MINT-FAMOTIDINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FAMOTIDINE

Tilgjengelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

A02BA03

INN (International Name):

FAMOTIDINE

Dosering :

20MG

Legemiddelform:

TABLET

Sammensetning:

FAMOTIDINE 20MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2023-06-23

Preparatomtale

Page 1 of 26
PRODUCT MONOGRAPH
PR
MINT-
FAMOTIDINE
Famotidine Tablets 20 mg and 40 mg
USP
Histamine H
2
Receptor Antagonist
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Revision:
June 7, 2023
Submission Control Number: 267823
Page 2 of 26
PRODUCT MONOGRAPH
Pr
MINT-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 double-blind, randomized, two-treatment, single-dose, crossover oral
bioequivalence study of
MINT-FAMOTIDINE 40 mg tablets (Mint Pharmaceuticals Inc.) and
Pr
TEVA-FAMOTIDINE
40 mg tablets (Teva Canada Limited) was conducted in healthy, adult
subjects under fasting
condition. A summary of the comparative bioavailability data from the
30 subjects included in
the statistical analysis is presented in the following table:
Page 3 of 26
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
Famotidine
(1 x 40 mg famotidine)
Geometric Mean
Arithmetic Mean (CV %)
Parameter
Test
1
Reference
2
% Ratio of
Geometric
Means
90% Confidence
Interval
AUC
T
(ng·h/mL)
723.42
746.47 (23.73)
756.54
775.48 (21.70)
95.6
91.5 – 99.9
AUC
I
(ng·h/mL)
744.65
767.16 (23.20)
775.41
794.66 (21.66)
96.0
92.0 – 100.2
C
max
(ng/mL)
112.15
115.82 (25.54)
119.11
123.07 (26.23)
94.2
88.3 – 100.4
T
max
3
(h)
2.25
(1.00- 5.00)
2.13
(0.67- 5.00)
T
1/2
4
(h)
5.02 (19.52)
4.66 (15.55)
1
MINT-FAMOTIDINE (famotidine) tablets, 40 mg (Mint Pharmaceuticals
Inc.).
2 Pr
TEVA-FAMOTIDINE (famotidine) tablets, 40 mg (Teva Canada Limited).
3
Expressed the median (range) only.
4
Expressed as the arithmetic mean (CV%) only.
INDICATIONS AND CLINICAL USE
MINT-FAMOTIDINE is indicated in the trea