DESTACURE (Desloratadine Syrup 2.5mg5ml)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DESLORATADINE

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

DESLORATADINE

Unit dalam pakej:

1 X 60 ml

Dikeluarkan oleh:

GRACURE PHARMACEUTICALS LTD.

Risalah maklumat

DESTACURE
Desloratadine Syrup 2.5mg/5ml
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What
_Destacure Syrup _
is used
for
2.
How
_Destacure Syrup _
works
_3._
_ _
Before you use
_Destacure Syrup _
_4._
_ _
How to use
_Destacure Syrup _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Destacure Syrup _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _DESTACURE SYRUP _USED FOR
_Destacure Syrup _
is indicated for the
rapid relief of symptoms associated
with allergic rhinitis, such as
sneezing, nasal discharge and
itching, congestion/stuffiness, as well
as ocular itching, tearing and redness.
_Destacure Syrup _
is also indicated for
the relief of symptoms associated
with urticarial such as the relief of
itching and the size and number of
hives.
HOW _DESTACURE SYRUP _WORKS
_Destacure Syrup _
contains
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 anti-
allergic 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.
BEFORE YOU USE _DESTACURE SYRUP _
-
_When you must not use it _
•
If you have an allergy to
desloratadine, loratadine or any
other ingredients of this product.
•
If you have poor kidney
function.
•
In children under one year of
age.
•
If you are pregnant; trying to get
pregnant or think you may be
pregnant.
•
If you are breast-feeding.
-
_Before you start to use it _
_ _
Please make sure you have
understood the explanation g

Ciri produk

For the use only of a registered Medical Practitioner or a Hospital or
a Laboratory
DESTACURE
(DESLORATADINE SYRUP 2.5MG/5ML)
COMPOSITION:
Each 5ml contains:
Desloratadine 2.5mg
DESCRIPTION:
Destacure is orange coloured syrupy liquid. It contains Desloratadine
as active ingredient and Sucrose, Glycerol,
Propylene Glycol, Disodium Edetate, Citric Acid Monohydrate, Color
Sunset Yellow Supra, Sodium Benzoate,
Sodium Citrate, Ess. Mix Fruit and Purified Water as excipients.
PHARMACODYNAMICS / PHARMACOKINETICS:
_PHARMACODYNAMIC PROPERTIES:_
Pharmacotherapeutic group: antihistamines – H1 antagonist,
ATC code: R06A X27
_Mechanism of action_
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.
_PHARMACOKINETIC PROPERTIES:_
_Absorption:_
From already published literature it is concluded that desloratadine
plasma concentrations can be detected within 30
minutes of desloratadine administration in adults and adolescents.
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.
_Distribution:_
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
There is no evidence of clinical