Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom
This medicine is indicated in adults for the local treatment, by intra-articular or periarticular injection, of the following conditions: rheumatoid arthritis; osteoarthritis; synovitis not associated with infection; tennis elbow; golfer’s elbow, and bursitis.
This medicine is also suitable for administration by the intramuscular route in conditions requiring systemic corticosteroids, e.g. suppression of inflammatory and allergic disorders such as bronchial asthma, anaphylaxis, ulcerative colitis and Crohn’s disease.
Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose or whenever possible, as a single morning dose on alternate days. Frequent patient review is required to titrate the dose against disease activity.
This medicine is not suitable for use in children.
Steroids should be used cautiously in the elderly since adverse effects are enhanced by old age (see section 4.4).
Intra-articular, periarticular or intramuscular injection.
For articular use: 5-25mg depending upon the size of the joint. The injections may be repeated when relapse occurs. No more than three joints should be treated in one day.
For intramuscular use: The dosage may vary from 25 to 100mg, given once or twice per week, as needed. It will depend upon the disease and its severity and the clinical response to this medicine. The maximum dosage should not exceed 100mg twice weekly.
Overdosage is unlikely with this medicine but there is no specific antidote available. Treatment should be symptomatic.
3 years.
Store at 15°C-25°C and protect from light.
1ml flint neutral glass ampoules.
10 ampoules are packed in a polystyrene pack within a cardboard sleeve.
Shake the ampoule well before use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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