COMPOSITION: Each 1 mL ampoule contains 4,0 mg Dexamethasone phosphate as the disodium salt, and 0,1% m/v sodium metabisulphite.
PHARMACOLOGICAL CLASSIFICATION: A.21.5.1 Corticosteroids and analogues
PHARMACOLOGICAL ACTION: Decasone (dexamethasone phosphate) 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 has a biological half-life in plasma of about 190 minutes and has relatively very weak sodium retaining properties.
INDICATIONS: Conditions where the anti-inflammatory and immunosuppressive effects of a corticosteroid are desirable, including intensive treatment during shorter periods.
CONTRA-INDICATIONS: Sensitivity to corticosteroids. Tuberculosis. Ocular herpes simplex. Primary glaucoma. Acute psychosis and psychoneurosis. Systemic infection. Peptic ulcer. Osteoporosis.
WARNING Decasone (dexamethasone phosphate) Injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use of large doses. Decasone (dexamethasone phosphate) should be used with extreme caution in the presence of congestive heart failure, hypertension, in patients with diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly patients.
DOSAGE AND DIRECTIONS FOR USE: Usual adult dosage ranges from 0,5 to 20 mg daily depending on the severity of the disorder.
Decasone (dexamethasone phosphate) may be administered intravenously or intramuscularly. The parenteral administration must be reserved for administration in emergencies or ad intensive therapy.
Intra-articular, intralesional intra-muscular or soft-tissue injection : 0,8 to 4 mg (depending on the size of the joint).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Decasone (dexamethasone phosphate) has little or no effect on sodium and water retention. Oedema, hypertension and an increased excretion of potassium with the possibility of hypokalaemic alkalosis may occur. Cardiac failure may be induced.
Excessive metabolic effects may lead to mobilisation of calcium and phosphorous, with osteoporosis and spontaneous fractures, nitrogen depletion and hyperglycaemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased. Increased appetite is reported.
The effect on tissue repair is manifest in delayed wound healing and increased susceptibility to all kinds of infection: including sepsis, fungal and viral infections have been reported, especially if patients are given antibiotics conjointly. Infections may also be masked.
Acute adrenal insufficiency may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or trauma.
Growth retardation in children has been reported. Large doses may produce symptoms typical of hyperactivity of the adrenal cortex with moon-face sometimes with hirsutism, buffalo hump, flushing, increased bruising, striae, and acne, sometimes leading to fully developed Cushing's syndrome. Sudden cessation of administration is dangerous. Withdrawal should therefore always be gradual, the rate depending upon the individual patient's response, the dose, the disease being treated and the duration of therapy. Adrenal function should be monitored throughout withdrawal and symptoms attributable to over-rapid withdrawal should be countered by resuming a higher dose and continuing the reduction at a slower rate.
Other adverse effects include amenorrhoea, hyperhidrosis, mental and neurological disturbances, intracranial hypertension, acute pancreatitis and aseptic necrosis of bone. Increase in the coagulability of blood may lead to thrombo- embolic complications. Peptic ulceration has been reported. Muscular weakness is an occasional side-effect.
Live vaccines should not be given to patients receiving high-dose systemic corticosteroid therapy; killed vaccines or toxoids may be given although the response may be attenuated. Children are at special risk of infection and may require prophylaxis and immunoglobulin. Patients receiving long courses of Decasone (dexamethasone phosphate) should be regularly checked for hypertension, glycosuria, hypokalaemia, gastric discomfort, and mental changes.
Sodium intake may need to be reduced and potassium supplements may be necessary. Monitoring of the fluid intake and output and daily weight records may give early warning of fluid retention. 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 slowly or by infusion to prevent cardiovascular collapse.
Concurrent administration of barbiturates, phenytoin, or rifampicin may enhance the metabolism and reduce the effects of Decasone (dexamethasone phosphate). Response to anticoagulants may be reduced or enhanced. Concurrent administration with the potassium-depleting diuretics, such as the thiazides or furosemide, 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: A clear colourless to slight yellowish solution in 1 mL clear ampoules.
PRESENTATION: 1 mL clear ampoules packed in containers of 10.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from light.
Keep out of reach of children.
Decasone Injection 4 mg/mL
NAME AND BUSINESS ADDRESS OF APPLICANT: Intramed (Pty) Ltd
6 Gibaud Road