Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Non-steroidal anti-inflammatory agent indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, degenerative joint disease of the hip, low-back pain, and acute gouty arthritis.
Also indicated in inflammation, pain and oedema following orthopaedic procedures; and the treatment of pain and associated symptoms of primary dysmenorrhoea.
The dosage of indometacin should be carefully adjusted to suit the needs of the individual patient.
Dosage in dysmenorrhoea: Up to 75 mg a day, starting with onset of cramps or bleeding, and continuing for as long as the symptoms usually last.
Dosage in acute gouty arthritis: 150 mg to 200 mg daily in divided doses until all symptoms and signs subside.
In order to reduce the possibility of gastro-intestinal disturbances, indometacin Capsules should always be taken with food or an antacid.
Indometacin should be used with particular care in older patients who are more prone to adverse reactions.
The safety and efficacy of indometacin in children has not yet been established.
In chronic conditions, starting therapy with a low dosage, increasing this gradually as necessary, and continuing a trial of therapy for an adequate period (in some cases, up to one month) will give the best results with a minimum of unwanted reactions. The recommended oral dosage range is 50 mg to 200 mg daily in divided doses.
The following symptoms may be observed following overdosage: nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, or lethargy. There have been reports of paraesthesia, numbness, and convulsions.
Treatment is symptomatic and supportive. The stomach should be emptied as quickly as possible if the ingestion is recent and correction of severe electrolyte abnormalities may need to be considered.
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. Once the stomach has been emptied, 25 or 50 g of activated charcoal may be given. Depending on the condition of the patient, close medical observation and nursing care may be required. The patient should be followed for several days because gastro-intestinal ulceration and haemorrhage have been reported as adverse reactions of indometacin. Use of antacids may be helpful.
The plasma elimination of indometacin is biphasic with the half-life of the terminal plasma half-life phase between 2.6 and 11.2 hours.
Shelf life: 36 months.
Do not store above 25°C. Keep in original package.
Indometacin Capsules 25 mg: high density bottles with high density polyethylene cap-to-cap closures containing 100 or 500 capsules. Opaque 250 micron PVC blisters with 20 micron aluminium lid. Each blister contains 10 capsules. Each pack contains 90 capsules.
Indometacin Capsules should always be taken with food or an antacid.
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