INDO-LEMMON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INDO-LEMMON (INDO-LEMMON).
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by blocking cyclooxygenase (COX-1 and COX-2) enzymes, reducing inflammation, pain, and fever.
| Metabolism | Hepatic metabolism via glucuronidation and conjugation; minor desmethylation. Metabolites are inactive. |
| Excretion | Renal excretion of unchanged drug and metabolites accounts for approximately 60% of elimination; biliary/fecal excretion accounts for approximately 40%. |
| Half-life | Terminal elimination half-life is approximately 2-4 hours in healthy adults; may be prolonged in elderly or patients with hepatic impairment. |
| Protein binding | Approximately 90-99% bound primarily to albumin. |
| Volume of Distribution | 0.17-0.23 L/kg, indicating distribution mainly in plasma and extracellular fluid. |
| Bioavailability | Oral: approximately 80%; Rectal: approximately 50-70% (first-pass metabolism); IM: 100%. |
| Onset of Action | Oral: 30-60 minutes; Rectal: 30-60 minutes; IM: 20-30 minutes. |
| Duration of Action | Analgesic and anti-inflammatory effects persist for 4-6 hours with standard dosing; duration may be dose-dependent. |
Oral: 25-50 mg 2-3 times daily. Maximum daily dose: 200 mg.
| Dosage form | CAPSULE |
| Renal impairment | GFR 30-60 mL/min: reduce dose by 25%; GFR 15-29 mL/min: reduce dose by 50%; GFR <15 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Weight ≥20 kg: 0.5-1 mg/kg/dose every 6-8 hours, maximum 4 mg/kg/day. Not recommended for children <20 kg. |
| Geriatric use | Initiate at lowest effective dose, typically 25 mg twice daily. Do not exceed 100 mg daily. Monitor renal function closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INDO-LEMMON (INDO-LEMMON).
| Breastfeeding | Indomethacin is excreted in breast milk in low amounts. M/P ratio approximately 0.15-0.20. Considered compatible with breastfeeding per AAP, but monitor infant for potential adverse effects (gastrointestinal, renal). Not recommended in nursing infants with thrombocytopenia or bleeding disorders. |
| Teratogenic Risk | First trimester: Increased risk of spontaneous abortion and congenital malformations (cardiovascular, gastroschisis) due to prostaglandin synthesis inhibition. Second/third trimester: Known fetal risks including oligohydramnios, premature ductus arteriosus closure, renal dysfunction, and necrotizing enterocolitis. Avoid after 20 weeks gestation unless indicated for ductus arteriosus closure. |
■ FDA Black Box Warning
Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. Increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
| Serious Effects |
["History of asthma, urticaria, or allergic reaction to aspirin or NSAIDs","Perioperative pain in coronary artery bypass graft (CABG) surgery","Active GI bleeding or ulceration","Advanced renal disease or significant renal impairment","Severe hepatic impairment","Third trimester of pregnancy (or known ductus arteriosus closure)","Neonates with active bleeding, thrombocytopenia, or necrotizing enterocolitis (for PDA use)"]
| Precautions | ["Cardiovascular risk: Hypertension, fluid retention, increased risk of CV events.","Gastrointestinal risk: GI bleeding, ulceration, perforation.","Renal effects: Acute renal insufficiency, especially in elderly or dehydrated patients.","Hepatic effects: Elevated liver enzymes, rare severe reactions.","Hematologic: Inhibition of platelet aggregation, prolonged bleeding time.","Ocular effects: Corneal deposits, visual disturbances with long-term use.","CNS effects: Headache, dizziness, confusion; rare aseptic meningitis.","Neonatal use: May cause necrotizing enterocolitis, renal impairment, or bleeding."] |
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| Fetal Monitoring | Maternal: Renal function, liver function, platelet count, and blood pressure. Fetal: Ultrasound for oligohydramnios, ductus arteriosus patency, and fetal growth if used for >48 hours after 24 weeks gestation. |
| Fertility Effects | Reversible inhibition of ovulation and luteinized unruptured follicle syndrome due to prostaglandin antagonism. May cause transient female infertility. No known male fertility effects. |