MYLAN-CIMETIDINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIMETIDINE

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

A02BA01

INN (International Name):

CIMETIDINE

Dosage:

600MG

Pharmaceutical form:

TABLET

Composition:

CIMETIDINE 600MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

HISTAMINE H2-ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0111925004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-09-22

Summary of Product characteristics

1
PRODUCT MONOGRAPH
MYLAN-CIMETIDINE
(Cimetidine Tablets, USP)
300 MG, 400 MG, 600 MG, 800 MG
Histamine H
2
Receptor Antagonist
Mylan Pharmaceuticals ULC
Date of Preparation: September 2, 2009
85 Advance Road
Etobicoke, Ontario
Date of Revision:
M8Z 2S6
2
PRODUCT MONOGRAPH
MYLAN-CIMETIDINE
(Cimetidine Tablets, USP)
300 mg, 400 mg, 600 mg, 800 mg
PHARMACOLOGICAL CLASSIFICATION
Histamine H
2
Receptor Antagonist
ACTION AND CLINICAL PHARMACOLOGY
Cimetidine,
competitively,
inhibits
the
action
of
histamine
on
the
H
2
receptor
of
parietal cells, reducing gastric acid output and concentration under
basal conditions, and also
when stimulated by food, insulin, histamine, pentagastrin, and
caffeine. Cimetidine is not an
anticholinergic agent.
Cimetidine produces a dose-related reduction in nocturnal acid
secretion of 47-83 % over a 6 to
8 hour period or of 54% over a 9 hour period following 400 mg b.i.d.
or 300 mg q.i.d.,
respectively, in patients with duodenal ulcer. Mean acid secretion
over a 24-hour period is
reduced by about 60% or less
following oral dosages of 800 mg daily
at bedtime, 400 mg b.i.d., or
300 mg q.i.d. Cimetidine indirectly reduces pepsin secretion by
decreasing the volume of
gastric juice; however, has no substantial effect on lower esophageal
sphincter pressure,
gastric motility or emptying, or biliary or pancreatic secretion.
PHARMACOKINETICS
In both healthy individuals and those with peptic ulcer or
Zollinger-Ellison syndrome, basal
gastric acid secretion is inhibited to a greater extent than is
meal-stimulated acid secretion at a
given blood concentration of cimetidine.
After oral administration, cimetidine is rapidly and well absorbed
with a plasma half life
of
∼
2 hrs. An average bioavailability is given between 60-70%, but may be
less in elderly
3
patients with reduced renal or hepatic function. The oral
bioavailability of a single 800
mg cimetidine tablet is comparable to that of a single dose of two 400
mg cimetidine
tablets.
Cimetidine
is
widely
distributed
and
is
15-25%
bound
to
plasma prot