XASTEN Ref.[115660] Active ingredients:

Posology

Dosage depends on the nature and severity of the disease and the individual response of the patient to treatment. In general, relatively high initial doses are administered, and they should be significantly higher in acute severe forms than in chronic diseases.

Unless otherwise prescribed, the following dosage recommendations apply:

• Cerebral oedema: Depending on the cause and severity, initial dose of 8–10 mg (up to 80 mg) i.v., followed by 16–24 mg (up to 48 mg)/day orally, divided into 3–4 (up to 6) individual doses for 4–8 days. A longer-term, lower-dose administration of Dexamethasone may be required during irradiation and in the conservative treatment of inoperable brain tumours.
• Cerebral oedema due to bacterial meningitis: 0.15 mg/kg body weight every 6 hours for 4 days, children: 0.4 mg/kg body weight every 12 hours for 2 days, starting before the first antibiotics.
• Severe acute asthma attack: Adults: 8–20 mg, then, if necessary, 8 mg every 4 hours. Children: 0.15–0.3 mg/kg body weight.
• Acute skin diseases: Depending on the nature and extent of the disease, daily doses of 8–40 mg. Followed by treatment with decreasing doses.
• Active phases of rheumatic systemic diseases: systemic lupus erythematosus 6–16 mg/day.
• Severely progressive form of active rheumatoid arthritis: in rapidly destructive forms 12–16 mg/day, in extra-articular manifestations 6–12 mg/day
• Severe infectious diseases, toxic states (e.g. tuberculosis, typhoid): 4–20 mg for a few days, only with concomitant anti-infective therapy.
• Palliative treatment of malignant tumours: initially 8–16 mg/day, in prolonged treatment 4–12 mg/day.
• Congenital adrenogenital syndrome in adulthood: 0.25–0.75 mg/day as a single dose. If necessary, addition of a mineralcorticoid (fludrocortisone). In cases of particular physical stress (e.g. trauma, surgery), intercurrent infections, etc., a 2- to 3-fold dose increase may be required and under extreme stress (e.g. birth) a 10-fold increase.

The tablets should not be split to adjust doses. If patients need a dose that cannot be provided by one or more tablets of 0.5mg, other appropriate formulations should be used.

Method of administration

The tablets should be taken during or after a meal. They should be swallowed whole, with a sufficient amount of liquid. The daily dose should be administered as a single dose in the morning, if possible (circadian therapy). In patients who require a high-dose therapy because of their disease, multiple daily dosing is often required to achieve maximum effect.

Depending on the underlying disease, clinical symptoms and response to therapy, the dose can be reduced at a faster or slower rate and the therapy stopped, or the patient is stabilised on a maintenance dose as low as possible and, if necessary, adrenal axis monitored. Basically, the dose and duration of treatment should be kept as high and long as necessary, but as low and short as possible. In principle, the dose should be reduced gradually.

In long-term therapy which is deemed necessary following initial treatment, patients should be switched to prednisone/prednisolone, because this leads to lower adrenal suppression.

In hypothyroidism or liver cirrhosis, low doses may be sufficient or a dose reduction may be necessary.

Symptoms

Acute intoxications with dexamethasone are not known. In case of chronic overdosing, an increase in undesirable effects, especially endocrine, metabolic and electrolyte-related effects, can be expected (see section 4.8).

Management

There is no known antidote to dexamethasone.

3 years.

Store in the original package in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions.