APO-CIMETIDINE USP 400MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CIMETIDINE

Available from:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (International Name):

CIMETIDINE

Units in package:

100Tablet Tablets; 500Tablet Tablets; 500 Tablet Tablets

Manufactured by:

APOTEX INC

Summary of Product characteristics

APO-CIMETIDINE
HISTAMINE H2 - RECEPTOR INHIBITOR
PHARMACOLOGY:
Cimetidine is a specific competitive histamine H2-receptor antagonist
which effectively inhibits gastric acid secretion. It is advocated for
the
treatment of conditions where the inhibition of gastric acid secretion
is
likely to be beneficial. It competitively inhibits the action of
histamine at
the histamine H2-receptors of the parietal cells and , thus,
represents a
new
class
of
pharmacological
agent,
the
histamine
H2-receptor
antagonist. Administered orally or i.v., cimetidine inhibits both
daytime
and nocturnal basal (non-stimulated) gastric acid secretion.
Cimetidine
significantly reduces gastric acid secretion stimulated by solid or
liquid
meals as well as that stimulated by histamine, pentagastrin, caffeine,
or
insulin
infusion.
It
is
generally
much
less
effective
in
inhibiting
carbachol (Carbarryl-choline chloride) stimulated acid secretion. The
extent of inhibition is dose-related. A 50% reduction in gastric acid
secretion is obtained by doses of cimetidine giving a blood
concentration
of 1 to 2 umol/L (0.25 to 5 ug/mL). Cimetidine reduces both hydrogen
ion
concentration
and
volume
of
gastric
secretion.
Addition
of
an
anticholinergic agent to cimetidine at dosages greater than 400mg does
not significantly enhance inhibition of acid output. Pepsin output is
decreased by cimetidine, largely due to reduced volume, but to a
lesser
extent
than
acid
output
in
the
same
patients.
Cimetidine
does
not
consistently
alter
gastric
emptying
or
lower
esophageal
sphincter
pressure.
Pancreatic
secretion
of
bicarbonate
and
enzymes
is
not
influenced
by
cimetidine.
Cimetidine
is
readily
absorbed
after
oral
administration; bio availability is about 70%. The plasma half-life is
approximately 2 hours, and most of a dose of cimetidine is recovered
in
the urine within 24 hours.
INDICATIONS:
For the treatment of duodenal ulcer therapy and prophylaxis of
recurrent
duodenal
ulcer; non-malignant gastric ulcer; gastroesophageal reflux
disease; management of upper gastroin