BCI FAMOTIDINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FAMOTIDINE

Доступно од:

BAKER CUMMINS INC

АТЦ код:

A02BA03

INN (Међународно име):

FAMOTIDINE

Дозирање:

40MG

Фармацеутски облик:

TABLET

Састав:

FAMOTIDINE 40MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

HISTAMINE H2-ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0118722002; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2017-08-30

Карактеристике производа

PRODUCT MONOGRAPH
BCI FAMOTIDINE TABLETS
(FAMOTIDINE TABLETS, USP)
20 MG AND 40 MG
THERAPEUTIC CLASSIFICATION
HISTAMINE H
2 RECEPTOR ANTAGONIST
MANUFACTURER:
IVAX PHARMACEUTICALS, INC.
DATE OF PREPARATION:
4400 BISCAYNE BLVD.,
AUGUST 13, 2004
MIAMI, FLORIDA 33137
USA
DISTRIBUTED BY:
BAKER CUMMINS, INC.
1 PLACE VILLE-MARIE, SUITE 3900
MONTREAL, QUEBEC, CANADA
H3B 4M7
CONTROL#: 093338
1
PRODUCT MONOGRAPH
BCI FAMOTIDINE TABLETS
(FAMOTIDINE TABLETS, USP)
20 MG AND 40 MG
THERAPEUTIC CLASSIFICATION
HISTAMINE H
2 RECEPTOR ANTAGONIST
ACTION AND CLINICAL PHARMACOLOGY
Famotidine is a competitive inhibitor of histamine H
2
-receptors. The primary clinically
important pharmacologic activity of famotidine is inhibition of
gastric juice secretion.
Famotidine reduces the acid and pepsin content, as well as the volume
of basal,
nocturnal, and stimulated gastric secretion.
COMPARATIVE BIOAVAILABILITY STUDIES
A comparative bioavailability study was performed under fasting
conditions using
healthy human volunteers. The rate and extent of absorption of
famotidine after a single
oral 40 mg dose of BCI Famotidine 40 mg tablets or Pepcid® 40 mg
tablets was
measured and compared. A summary of the pharmacokinetic parameters is
given in the
table on the following page:
2
Famotidine
(1 x 40 mg)
From measured data
Geometric Mean
Arithmetic Mean (CV%)
PARAMETER
TEST
BCI FAMOTIDINE
TABLETS
REFERENCE
PEPCID®
†
% RATIO OF
GEOMETRIC
MEANS
CONFIDENCE
INTERVAL
AUC
T
(ng.h/mL)
906.1
939.5 (27.4)
855.61
892.8 (30.5)
106
(98, 114)
AUC
I
(ng.h/mL)
927.03
961.8 (27.7)
874.04
911.6 (30.4)
106
(98.3, 114)
C
MAX
(ng/mL)
138.20
144.2 (29.2)
131.71
137.96 (31.6)
105
(95.8, 115)
T
MAX
*
(h)
2.7 (43.5)
2.65 (37.8)
T
½
*
(h)
4.38 (20.52)
4.43 (17.18)
†
Pepcid® is manufactured by Merck Frosst Canada and Company. Pepcid®
was purchased in Canada.
INDICATIONS AND CLINICAL USE
BCI Famotidine Tablets are indicated in the treatment of the following
conditions where
a controlled reduction of gastric secretion is required:
1.
Treatment of acute duodenal ulcer;