COMPOSITION: 100 mg Hydrocortisone as sodium succinate.
500 mg Hydrocortisone as sodium succinate.
Diluent containing 0,5% Benzyl alcohol as bacteriostat.
PHARMACOLOGICAL CLASSIFICATION: A.21.5.1 Corticosteroids and analogues.
A.34 Others Diluent
PHARMACOLOGICAL ACTION: Hydrocortisone sodium succinate acts by controlling the rate of protein synthesis. It forms a steroid-receptor complex with receptor proteins, moves into the nucleus where it binds the chromatin and thus directs the genetic apparatus to transcribe RNA. It also delays the mineralocorticoid activity.
INDICATIONS: As substitution therapy in the treatment of adrenal insufficiency states, where high levels of hydrocortisone are required rapidly.
In patients with known or suspected adrenal insufficiency prior to surgery, or if shock, severe trauma or other stress conditions occur.
Hydrocortisone sodium succinate is also used for the symptomatic relief of inflammatory conditions and as an immunosuppressant.
CONTRA-INDICATIONS: Hypersensitivity to corticosteroids. Tuberculosis. Ocular herpes simplex. Primary glaucoma. Acute psychosis and psychoneurosis. Systemic infection. Peptic ulcer. Osteoporosis.
WARNINGS: Hydrocortisone sodium succinate injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use of large doses. Hydrocortisone sodium succinate should be given with extreme caution in the presence of congestive heart failure, hypertension in patients with diabetes mellitus, chronic renal failure, uraemia and in elderly patients.
DOSAGE AND DIRECTIONS FOR USE: Hydrocortisone sodium succinate is administered intravenously, intramuscularly or by intravenous infusion. The dose is 100 to 500 mg Hydrocortisone succinate given 3 to 4 times in 24 hours, dosage depending on the severity of the condition and the response.
Children up to 1 year may be given 25 mg, 1 to 5 years 50 mg and 6 to 12 years 100 mg.
Hydrocortisone sodium succinate may be administered in conjunction with suitable intravenous solutions, eg. Dextrose 5% and Sodium Chloride 0,9%, by intravenous infusion, in the desired volume of solution.
If reconstituted with the diluent provided, the solution is stable for 3 days.
The addition of Hydrocortisone sodium succinate to the solution for intravenous use should be made at the time of administration.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Hydrocortisone sodium succinate may cause electrolyte disturbances, characterized by hypertension and oedema due to the retention of sodium and water and the increase in potassium excretion. Increased potassium excretion may cause hypokalaemic alkalosis. Increased susceptibility to infection (e.g. sepsis, fungal and viral) and delayed wound healing. Cardiac failure. Peptic ulcerations with haemorrhage and perforation. Glycosuria. Osteoporosis and spontaneous fractures. Increased appetite. Posterior subcapsular cataract. Atrophy of the adrenal cortex and acute adrenal insufficiency during prolonged treatment. Inhibition or arrest of growth in children. Cushing syndrome. Amenorrhoea. Behavioural disturbances, including mental and neurological disturbances. Intracranial hypertension. Thrombo-embolic complications. Lymphocytopaenia. Myopathy. Hyperglycaemia with accentuation or precipitation of the diabetic state. Insulin requirements of diabetic patients are increased. Infections may be masked by anti-inflammatory properties of Hydrocortisone sodium succinate. Hyperhydrosis and aseptic necrosis of bone may occur. Live vaccines should not be given to patients receiving high doses of Hydrocortisone sodium succinate. Patients receiving long courses of Hydrocortisone sodium succinate should be regularly checked for hypertension, glycosuria, hypokalaemia, gastric discomfort and mental changes. Sodium intake may have to be reduced and potassium supplements administered. Daily mass records may indicate fluid retention and back pain may signify osteoporosis. Children are at special risk from raised intracranial pressure. Infections should be treated as an emergency. Large doses should be given by infusion to prevent cardiovascular collapse. Concurrent administration of barbiturates, phenytoin or rifampicin may enhance the metabolism and reduce the effects of Hydrocortisone sodium succinate. Response to anti-coagulants may be reduced or enhanced. Concurrent administration of Hydrocortisone sodium succinate with potassium depleting diuretics may cause excessive potassium loss.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See "Side-effects and special precautions". Treatment is symptomatic and supportive.
IDENTIFICATION: Amorphous hygroscopic white to slightly off white powder or solid in a clear vial.
Diluent: ampoules containing a clear colourless solution.
PRESENTATION: Cartons containing five vials and five ampoules of diluent.
STORAGE INSTRUCTIONS: Store below 25°C.
Protect from light.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
Marketed by: Intramed, Division of Pharmacare
6 Gibaud Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: October 1990
KOHLER C&P P.E.