineapple/coconut/mint flavored and contains 1% alcohol; rectal suppositories contain 50 mg. Product appearance/excipients vary; check actual package. Neonatal IV, compounded preparations and unverified crushing/tube instructions are excluded.

Selected IR: 20–25°C, protect from light, tight light-resistant child-resistant container. Selected ER: 20–25°C, protect from moisture. Indocin suspension: below 30°C, avoid above 50°C, do not freeze. Suppositories: refrigerate 2–8°C. Follow actual expiry and secure all forms from children; no compounded beyond-use date is inferred.