Indomethacin (Indometacin)

SOURCE: no eMC/UK SPC was present in this bundle (providers.emc is null) - this draft is distilled from the US FDA prescribing information for indomethacin capsules (openFDA/DailyMed, PD-Rx Pharmaceuticals, label date 2026-05-27) and must be verified against the UK SPC before use. TITRATION: if 25 mg two or three times a day is well tolerated, increase the daily dosage by 25 mg or by 50 mg if required by continuing symptoms, at weekly intervals, until a satisfactory response is obtained or a total daily dose of 150 to 200 mg is reached. In patients who have persistent night pain and/or morning stiffness, giving a large portion of the total daily dose - up to a maximum of 100 mg - at bedtime may be helpful. In acute flares of chronic rheumatoid arthritis it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and observe the patient closely; if severe adverse reactions occur, stop the drug. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued. OTHER INDICATIONS ON THE SAME LABEL: acute painful shoulder (bursitis and/or tendinitis) 75 to 150 mg daily in 3 or 4 divided doses, discontinued after the signs and symptoms of inflammation have been controlled for several days, usual course of therapy 7 to 14 days; acute gouty arthritis 50 mg three times a day until pain is tolerable, then the dose should be rapidly reduced to complete cessation of the drug (definite relief of pain has been reported within 2 to 4 hours, tenderness and heat usually subside in 24 to 36 hours and swelling gradually disappears in 3 to 5 days). GENERAL: use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals; adverse reactions generally appear to correlate with the dose, so every effort should be made to determine the lowest effective dosage for the individual patient. ELDERLY: as advancing years appear to increase the possibility of adverse reactions, indomethacin capsules should be used with greater care in the elderly; indomethacin may cause confusion or, rarely, psychosis, and because elderly patients are more likely to have decreased renal function, use caution and consider monitoring renal function. No US hepatic-impairment dosing statement was retrieved in this bundle.

US labelling: safety and effectiveness in paediatric patients 14 years of age and younger has not been established, and indomethacin capsules should not be prescribed for pediatric patients 14 years of age and younger unless toxicity or lack of efficacy associated with other drugs warrants the risk. If a decision is made to use indomethacin for paediatric patients two years of age or older, such patients should be monitored closely with periodic assessment of liver function - there have been cases of hepatotoxicity, including fatalities, reported in paediatric patients with juvenile rheumatoid arthritis. If treatment is instituted, 'a suggested starting dose is 1 to 2 mg/kg/day given in divided doses' - this is a range, so no single per-kg value is given and dosePerKg is left null rather than inventing a figure. As symptoms subside, the total daily dosage should be reduced to the lowest level required to control symptoms. Verify against a children's formulary and against the UK SPC before prescribing. Source: US FDA labelling (openFDA/DailyMed) §8.4 - no UK SPC paediatric text was fetched, and the §8.4 text is truncated at the source-fetch limit.