REXOLONE SYRUP

Country: Malaysia

Language: English

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

Active ingredient:

PREDNISOLONE

Available from:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

PREDNISOLONE

Units in package:

100 ml mL

Manufactured by:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REXOLONE SYRUP
Prednisolone (3mg/5ml)
1
WHAT IS IN THIS LEAFLET
1.
What Rexolone is used for
2.
How Rexolone works
3.
Before you use Rexolone
4.
How to use Rexolone
5.
While you are using Rexolone
6.
Side effects
7.
Storage and disposal of Rexolone
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT REXOLONE IS USED FOR
For
the
treatment
of
adrenal
insufficiency, immunosuppressant, anti-
inflammatory and suppressive treatment
of allergic reaction.
HOW REXOLONE WORKS
Rexolone
contains
Prednisolone
as
active ingredient. It works by entering
inflammatory
cells
and
blocking
the
inflammatory reaction.
BEFORE YOU USE REXOLONE
_- When you must not use it _
Do not use:
•
in individuals with gastric ulceration,
psychoses (mental health) and severe
psychoneurosis
(mental
health),
osteoporosis
(brittle
bone),
acute
infections, and vaccination with live
vaccines.
•
if
you
have
tuberculosis
(bacterial
infections that mainly affects the lungs)
•
if you have hypersensitivity to any of
the ingredient of Rexolone.
_ _
_-Before you start to use it _
-Some
medicines
may
increase
the
effects of Prednisolone and your doctor
may wish to monitor you carefully if you
are
taking
these
medicines
(
_including _
_some _
_medicines _
_for _
_HIV _
_such _
_as _
_cobicistat) _
_ _
-Talk
to
your
doctor
before
taking
Rexolone, if you have:
Systemic
sclerosis
(an
autoimmune
disorder). Taking daily doses of 15 mg or
more may increases the risk of a serious
compilation
called
scleroderma
renal
crisis
which
may
cause
your
blood
pressure to increase and reduce urination
_-Use in elderly _
Use
with
caution
in
the
presence
of
congestive heart failure or high blood
pressure,
diabetes,
epilepsy (seizures),
increased
eye
pressure,
infectious
diseases,
eye
herpes
simplex
(eye
infection),
chronic
kidney
failure
and
uremia (excess of waste products in the
blood) in elderly persons.
_-Use in children _
Long term use of corticosteroids may
suppress growth and

Summary of Product characteristics

REXOLONE SYRUP
NAME AND STRENGTH OF ACTIVE INGREDIENTS:
Each 5ml contains:
Prednisolone……………………………………………………………………………………...3mg
Preservative:
Sodium
Benzoate…………………………………………………………………………...0.1%
w/v
PRODUCT DESCRIPTION
Light pink liquid with raspberry flavour.
PHARMACODYNAMICS
Prednisolone is extensively bound to plasma proteins. It is excreted
in the urine as free and
conjugated metabolites, together with an appreciable proportion of
unchanged prednisolone.
Prednisolone crosses the placenta and small amounts are excreted in
the breast milk.
PHARMACOKINETICS
Prednisolone is readily absorbed from the gastro-intestinal tract.
Peak plasma concentrations
of prednisolone are obtained in 1 or 2 hours after administration by
mouth, and it has a usual-
plasma half-life of 2 to 4 hours. Its initial absorption, but not its
overall bioavailability is
affected by food.
INDICATIONS
For the treatment of adrenal insufficiency.
- Immunosuppressant.
- Anti-inflammatory.
- Suppressive treatment of allergic reaction
RECOMMENDED DOSE
ADULT
Initially: 10-20mg (16.7-33.3ml) daily, once or in divided doses
(severe disease, up to 60mg
daily in divided doses)
Maintenance: 2.5-15mg (4.17-25ml) daily, once or in divided doses.
CHILDREN
Initially: 0.2-2mg/kg (0.33-3.33ml/kg) body weight daily in divided
doses
Tapering: Gradually reduce by 2.5mg (4.17ml) to maintenance.
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
Unless
considered
life-saving,
it
is
contraindicated
in
patients
with
gastric
ulceration,
psychoses and severe psychoneurosis, osteoporosis, acute infections,
and vaccination with live
vaccines. Patients with active or doubtfully quiescent tuberculosis
should not be given
corticosteroid except, very rarely, as adjuncts to treatment with
anti-tubercular drugs. Patients
should receive chemoprophylaxis if corticosteroid therapy is
prolonged.
Hypersensitivity to any of the ingredient of Rexolone.
WARNING AND PRECAUTIONS