Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden
Betamethasone is a glucocorticosteroid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. It may be indicated in the following conditions:
Status asthmaticus and acute allergic reactions, including anaphylactic reactions to drugs. Betnesol Injection/Betamethasone Injection supplements the action of adrenaline.
Severe shock arising from surgical or accidental trauma or overwhelming infection.
Acute adrenal crisis caused by abnormal stress in Addison’s disease, Simmonds' disease, hypopituitarism following adrenalectomy, and when adrenocortical function has been suppressed by prolonged corticosteroid therapy.
Soft tissue lesions such as tennis elbow, tenosynovitis and bursitis.
NB. Betnesol Injection/Betamethasone Injection does not replace other forms of therapy for the treatment of shock and status asthmaticus.
4 to 20mg betamethasone (1 to 5ml) administered by slow intravenous injection over half to one minute. This dose can be repeated three or four times in 24 hours, or as required, depending upon the condition being treated and the patient’s response.
Alternatively, Betnesol Injection/Betamethasone Injection may be given by intravenous infusion. The same dose can be given by deep intramuscular injection but the response is likely to be less rapid, especially in shock. This dose can be repeated three or four times in 24 hours depending upon the condition being treated and the patient’s response.
Infants up to 1 year may be given 1mg betamethasone intravenously; children aged 1 to 5 years, 2mg; 6 to 12 years, 4mg (1ml). This dose can be repeated three or four times in 24 hours, depending upon the condition being treated and the patient’s response.
Betnesol Injection/Betamethasone Injection may be administered by slow intravenous injection, deep intramuscular injection or subconjunctival injection. Alternatively, Betnesol Injection/Betamethasone Injection may be given by intravenous infusion. Local injections of Betnesol Injection/Betamethasone Injection may be used when treating soft tissue lesions (see below).
The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see section 4.4).
Local injections of 4 to 8mg Betnesol Injection/Betamethasone Injection may be used when treating soft tissue lesions in adults; children may require smaller doses. This dose can be repeated on two or three occasions depending upon the patient’s response.
Betnesol Injection/Betamethasone Injection has also been administered sub-conjunctivally as a single injection of 0.5 to 1ml.
Intrathecal use is not recommended.
Should overdosage occur, the possibility of adrenal suppression should be minimised by a gradual reduction of dosage over a period of time. The patient may need support during any further trauma.
36 months.
Do not store above 25°C. Store in the original package in order to protect from light.
1ml clear, one-point cut (OPC) colourless glass Type 1 Ph Eur ampoules packed in cartons of 5 ampoules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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