CLARINASE SYRUP

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LORATADINE; PSEUDOEPHEDRINE SULPHATE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

R01BA52

Dosage:

5 mg/5 ml

Pharmaceutical form:

SYRUP

Composition:

LORATADINE 5 mg/5 ml; PSEUDOEPHEDRINE SULPHATE 60 mg/5 ml

Administration route:

ORAL

Prescription type:

Pharmacy Only

Manufactured by:

Sanofi-Aventis Argentina S.A.

Authorization status:

ACTIVE

Authorization date:

1999-03-24

Patient Information leaflet

S-000434-CLD-SY-MOWPI.1 
CLARINASE
®
 Syrup 
Brand of loratadine and pseudoephedrine sulfate 

This insert contains basic prescribing information only. 

Non-Sedating Antihistamine/Decongestant Syrup 

DESCRIPTION:  CLARINASE Syrup is clear yellowish syrup with a
characteristic peach odour and 
taste and free from foreign matter. Each 5 ml
of CLARINASE Syrup contains 5 mg loratadine and 60 
mg pseudoephedrine sulfate. Inactive ingredients: propylene glycol, sorbitol, sodium benzoate,
citric 
acid, sucrose, artificial flavor and purified water.
Preservative: Sodium benzoate 1 mg/ml. 

ACTION:  Loratadine is a potent long-acting
tricyclic antihistamine with selective peripheral H
1
-
receptor antagonistic activity. 

Pseudoephedrine sulfate, one of the naturally occurring
alkaloids of the _Ephedra  _and an orally 
administered vasoconstrictor, produces a gradual but sustained
decongestant effect facilitating 
shrinkage of congested
mucosa in upper respiratory areas. The mucuos membrane of the respiratory 
tract is decongested through the action of the
sympathetic nerves. 

PHARMACODYNAMIC PROPERTIES: During studies of
its effects on the CNS, loratadine has 
exhibited no depressant activity and no acute
anticholinergic activity. 

Loratadine has exhibited a very
low affinity for membrane receptors from the
cerebral cortex and does 
not readily penetrate into the CNS. Whole
body autoradiographic studies in rats and monkeys, 
radiolabeled tissue
distribution studies in mice and rats, and _in vivo _radioligand studies in
mice have 
shown that neither loratadine nor its metabolites readily
cross the blood-brain barrier. 

Radioligand binding studies with guinea pig pulmonary
and brain H1-receptors indicate that there was 
preferential binding to peripheral versus 

Summary of Product characteristics

Non-Sedating Antihistamine/Decongestant Syrup
DESCRIPTION: CLARINASE
®
Syrup is a clear yellowish syrup with a characteristic peach odour and
taste and free from foreign
matter. Each 5 ml of CLARINASE
®
Syrup contains 5 mg loratadine and 60 mg pseudoephedrine sulfate.
Inactive ingredients:
propylene glycol, sorbitol, sodium benzoate, citric acid, sucrose,
artificial flavor and purified water. Preservative: Sodium benzoate 1
mg/ml.
ACTION: Loratadine is a potent long-acting tricyclic antihistamine
with selective peripheral H1-receptor antagonistic activity.
Pseudoephedrine sulfate, one of the naturally occurring alkaloids of
the _Ephedra _and an orally administered vasoconstrictor,
produces a gradual but sustained decongestant effect facilitating
shrinkage of congested mucosa in upper respiratory areas. The
mucous membrane of the respiratory tract is decongested through the
action of the sympathetic nerves.
PHARMACODYNAMIC PROPERTIES: During studies of its effects on the CNS,
loratadine has exhibited no depressant activity and
no acute anticholinergic activity.
Loratadine has exhibited a very low affinity for membrane receptors
from the cerebral cortex and does not readily penetrate into the
CNS. Whole body autoradiographic studies in rats and monkeys,
radiolabeled tissue distribution studies in mice and rats, and _in
vivo _
radioligand studies in mice have shown that neither loratadine nor its
metabolites readily cross the blood-brain barrier.
Radioligand binding studies with guinea pig pulmonary and brain H
1
-receptors indicate that there was preferential binding to
peripheral versus central nervous system H
1
-receptors.
The sedation profile of loratadine, 10 mg daily, is comparable to that
of placebo and, during long term treatment, there were no
clinically significant changes in vital signs, laboratory test values,
physical examinations or electrocardiograms. In studies with
loratadine tablets at doses two to four times higher than the
recommended dose of 10 mg, a dose-related increase in the incidence
of