Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Bristol-Myers Squibb Pharmaceuticals Unlimited Company, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, Dublin, D15 T867
Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.
Intradermal use: for lichen simplex chronicus (neuro-dermatitis), granuloma annulare, lichen planus, keloids, alopecia areata and hypertrophic scars.
Adcortyl is for intra-articular or intra-dermal injection ONLY. The safety and efficacy of administration by other routes has yet to be established (see sections 4.3 and 4.4). Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals.
The dose of Adcortyl injection for intra-articular administration, and injection into tendon sheaths and bursae, is dependent on the size of the joint to be treated and on the severity of the condition. Doses of 2.5-5 mg (0.25-0.5 ml) for smaller joints and 5-15 mg (0.5-1.5 ml) for larger joints usually alleviate the symptoms. Triamcinolone acetonide 40 mg/ml (Kenalog) is available to facilitate administration of larger doses (see section 4.4 re Achilles tendon).
Intradermal dosage is usually 2-3 mg (0.2-0.3 ml), depending on the size of the lesion. No more than 5 mg (0.5 ml) should be injected at any one site. If several sites are injected the total dosage administered should not exceed 30 mg (3 ml). The injection may be repeated if necessary, at one or two week intervals.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close supervision is required to avoid life-threatening reactions.
Adcortyl is not recommended in children under 6 years. Adcortyl intra-articular/intradermal may be used in older children in suitably adjusted dosages. Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases (see section 4.4).
Not applicable.
36 months.
In an upright position. Do not store above 25°C. Avoid freezing.
Carton containing glass ampoules 5 × 1 ml or individually cartoned multidose vials of 5 ml.
No special handling instructions.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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