AERIUS

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

DESLORATADINE

Available from:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (International Name):

DESLORATADINE

Dosage:

0.5 MG

Pharmaceutical form:

SIRUP

Units in package:

DUS, 1 BOTOL @ 60 ML

Manufactured by:

SCHERING-PLOUGH LABO NV - Belgium

Authorization date:

2021-08-24

Summary of Product characteristics

AERIUS
 SYRUP
Desloratadine
DESCRIPTION: Each 1 ml of syrup contains 0.5 mg of desloratadine.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: antihistamines – H
1
antagonist, ATC code : R06A X27
Desloratadine is a non-sedating, long acting histamine antagonist with
selective peripheral H
1
-
receptors antagonist activity. After oral administration desloratadine
selectively blocks peripheral
histamine H
1
-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.
Efficacy of Aerius syrup has not been investigated in separate
paediatric trials. Safety of Aerius
syrup was demonstrated in three-paediatric trials. Children ages 1
through 11 years of age who
were candidates for antihistamine therapy received a daily dose of
1.25 mg (1-5 years of age) and
2.5 mg (6 through 11 years of age). Treatment was well tolerated as
documented by clinical
laboratory
tests,
vital
signs,
and
ECG
interval
data,
including
QTc.
When
given
at
the
recommended doses, the plasma concentration of desloratadine (see
Pharmacokinetic properties)
was comparable in the paediatric and adult populations. Thus, since
the course of SAR/CIU and
the profile of desloratadine are similar in adults and paediatric
patients, desloratadine efficacy data
in adults can be extrapolated to the paediatric population.
In a multiple dose clinical trial, in adults and adolescents, in which
up to 20 mg of desloratadine
was administered daily for 14 days, no statistically or clinically
relevant cardiovascular effect was
observed. In a clinical pharmacology trial, in adults and adolescents,
in which desloratadine was
administered