SINGULAIR 4MG ORAL GRANULES

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

MONTELUKAST SODIUM

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

MONTELUKAST SODIUM

Unit dalam pakej:

7sachet (sample) Sachets; 28sachet Sachets

Dikeluarkan oleh:

Patheon Manufacturing Services LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SINGULAIR
®
Montelukast Sodium (4mg Oral Granules, 4mg Chewable Tablets, 5mg
Chewable Tablets, 10mg Film-Coated Tablets)
Copyright 2021 Organon group of companies. All rights reserved.
1
WHAT IS IN THIS LEAFLET
1.
What
_SINGULAIR _
is used for
2.
How
_SINGULAIR _
works
3.
Before you use
_SINGULAIR _
4.
How to use
_SINGULAIR _
5.
While you are using
_SINGULAIR _
6.
Side effects
7.
Storage and disposal of
_SINGULAIR _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _SINGULAIR _IS USED FOR
Your doctor has prescribed
_SINGULAIR _
(montelukast sodium)
to treat:
•
Asthma, including preventing
your asthma symptoms during the day
and night.
_SINGULAIR _
also prevents
the narrowing of airways triggered by
exercise.
•
Allergic rhinitis (seasonal and
perennial), including daytime and
nighttime symptoms: nasal congestion,
runny nose, nasal itching, and
sneezing; nasal congestion upon
awakening, difficulty going to sleep,
and nighttime awakenings; tearing,
itchy, red, and puffy eyes.
HOW _SINGULAIR _WORKS
_SINGULAIR _
is a leukotriene receptor
antagonist that blocks substances
called leukotrienes. Leukotrienes cause
narrowing and swelling of airways in
your lungs. Blocking leukotrienes
improves asthma symptoms and helps
prevent asthma attacks. Leukotrienes
also cause allergy symptoms. Blocking
leukotrienes improves allergic rhinitis
(seasonal and perennial, also known as
outdoor and indoor nasal allergies).
BEFORE YOU USE _SINGULAIR _
_ _
_-When you must not take it _
Do not take
_SINGULAIR _
if you or your
child
•
are allergic to any of its components.
_-Before you start to use it _
Tell your doctor (or health care
provider) about any medical problems
or allergies you or your child has now
or has had.
USE IN CHILDREN
For children 6 to 14 years old,
_SINGULAIR _
5-mg chewable tablets are
available.
For children 2 to 5 years old,
_SINGULAIR _
4-mg chewable tablets
WHAT IS ALLERGIC RHINITIS?
•
Seasonal allergic rhinitis

Ciri produk

Page 1 of 17
I. THERAPEUTIC CLASS
II. INDICATIONS
MECHANISM OF ACTION
III. DOSAGE AND ADMINISTRATION
LPC-OG0476-MF-052019-MALAYSIA
LOCAL PRODUCT CIRCULAR
TABLETS/CHEWABLE TABLETS/ORAL GRANULES
SINGULAIR
®
(MONTELUKAST SODIUM)
SINGULAIR
®
(montelukast sodium) is a selective and orally active leukotriene
receptor
antagonist that specifically inhibits the cysteinyl leukotriene CysLT
1
receptor.
For the prophylaxis and chronic treatment of asthma in adults and
pediatric patients 12 months
of age and older.
SINGULAIR is indicated in adults and pediatric patients 2 years of age
and older for the relief
of daytime and nighttime symptoms of seasonal allergic rhinitis.
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 has been shown to increase nasal
airway resistance and
symptoms of nasal obstruction.
Montelukast is a potent, orally active compound that significantly
improves parameters of
asthmatic inflammation. Based on biochemical and pharmacological
bioassays, it binds with
high affinity and selectivity to the CysLT
1
receptor (in preference to other pharmacologically
important airway receptors such as the prostanoid, cholinergic, or
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