INDOKRIS Hard gelatin capsule Ref.[115654] Active ingredients: Indometacin

It should be used with caution in the elderly (risk of serious side effects and fatalities. Cautions are also required in patients with connective tissue disorders, Crohn’s disease or ulcerative colitis. Cautions should be taken in epilepsy, parkinsonism, psychiatric disturbances; during prolonged therapy ophthalmic and blood examinations particularly advisable. Dizziness produced by Indomethacin may affect performance of skilled (e.g. Driving). Indomethacin should be cautiously used in infants with PDA and oliguria.

Hepatic impairment

It should be used with caution in patients with hepatic impairment; there is an increased risk of gastro-intestinal bleeding and fluid retention. It should be avoided in severe liver disease.

Renal impairment

It should be avoided in if possible or use with caution in patients with renal impairment; the lowest effective dose should be used for the shortest possible duration, and renal function should be monitored. Sodium and water retention may be occur and renal function may deteriorate, possibly leading to renal failure; deterioration in renal function has also been reported after topical use.

CSM Advice (gastro-intestinal side-effects)

All NSAIDs are associated with serious gastro-intestinal toxicity; the risk is higher in the elderly. Evidence on the relative safety of 7 non-selective NSAIDs indicates differences in the risks of serious upper gastrointestinal side-effects. Indomethacin is associated with intermediate risk of gastrointestinal toxicity. The CSM also contra-indicates non-selective NSAIDs in patients with a history of peptic ulceration.

It increases the risk of renal impairment when given with ACE Inhibitors, angiotensin-II receptor antagonist. NSAIDS antagonise hypotensive effect of ACE Inhibitors, angiotensin-II receptor antagonist, adrenergic neurone blockers, alpha-blockers, betablocker, Ca channel blocker, clonidine, diazoxide, methyldopa, moxonidine, nitrates, hydralazine, monoxidil & sodium nitroprusside. Avoid concomitant use of NSAIDS with NSAIDS as it increase the side effect, & also with anticoagulants & diuretics. Possible severe drowsiness when Indomethacin given with Haloperidol; effects of Desmopressin enhanced by Indomethacin. It reduces excretion of Methotrexate. It possibly increases the plasma concentration of cardiac glycosides and amikacin & gentamicin in neonates, Increased risk of nephrotoxicity & bleeding when given with anticoagulants, clopidogrel, iloprost & penicillamine.

Avoid use of Indomethacin during pregnancy or avoiding them unless the potential benefits outweigh the risk. Indomethacin should be avoided during the third trimester because is associated with a risk of closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the newborn. In addition, the onset of labour may be delayed and its duration may be increased. Indomethacin can appear in breast milk in very low concentrations. It should be used with caution during breast-feeding.

Not known.

Gastro-intestinal discomfort, nausea, diarrhoea, and occasionally bleeding and ulceration occur. Blood disorders have also occurred. Fluid retention may occur; blood pressure may be raised. Renal failure may be provoked by Indomethacin, especially in patients with renal impairment.

NA.