Hydrocortisone 5 mg Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Hydrocortisone

זמין מ:

Renata Pharmaceuticals (Ireland) Limited

קוד ATC:

H02AB09

INN (שם בינלאומי):

Hydrocortisone

טופס פרצבטיות:

Tablet

איזור תרפויטי:

hydrocortisone

מצב אישור:

Not marketed

תאריך אישור:

2024-02-02

מאפייני מוצר

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it should be withdrawn gradually over a period of weeks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