LUKAFAST montelukast (as sodium) 5mg chewable tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

montelukast sodium

Available from:

Fair-Med Healthcare Australia Pty Ltd

INN (International Name):

montelukast sodium

Authorization status:

Registered

Patient Information leaflet

LUKAFAST
CONSUMER MEDICINE INFORMATION
Montelukast (as sodium) 4 mg and 5 mg chewable tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions people ask about LUKAFAST.
It does not contain all the available information. It does not take
the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking LUKAFAST
against the benefits they expect it product will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT LUKAFAST IS USED FOR
LUKAFAST are used to prevent asthma symptoms, including those that
occur during the day and at
night-time. It also prevents the narrowing of airways triggered by
exercise.
If
you
have
seasonal
allergic
rhinitis
(hay
fever),
LUKAFAST
also
treat
your
allergic
rhinitis
symptoms.
It can be used in children 2 years of age and older.
LUKAFAST 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
LUKAFAST each night or as
prescribed.
As a preventive medicine for asthma, LUKAFAST 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 LUKAFAST.
Asthma is a lung disease and has the following characteristics:
•
narrowed airways causing breathing to become difficult;
•
inflamed airways, which means the lining of airways become swollen;
and
•
sensitive airways that react to many things, such as cigarette smoke,
pollen, or cold air.
Symptoms of asthma include coughing, wheezing and chest tightness. Not
all people with asthma
wheeze. For some, coughing may be the only symptom of asthma. Symptoms
often occur during the
night or after exercise.
For further information about asthma, contact the Asthma Foundation in
your state on 1800 645 130,
or www.asthmaaustralia.

Summary of Product characteristics

Page 1 of 16
PRODUCT INFORMATION
LUKAFAST
TM
CHEWABLE TABLETS
NAME OF THE MEDICINE
Active substance:
Montelukast (as sodium)
Chemical name:
Sodium [1-[[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-
yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-
methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate
Molecular formula
C
35
H
35
ClNNaO
3
S
Molecular weight:
608
CAS number:
151767-02-1
Chemical structure:
DESCRIPTION
Montelukast sodium is a hygroscopic, optically active, white or almost
whitepowder. Montelukast
sodium is freely soluble water and in methylene chloride, freely
soluble to very soluble in ethanol
(96 per cent). Montelukast is the optically active R stereoisomer.
LUKAFAST is available as chewable tablets containing 4 mg & 5 mg
montelukast as sodium.
LUKAFAST contains the following inactive ingredients: mannitol,
microcrystalline cellulose,
hydroxypropylcellulose, croscarmellose sodium, iron oxide red CI77491,
aspartame, CD95 Art
Cherry FL SD #594 and magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMICS
The cysteinyl leukotrienes (LTC
4
, LTD
4
, LTE
4
), are potent inflammatory eicosanoids released
from various cells including mast cells and eosinophils. These
important pro-asthmatic mediators
bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1
(CysLT
1
) receptor is found in
the human airway (including airway smooth muscle cells and airway
macrophages) and on other
pro-inflammatory cells (including eosinophils and certain myeloid stem
cells). CysLTs have been
correlated with the pathophysiology of asthma and allergic rhinitis.
In asthma, leukotriene-
mediated effects include a number of airway actions, including
bronchoconstriction, mucous
secretion, vascular permeability, and eosinophil recruitment. In
allergic rhinitis, CysLTs are
released from the nasal mucosa after allergen exposure during both
early- and late-phase
reactions and are associated with symptoms of allergic rhinitis.
Intranasal challenge with CysLTs
Page 2 of 16
has been shown to increase nasal airway resistance and symptoms of
nasal o