Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Hydrocortisone
Renata (UK) Limited
H02AB; H02AB09
Hydrocortisone
20 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Glucocorticoids; hydrocortisone
Authorised
2017-10-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg Hydrocortisone Excipient(s) with known effect: Each tablet contains 157.6 mg lactose monohydrate (equivalent to 149.7mg lactose anhydrous) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 10.9 x 7.1 mm white, oval, flat, bevelled tablets with a single break line on one side and imprinted “H” on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid • For use as replacement therapy in congenital adrenal hyperplasia in children. • Pre-operatively, and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage must be individualised according to the response of the individual patient. _Replacement therapy_ Paediatric population: In chronic adrenocortical insufficiency, the dosage should be approximately 0.4 to 0.8 mg/kg/day in two or three divided doses, adjusted to the needs of the individual child. In patients requiring replacement therapy, the daily dose should be given when practicable, in two doses. The first dose in the morning should be larger than the second dose in the evening, thus simulating the normal diurnal rhythm of cortisol secretion. _Use in serious trauma or illness with known adrenal insufficiency or doubtful adrenocortical reserve_ Paediatric population: Doses are generally higher than that used for chronic adrenocortical insufficiency and should be selected as appropriate for the clinical situation. 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 the Read the complete document