NOVO-CIMETINE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIMETIDINE (CIMETIDINE HYDROCHLORIDE)

Available from:

TEVA CANADA LIMITED

ATC code:

A02BA01

INN (International Name):

CIMETIDINE

Dosage:

150MG

Pharmaceutical form:

SOLUTION

Composition:

CIMETIDINE (CIMETIDINE HYDROCHLORIDE) 150MG

Administration route:

INTRAMUSCULAR

Units in package:

2ML

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0111925008; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-04-30

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
NOVO-CIMETINE TABLETS
Cimetidine
200 mg, 300 mg, 400 mg, 600 mg, and 800 mg
PR
NOVO-CIMETINE INJECTION
Cimetidine Hydrochloride Injection
300 mg/2 mL cimetidine
HISTAMINE H2 RECEPTOR ANTAGONIST
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
DATE OF PREPARATION:
M1B 2K9
May 23, 2014
Control # 173478
2
PRODUCT MONOGRAPH
Pr
NOVO-CIMETINE Tablets
Cimetidine
2OO mg, 300 mg, 400 mg, 600 mg, and 800 mg
Pr
NOVO-CIMETINE Injection
Cimetidine Hydrochloride Injection
300 mg/2 mL cimetidine
THERAPEUTIC CLASSIFICATION
Histamine H
2
Receptor Antagonist
ACTION AND CLINICAL PHARMACOLOGY
Cimetidine competitively inhibits the action of histamine at the
histamine H
2
-receptor and thus
represents a new class of pharmacological agents, the histamine H
2
-receptor antagonists.
Cimetidine is not an anticholinergic agent. Studies have shown that
cimetidine inhibits both
daytime and nocturnal basal gastric acid secretion. Cimetidine also
inhibits gastric acid secretion
stimulated by food, histamine, pentagastrin, caffeine, and insulin.
Its ability to inhibit gastric acid
secretion via this unique mechanism of action permits a new approach
to the treatment of acid-
related gastrointestinal disorders. In addition to its antisecretory
effects, cimetidine also has
cytoprotective properties.
In therapeutic studies, patients with NSAID-induced lesions or ulcers
had symptomatic relief and
healing when cimetidine was co-administered with the existing NSAID
therapy.
Cimetidine is absorbed rapidly after oral administration. The plasma
half-life is approximately 2
hours. The principal route of excretion is the urine.
The degree and duration of inhibition of basal and stimulated gastric
acid secretion are dose
related; the data suggest that 80% or higher inhibition throughout a
24 hour period can be
achieved by a dosage regimen of 1.2 g daily given in divided doses.
Cimetidine 300 mg reduced
total pepsin output as a result of the decrease in volume of gastric
juice. The drug had no effect
on the rate of gastric emptyin