ULCIDINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FAMOTIDINE

Available from:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

ATC code:

A02BA03

INN (International Name):

FAMOTIDINE

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

FAMOTIDINE 40MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0118722002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-07-30

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
Ulcidine
Famotidine Tablets 20 mg; 40 mg, USP
HISTAMINE H
2
RECEPTOR ANTAGONIST
Valeant Canada limitée/Limited Date of Preparation:
4787 Levy Street
May 6, 2005
Montreal, Quebec
H4R 2P9
Control #: 098469
2
PRODUCT MONOGRAPH
Pr
Ulcidine
Famotidine tablets 20 mg; 40 mg, USP
Histamine H
2
Receptor Antagonist
CLINICAL PHARMACOLOGY
Ulcidine (famotidine) is a competitive inhibitor of histamine H
2
-receptors. The primary clinically
important pharmacologic activity of Ulcidine is inhibition of gastric
juice secretion. Ulcidine
reduces the acid and pepsin content, as well as the volume, of basal,
nocturnal, and stimulated
gastric secretion.
PHARMACOKINETICS
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Absorption: rapid, incomplete, oral bioavailability: 40-45 %
______________________________________________________________________________
Protein binding: low (15-20 %)
______________________________________________________________________________
Biotransformation: hepatic, minimal first pass metabolism
______________________________________________________________________________
Elimination half-life: with normal renal function 2.5-3.5 hrs with
reduced creatinine clearance
10: 20 or more < hrs
Mean serum concentration resulting in 50 % inhibition of
pentagastrin-stimulated acid secretion:
13 ng/mL
______________________________________________________________________________
Tmax:
1 to 3 hrs
______________________________________________________________________________
Time to peak effect:
1 to 3 hrs
______________________________________________________________________________
Onset of action:
1 hr
______________________________________________________________________________
3
Duration of action:
(nocturnal and basal) 10 to 12 hrs
______________________________________________________________________________
Elimination:
primarily renal (65-70%)
metabolic (30-35%)
Renal Clearance: 250-450 mL/min
___________________________________________________________________