FAMOTIDINE TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FAMOTIDINE

Available from:

IVAX PHARMACEUTICALS INCORPORATED

ATC code:

A02BA03

INN (International Name):

FAMOTIDINE

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

FAMOTIDINE 40MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2018-07-24

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
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.,
NOVEMBER 3, 2003
MIAMI, FLORIDA, USA
33137
CONTROL # 080642
DISTRIBUTED BY:
IVAX PHARMACEUTICALS CANADA INC.
1 PLACE VILLE-MARIE, SUITE 3900
MONTREAL, QUEBEC, CANADA
H3B 4M7
1
PRODUCT MONOGRAPH
PR
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 IVAX 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
IVAX 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
Famotidine tablets are indicated in the treatment of the following
conditions where a
controlled reduction of gastric secretion is required:
1.
Treatment of acute duoden