| Description |
Indomethacin (D-Indomethacin) has prominent anti-inflammatory effects with antipyretic and analgesic actions.
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| Mode of action |
Indomethacin (D-Indomethacin) is an inhibitor of prostaglandin synthetase. The analgesic effects result from both peripheral and central effects and are distinct from its anti-inflammatory property.
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| Pharmacokinetics |
Following oral administration, indomethacin is rapidly and completely absorbed. Food delays absorption, but does not reduce overall bioavailability. Rectal administration produces earlier but lowers peak plasma concentration. The overall bioavailability after rectal indomethacin administration is 80%. Indomethacin is 90-94% protein bound. Only very small amounts pass into the brain and into breast milk; some crosses the placenta. Indomethacin is extensively metabolized in the liver. The major route of elimination is in the urine. Only a small amount is excreted unchanged in the faeces.
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| Composition |
D-Indomethacin25 mg Capsule: Each capsule contains Indomethacin BP 25 mg.
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| Indications |
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Pain and moderate to severe inflammation in acute gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea, closure of patent ductus arteriosus in premature babies.
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| Dosage & administration |
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Capsule: Rheumatic disease: 50-200 mg daily in divided doses, with food; Child not recommended.
Acute gout: 150-200 mg daily in divided doses.
Dysmenorrhoea: Upto 75 mg daily.
SR Capsule: 1 capsule 1-2 times daily; Child not recommended.
Suppository: 100 mg at night and in the morning if required; Child not recommended.
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| Contraindications |
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Indomethacin is contraindicated in children, pregnant and lactating women; active peptic ulcer; a history of recurrent gastrointestinaI lesions; sensitivity to indomethacin, aspirin or other NSAIDs.
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| Side effects |
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Frequently gastrointestinaI disturbances (including diarrhoea), headache, dizziness and dyspepsia. If headache persists even after dosage reduction, indomethacin should be withdrawn. Also gastrointestinaI ulceration and bleeding; rarely drowsiness, confusion, insomnia, convulsions, psychiatric disturbances, depression, syncope, hypertension, hyperglycemia and blurred vision. Suppository may cause rectal irritation and occasional bleeding.
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| Use in pregnancy & lactation |
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It is not known whether indomethacin is safe to use in pregnant and lactating women. So it should not be given to such groups.
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| Precautions |
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Indomethacin should be used with care in patients with epilepsy, parkinsonism, psychiatric disturbances. Rectal administration should be avoided in proctitis and haemorrhoids.
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| Drug interactions |
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Aspirin may decrease, and diflunisal and probenecid may increase plasma levels of indomethacin. The antihypertensive effect of beta-blockers and the diuretic and antihypertensive effects of thiazides and frusemide may be reduced by indomethacin. It reduces the tubular secretion and therefore potentiates the toxicity of methotrexate. There is an increased risk of gastrointestinal bleeding when corticosteroids are administered concomitantly with NSAIDs.
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| Overdosage |
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Nausea, vomiting, intense headache, dizziness, mental confusion, disorientation or lethargy may be observed following overdosage of indomethacin. There have been reports of paresthesias, numbness and convulsions. Treatment is symptomatic and supportive. The stomach should be emptied as quickly as possible if the ingestion is recent. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac. If the patient is unable to vomit, gastric lavage should be performed.
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| Storage |
Store in a cool and dry place, protected from light.
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| Packaging |
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D-Indomethacin25 mg Capsule: Each carton contains 10x10 capsules in blister pack.
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