MONTELUKAST GH montelukast (as sodium) 5 mg chewable tablet blister pack

Summary of Product characteristics

                                Page 1 of 23
PRODUCT INFORMATION
MONTELUKAST GH 4MG, 5MG AND 10MG
NAME OF MEDICINE
Montelukast sodium
DESCRIPTION
Montelukast sodium, the active ingredient in Montelukast GH, is a
selective and orally active
leukotriene receptor antagonist that inhibits the cysteinylleukotriene
CysL
T1 receptor.
Montelukast
sodium
is
described
chemically
as
sodium
[1-[[[(1
_R_
)-1-[3-[(
_E_
)-2-(7-
chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-
methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate.
The
empirical
formula
is
C
35
H
35
ClNNaO
3
S, and
its
molecular
weight
is
608.18.
The
structural formula is:
CAS NUMBER: 151767-02-1
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 tablet contains 10.4 mg montelukast sodium, which is
equivalent to 10.0 mg of
montelukast, the free acid. Each 5-mg chewable tablet contains 5.2 mg
montelukast sodium,
which is equivalent to 5.0 mg of montelukast, the free acid. Each 4-mg
chewable tablet
contains 4.16 mg montelukast sodium, which is equivalent to 4.0 mg of
montelukast, the free
acid.
Each 10-mg tablet contains the following inactive ingredients:
mannitol, microcrystalline
cellulose,
croscarmellose
sodium,
iron
oxide
red,
iron
oxide
yellow,
cherry
flavour,
aspartame and magnesium stearate. Each 4-mg and 5-mg chewable tablet
contains the
following
inactive
ingredients:
mannitol,
microcrystalline
cellulose,
iron
oxide
red,
croscarmellose sodium, cherry flavour, aspartame, and magnesium
stearate.
Page 2 of 23
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
(CysLT1) receptor is found in the human airway (including airway

                                
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