Aerius D-12 Modified Release Tablets 2.5mg120mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

(IR Layer) Desloratadine, Micronized; (SR Layer) Pseudoephedrine sulfate

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

R01BA52

Dosage:

2.5mg

Pharmaceutical form:

TABLET, DELAYED RELEASE

Composition:

(IR Layer) Desloratadine, Micronized 2.5mg; (SR Layer) Pseudoephedrine sulfate 120.0mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Patheon Inc., Whitby Operations

Authorization status:

ACTIVE

Authorization date:

2010-03-05

Patient Information leaflet

PACKAGE INSERT/PROFESSIONAL BROCHURE  

AERIUS
®
 D-12 Tablets  
Brand of desloratadine and pseudoephedrine sulphate  
Long-Acting, Non-sedating Antihistamine/Decongestant Tablets 

DESCRIPTION: 
Aerius D-12 Tablet is an oval bilayer uncoated, modified-release tablet with a blue layer and a white layer. The 
blue layer is embossed with "D12". The blue immediate release (IR) layer contains 2.5 mg of desloratadine and 
the white sustained release (SR) layer contains 120 mg of pseudoephedrine sulphate. 

Inactive Ingredients: hypromellose 2208, microcrystalline cellulose, povidone, magnesium stearate, silicon 
dioxide, corn starch, edetate sodium, citric acid, stearic acid, and Indigo Carmine E132 Aluminum Lake.  

ACTIONS: Desloratadine is a long acting tricyclic histamine antagonist with selective H1-receptor histamine 
antagonist activity. Receptor binding data indicates that at a concentration of 2 -  3 ng/ml (7 nanomolar), 
desloratadine shows significant interaction with the human histamine H1 receptor. Desloratadine has an 
antihistamine potency approximately 3.5 - 20 times greater than loratadine in vitro and 2.5 - 4 times greater 
than loratadine in animals. Desloratadine inhibited histamine release from human mast cells in vitro. Results of a 
radiolabeled tissue distribution study in rats and a radioligand H1-receptor binding study in guinea pigs showed 
that desloratadine did not readily cross the blood brain barrier.  

Pseudoephedrine sulphate is an orally active sympathomimetic amine
and exerts a decongestant action on the 
nasal mucosa. Pseudoephedrine sulphate
is recognized as an effective agent for the
relief of nasal congestion 
due to allergic rhinitis. Pseudoephedrine produces peripheral
effects similar to those of ephedrine and central 
effect

Summary of Product characteristics

S-CCDS-OG4117A-TBr-052023
AERIUS® D-12 Tablets
Brand of desloratadine and pseudoephedrine sulphate
Long-Acting, Non-sedating Antihistamine/Decongestant Tablets
DESCRIPTION:
AERIUS D-12 Tablet is an oval bilayer uncoated, modified-release
tablet with a blue layer and a white layer.
The blue layer is embossed with "D12". The blue immediate release (IR)
layer contains 2.5 mg of
desloratadine and the white sustained release (SR) layer contains 120
mg of pseudoephedrine sulphate.
Inactive Ingredients: hypromellose 2208, microcrystalline cellulose,
povidone, magnesium stearate, silicon
dioxide, corn starch, edetate sodium, citric acid, stearic acid, and
Indigo Carmine E132 Aluminum Lake.
ACTIONS: Desloratadine is a long acting tricyclic histamine antagonist
with selective H1-receptor histamine
antagonist activity. Receptor binding data indicates that at a
concentration of 2 – 3 ng/ml (7 nanomolar),
desloratadine shows significant interaction with the human histamine
H1 receptor. Desloratadine has an
antihistamine potency approximately 3.5 - 20 times greater than
loratadine
in vitro
and 2.5 - 4 times greater
than loratadine in animals. Desloratadine inhibited histamine release
from human mast cells
in vitro
. Results
of a radiolabeled tissue distribution study in rats and a radioligand
H1-receptor binding study in guinea pigs
showed that desloratadine did not readily cross the blood brain
barrier.
Pseudoephedrine sulphate is an orally active sympathomimetic amine and
exerts a decongestant action
on the nasal mucosa. Pseudoephedrine sulphate is recognized as an
effective agent for the relief of nasal
congestion due to allergic rhinitis. Pseudoephedrine produces
peripheral effects similar to those of
ephedrine and central effects similar to, but less intense than,
amphetamines. It has the potential for
excitatory side effects.
CLINICAL PHARMACOLOGY:
Pharmacodynamic Properties:
Wheal and Flare: Human histamine skin wheal studies following single
and repeated 5 mg doses of
desloratadine have shown that the drug exhibits