CLARITIN SYRUP 1MG/ML

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

LORATADINE

Beszerezhető a:

SCHERING-PLOUGH CANADA INC

ATC-kód:

R06AX13

INN (nemzetközi neve):

LORATADINE

Adagolás:

1MG

Gyógyszerészeti forma:

SYRUP

Összetétel:

LORATADINE 1MG

Az alkalmazás módja:

ORAL

db csomag:

100ML

Recept típusa:

OTC

Terápiás terület:

SECOND GENERATION ANTIHISTAMINES

Termék összefoglaló:

Active ingredient group (AIG) number: 0120416002; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2012-07-24

Termékjellemzők

PRODUCT MONOGRAPH
CLARITIN*
(loratadine)
10 mg Tablets
10 mg Rapid Dissolve Tongue Tablets
1 mg/mL Syrup
Histamine H
1
receptor antagonist
Schering Canada Inc.
DATE OF PREPARATION
3535 Trans-Canada
March 2, 1993
Pointe-Claire, Quebec
DATE OF LATEST REVISION_:_
H9R 1B4
July 26, 2004
CONTROL # 090899
*Reg. T.M. of Schering Canada Inc.
PRODUCT MONOGRAPH
NAME OF DRUG
CLARITIN*
(loratadine)
Tablets - 10 mg
Rapid Dissolve Tongue Tablets - 10 mg
Syrup - 1 mg/mL
THERAPEUTIC CLASSIFICATION
Histamine H
1
receptor antagonist
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. 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-1/2) ranged from 7.8-11.0 hours.
Descarboethoxyloratadine, 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-1/2
ranged from 17 to 24
2
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-1/2 at
steady
state
levels
for
loratadine
and
its
metabolite
were
14.4
and
18.7
hours,
respectively, similar to that reported following a single oral dose.
The confidence intervals for Cmax and AUC(I) are within the 80-125%
range indicating
that the CLARITIN* Rapid Dissolve Tongue Tablets were bioe