MONTELUKAST GH montelukast (as sodium) 5 mg chewable tablet blister pack
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
उत्पाद विशेषताएं
(SPC)
01-12-2017
सार्वजनिक आकलन रिपोर्ट
(PAR)
28-11-2017
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
montelukast sodium
थमां उपलब्ध:
Torrent Australasia Pty Ltd
INN (इंटरनेशनल नाम):
montelukast sodium
प्राधिकरण का दर्जा:
Registered
उत्पाद विशेषताएं
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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