Avalair 4mg Chewable Tablet

Country: Malaysia

Language: English

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

Active ingredient:

MONTELUKAST SODIUM

Available from:

Nano Medic Care Sdn. Bhd.

INN (International Name):

MONTELUKAST SODIUM

Units in package:

28tablet Tablets

Manufactured by:

CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.

Patient Information leaflet

Page 1 of 2
_Consumer Medication Information leaflet (RiMUP) _
AVALAIR CHEWABLE TABLETS 4MG
Montelukast Sodium 4.16mg, equivalent to Montelukast 4mg
_WHAT IS IN THIS LEAFLET: _
a)
What Avalair is used for
b)
How Avalair works
c)
Before you use Avalair
d)
How to use Avalair
e)
While you are using Avalair
f)
Side effects
g)
Storage and disposal of Avalair
h)
Product description
i)
Manufacturer
j)
Product Registration Holder
k)
Date of revision
WHAT AVALAIR IS USED FOR
The
name
of
your
medicine
is
Avalair
Chewable
Tablets
4mg
(Called
‘Avalair’
in
this
leaflet).
Avalair contains a medicine called
montelukast sodium.
Avalair is used to prevent and treat
chronic
asthma
in
adults
and
pediatrics patients 12 months of age
and older.
It
is
also
used
for
the
relief
of
daytime and nighttime symptoms of
seasonal allergic rhinitis (hay fever)
in adults and pediatrics patients 2
years of age and older.
HOW AVALAIR WORKS:
Avalair
is
a
leukotriene
receptor
antagonist
that
blocks
substances
called
leukotrienes.
Leukotrienes
cause
narrowing
and
swelling
of
airways
in
your
lungs.
Blocking
leukotrienes
improves
asthma
symptoms and helps prevent asthma
attacks.
Leukotrienes
also
cause
allergy
symptoms.
Blocking
leukotrienes
improves
allergic
rhinitis (seasonal and perennial, also
known as outdoor and indoor nasal
allergies).
BEFORE YOU USE AVALAIR
_When you must not use it. _
_ _
Do not take this medicine and tell
your doctor if you or your child:

Are
allergic
to
any
of
its
components.

If you have ‘phenylketonurics’
as
this
product
contains
Aspartame.
_Before you start to use it _
Check with your doctor or pharmacist
before taking this medicine:
•
If
you
have
any
medical
problems
or
allergies
you
or
your child has now or has had.
•
If you are pregnant or planning
to become pregnant.
•
If you are breast feeding or plan
to breastfeed.
_ _
_Taking other medicines _
In
general,
Avalair
does
not
interfere with other medicines that
you or your child may be taking.
However,
some
medicines
may
affect
how
Avalair
works,
o

Summary of Product characteristics

Page 1 of 3
COMPOSITION:
Each chewable tablet contains:
Montelukast sodium 4.16mg, equivalent to Montelukast 4.0 mg
PRODUCT DESCRIPTION:
Avalair 4mg Tablet is a pink, oval, bi-convex shaped chewable tablets,
engraved with “CCP D79” on one side.
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMI
c
PROPERTIES
ATC code : R03D C03
Montelukast is a selective and active leukotriene receptor antagonist.
Montelukast
inhibits
bronchoconstriction
due
to
antigen
challenge.
Montelukast is a selective leukotriene receptor antagonist of the
cysteinyl
leukotriene CysLT 1 receptor. The cysteinyl leukotrienes (LTC 4, LTD
4,
LTE 4) are products of arachidonic acid metabolism that are released
from
various cells, including mast cells and eosinophils. They bind to
cysteinyl
leukotriene receptors (CysLT) found in the human airway. Binding of
cysteinyl leukotrienes to leukotriene receptors has been correlated
with the
pathophysiology
of
asthma,
including
airway
edema,
smooth
muscle
contraction, and altered cellular activity associated with the
inflammatory
process, factors that contribute to the signs and symptoms of asthma.
It binds to cysteinyl leukotrienes (CysLT) type-1 receptors found in
human
airway (smooth muscle cells and macrophages), which prevents airway
edema, smooth muscle contraction and other respiratory inflammation.
The
leukotrienes are also released from the nasal mucosa after allergen
exposure
where montelukast sodium may inhibit symptoms of allergic rhinitis.
Montelukast binding to the CysLT1 receptor is high-affinity and
selective,
preferring the
CysLT1
receptor to
other
pharmacologically important
airway receptors, such as the prostanoid, cholinergic, or
beta-adrenergic
receptor. Montelukast inhibits physiologic actions of LTD4 at the
CysLT1
receptors, without any agonist activity.
Montelukast causes bronchodilation within 2 hours of oral
administration;
these effects were additive to the bronchodilation caused by a
β-agonist.
PHARMACOKINETIC PROPERTIES
_ABSORPTION_
:
Montelukast is rapidly and nearly completely abs