Montemac 4 (Montelukast Chewable Tablets 4mg)

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

MONTELUKAST SODIUM

थमां उपलब्ध:

BioCare Pharmaceutical (M) Sdn. Bhd.

INN (इंटरनेशनल नाम):

MONTELUKAST SODIUM

पैकेज में यूनिट:

10 x 10 tablet Tablets

द्वारा बनाया गया:

Macleods Pharmaceuticals Limited

सूचना पत्रक

_ _
_ _
_Consumer Medication information Leaflet (RiMUP) _
MONTEMAC 4
(MONTELUKAST CHEWABLE TABLETS 4 MG)
1
WHAT IS IN THIS LEAFLET
1. What
MONTEMAC 4
is used for r
2. How
MONTEMAC 4
works
3. Before you use
MONTEMAC 4
4. How to use
MONTEMAC 4
5. While you are using it
6. Side effects
7. Storage and Disposal of
MONTEMAC 4
8. Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
WHAT MONTEMAC 4 IS USED FOR
MONTEMAC 4 is used for the
prophylaxis and chronic treatment
of asthma in adults and pediatric
patients 12
months of age
and
older. Montelukast is indicated in
adults
and
pediatric
patients
2
years of age and older for the
relief
of
daytime
and
nightime
symptoms
of
seasonal
allergic
rhinitis.
HOW MONTEMAC 4 WORKS
MONTEMAC 4 is a leukotriene
receptor
antagonist
that
blocks
substances
called
leukotrienes.
Leukotrienes cause narrowing and
swelling of airways in the lungs.
By
blocking
leukotrienes,
MONTEMAC 4 improves asthma
symptoms
and
helps
control
asthma.
BEFORE YOU USE MONTEMAC 4
_When you must not take it_
Do not take Montelukast Tablet if
your
child
is
allergic
(hypersensitive) to montelukast or
any
of
the
other
ingredients
of
MONTEMAC 4.
_ _
_Before you start to take it_
If your child’s asthma or breathing
gets
worse,
tell
your
doctor
immediately. Oral MONTEMAC
4
is
not
meant
to
treat
acute
asthma
attacks.
If
an
attack
occurs,
follow
the
instructions
your doctor has given your child.
Always have your child’s inhaled
rescue
medicine
for
asthma
attacks with you.
It is important that your child take
all asthma medications prescribed
by your doctor. MONTEMAC 4
should not be used instead of other
asthma medications your doctor
has prescribed for your child.
Any
patients
on
anti-asthma
medicines should be aware that if
your child develops a combination
of
symptoms
such
as
flu-like
illness,
pins
and
needles
or
numbness
of
arms
or
legs,
worsening
of
pulmonary
symptoms,
and/or
rash,
you
should
consult
your
child’s
doctor.
Your
child
should
not
take
acetylsalicylic acid (aspirin

उत्पाद विशेषताएं

For the use only of a Registered Medical Practitioner or a Hospital or
a
Laboratory
MONTEMAC 4
Montelukast Sodium Chewable Tablets 4 mg
COMPOSITION
Each chewable tablet contains:
Montelukast Sodium USP 4.16 mg
Equivalent to Montelukast…...4 mg
DESCRIPTION
Montelukast sodium is leukotriene receptor antagonist.
Chemically,
Montelukast
sodium
is
[R-(E)]-1-[[[1-[3-[2-(7-chloro-
2 q u i
n o l
i
n y l
) e t h e n y l
] p h e n y l
] - 3 - [ 2 - ( 1 - h y d r o x y - 1 -
methylethyl)phenyl]propyl]thio]methyl] cyclopropane acetic acid,
monosodium
salt. Its molecular formula is C35H35ClNNaO3S, and molecular weight is
608.18.
PHARMACEUTICAL FORM
Pink color, oval, biconvex, uncoated chewable mottle tablet debossed
with 'CL
55' on one side and plain on other side
PHARMACOLOGICAL CLASSIFICATION
Leukotriene Receptor Antagonist
PHARMACOLOGICAL ACTION:
_PHARMACOKINETICS_
Absorption : Montelukast is rapidly absorbed following oral
administration. The
mean oral bioavailability is 64%. The oral bioavailability and Cmax
are not
influenced by a standard meal. For the 5 mg chewable tablet, the Cmax
is
achieved in two hours after administration in adults in the fasted
state. The mean
oral bioavailability is 73% and is decreased to 63% by a standard
meal. After
administration of the 4 mg chewable tablet to paediatric patients 2 to
5 years of
age in the fasted state, Cmax is achieved 2 hours after
administration. The mean
Cmax is 66% higher while mean Cmin is lower than in adults receiving a
10 mg
tablet.
Distribution : Montelukast is more than 99% bound to plasma proteins.
The
steady-state
volume
of
distribution
of
montelukast
averages
8-11
litres.
Biotransformation Montelukast is extensively metabolised. In studies
with
therapeutic doses, plasma concentrations of metabolites of montelukast
are
undetectable at steady state in adults and children. Cytochrome P450
2C8 is the
major enzyme in the metabolism of montelukast. Additionally CYP 3A4,
and 2C9
may have a minor contribution, although itraconazole, an inhibitor of
CYP 3A4,
was show