BLOKTIENE CHEWABLE TABLET 4mg

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

MONTELUKAST SODIUM

Tilgjengelig fra:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (International Name):

MONTELUKAST SODIUM

Enheter i pakken:

10x10'stablet Tablets; 3x10'stablet Tablets

Produsert av:

Actavis Ltd.

Informasjon til brukeren

_Consumer Medication Information Leaflet (RiMUP)_
BLOKTIENE CHEWABLE TABLETS
Montelukast Sodium (4mg, 5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Bloktiene is used for
2.
How Bloktiene works
3.
Before you use Bloktiene
4.
How to take Bloktiene
5.
While
you
are
using
Bloktiene
6.
Side Effects
7.
Storage
and
Disposal
of
Bloktiene
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
BLOKTIENE
IS
USED
FOR
Your
doctor
has
prescribed
BLOKTIENE
(montelukast
sodium, ACTAVIS) to treat:
• Asthma, including preventing
your asthma symptoms during
the day and night. BLOKTIENE
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 BLOKTIENE WORKS
BLOKTIENE
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 BLOKTIENE
_-When you must not take it _
Do not take BLOKTIENE if
you or your child
•
are
allergic
to
any
of
its
components.
_-Before you start to take it_
Tell your doctor (or health care
provider)
about
any
medical
problems
or
allergies
you
or
your child has now or has had.
Use in children
For children 6 to 14 years old,
BLOKTIENE
5-mg
chewable
tablets are available.
For children 2 to 5 years old,
BLOKTIENE
4-mg
chewable
tablets are available.
Safety
and
effectiveness
of
BLOKTIENE
in
children
less
than
12
months
old
have
not
been established.
Use in pregnancy
Women
who
are
pregnant
or
intend
to
become
pregnant
should
consult
their
doctor
before takin

Preparatomtale

BLOKTIENE
PRODUCT NAME
Bloktiene_ _Chewable Tablet 4mg
Bloktiene Chewable Tablet 5mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Montelukast sodium 4.16mg equivalent to 4mg
montelukast
Montelukast sodium 5.20mg equivalent to 5mg
montelukast
PRODUCT DESCRIPTION
4mg: Pink, mottled, oval, biconvex tablets, 7.8 x 11mm, with
M4 on one side.
5mg: Pink, mottled, round, biconvex tablets, 9.5mm, with
M5 on one 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 ß