DEXAMETHASONE INJECTION 4MG/1ML
Each 1mL contains 4.0 mg dexamethasone phosphate as the disodium
Dexamethasone phosphate is a glucocorticoid and 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. It
has little or no effect on sodium and water retention.
Coriticosteroids are used where their anti- inflammatory and
immunosuppressive effects are desirable, including intensive
treatment during shorter periods.
Dexamethasone phosphate is contra- indicated in a patient that has
hypersensitivity to corticosteroids, tuberculosis, psychoses,
severe psychoneuroses, acute infection, peptic ulcer or
The safety in pregnancy and lactation has not been established.
MICRO DEXAMETHASONE PHOSPHATE INJECTION should not be administered
intrathecally or subconjuctivally.
Toxic effects may result from withdrawal or from continued use or
large doses. Dexamethasone phosphate should be used with extreme
caution in the presence of congestive heart failure, hypertension,
in patients with diabetes mellitus, epilepsy, glaucoma, ocular
herpes simplex, 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.
Dexamethasone phosphate may be administered by slow intravenous
injection or intramuscularly. In the treatment of cerebral oedema
caused by malignancy, an initial intravenous dose of 10 mg is
usually given, followed by 4 mg intramuscularly, every 6 hours. A
response is usually obtained after 12 to 24 hours and dosage may be
reduced after 2 to 4 days.
The injection may also be given by intra- articular, intralesional,
intramuscular or soft tissue injection. For intra-articular
injection, dose equivalent to 0,8 to 4 mg (depending on the size of
the joint), are given.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
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.
In extreme cases, 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.
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.
Patients with active or doubtfully quiescent tuberculosis should
not be given corticosteroids. Similarly, patients already receiving
corticosteroid therapy are more susceptible to infection, the
symptoms of which, moreover, may be masked until an advanced stage
has been reached. Warnings have recently been issued about the
risks of chickenpox and severe herpes zoster being increased in
patients receiving systematic corticosteroids, and patients should
avoid close personal contact with either infection.
Store below 25°C. Protect from light. Keep out of reach of