Anti-Inflammatory Agent, GMP Medicine Injection,

Composition:
Each ampoule contains 4mg Dexame. phosphate,

Pharmacological Action:
Dexame. 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:
Sensitive to corticosteroids, Tuberculosis, Ocular herpes simplex, Primary glaucoma. Acute psychosis and psychoneurosis, Systemic infection, Peptic ulcer, Osteoporosis.

Warning:
Dexame. phosphate Injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use of large doses. Dexame. 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 indications for use.:
Usual adult dosage ranges from 0,5 to 20 mg daily depending on the severity of the disorder. Dexame. 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 4mg (depending on the size of the joint).

Side-effects:
Dexame. 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 hypergtycaemia 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.

Storage:
Store below 25ºC. Protect from light. Keep out of reach of children.


  Composition:
Each ampoule contains 4mg Dexame. phosphate,

Pharmacological Action:
Dexame. 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:
Sensitive to corticosteroids, Tuberculosis, Ocular herpes simplex, Primary glaucoma. Acute psychosis and psychoneurosis, Systemic infection, Peptic ulcer, Osteoporosis.

Warning:
Dexame. phosphate Injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use of large doses. Dexame. 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 indications for use.:
Usual adult dosage ranges from 0,5 to 20 mg daily depending on the severity of the disorder. Dexame. 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 4mg (depending on the size of the joint).

Side-effects:
Dexame. 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 hypergtycaemia 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.

Storage:
Store below 25ºC. Protect from light. Keep out of reach of children.