Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Hydrocortisone
Renata Pharmaceuticals (Ireland) Limited
H02AB09
Hydrocortisone
Tablet
hydrocortisone
Not marketed
2024-02-02
Health Products Regulatory Authority 02 February 2024 CRN00D7KJ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg hydrocortisone. Excipient(s) with known effect: Each tablet contains 39.4 mg lactose monohydrate (equivalent to 37.4 mg lactose anhydrous). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 6.5 × 3.5 mm, white, oval, flat, bevelled with imprinted "H5" on one side and bisect on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid For use as replacement therapy in primary, secondary or acute adrenocortical insufficiency. Pre-operatively, and during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenocortical reserve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage must be individualized according to the response of the individual patient. The lowest possible dose should be used. _ _ 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 dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it should be withdrawn gradually over a period of weeks to months, depending on dosage and duration of therapy. _In chronic adrenocortical insufficiency_, a dosage of 20-30 mg a day is usually recommended, sometimes together with 4-6 g of sodium chloride or 50-300 micrograms of fludrocortisone daily. When immediate support is mandatory, one of the soluble adrenocortical corticosteroid preparations (e.g., dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life-saving. _Paediatric population_: in chronic adrenocortical insuffic Prečítajte si celý dokument