FAMOTIDINE IV INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

FAMOTIDINE

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

A02BA03

INN (Tarptautinis Pavadinimas):

FAMOTIDINE

Dozė:

10MG

Vaisto forma:

SOLUTION

Sudėtis:

FAMOTIDINE 10MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

4/20/50ML

Recepto tipas:

Prescription

Gydymo sritis:

HISTAMINE H2-ANTAGONISTS

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2015-10-16

Prekės savybės

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