LIBERATOR TABLET (EXTENDED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LORATADINE; PSEUDOEPHEDRINE SULFATE

Διαθέσιμο από:

SCHERING-PLOUGH CANADA INC

Φαρμακολογική κατηγορία (ATC):

R01BA52

INN (Διεθνής Όνομα):

PSEUDOEPHEDRINE, COMBINATIONS

Δοσολογία:

10MG; 240MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

Σύνθεση:

LORATADINE 10MG; PSEUDOEPHEDRINE SULFATE 240MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

5/10

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

SECOND GENERATION ANTIHISTAMINES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2012-07-24

Αρχείο Π.Χ.Π.

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