ASTHATOR 4 MG CHEWABLE TABLET

국가: 말레이시아

언어: 영어

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

유효 성분:

MONTELUKAST SODIUM

제공처:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (International Name):

MONTELUKAST SODIUM

패키지 단위:

30Tablet Tablets; 100 Tablet Tablets

Manufactured by:

TORRENT PHARMACEUTICALS LTD.

환자 정보 전단

_Consumer Medication Information Leaflet (RiMUP) _
ASTHATOR TABLET
®
Montelukast Sodium (4mg, 5mg, 10mg)
WHAT IS IN THIS LEAFLET
1.
What Asthator is used for
2.
How Asthator works
3.
Before you use Asthator
4.
How to use Asthator
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Asthator
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ASTHATOR IS USED FOR
Asthator
is
indicated
in
adults
and
pediatrics 2 years of age and older for:
-
The prevention and chronic treatment
of asthma
-
The relief of day time and night time
symptoms
of
allergic
rhinitis
(inflammation of the mucous membrane
inside the nose).
HOW ASTHATOR WORKS
Asthator
contains
active
ingredient
montelukast.
Montelukast
is
a
leukotriene
receptor
antagonist
that
blocks
substances
called
leukotrienes.
Leukotrienes
cause
narrowing
and
swelling of airways in the lungs and also
cause
allergy
symptoms.
By
blocking
leukotrienes,
it
improves
asthma
symptoms,
helps
control
asthma
and
improves allergy symptoms.
BEFORE YOU USE ASTHATOR
-
_When you must not use it _
Do
not
use
Asthator
if
you
are
hypersensitive to the active substance or
to any of the excipients.
-
_Pregnancy and lactation _
•
Do
not
take
Asthator
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant.
•
Do
not
take
Asthator
if
you
are
breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it _
•
Oral Asthator should not be used to
treat acute asthma attacks.
•
Asthator
should
not
be
abruptly
substituted
for
inhaled
or
oral
corticosteroids.
•
If
you
were
on
therapy
with
anti-
asthma
agents
including
Asthator,
you
may present with systemic eosinophilia
(a
higher
than
normal
level
of
eosinophils - a type of disease-fighting
white blood cell), sometimes presenting
with
clinical
features
of
vasculitis
(an
inflammation
of
blood
vessels)
consistent with Churg-Strauss syndrome,
a condition which is often treated with
systemic corticosteroid therapy.
•

제품 특성 요약

xxxxxxxx-5253
BRAND OR PRODUCT NAME :
ASTHATOR 4 MG CHEWABLE TABLET
ASTHATOR 5 MG CHEWABLE TABLET
ASTHATOR 10 MG TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S):
ASTHATOR 4 MG CHEWABLE TABLET
Each chewable tablet contains:
Montelukast sodium 4.16mg eq. to Montelukast 4 mg
Colour: Red Oxide of Iron
ASTHATOR 5 MG CHEWABLE TABLET
Each chewable tablet contains:
Montelukast sodium 5.20mg eq. to Montelukast 5 mg
Colour: Red Oxide of Iron
ASTHATOR 10 MG TABLET
Each uncoated tablet contains:
Montelukast sodium 10.40mg eq. to Montelukast 10 mg
Colour: Red Oxide of Iron & Yellow Oxide of Iron
PRODUCT DESCRIPTION:
ASTHATOR 4: Pink colored, oval biconvex shaped, uncoated tablets, with
break line on both the sides.
ASTHATOR 5: Pink colored, round shaped, uncoated tablets, with break
line on both the sides.
ASTHATOR 10: Light brown colored, round biconvex shaped, uncoated
tablets, with break line on both the sides.
DOSAGE FORM:
Uncoated / Chewable Tablets
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of
arachidonic acid metabolism and are released from various cells,
including mast cells and eosinophils. These eicosanoids bind to
cysteinyl leukotriene receptors (CysLT) found in the human airway.
Cysteinyl leukotrienes and leukotriene receptor occupation have been
correlated with the pathophysiology of asthma, including airway
edema, smooth muscle contraction, and altered cellular activity
associated with the inflammatory process, which contribute to the
signs
and symptoms of asthma.
Montelukast is an orally active compound that binds with high affinity
and selectivity to the CysLT1 receptor (in preference to other
pharmacologically important airway receptors, such as the prostanoid,
cholinergic, or (beta) -adrenergic receptor). Montelukast inhibits
physiologic actions of LTD4 at the CysLT1 receptor without any agonist
activity.
PHARMACOKINETICS:
_ABSORPTION: _
Montelukast is rapidly absorbed following oral administration.After
administration of the 10 mg tablet to fasted ad