MONTULAR 10MG TABLET (MONTELUKAST)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MONTELUKAST SODIUM

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

MONTELUKAST SODIUM

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

KUSUM HEALTHCARE PVT. LTD.

Risalah maklumat

MONTULAR
MONTELUKAST TABLETS 10 MG
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_MONTULAR _
is used for
2.
How
_MONTULAR _
works
3.
Before you use
_MONTULAR_
4.
How to use
_MONTULAR _
While you
are using it
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_MONTULAR_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MONTULAR _IS USED FOR
Use to treat:

Asthma, including preventing your
asthma symptoms during the day
and night. MONTULAR also
prevents the narrowing of airways
triggered by exercise.

Allergic rhinitis (seasonal and
perennial), including daytime and
nighttime symptoms: nasal
congestion, runny nose, nasal
itching, and sneezing; nasal
congestion upon awakening,
difficulty going to sleep, and
nighttime awakenings; tearing,
itchy, red, and puffy eyes.
HOW _MONTULAR _WORKS
The mechanism of action of Montelukast
is based on the blockage of cysteinyl
leukotriene (CysLT) receptors. The
cysteinyl leukotrienes (LTC
4
, LTD
4
,
LTE
4
) are potent inflammatory
eicosanoids and have been correlated
with the pathophysiology of asthma and
allergic rhinitis.
BEFORE YOU USE _MONTULAR_
-
_When you must not use it _
Patients should be advised never to use
oral montelukast to treat acute asthma
attacks
Montelukast should not be substituted
abruptly for inhaled or oral
corticosteroids.
_ _
_Use in pregnancy _
Women who are pregnant or intend to
become pregnant should consult their
doctor before taking MONTULAR.
_ _
_ _
_Use in breast-feeding _
It is not known if MONTULAR appears
in breast milk. You should consult your
doctor before taking MONTULAR if you
are breast-feeding or intend to breast-
feed.
_ _
-
_Before you start to use it _
Your doctor needs to know before you
take MONTULAR, if you have or have
had any of the following conditions:

allergies you have now or have had

And if you are taking any
medication, such as phenytoin,
phenobarbital and rifampicin, as
these medicines should not be taken
toge

Ciri produk

MONTULAR
MONTELUKAST SODIUM TABLETS 10 MG
GENERAL CHARACTERISTIC
_GENERAL PHYSICO-CHEMICAL PROPERTIES _
Beige colored, round shape, biconvex, film coated tablets, plain on
both sides.
COMPOSITION
Each film coated tablet contains
Montelukast Sodium equivalent to Montelukast USP………….10 mg
_EXCIPIENTS: _
Microcrystalline cellulose (Avicel PH102), croscarmellose sodium,
sodium lauryl
sulphate, magnesium stearate, purified water and opadry 20A520035
yellow.
PHARMACODYNAMIC PROPERTIES
PHARMACOTHERAPEUTIC GROUP:
Leukotriene receptor antagonists
ATC CODE:
R03D C03
_MECHANISM OF ACTION _
The cysteinyl leukotrienes (LTC
4
, LTD
4
, LTE
4
) are potent inflammatory eicosanoids released from
various cells including mast cells and eosinophils. These important
pro-asthmatic mediators bind to
cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT
1
) receptor is found in the
human airway (including airway smooth muscle cells and airway
macrophages) and on other pro-
inflammatory cells (including eosinophils and certain myeloid stem
cells). CysLTs have been
correlated with the pathophysiology of asthma and allergic rhinitis.
In asthma, leukotriene-mediated
effects
include
bronchoconstriction,
mucous
secretion,
vascular
permeability,
and
eosinophil
recruitment. In allergic rhinitis, CysLTs are released from the nasal
mucosa after allergen exposure
during both early- and late-phase reactions and are associated with
symptoms of allergic rhinitis.
Intranasal challenge with CysLTs has been shown to increase nasal
airway resistance and symptoms
of nasal obstruction.
PHARMACODYNAMIC EFFECTS
Montelukast is an orally active compound which binds with high
affinity and selectivity to the
CysLT
1
receptor. In clinical studies, montelukast inhibits
bronchoconstriction due to inhaled
LTD
4
at doses as low as 5 mg. Bronchodilation was observed within 2 hours
of oral administration.
The bronchodilation effect caused by a beta-agonist was additive to
that caused by montelukast.
Treatment with montelukast inhibited both early- an