Avalair 5mg Chewable Tablet

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

MONTELUKAST SODIUM

Tersedia dari:

Nano Medic Care Sdn. Bhd.

INN (Nama Internasional):

MONTELUKAST SODIUM

Unit dalam paket:

28tablet Tablets

Diproduksi oleh:

CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.

Selebaran informasi

Muka surat 1 dpd 2
_Consumer Medication Information leaflet (RiMUP) _
AVALAIR CHEWABLE TABLETS 5MG
Montelukast Sodium 5.2mg, equivalent to Montelukast 5mg
_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
5mg
(Called
‘Avalair’
in
this
leaflet).
Avalair
contains
a
medicine
called
montelukast sodium.
Avalair is used to prevent and treat
chronic asthma and for the relief of
daytime and nighttime symptoms of
seasonal allergic rhinitis (hay fever)
in adults and pediatrics patients 12
months 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,
or
Avalair
may
affect
how
your
other
medicines
work.
They
include:
•
Gemfibroz

Karakteristik produk

COMPOSITION:
Each chewable tablet contains:
Montelukast sodium 5.2mg, equivalent to Montelukast 5.0 mg
PRODUCT DESCRIPTION:
Avalair 5mg Tablet is a pink, round, bi-convex-shaped chewable
tablets,
9.6mm diameter, engraved with “CCP 78” 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