Hydrocortisone 10 mg Tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Hydrocortisone

MAH:

Renata (UK) Limited

ATC_code:

H02AB; H02AB09

INN:

Hydrocortisone

dosage:

10 milligram(s)

pharmaceutical_form:

Tablet

prescription_type:

Product subject to prescription which may not be renewed (A)

therapeutic_area:

Glucocorticoids; hydrocortisone

authorization_status:

Authorised

authorization_date:

2017-10-20

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Hydrocortisone
Excipient(s) with known effect:
Each tablet contains 78.8 mg lactose monohydrate (equivalent to 74.9mg
lactose anhydrous)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
8 x 5.25 mm white, oval, flat, bevelled tablets with imprinted “H”
on one side and plain on the other side.
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 dosage temporarily.
_Pre-operative use_
Anaesthetists must be