PEDIAIR (Montelukast Granules BP 4mg)

Страна: Малайзия

Език: английски

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

Активна съставка:

MONTELUKAST SODIUM

Предлага се от:

UNIMED SDN BHD

INN (Международно Name):

MONTELUKAST SODIUM

Броя в опаковка:

28 Sachets

Произведено от:

XL Laboratories Pvt. Ltd.

Листовка

PEDIAIR
_Consumer Medication Information Leaflet (RiMUP)_
Montelukast Granules BP 4mg
1
WHAT IS IN THIS LEAFLET
1.
What
_PEDIAIR_
is used for
2.
How
_PEDIAIR_
works
3.
Before you use
_PEDIAIR_
4.
How to use
_PEDIAIR_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_PEDIAIR_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _PEDIAIR _USED FOR
Your doctor has given to you or your
child
_PEDIAIR _
to treat:
•
Asthma, including preventing
your asthma symptoms during
the day and night.
•
Allergic rhinitis (seasonal),
including relieving daytime and
night time symptoms: nasal
congestion, runny nose, nasal
itching, and sneezing; nasal
congestion upon awakening,
difficulty going to sleep, and
night time awakenings; tearing,
itchy, red, and puffy eyes.
HOW _PEDIAIR_ WORKS
_PEDIAIR_
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).
BEFORE YOU USE _PEDIAIR _
-
_When you must not use it_
Do not take
_PEDIAIR _
if you or your
child
_ _
has allergic to the ingredients
of this product.
-
_Before you start to use it_
Please make sure you have
understood the explanation given by
your doctor or pharmacist before
taking this medicine. Speak to your
doctor /pharmacist if you or your
child have any other health related
problems.
_Pregnancy and Lactation _
_Pregnancy:_
Women who are
pregnant or intend to become
pregnant should consult their doctor
before taking montelukast.
_Lactation:_
It is not known if
montelukast appears in breast milk.
You should consult your doctor
before taking montelukast if you are
breast-feeding or intend to breast-
feed.
-
_Taking other medications_
Tell your doctor if you or your child
are taking any other medicines,
including any that y

Данни за продукта

Size : 165x120 mm
FORMULATION:
Each Sachet (1g) Contains:
Montelukast Sodium USP 4.16 mg
Eq. to Montelukast 4 mg
PRODUCT DESCRIPTION:
White to off-white granular powder.
PHARMACODYNAMICS/ PHARMACOKINETICS
PHARMACOTHERAPEUTIC GROUP
:
Leukotriene receptor antagonists
ATC-CODE:
R03D C03
MECHANISM OF ACTION
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory
eicosanoids released from various
cells including mast cells and eosinophils. These important
pro-asthmatic mediators bind to cysteinyl
leukotriene
receptors
(CysLT)
found
in
the
human
airway
and
cause
airway
actions,
including
bronchoconstriction, mucous secretion, vascular permeability, and
eosinophil recruitment.
PHARMACODYNAMIC EFFECTS
Montelukast is an orally active compound, which binds with high
affinity and selectivity to the CysLT1
receptor.
PHARMACOKINETICS
_ABSORPTION:_
Montelukast is rapidly and nearly completely absorbed following oral
administration. The
mean oral bioavailability is 64%. The oral bioavailability and Cmax
are not influenced by a standard meal.
_DISTRIBUTION:_
Montelukast is more than 99% bound to plasma proteins. The
steady-state volume of
distribution of montelukast averages 8 to 11 liters.
_METABOLISM:_
Montelukast is extensively metabolized in the liver by cytochrome P450
isoenzymes
CYP3A4 and CYP2C9. Therapeutic plasma concentrations of montelukast do
not inhibit cytochromes
P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.
_ELIMINATION:_
Montelukast and its metabolites are excreted principally in the faeces
via the bile. Elimination
Half-life: 2.7 to 5 hours.
INDICATION:
● For the prophylaxis and chronic treatment of asthma in adults and
pediatric patients 12
months of age and older.
● Indicated in adults and pediatric patients 2 years of age and
older for the relief of daytime and
nighttime symptoms of seasonal allergic rhinitis
RECOMMENDED DOSAGE:
● Montelukast should be taken once daily. For asthma, the dose
should be taken in the evening. For allergic
rhinitis, the time of administration may be individualized to