Hydrocortison Orion 10mg Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

HYDROCORTISONE

Available from:

ORION PHARMA (MY) SDN. BHD.

INN (International Name):

HYDROCORTISONE

Units in package:

100 Tablets

Manufactured by:

ORION CORPORATION, ORION PHARMA

Patient Information leaflet

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HYDROCORTISON ORION 10 MG TABLET
Hydrocortisone (10 mg)
___________________________________________________________________________________________________________
__________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Hydrocortison is used for
2.
How Hydrocortison works
3.
Before
you
start
to
take
Hydrocortison
4.
How to take Hydrocortison
5.
While you are taking it
6.
Side effects
7.
Storage
and
Disposal
of
Hydrocortison
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT HYDROCORTISON IS USED FOR
Hydrocortisone is used:
-
to
treat
low
hydrocortisone
levels
caused by diseases of the adrenal gland
(such
as
Addison’s
disease,
adrenocortical insufficiency);
-
in the treatment of hypopituitarism (a
condition in which the pituitary gland
does not produce normal amounts of
some or all of its hormones);
-
to treat congenital adrenal hyperplasia
which
affects
your
body’s
natural
production of steroids;
-
in conditions where systemic (oral or
injectable)
glucocorticoid
therapy
is
needed
Your
doctor
will
tell
you
for
which
disease or symptom (s)he has prescribed
Hydrocortison for you.
HOW HYDROCORTISON WORKS
Hydrocortisone or cortisol is a natural
glucocorticoid (corticosteroid hormone).
It acts by binding to steroid receptors in
the cytoplasm. It acts mainly by reducing
the local inflammation reaction. It e.g.
alleviates
inflammation
symptoms
and
eliminates allergic symptoms.
BEFORE YOU START TO TAKE HYDROCORTISON
_- When you must not take it _
Do not take Hydrocortison if you are
allergic
to
hydrocortisone,
or
the
ingredients listed at the end of this leaflet.
_- Before you start to take _
_it _
Talk to your doctor or pharmacist before
taking Hydrocortison, if you have:
-
bacterial, fungal, viral or parasitic
infections.
-
gastric or duodenal ulcer
-
diabetes
-
bone loss (osteoporosis)
-
serious mood disorder, or psychosis
-
high blood pressur

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Hydrocortison Orion 10mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg hydrocortisone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hydrocortison Orion 10mg Tablet is a white, round, flat
bevelled-edged, scored uncoated tablet
approx. 7 mm diameter with code ORN 45.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adrenocortical insufficiency (Addison’s disease), diminution of
anterior pituitary function
(hypopituitarism), congenital adrenal hyperplasia. Conditions where
systemic glucocorticoid
therapy is indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As replacement therapy, 20 to 30mg daily, usually approximately 2/3 of
this amount in the morning
and 1/3 in the early evening. If necessary, the morning dose may be
taken in 2 parts. In the other
indications, 40 to 200mg daily; in short-term use in special
indications, even higher doses.
Paediatric population
In children, the dosage is individual. In adrenocortical
insufficiency, 7.5 to 15mg/m2/day divided
in 3 equal doses (first thing in the morning, in the afternoon, and
late in the evening); the
morning dose may also be larger than the other doses. In congenital
adrenal hyperplasia, usually
10mg/m2/day divided in 3 doses. In hypopituitarism, 2.5mg 3 times
daily.
Dosing in special situations
Hydrocortisone replacement therapy:
In patients receiving hydrocortisone replacement therapy, the dosage
of Hydrocortison should
be increased 2–4-fold in stressful situations, such as in connection
with injuries, infections or
surgery. If necessary, the patient should be switched to parenteral
treatment.
Pharmacological glucocorticoid therapy:
Long-term systemic glucocorticoid therapy causes adrenocortical
insufficiency that may
persist for months after treatment cessation. Therefore, the dosage of
Hydrocortison should be
increased in stressful situations such as in connection with
infections.
In order to avoid glucocort