BCI FAMOTIDINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FAMOTIDINE

Disponibil de la:

BAKER CUMMINS INC

Codul ATC:

A02BA03

INN (nume internaţional):

FAMOTIDINE

Dozare:

40MG

Forma farmaceutică:

TABLET

Compoziție:

FAMOTIDINE 40MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HISTAMINE H2-ANTAGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2017-08-30

Caracteristicilor produsului

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;