Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: Rex Medical Limited, PO Box 18-119, Glen Innes, Auckland Telephone (09) 574 6060
IBUGESIC tablets are indicated for analgesic and anti-inflammatory effect in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, IBUGESIC tablets are indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low-back pain.
IBUGESIC tablets can also be used in soft-tissue injuries such as sprains and strains.
IBUGESIC tablets are also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain.
IBUGESIC tablets are also indicated for the relief of neuralgia, migraine, headache, feverishness and for the relief of the symptoms of cold and influenza.
After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest duration should be used.
The recommended initial daily dose of IBUGESIC tablets is 1200-1800 mg per day in divided doses. Some patients can be maintained on 600-1200 mg per day. In severe of acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, providing that the total daily dose does not exceed 2400 mg in divided doses.
The daily dosage of IBUGESIC tablets is 20 mg per kg of body weight in divided doses. In juvenile rheumatoid arthritis up to 40 mg per kg of bodyweight in divided doses may be given. In children weighing less than 30 kg the total dose should not exceed 500 mg in a 24 hour period.
Elderly patients are more prone to adverse effects. Caution must be taken with dosage in this group and also in patients with renal impairment or impaired liver function.
Clinical features of overdose with ibuprofen that may result are depression of the central nervous system and the respiratory system.
Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount of ibuprofen, use of activated charcoal should be considered. Alternatively, in adults, gastric lavage may be considered for potentially life-threatening overdoses.
Shelf life is 36 months (3 years) from manufacture.
Store below 25°C.
Ibugesic tablets are available in PVC/Al blister packs of 120 and 1000 tablets.
No special requirements.
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