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. |
| Molecular Weight | 357.79 |
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 | Use is contraindicated due to risk of premature closure of ductus arteriosus and oligohydramnios; NSAIDs are generally avoided in first trimester. |
| 2nd trimester | Use with caution; lowest effective dose for shortest duration. Risk of premature closure of ductus arteriosus and oligohydramnios if used for prolonged periods. |
| 3rd trimester | Contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and fetal renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for INDO-LEMMON (INDO-LEMMON).
| Placental transfer | Indomethacin crosses the placenta readily; fetal concentrations reach approximately 50% of maternal serum levels. |
| Breastfeeding | Indomethacin is excreted into breast milk in very low amounts. The relative infant dose is less than 1% of the maternal weight-adjusted dose. Considered compatible with breastfeeding, but use caution in infants with cardiovascular or renal impairment. |
■ 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 |
Active peptic ulcer disease or GI bleedingHistory of NSAID-induced asthma or urticariaSevere hepatic or renal impairment (CrCl < 30 mL/min)Advanced cardiovascular disease (NYHA III-IV)Prophylaxis before coronary artery bypass graft (CABG) surgeryPregnancy (third trimester, and generally avoided in first two trimesters)
| 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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| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |
| Food/Dietary |
| Avoid alcohol. Take with food or milk to minimize gastrointestinal irritation. No other specific food restrictions; however, a balanced diet is recommended. |
| Clinical Pearls | INDO-LEMMON (indomethacin) is a potent NSAID with strong anti-inflammatory effects but also a high risk of gastrointestinal ulceration and bleeding. Use the lowest effective dose for the shortest duration. Renal impairment and hyperkalemia are concerns, especially in elderly or volume-depleted patients. Monitor renal function, CBC, and liver enzymes. Avoid in patients with NSAID-sensitive asthma, nasal polyps, or urticaria. Can cause drowsiness or dizziness; caution with activities requiring alertness. May mask signs of infection. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not take with other NSAIDs (e.g., ibuprofen, naproxen) or aspirin without doctor approval. · Report black/tarry stools, bloody vomit, or severe abdominal pain immediately. · Avoid alcohol as it increases stomach irritation risk. · Stay hydrated and monitor for swelling or shortness of breath (fluid retention). · Use caution when driving or operating machinery if drowsy or dizzy. · Do not take if you have a history of allergic reaction to NSAIDs or aspirin. · Consult doctor before use if pregnant (avoid in third trimester) or breastfeeding. |