BCI FAMOTIDINE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FAMOTIDINE

Dostupné z:

BAKER CUMMINS INC

ATC kód:

A02BA03

INN (Medzinárodný Name):

FAMOTIDINE

Dávkovanie:

40MG

Forma lieku:

TABLET

Zloženie:

FAMOTIDINE 40MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

HISTAMINE H2-ANTAGONISTS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2017-08-30

Súhrn charakteristických

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;