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

Source: Registered Drug Product Database (NG)  Publisher: Krishat Pharma Industries Limited, KM 15, Lagos-Ibadan Expressway, Ibadan, Oyo State, NIGERIA, Email: info@krishatpharma.com, Company contacts details: operations@krishatpharma.com

4.1. Therapeutic indications

Indomethacin is indicated in treatment of pain & moderate to severe inflammation in rheumatic disease and other acute musculoskeletal disorders; acute gout; dysmenorrhoea; premature labour. In children it is used in relief of pain & inflammation in rheumatic diseases including juvenile idiopathic arthritis & is also useful in neonatal complication such as transient impairment of renal function & premature closure of ductus arteriosus.

4.2. Posology and method of administration

Adult

Rheumatic disease 50-200 mg daily in divided dose.

Acute gout 150-200 mg daily in divided doses.

Dysmenorrhoea up to 75 mg daily.

The capsule must be taken with food to minimize gastric distress. The total daily dose should not exceed 200 mg per day.

Child

1 month-18 years: 0.5-1 mg/kg twice daily.

Higher doses may be used under specialist supervision.

Method of administration

Oral.

4.9. Overdose

Overdose symptoms of Indomethacin includes headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea. In cases of significant poisoning acute renal failure and liver damage are possible. Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 30°C, protect from light and moisture.

KEEP OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

10 Capsules PVC/ALU blister Pack & 10 Blister pack in a monocarton (10x10 Capsules).

6.6. Special precautions for disposal and other handling

No special requirements.

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