CLARITYN-D 24HOUR EXTENDED RELEASE TABLET

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LORATADINE; PSEUDOEPHEDRINE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

R01BA52

Dosage:

10 mg

Pharmaceutical form:

TABLET, SUGAR COATED

Composition:

LORATADINE 10 mg; PSEUDOEPHEDRINE 240 mg

Administration route:

ORAL

Prescription type:

Pharmacy Only

Manufactured by:

SAG Manufacturing S.L.U.

Authorization status:

ACTIVE

Authorization date:

2003-04-01

Patient Information leaflet

Brand of loratadine and pseudoephedrine sulfate
Extended-Release, Non-Sedating Antihistamine / Decongestant Tablets
DESCRIPTION
Each Clarityn-D
®
24 Hour Extended Release Tablet contains 10 mg loratadine and 240 mg
pseudoephedrine sulfate.
The loratadine component is released immediately, whereas the
pseudoephedrine component is released slowly from the core
allowing for once daily administration.
Excipients: Hydroxypropyl Methylcellulose, Ethylcellulose, Calcium
Hydrogen Phosphate, Polyvidone, Silicon Dioxide,
Magnesium Stearate, Hydroxypropyl Methylcellulose, Polyethylene
Glycol, White Color Dispersion and Macrogol 400.
ACTIONS
Loratadine
Loratadine is a potent long-acting tri-cyclic antihistamine with
selective peripheral H
1
-receptor antagonistic activity.
Pseudoephedrine
Pseudoephedrine sulfate, one of the naturally occurring alkaloids of
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 on the sympathetic nerves.
The combination of loratadine and pseudoephedrine sulfate controls
histamine mediated symptoms and relieves the nasal
congestion associated with allergic rhinitis and the common cold.
PHARMACODYNAMIC PROPERTIES
Loratadine
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 syste