AERIUS ORAL SOLUTION 0.5 mgml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Desloratadine, micronized

Disponível em:

ORGANON SINGAPORE PTE. LTD.

Código ATC:

R06AX27

Dosagem:

0.5 mg/ml

Forma farmacêutica:

SOLUTION

Composição:

Desloratadine, micronized 0.5 mg/mL

Via de administração:

ORAL

Tipo de prescrição:

Prescription Only

Fabricado por:

Organon Heist bv

Status de autorização:

ACTIVE

Data de autorização:

2004-04-05

Folheto informativo - Bula

 
1 

AERIUS
®
 SYRUP  
Brand of desloratadine 

DESCRIPTION:  Each 1 ml of AERIUS
®
 Syrup contains 0.5 mg of desloratadine. AERIUS
®
 Syrup is a clear, 
orange solution.  Inactive Ingredients:  propylene glycol, sorbitol
liquid, citric acid anhydrous, sodium citrate 
dihydrate, sodium benzoate, disodium edetate, sucrose, natural and
artificial flavor, FD&C Yellow Dye No. 6 
and purified water. Preservative: sodium benzoate 1.00 mg/ml. 

ACTIONS:  Desloratadine is a non-sedating long-acting histamine
antagonist with potent, selective peripheral 
H
1
-receptor antagonist activity. Desloratadine has demonstrated
antiallergic, antihistaminic, and anti-
inflammatory activity. 

In addition to antihistaminic activity, desloratadine
has demonstrated antiallergic and anti-inflammatory activity 
from numerous _in vitro_ (mainly conducted on cells of human origin)
and _in vivo_ studies. These studies have 
shown that desloratadine inhibits the broad cascade of events that
initiate and propagatE allergic inflammation, 
including, 

• 
the release of proinflammatory cytokines including IL-4, IL-6, IL-8,
IL-13,  
• 
the release of important proinflammatory chemokines such as RANTES
(Regulated upon Activation, 
Normal T-cell Expressed and Secreted),  
• 
superoxide anion production by activated polymorphonuclear
neutrophils,  
• 
eosinophil adhesion and chemotaxis, 
• 
the expression of the adhesion molecules such as P-selectin, 
• 
IgE-dependent release of histamine, prostaglandin (PGD2), and
leukotriene (LTC4), 
• 
the acute allergic bronchoconstrictor response and allergic cough in
animal models. 

PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite
of loratadine. Non-clinical studies 
conducted with desloratadine and loratadine demonstrated that there
are no qualitative or quantitative 
differences in the toxicity profile of desloratadine and loratadine at
comparable levels of exposure to 
desloratadine. 

No

Características técnicas

S-CCDS-MK4117-MTL-112017
AERIUS® Syrup and Oral Solution
Brand of desloratadine
DESCRIPTION for AERIUS® Syrup: Each 1 ml of AERIUS® Syrup contains
0.5 mg of desloratadine. AERIUS®
Syrup is a clear, orange solution. Inactive Ingredients: propylene
glycol, sorbitol liquid, citric acid anhydrous,
sodium citrate dihydrate, sodium benzoate, disodium edetate, sucrose,
natural and artificial flavor, FD&C Yellow
Dye No. 6 and purified water. Preservative: sodium benzoate 1.00
mg/ml.
DESCRIPTION for Oral Solution: Each 1 ml of AERIUS® Oral Solution
contains 0.5 mg of desloratadine.
AERIUS® Oral Solution is a clear solution. Inactive Ingredients:
propylene glycol, sorbitol liquid, citric acid
anhydrous, sodium citrate dihydrate, disodium edetate, hypromellose,
sucralose, natural and artificial flavor, and
purified water.
ACTIONS: Desloratadine is a non-sedating long-acting histamine
antagonist with potent, selective peripheral H
1
-
receptor antagonist activity. Desloratadine has demonstrated
antiallergic, antihistaminic, and anti-inflammatory
activity.
In addition to antihistaminic activity, desloratadine has demonstrated
antiallergic and anti-inflammatory activity
from numerous
in vitro
(mainly conducted on cells of human origin) and
in vivo
studies. These studies have
shown that desloratadine inhibits the broad cascade of events that
initiate and propagate allergic inflammation,
including,
•
the release of proinflammatory cytokines including IL-4, IL-6, IL-8,
IL-13,
•
the release of important proinflammatory chemokines such as RANTES
(Regulated upon Activation,
Normal T-cell Expressed and Secreted),
•
superoxide anion production by activated polymorphonuclear
neutrophils,
•
eosinophil adhesion and chemotaxis,
•
the expression of the adhesion molecules such as P-selectin,
•
IgE-dependent release of histamine, prostaglandin (PGD2), and
leukotriene (LTC4),
•
the acute allergic bronchoconstrictor response and allergic cough in
animal models.
PRECLINICAL TOXICOLOGY: Desloratadine is the primary active met