LIBERATOR TABLET (EXTENDED-RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LORATADINE; PSEUDOEPHEDRINE SULFATE

Disponible desde:

SCHERING-PLOUGH CANADA INC

Código ATC:

R01BA52

Designación común internacional (DCI):

PSEUDOEPHEDRINE, COMBINATIONS

Dosis:

10MG; 240MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

LORATADINE 10MG; PSEUDOEPHEDRINE SULFATE 240MG

Vía de administración:

ORAL

Unidades en paquete:

5/10

tipo de receta:

OTC

Área terapéutica:

SECOND GENERATION ANTIHISTAMINES

Resumen del producto:

Active ingredient group (AIG) number: 0245861001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2012-07-24

Ficha técnica

PRODUCT MONOGRAPH
LIBERATOR*
Extended Release Caplets
(loratadine 10 mg/pseudoephedrine sulfate 240 mg)
Histamine H
1
receptor antagonist/Sympathomimetic amine
Schering Canada Inc.
DATE OF PREPARATION
3535 Trans-Canada
October 6, 1999
Pointe-Claire, Quebec
Revised
H9R 1B4
July 21, 2004
Control # 090901 & 091736
* Reg. T.M. of Schering Canada Inc.
2
PRODUCT MONOGRAPH
NAME OF DRUG
LIBERATOR
Extended Release Caplets
(loratadine 10mg/pseudoephedrine sulfate USP 240mg)
THERAPEUTIC CLASSIFICATION
Histamine H
1
receptor antagonist/Sympathomimetic Amine
ACTIONS AND CLINICAL PHARMACOLOGY
Loratadine is a long-acting tricyclic antihistamine with selective
peripheral H
1
receptor antagonistic
activity. It exhibits a dose-related inhibition of the
histamine-induced skin wheal and flare response
in humans which is rapid in onset, is apparent at two hours and
persists throughout the 24 hour
observation period (Roman et al. 1986). Single oral doses up to 160 mg
and repeat daily doses of
40 mg for up to 13 weeks were well tolerated with the incidence of
sedation and dry mouth being
no different from placebo.
14
C-loratadine is rapidly absorbed reaching Cmax values (4.7, 10.8 and
26.1_ng/mL) at 1.5, 1.0 and
1.3 hours for the 10, 20 and 40 mg dose, respectively. The loratadine
elimination half-life (T-1/2ß)
ranged from 7.8-11.0 hours.
Descarboethoxy-loratadine, the major active metabolite, reached Cmax
values (4.0, 9.9 and 16.0
ng/mL) at 3.7, 1.5 and 2.0 hours after a dose of 10, 20 and 40 mg,
respectively. Its T-1/2ß ranged
from 17 to 24 hours. The accumulation indices, calculated by Cmax and
the area under the curve
(AUC) ratios did not change after the 5th day, indicating little or no
accumulation of either
loratadine or its metabolite after a multiple once per day dosage
regimen. The T-1/2ß at steady state
levels for loratadine and its active metabolite were 14.4 and 18.7
hours, respectively, similar to that
reported following a single oral dose (Hilbert et al. 1987).
3
Approximately 82% of the
14
C-loratadine dose is excret