FAMOTIDINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FAMOTIDINE

Available from:

SANIS HEALTH INC

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:

APPROVED

Authorization date:

2023-04-19

Summary of Product characteristics

Page 1 of 30
PRODUCT MONOGRAPH
PR
FAMOTIDINE
Famotidine Tablets
20 mg and 40 mg
USP
Histamine H
2
Receptor Antagonist
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
APR 19, 2023
Submission Control Number: 273498
Page 2 of 30
PRODUCT MONOGRAPH
Pr
FAMOTIDINE
Famotidine Tablets
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 single dose, two-way crossover comparative bioavailability study of
FAMOTIDINE 40
mg tablets (Sanis Health Inc.) with PEPCID
®
40 mg tablets (Merck, Sharp & Dohme,
Canada) was conducted in healthy, adult, male subjects under fasting
conditions.
Comparative bioavailability data from 24 subjects that were included
in the statistical
analysis are presented in the following table:
Page 3 of 30
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
Famotidine
(1 x 40 mg)
Geometric Mean
Arithmetic Mean (CV%)
Parameter
Test
1
Reference
2
% Ratio of
Geometric Means
90% Confidence
Interval
AUC
T
(ng
·
h/mL)
760.0
804.4 (30)
691.5
751.1 (41)
110
98 - 124
AUC
I
(ng
·
h/mL)
811.9
858.6 (31)
749.2
828.9 (51)
108
96 - 122
C
max
(ng/mL)
133.9
142.0 (32)
121.3
127.0 (30)
110
99 - 123
T
max
3
(h)
2.4 (35)
2.6 (36)
T
1/2
3
(h)
4.09 (74)
4.26 (92)
1
FAMOTIDINE (famotidine) tablets, 40 mg (Sanis Health Inc.)
2
PEPCID
®
(famotidine) tablets, 40 mg (Merck, Sharp & Dohme, Canada)
3
Expressed as the arithmetic mean (CV%) only
A single dose, two-way crossover comparative bioavailability study of
FAMOTIDINE 20
mg tablets (Sanis Health Inc.) with PEPCID
®
20 mg tablets (Merck, Sharp & Dohme,
Canada) was conducted in healthy, adult, male subjects under fasting
conditions.
Comparat