Terry White Chemists Montelukast

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Montelukast sodium

Available from:

Apotex Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

TERRY WHITE CHEMISTS
MONTELUKAST

_Contains the active ingredient montelukast (as montelukast sodium)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about montelukast. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Montelukast.
It contains the active ingredient
montelukast (as montelukast
sodium).
It is used to:
•
prevent asthma symptoms,
including those that occur during
the day and at night-time
•
prevent the narrowing of airways
triggered by exercise
•
seasonal allergic rhinitis (hay
fever) symptoms
Montelukast tablets are not used to
treat an acute attack of asthma. If an
acute attack occurs, follow your
doctor's instructions for your reliever
medicine, and keep taking your
montelukast tablets each night or as
prescribed.
As a preventive medicine for asthma,
montelukast can be used alone or in
combination with other preventive
medicines, such as inhaled
corticosteroids. Your doctor may
reduce your dose of inhaled
corticosteroid while you are taking
montelukast.
Asthma is a lung disease and has the
following characteristics:
•
narrowed airways causing
breathing to become difficult
•
inflame

Summary of Product characteristics

Product Information 
– Australia 
Terry White Chemists MONTELUKAST TABLET 
Page 1 
TERRY WHITE CHEMISTS MONTELUKAST TABLET 

NAME OF THE MEDICINE 
Montelukast sodium. 

Chemical Name:  
[R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-
methylethyl)phenyl]propyl]thio]methyl] cyclopropane acetic acid, monosodium salt. 

Structural Formula: 

Molecular Formula: 
C
35
H
35
ClNNaO
3
S 

Molecular Weight: 
608.18 

CAS Registry Number:  151767-02-1 

DESCRIPTION 
Montelukast sodium is a hygroscopic, optically active, white
to off-white, free-flowing powder. 
Montelukast sodium is freely soluble in ethanol,
methanol, and water and practically insoluble in 
acetonitrile. Montelukast is the optically active R stereoisomer. 

Each 10-mg film-coated tablet
contains 10.4 mg montelukast sodium, which is equivalent to 
10.0 mg of montelukast, the free acid. 
In addition, each 10 mg tablet contains the following inactive ingredients: Lactose Anhydrous, Cellulose 
Microcrystalline,  Croscarmellose  Sodium,  Silica  Colloidal  Anhydrous,  Magnesium  Stearate, 
Hypromellose, Hydroxypropylcellulose, Yellow Iron Oxide, Red Iron Oxide and Titanium Dioxide. 

Each 5 mg chewable tablet contains montelukast sodium equivalent to 5.0 mg of montelukast, the free 
acid. Each 4 mg chewable tablet contains montelukast sodium equivalent to 4.0 mg of montelukast, the 
free acid.  
In  addition,  each  4  mg  and  5  mg  chewable  tablet  contains  the  following  inactive  ingredients:  Mannitol, 
Cellulose  Microcrystalline,  Croscarmellose  Sodium,  Aspartame,  Magnesium  Stearate,  Cherry  501027 
AP0551 and Red Iron Oxide. 

PHARMACOLOGY 
PHARMACOKINETICS   
Absorption 
Montelukast
is rapidly and nearly completely absorbed following oral administratio