SYNERRV DESLORATADINE 5 (DESLORATADINE TABLETS 5MG)

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

DESLORATADINE

Disponibil de la:

SYNERRV SDN BHD

INN (nume internaţional):

DESLORATADINE

Unități în pachet:

10 x 10 Tablets; 5 x 10 Tablets; 1 x 10 Tablets

Produs de:

IND-SWIFT LIMITED

Prospect

_Consumer Medication Information Leaflet (RiMUP) _
SYNERRV DESLORATADINE 5
Desloratadine Tablets 5mg
1
WHAT IS IN THIS LEAFLET
1.
What
_SYNERRV _
_DESLORATADINE _
is used for
_2._
_ _
How
_SYNERRV _
_DESLORATADINE _
works
_ _
_3._
_ _
Before you use
_SYNERRV _
_DESLORATADINE _
_4._
_ _
How to use
_SYNERRV _
_DESLORATADINE _
_5._
_ _
While you are using
_SYNERRV DESLORATADINE _
6.
Side effects
7.
Storage and Disposal of
_SYNERRV DESLORATADINE _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT _SYNERRV _
_DESLORATADINE _IS USED FOR
_SYNERRV DESLORATADINE _
relieves symptoms associated
with 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.
_SYNERRV DESLORATADINE _
is
also used to relieve the symptoms
associated with urticaria (a skin
condition caused by an allergy).
These symptoms include itching
and hives.
Relief of these symptoms lasts a
full day and helps you to resume
your normal daily activities and
sleep.
HOW _SYNERRV _
_DESLORATADINE _WORKS
_SYNERRV DESLORATADINE _
is
an antiallergy medicine that does
not make you drowsy. It helps
control your allergic reaction and
its symptoms.
BEFORE YOU USE _SYNERRV _
_DESLORATADINE _
_-_
_ _
_When you must not use it _
•
Do not use
_SYNERRV _
_DESLORATADINE _
if you are
allergic (hypersensitive) to
desloratadine, to any of the other
ingredients of
_SYNERRV _
_DESLORATADINE _
or to
loratadine.
_-_
_ _
_Before you start to use it _
_-_
_ _
Talk to your doctor or
pharmacist before taking
_SYNERRV DESLORATADINE _
if
you have medical or familial
history of seizures.
Efficacy and safety of
_SYNERRV _
_DESLORATADINE _
in children
under 12 years of age have not
been established.
_Pregnancy and breast-feeding _
•
Ask your doctor or pharmacist
for advice before taking any
medicine during pregnancy and
breast-feeding.
•
If you are pregnant or nursing a
baby,

Caracteristicilor produsului

SYNERRV DESLORATADINE 5
Desloratadine Tablets 5mg
COMPOSITION:
Each film coated tablet contains:
Desloratadine
5mg
Colours:
Indigo Carmine and Titanium Dioxide
Excipients
q.s.
PRESENTATION:
Light blue colored, round shaped, biconvex, film coated tablets with
both
sides plain.
PROPERTIES:
Desloratadine is used as antihistaminic, to be administered orally.
The chemical name of
Desloratadine
is
8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta
[1,2-
b]pyridine Its emperical formula is C
19
H
19
ClN
2
and molecular weight is 310.8. Structural
formula is as shown:
CLINICAL PHARMACOLOGY :
PHARMACODYNAMICS :
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. 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 AND DRUG METABOLISM:
ABSORPTION
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.
DISTRIBUTION
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
There is no evidence of
clinically relevant medicine accumulatio