Monulair Chewable Tablet 5mg

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

MONTELUKAST SODIUM

Dostupné z:

CAMBER LABORATORIES SDN. BHD.

INN (Medzinárodný Name):

MONTELUKAST SODIUM

Počet v balení:

100tablet Tablets; 500tablet Tablets; 500tablet Tablets; 500tablet Tablets; 100tablet Tablets; 30tablet Tablets; 30tablet Tablets

Výrobca:

Hetero Labs Ltd., Unit V

Príbalový leták

_Consumer Medication Information Leaflet (RiMUP) _
1
MONULAIR CHEWABLE TABLET 5MG
MONTELUKAST SODIUM 5MG
WHAT IS IN THIS LEAFLET
1.
What Monulair Chewable Tablet
5mg is used for
2.
How Monulair Chewable Tablet
5mg works
3.
Before you use Monulair
Chewable Tablet 5mg
4.
How to use Monulair Chewable
Tablet 5mg
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Monulair
Chewable Tablet 5mg
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MONULAIR CHEWABLE TABLET
5MG IS USED FOR
Your doctor has prescribed Monulair
Chewable Tablet 5mg to treat:
•
Asthma, including preventing
your asthma symptoms during the
day and night. Monulair Chewable
Tablet
5mg
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.
Asthma is a long term disease with
characteristics that include:
There are
two
types
of
allergic
rhinitis:
HOW MONULAIR CHEWABLE TABLET 5MG
WORKS
Monulair Chewable Tablet 5mg is a
leukotriene
receptor
antagonist
that
blocks substances called leukotrienes.
Leukotrienes
cause
narrowing
and
swelling of airways in the lungs. By
blocking
leukotrienes,
Monulair
Chewable
Tablet
5mg
improves
asthma symptoms and helps control
asthma.
BEFORE YOU USE M
ONULAIR CHEWABLE
TABLET 5MG
_-_
_ _
_When you must not use it _
Do
not
take
Monulair
Chewable
Tablet 5mg if you or your child is
allergic
(hypersensitive)
to
montelukast
or
any
of
the
other
ingredients
of
Monulair
Chewable
Tablet 5mg.
_-_
_ _
_Before you start to use it _
Tell your doctor about any medical
problems
or
allergies
you
or
your
child has now or has had.
_-_
_ _
_Taking other medicines _
Some
medicines
may
affect
how
Monulair
Chewable
Tablet
5mg
works, or Monulair Chewable Tablet
5mg may affect how other medicines
work.
Please
tel

Súhrn charakteristických

1
MONULAIR CHEWABLE TABLET 5 MG
PRODUCT NAME
Monulair Chewable Tablet 5 mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each tablet contains Montelukast sodium equivalent to 5 mg of
Montelukast.
PRODUCT DESCRIPTION
Light pink to pink coloured, speckled, round, biconvex shaped,
chewable tablets debossed with 'I' on one side and '113' on the other
side.
PHARMACODYNAMICS
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.
PHARMACOKINETICS ABSORPTION
Montelukast is rapi