Indomethacin
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Indomethacin
Indocin (oral, IV, suppository), Tivorbex (low-dose), Indo-Lemmon
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Summary
Common uses
Acute gouty arthritis (FDA; the classic first-line indication)0, Moderate-to-severe rheumatoid arthritis (FDA)0, Osteoarthritis (FDA)0, Ankylosing spondylitis (FDA)0, Calcium pyrophosphate deposition disease (pseudogout, off-label)0, Acute migraine and hemicrania continua (off-label; the latter is a uniquely indomethacin-responsive headache syndrome)0, Patent ductus arteriosus closure in preterm neonates (FDA, IV; Indocin IV)0
Pharmacy
Starting dose
Acute gout: 50 mg PO TID until symptom relief, then taper; maximum 200 mg/day for 3-5 days. Rheumatoid arthritis / osteoarthritis: 25-50 mg PO BID-TID. Patent ductus arteriosus: 0.2 mg/kg IV, then 0.1-0.2 mg/kg every 12-24 hours for 2 doses
Preparations
Capsules 25, 50 mg; ER capsules 75 mg; oral suspension 25 mg/5 mL; suppositories 50 mg; injection 1 mg/vial (PDA closure)
US FDA Max
200 mg/day (typical adult oral)
Pharmacology
Routes
Oral, rectal, intravenous (PDA closure only)
Onset
30-60 minutes (oral); rapid relief in acute gout
Duration
4-6 hours (IR); 24 hours (ER)
Half-life
4-5 hours[1]
Bioavailability
~100% (oral)[1]
Pregnancy
Avoid from 20 weeks gestation onward per FDA's 2020 expanded NSAID warning; contraindicated from 30 weeks (risk of premature ductus arteriosus closure, which is paradoxically the basis of the neonatal PDA-closure indication)[1]
Legal status
Rx-only in US
Purported mechanism
Non-selective COX-1 and COX-2 inhibitor with high potency relative to other NSAIDs, the basis of its acute-gout efficacy and the uniquely indomethacin-responsive hemicrania continua syndrome. The PDA closure indication uses prostaglandin inhibition therapeutically: the ductus arteriosus stays patent via prostaglandin E1, and inhibiting its synthesis closes the shunt.0 Among the higher-cardiovascular-risk NSAIDs, with elevated GI bleeding risk compared to the class average. Notable for CNS adverse effects uncommon with other NSAIDs: paradoxical headache, dizziness, depression, and confusion in elderly patients (Beers-list concerns)[1].
References
- ↑ 1.0 1.1 1.2 1.3 FDA Prescribing Information, Indocin (indomethacin), Iroko/Egalet, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s044lbl.pdf