Avorius 5mg Tablet

Land: Maleisië

Taal: Engels

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

Werkstoffen:

DESLORATADINE

Beschikbaar vanaf:

APEX PHARMACY MARKETING SDN. BHD.

INN (Algemene Internationale Benaming):

DESLORATADINE

Eenheden in pakket:

1x10tablet Tablets; 3X10tablet Tablets

Geproduceerd door:

IND-SWIFT LIMITED

Bijsluiter

_Consumer Medication Information Leaflet (RiMUP) _
_ _
AVORIUS 5MG TABLET
DESLORATADINE 5MG
1
WHAT IS IN THIS LEAFLET
1.
What Avorius is used
for
2.
How it works
3.
Before you use
Avorius
4.
How to use Avorius
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Avorius
8.
Product Description
9.
Manufacturer
10.
Product Registration
Holder
11.
Date of Revision
WHAT AVORIUS IS USED FOR
Avorius is used for the rapid
relief
of
symptoms
associated
with
seasonal
allergic
rhinitis
(inflammation of the nasal
passages
caused
by
an
allergy,
for
example,
hay
fever
or
allergy
to
dust
mites).
These
symptoms
include sneezing, runny or
itchy nose, itchy palate, and
itchy, red or watery eyes.
Avorius
is
also
used
to
relieve
the
symptoms
associated with urticaria (a
skin condition caused by an
allergy).
These
symptoms
include itching and hives.
HOW IT WORKS
Avorius
is
an
antiallergy
medicine that does not make
you drowsy. It helps control
your allergic reaction and its
symptoms.
BEFORE YOU USE AVORIUS
When you must not use it
Do not use Avorius if you
are allergic (hypersensitive)
to desloratadine, to any of
the
other
ingredients
of
Avorius or to loratadine.
Before you start to use it
Efficacy
and
safety
of
Avorius Tablets in children
under 12 years of age have
not been established.
The use of desloratadine is
not recommended in breast-
feeding women and during
pregnancy.
Talk
to
your
doctor,
pharmacist or nurse before
taking desloratadine if you
have
medical
or
familial
history of seizures.
Taking other medicines
Tell your doctor if you are
taking any other medicines,
including any that you buy
without a prescription from
a pharmacy, supermarket or
health food shop.
HOW TO USE AVORIUS
How much to use
Adults and adolescents (12
years of age and over):
_ _
one
tablet once a day.
When to use it
Swallow
the
tablet
whole
with water, with or without
food.
How long to use it
Continue
taking
your
medicine for as long as your
doctor tells you.
Do not stop taking it unless
your doctor tells you to -
even if you feel bette

Productkenmerken

COMPOSITION
Desloratadine………………………………………………………………………
5mg
PRODUCT DESCRIPTION
Light blue colored, round shaped, biconvex, film coated tablets with
both side plain.
PHARMACODYNAMICS
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code:
R06A X27
Desloratadine
is
a
non-sedating,
long-acting
histamine
antagonist
with
selective
peripheral H1-receptor antagonist activity. After oral administration,
desloratadine
selectively
blocks
peripheral
histamine
H1-receptors
because
the
substance
is
excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from
_in vitro _
studies. These
include inhibiting the release of proinflammatory cytokines such as
IL-4, IL-6, IL-8,
and IL-13 from human mast cells/basophils, as well as inhibition of
the expression of
the adhesion molecule P-selectin on endothelial cells. The clinical
relevance of these
observations remains to be confirmed.
PHARMACOKINETICS
Desloratadine
plasma
concentrations
can
be
detected
within
30
minutes
of
administration. Desloratadine is well absorbed with maximum
concentration achieved
after approximately 3 hours; the terminal phase half-life is
approximately 27 hours.
The
degree
of
accumulation
of
desloratadine
was
consistent
with
its
half-life
(approximately 27 hours) and a once daily dosing frequency. The
bioavailability of
desloratadine was dose proportional over the range of 5 mg to 20 mg.
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
There is no
evidence of clinically relevant medicine accumulation following once
daily dosing of
desloratadine (5 mg to 20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not
been identified
yet, and therefore, some interactions with other medicinal products
can not be fully
excluded. Desloratadine does not inhibit CYP3A4
_in vivo, _
and
_in vitro _
studies have
shown that the medicinal product does not inhibit CYP2D6 and is
neither a s