HYDROCORTISONE Solution for injection Ref.[7549] Active ingredients: Hydrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Therapeutic indications

This presentation permits rapid use in emergency situations involving the following conditions:

Status asthmaticus and acute allergic reactions, including anaphylactic reaction to drugs. This medicine supplements the action of adrenaline.

Severe shock arising from surgical or accidental trauma or overwhelming infection.

Acute adrenal insufficiency caused by abnormal stress in Addison’s disease, hypopituitarism, following adrenalectomy, and when adrenocortical function has been suppressed by prolonged corticosteroid therapy.

Soft tissue lesions such as tennis elbow, tenosynovitis, or bursitis.

Note: This medicine does not replace other forms of therapy for the treatment of shock and status asthmaticus.

Posology and method of administration

Undesirable effects may be minimised by using the lowest effective dose for the minimum period. Frequent patient review is required to titrate appropriately the dose against disease activity (see Section 4.4).

Systemic therapy in adults

100 to 500mg hydrocortisone (1 to 5ml) administered by slow intravenous injection, taking at least half to one minute. This dose can be repeated three or four times in 24 hours, depending upon the condition being treated and the patient’s response. Alternatively, This medicine may be given as an intravenous infusion. A clinical effect is seen in two to four hours, and it persists for up to eight hours after intravenous injection. The same dose can be given by intramuscular injection, but the response is likely to be less rapid, especially in shock.

Systemic therapy in children

As a guide, infants up to 1 year may be given 25mg hydrocortisone intravenously; children 1 to 5 years, 50mg; 6 to 12 years, 100mg (1ml). This dose can be repeated three or four times in 24 hours depending upon the condition being treated and the patient’s response.

Other uses

Local treatment of soft-tissue lesions – 100 to 200mg. This daily dose may be repeated on two or three occasions depending upon the patient’s response.

This medicine is not recommended for intrathecal use.

Route(s) of administration

Intravenous or intramuscular injection, or injection into soft tissues.

Overdose

None stated.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Store below 25°C. Keep the ampoules in the outer carton.

Nature and contents of container

1ml and 5ml neutral glass ampoules.

Special precautions for disposal and other handling

No special instructions.

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