INDOMETHACIN CAPSULE 25mg

Indications:

The treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute musculoskeletal disorders and acute gout.

Contra-indications:

Active peptic ulcer or a history of recurrent gastro-intestinal lesions. Sensitivity to aspirin, indometacin or other non-steroidal anti-inflammatory agents.

Pregnancy or lactation.

Patients operating machinery.

Patients with epilepsy, parkinsonism, psychiatric disturbances or porphyria.

Children, since conditions for safe use have not been established.

Severe heart failure.

Adverse Effects:

Most adverse effects are dose related

Gastro-intestinal adverse effects are common and include anorexia, nausea (with or without vomiting) dyspepsia, abdominal pain and diarrhoea. Infrequently, ulceration of the upper GI tract, sometimes with perforation and haemorrhage, has occurred. Acute pancreatitis has been reported. Hepatic involvement is rare, though fatal cases of hepatitis and jaundice have been reported.

CNS effects are also common. Severe frontal headache may occur in 25 - 50% of patients who take the drug chronically. Dizziness, light-headedness, vertigo and mental confusion are also frequent. Depression and psychosis have also been reported but the incidence is less than 1%.

Haemopoietic reactions, including neutropenia, thrombocytopenia and, rarely, aplastic anaemia have been reported.

Hypersensitivity reactions, manifested as rashes, itching, urticaria or rarely acute asthma, may occur.

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Drug Interactions:

1.Probenecid. The plasma concentration of Indometacin is increased.

2.Frusemide. The natriuretic and anti-hypersensitivity effects are antagonised by Indometacin.

3.Thiazide diuretics and beta-blocking agents. Indometacin reduces the anti-hypertensive effects of these compounds.

4.Antacids. The bioavailability of Indometacin may be reduced by concomitant antacid therapy.

5.Triamterene. Acute renal failure has been reported with concomitant Indometacin therapy.

Precautions & Warning:

Indometacin should be used with great care in elderly patients. Indometacin should be used with caution in patients with impaired renal function. Indometacin inhibits platelet aggregation and prolongs bleeding time. It should be used with caution therefore in patients with bleeding disorders, and concurrent administration of anti-coagulant agent may be hazardous because of increased risk of gastrointestinal bleeding.

Peptic ulcer has been reported in a small proportion of patients. If G.I. bleeding occurs, indometacin should be discontinued immediately. Indometacin may mask the signs and symptoms of infection. If clinical signs of hepatic disease develop, or if liver function tests become abnormal, indometacin should be withdrawn. Indometacin should be given with or immediately after food in order to lessen the incidence and severity of gastrointestinal side-effects.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

Use in Pregnancy and Nursing Mothers:

Indometacin is contraindicated during pregnancy and lactation.

Treatment/antidote in The Event of Overdose:

Gastric lavage should be performed if ingestion is recent. Otherwise, supportive measures and observation.

Storage instructions:

Store below 25℃. Protect from moisture. Keep out of reach of children.