Posology : מינונים

4.2. Posology and method of administration
Posology

Dexamethasone Kalceks contains 4 mg or 8 mg of dexamethasone phosphate per ampoule for intravenous and intramuscular injection. It can be applied directly or it can be added to the solutions detailed in section 6.6 and given through a drip.

DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.

Intravenous route
Idiopathic thrombocytopenic purpura in adult by the intravenous route (the intramuscular route is contraindicated).

Intravenous and intramuscular route
As with other steroids, disease permitting, the most suitable posology of Dexamethasone Kalceks is:
 a)      Single daily dose (with diurnal rhythm), since this causes less disruption of the hypothalamic-pituitary-adrenal (HPA) axis.
 b)      Single dose every second day to prevent iatrogenic Cushing's Syndrome and suppression of the HPA axis.

The initial dosage of Dexamethasone Kalceks varies from 0.5 to 9 mg a day, depending on the disease being treated. In less severe diseases, doses lower than 0.5 mg may suffice, while in more severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If a satisfactory clinical response does not occur after a reasonable period of time, discontinue therapy and transfer the patient to another therapy.

After a favourable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness and the effect of stress (e.g., surgery, infection, trauma).
During stress it may be necessary to increase dosage temporarily.

If the drug is to be stopped after a few days of treatment, it should be withdrawn gradually.

For the treatment of cerebral oedema, Dexamethasone Kalceks will be administered intravenously and once only at a dose of 8 mg and will then be continued with 4 mg every 6 hours, intramuscularly, until the cerebral oedema symptoms have remitted.
Response is normally achieved after 12-24 hours and dosage may be reduced after two to four days and gradually withdrawn over a period of 5 to 7 days.

In acute allergic disorders or in exacerbations of chronic allergic processes Dexamethasone Kalceks may be given intramuscularly as follows: 4 mg or 8 mg the first day, 4 mg on days two to four and 2 mg on days five to seven.


Paediatric population
In children, the recommended daily dose is 0.08-0.3 mg/kg or 2.5-10 mg/m².
Posology must be adjusted in patients with kidney and liver failure.