LUKAFAST montelukast (as sodium) 10 mg film coated tablets bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

montelukast sodium, Quantity: 10.38 mg (Equivalent: montelukast, Qty 10 mg)

Disponible des:

Strides Pharma Science Pty Ltd

Designació comuna internacional (DCI):

montelukast sodium

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: magnesium stearate; lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; hyprolose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; Carnauba Wax

Vía de administración:

Oral

Unidades en paquete:

30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Prophylaxis and treatment of chronic asthma in adults 15 years of age and older. ,Symptomatic treatment of seasonal allergic rhinitis.

Resumen del producto:

Visual Identification: Beige coloured, rounded square shaped, film-coated tablets debossed with X on one side and 54 on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2013-04-03

Informació per a l'usuari

LUKAFAST
CONSUMER MEDICINE INFORMATION
Montelukast (as sodium) 10 mg film-coated 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 this 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.
LUKAFAST are not recommended for infants and children under 15 years
of age.
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

Fitxa tècnica

Page 1 of 14
PRODUCT INFORMATION
LUKAFAST
TM
FILM-COATED 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
white powder. Montelukast
sodium is freely soluble water and 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 film-coated tablets containing 10 mg
montelukast (as sodium).
Each 10 mg film-coated tablet contains the following inactive
ingredients: microcrystalline
cellulose, lactose, croscarmellose sodium, hydroxypropylcellulose,
magnesium stearate and
Opadry Complete film coating system 20A82539 Yellow.
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 14
has been shown to increase nasal airway resistance and sy