Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**Dosage and Administration** Adults: For substitution therapy 20–30 mg/day, of which generally approx. 2/3 in the morning and 1/3 early in the evening. If necessary, the morning dose can be taken in two portions. For other indications, 40–200 mg/day, in short-term use for special indications even higher doses. Children: Dosage in children is individualised. In adrenocortical insufficiency, 7.5–15 mg/m2/day divided into three equal doses (immediately in the morning, in the afternoon, and late in the evening). The morning dose can also be higher than the other doses. In congenital adrenal hyperplasia, generally 10 mg/m2/day divided into three doses. In hypopituitarism, 2.5 mg three times daily. For dosage in stress situations, See Special Warning/Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
ORAL
Medical Information
**Indications** Adrenocortical insufficiency (Addison's disease), diminution of anterior pituitary function (hypopituitarism), congenital adrenal hyperplasia. Conditions where systemic glucocorticoid therapy is indicated.
**Contraindications** Tuberculosis and other acute or chronic bacterial and viral infections without antibiotic or chemotherapeutic protection, hypersensitivity to any ingredient of the preparation.
C05AA01
hydrocortisone
Manufacturer Information
ORION PHARMA (SG) PTE. LTD.
ORION CORPORATION (ESPOO PLANT)
Orion Corporation (Turku Plant)
Orion Corporation (Salo Plant) (Primary and Secondary Packager)
Active Ingredients
Documents
Package Inserts
HYDROCORTISON Tablet PI.pdf
Approved: June 14, 2021