Montemac 5 (Montelukast Chewable Tablets 5mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MONTELUKAST SODIUM

Boleh didapati daripada:

BioCare Pharmaceutical (M) Sdn. Bhd.

INN (Nama Antarabangsa):

MONTELUKAST SODIUM

Unit dalam pakej:

10 X 10tablet Tablets

Dikeluarkan oleh:

Macleods Pharmaceuticals Limited

Risalah maklumat

_ _
_ _
_Consumer Medication information Leaflet (RiMUP) _
MONTEMAC 5
(MONTELUKAST CHEWABLE TABLETS 5 MG)
1
WHAT IS IN THIS LEAFLET
1. What
MONTEMAC 5
is used for r
2. How
MONTEMAC 5
works
3. Before you use
MONTEMAC 5
4. How to use
MONTEMAC 5
5. While you are using it
6. Side effects
7. Storage and Disposal of
MONTEMAC 5
8. Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
WHAT MONTEMAC 5 IS USED FOR
MONTEMAC 5 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 5 WORKS
MONTEMAC 5 is a leukotriene
receptor
antagonist
that
blocks
substances
called
leukotrienes.
Leukotrienes cause narrowing and
swelling of airways in the lungs.
By
blocking
leukotrienes,
MONTEMAC 5 improves asthma
symptoms
and
helps
control
asthma.
BEFORE YOU USE MONTEMAC 5
_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 5.
_ _
_Before you start to take it_
If your child’s asthma or breathing
gets
worse,
tell
your
doctor
immediately. Oral MONTEMAC
5
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 5
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

Ciri produk

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
MONTEMAC 5 MONTELUKAST CHEWABLE TABLETS 5 MG
COMPOSITION
Each chewable tablet contains:
Montelukast Sodium USP 5.2 mg
Equivalent to Montelukast…...5 mg
DESCRIPTION
Montelukast sodium is leukotriene receptor antagonist.
Chemically, Montelukast sodium is
[R-(E)]-1-[[[1-[3-[2-(7-chloro-2quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1
-methylethyl)phenyl]propyl]thio]methyl] cyclopropane acetic acid,
monosodium salt. Its molecular formula is C H ClNNaO S, and molecular
35
35
3
weight is 608.18.
PHARMACEUTICAL FORM
Pink color, mottled, circular, biconvex, uncoated chewable tablet
debossed with 'CL 56' 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 shown not to change
pharmacokinetic variables o