FAMOTIDINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FAMOTIDINE

Saatavilla:

SANIS HEALTH INC

ATC-koodi:

A02BA03

INN (Kansainvälinen yleisnimi):

FAMOTIDINE

Annos:

20MG

Lääkemuoto:

TABLET

Koostumus:

FAMOTIDINE 20MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HISTAMINE H2-ANTAGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0118722001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-04-19

Valmisteyhteenveto

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