NTP-FAMOTIDINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FAMOTIDINE

Доступна з:

TEVA CANADA LIMITED

Код атс:

A02BA03

ІПН (Міжнародна Ім'я):

FAMOTIDINE

Дозування:

20MG

Фармацевтична форма:

TABLET

Склад:

FAMOTIDINE 20MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100/500

Тип рецепту:

Prescription

Терапевтична области:

HISTAMINE H2-ANTAGONISTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2015-08-06

Характеристики продукта

PRODUCT MONOGRAPH
NTP-FAMOTIDINE TABLETS
(famotidine tablets, USP)
20 mg and 40 mg
Histamine H
2
Receptor Antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166002
Date of Preparation:
July 19, 2013
-1-
PRODUCT MONOGRAPH
NTP-FAMOTIDINE TABLETS
(famotidine tablets, USP)
20 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.
A comparative, two-way single dose bioavailability study was performed
on two 40 mg
famotidine products, NTP-FAMOTIDINE 40 mg tablets and PEPCID
®
40 mg tablets.
The pharmacokinetic data calculated for famotidine in the
NTP-FAMOTIDINE and
PEPCID
®
tablet formulations is tabulated below:
PHARMACOKINETIC INDICES FOR FAMOTIDINE:
NTP-Famotidine
40mg
Pepcid®
40mg
Percebtage of
Pepcid®
AUC
T
(ng
C
h/mL)
757
804 (30)
692
751 (41)
109
AUC
I
(ng
C
h/mL)
804
857 (32)
735
799 (42)
109
Cmax
(ng/mL)
134
142 (32)
122
127 (30)
110
Tmax*
( h )
2.42 (0.86)
2.56 (0.92)
-
T
1/2*
( h )
3.53 (3.48)
2.99 (0.85)
-
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, NTP-FAMOTIDINE 20 mg tablets and PEPCID
®
20 mg tablets.
The pharmacokinetic data calculated for famotidine in the
NTP-FAMOTIDINE and
PEPCID
®
tablet formulations is tabulated below:
-2
-
PHARMACOKINETIC INDICES FOR FAMOTIDINE:
NTP-Famotidine
2x20mg
Pepcid®
2x20mg
Percebtage of
Pepcid®
AUC
T
(ng
C
h/mL)
596
635 (34)
602
646 (34)
96
AUC
I
(ng
C
h/mL)
645
682 (30)
665
708 (34)
103
Cmax
(ng/mL)
114
122 (37)
110
120 (42)
96
Tmax*
( h )
2.63 (0.82)
2.46 (0.66)
-
T
1/2*
( h )
2