FAMOTIDINE IV INJECTION SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FAMOTIDINE

Доступна з:

TEVA CANADA LIMITED

Код атс:

A02BA03

ІПН (Міжнародна Ім'я):

FAMOTIDINE

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

FAMOTIDINE 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

2ML

Тип рецепту:

Prescription

Терапевтична области:

HISTAMINE H2-ANTAGONISTS

Огляд продуктів:

Active ingredient group (AIG) number: 0118722003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2014-03-20

Характеристики продукта

PRODUCT MONOGRAPH
TEVA-FAMOTIDINE TABLETS
(famotidine tablets, USP)
20 mg and 40 mg
FAMOTIDINE IV INJECTION
(famotidine injection)
10 mg/mL
Histamine H
2
Receptor Antagonist
Teva Canada Limited.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
April 1, 2014
Submission Control: 171678
PRODUCT MONOGRAPH
TEVA-FAMOTIDINE TABLETS
(famotidine tablets, USP)
20 and 40 mg
FAMOTIDINE IV INJECTION
(famotidine injection)
10 mg/mL
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.
A comparative, two-way single dose bioavailability study was performed
on two 40 mg
famotidine products, TEVA-FAMOTIDINE 40 mg tablets and PEPCID
®
40 mg tablets.
The pharmacokinetic data calculated for famotidine in the
TEVA-FAMOTIDINE and
PEPCID
®
tablet formulations is tabulated below:
Pharmacokinetic Indices for Famotidine:
TEVA-FAMOTIDINE
PEPCID
®
Percentage
40 mg
40 mg
of Pepcid
®
AUC
T
757
692
109
(ng
C
h/mL)
804 (30)
751 (41)
AUC
I
804
735
109
(ng
C
h/mL)
857 (32)
799 (42)
Cmax
134
122
110
(ng/mL)
142 (32)
127 (30)
Tmax*
2.42 (0.86)
2.56 (0.92)
__
( h )
T
1/2*
3.53 (3.48)
2.99 (0.85)
—
( h )
Geometric mean
Arithmetic mean (CV)
*For the Tmax and T
1/2
parameters these are the Arithmetic means (standard deviation).
A comparative, two-way single dose bioavailability study was performed
on two 20 mg
famotidine products, TEVA-FAMOTIDINE 20 mg tablets and PEPCID
®
20 mg tablets.
The pharmacokinetic data calculated for famotidine in the
TEVA-FAMOTIDINE and
PEPCID
®
tablet formulations is tabulated below:
Pharmacokinetic Indices for Famotidine:
TEVA-FAMOTIDINE
PEPCID
®
Percentage
( 2 x 20 mg)
(2 x 20 mg)
of Pepcid
®
AUC
T
596
602
96
(ng
C
h/mL)
635 (34)
646 (34)
AUC
I
645
665
103
(ng