Solu-Cortef Ref.[2685] Active ingredients: Hydrocortisone

Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.

Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient’s response and clinical condition.

In general high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilised – usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.

Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.

Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy.

In patients with liver disease, there may be an increased effect (see section 4.4) and reduced dosing may be considered.

Elderly patients: Solu-Cortef is primarily used in acute short-term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (see Special warnings and special precautions for use).

Children: While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight but should not be less than 25 mg daily (see Special warnings and special precautions for use).

Preparation of solutions: For intravenous or intramuscular injection prepare the solution aseptically by adding not more than 2 ml of Sterile Water for Injections to the contents of one vial of Solu-Cortef 100 mg, shake and withdraw for use.

For intravenous infusion, first prepare the solution by adding not more than 2 ml of Sterile Water for Injections to the vial; this solution may then be added to 100 ml – 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction).

When reconstituted as directed the pH of the solution will range from 7.0 to 8.0.

There is no clinical syndrome of acute overdosage with Solu-Cortef. Hydrocortisone is dialysable.

Shelf-life of the medicinal product as packaged for sale: 60 months.

After reconstitution with Sterile Water for Injections, use immediately, discard any remainder.

Store below 25°C.

Refer to Section 4.2 Dosage and Administration. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Type I flint glass vials with a butyl rubber plug and metal seal. Each vial of Solu-Cortef 100 mg contains the equivalent of 100 mg hydrocortisone as the sodium succinate for reconstitution with 2 ml of Sterile Water for Injections.

No special requirements.