FAMOTIDINE IV INJECTION SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

FAMOTIDINE

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

A02BA03

INN (Jina la Kimataifa):

FAMOTIDINE

Kipimo:

10MG

Dawa fomu:

SOLUTION

Tungo:

FAMOTIDINE 10MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

4/20/50ML

Dawa ya aina:

Prescription

Eneo la matibabu:

HISTAMINE H2-ANTAGONISTS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2015-10-16

Tabia za bidhaa

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