Dexamethasone (Paediatric)

PAEDIATRIC DOSING IS RECORDED IN THE paedDose FIELD AND MUST BE VERIFIED AGAINST A CHILDREN'S FORMULARY. 'The dose should be titrated to the individual patient response and disease severity until satisfactory. In order to minimise side effects, the lowest effective possible dosage should be used.' 'The below mentioned dosing recommendations are given for guidance only. The initial and daily doses should always be determined based on individual patient response and disease severity.' FULL ADULT INDICATION LIST (section 4.2): cerebral oedema 6 to 16 mg (up to 24 mg) per day orally, divided into 3 to 4 individual doses, initial dose and duration depending on cause and severity; acute asthma in adults 16 mg per day for two days; acute skin diseases daily doses of 8 to 40 mg, in some cases up to 100 mg, followed by down-titration according to clinical need; systemic lupus erythematosus 6 to 16 mg per day; active rheumatoid arthritis with severe progressive course 12 to 16 mg per day for fast destructive forms and 6 to 12 mg per day with extra-articular manifestations; idiopathic thrombocytopenic purpura 40 mg for 4 days in cycles; palliative treatment of neoplastic diseases 3 to 20 mg per day, with very high doses up to 96 mg also used; prophylaxis and treatment of emesis induced by cytostatics or emetogenic chemotherapy 8 to 20 mg prior to chemotherapy then 4 to 16 mg/day on days 2 and 3; prevention and treatment of postoperative vomiting a single dose of 8 mg before surgery; symptomatic multiple myeloma, acute lymphocytic leukaemia, acute lymphoblastic leukaemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products, usually 40 mg or 20 mg once per day with dose and frequency varying by therapeutic protocol. TUBERCULOUS MENINGITIS (weight-based, not paediatric-specific in the source): 'Patients with grade II or III disease received intravenous treatment for four weeks (0.4 mg/kg/day for week 1, 0.3 mg/kg/day for week 2, 0.2 mg/kg/day for week 3, and 0.1 mg/kg/day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. Patients with grade I disease received two weeks of intravenous therapy (0.3 mg/kg/day for week 1 and 0.2 mg/kg/day for week 2) and then four weeks of oral therapy (0.1 mg/kg/day for week 3, then a total of 3 mg/day, decreasing by 1 mg each week).' LONG-TERM TREATMENT: after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression of adrenal cortex function. DISCONTINUATION: acute adrenocortical failure may occur after abrupt discontinuation of long-term treatment with large doses, so doses should be gradually reduced and treatment discontinued gradually. FORMULATION CAVEAT: this SPC is for a 10 mg soluble tablet which 'is not suitable for subdivision of dose either as tablet or as solution (after dissolving in glass of water)' - other tablet strengths most appropriate for the prescribed dose should be selected, which matters for the small paediatric doses below. HEPATIC IMPAIRMENT: in severe liver disease dose adjustment may be necessary; biological effects may be potentiated due to slower metabolism and hypoalbuminaemia. SOURCE COMPLETENESS: eMC section 4.5 (interactions) was NOT captured in this bundle and sections 4.4 and 4.8 were truncated at the source-fetch limit.

dosePerKg is left null because the SPC states DIFFERENT per-kg figures for different paediatric indications - a single number would be misleading. VERBATIM SPC section 4.2: 'Acute asthma: Adults: 16 mg / day for two days. Children: 0.6 mg / kg body weight for one or two days.' 'Croup: Children: 0.15 mg/kg - 0.6 mg/kg in a single dose.' Those two lines are the only paediatric numeric doses in this source. The general paediatric paragraph states in full: 'The excretion of dexamethasone is approximately equal in children and adults if dosage is adjusted to their body area. Dosage should be planned bearing in mind possible effects upon growth and development and for signs of adrenal suppression.' No paediatric dose is stated for any other indication, and no paediatric maximum dose is given. Growth suppression in infancy, childhood and adolescence and increased intracranial pressure with papilloedema in children (pseudotumor cerebri), usually following discontinuation of treatment, are listed in section 4.8. Verify against a children's formulary before use.