Mucoease Plus Syrup

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Carbocisteine; PROMETHAZINE HYDROCHLORIDE

Boleh didapati daripada:

PHARMANIAGA MANUFACTURING BERHAD

INN (Nama Antarabangsa):

Carbocisteine; PROMETHAZINE HYDROCHLORIDE

Unit dalam pakej:

120 ml

Dikeluarkan oleh:

PHARMANIAGA MANUFACTURING BERHAD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
MUCOEASE PLUS SYRUP
Carbocisteine (100 mg), Promethazine Hydrochloride (2.50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Mucoease Plus Syrup
_ _
is used
for
2.
How Mucoease Plus Syrup works
3.
Before you use Mucoease Plus
Syrup
4.
How to use Mucoease Plus Syrup
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Mucoease
Plus Syrup
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MUCOEASE PLUS SYRUP IS USED
FOR
Mucoease Plus Syrup
_ _
is used for the
relief of cough due to cold and allergy.
HOW MUCOEASE PLUS SYRUP WORKS
Mucoease
Plus
Syrup
combines
two
active
ingredients,
carbocisteine
(mucolytics)
and
promethazine
hydrochloride
(antihistaminic,
phenothiazines).
Carbocisteine works by making mucus
(phlegm)
less
sticky.
This
makes
the
mucus easier to cough up.
Promethazine
works
by
blocking
the
effects
of
a
certain
natural
substance
(histamine),
which
causes
allergy
symptoms. It also has sedating effects
which
is
useful
in
people
with
disturbing sleep.
BEFORE YOU USE MUCOEASE PLUS SYRUP_ _
-
_When you must not use it _
Do not take Mucoease Plus Syrup if:
•
You are allergic (hypersensitive) to
carbocisteine.
•
You are allergic (hypersensitive) to
promethazine (antihistamine).
•
You
are
allergic
to
any
of
the
ingredients listed at the end of this
leaflet.
•
Your child is less than 2 years of age.
•
You are suffering from Central Nerve
System
(nerve
tissues
that
controls
body activity) depression.
•
You are taking antidepressants (drugs
for mood disorder) in past 14 days.
•
You
have
low
numbers
of
white
blood cells (agranulocytosis) in the
past.
•
You
have
affected
respiratory
function
(e.g.
sleep
apnea
(serious
sleep disorder)).
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking Mucoease Plus Syrup
_ _
-
_Before you start to use it _
Discuss with your doctor or pharmacist
if:
_Related to carbocisteine: _
•
You
hav

Ciri produk

SYRUP
®
MUCOEASE
_Plus_
DESCRIPTION
Clear, yellow syrup.
COMPOSITION
Each
5
mL
contains
Carbocisteine
100
mg
and
Promethazine HCI 2.5 mg.
PHARMACODYNAMICS
Mucoease Plus Syrup combines the mucolytic and
muco-regulatory properties of carbocisteine with the
antihistaminic and antitussive properties of prometha-
zine.
Carbocisteine is a mucolytic agent that reduces goblet
cell
hyperplasia
in
the
management
of
respiratory
disorders
associated
with
abnormally
excessive
or
viscous mucus secretion.
Promethazine is an H1 antihistamine, phenothiazine
with an aliphatic side chain, characterized by:
All
antihistamines
are
opposed
to
the
effects
of
histamine, particularly on the skin, bronchi, intestine
and blood vessels, through more or less reversible
competitive
antagonism.
Most
have
an
antitussive
effect, which is mild in itself but potentiates the effects
of central morphine antitussive as well as those of other
bronchodilators such as sympathomimetic amines, with
which they are often combined.
PHARMACOKINETICS
Carbocisteine is rapidly and well absorbed after an oral
dose and peak plasma concentrations occur about 2
hours. Bioavailability is low, less than 10% of the dose
administered,
probably
because
of
intraluminal
metabolism and a marked first-pass hepatic effect.
Carbocisteine
penetrates
into
lung
tissues
and
respiratory mucus. Carbocisteine is metabolised via
acetylation,
decarboxylation
and
sulfoxidation
by
genetic
polymorphism.
It
undergoes
extensive
hepatic-first
pass
metabolism
via
hydroxylation
by
CYP2D6
and
N-demethylation
by
CYB2B6.
The
elimination
half-life
is
approximately
two
hours.
Carbocisteine is excreted via urine, as unchanged drug
and metabolites.
The bioavailability of promethazine is between 13%
and 40%. 1.5-3 hours are necessary before peak
plasma
concentration
is
reached.
The
volume
of
distribution is high, because of the substance liposolu-
bility, around 15 L/kg. The fraction bound to plasma
proteins reaches 75 - 80%. The half-life is between 10
and 15 hours. Metabolism consists of sulfoxidat