PANTOZOL

Maa: Indonesia

Kieli: indonesia

Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiivinen ainesosa:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Saatavilla:

TAKEDA INDONESIA - Indonesia

INN (Kansainvälinen yleisnimi):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Annos:

40 MG

Lääkemuoto:

TABLET SALUT ENTERIK

Kpl paketissa:

DUS, 1 BLISTER @ 7 TABLET SALUT ENTERIK

Valmistaja:

TAKEDA Gmbh - Germany

Valtuutus päivämäärä:

2016-01-20

Valmisteyhteenveto

INSTRUCTIONS FOR USE
Pantozol
®
40 mg
ACTIVE INGREDIENT:
PANTOPRAZOLE SODIUM SESQUIHYDRATE
COMPOSITION
_Active ingredient_
1 gastro-resistant tablet contains :
Pantoprazole
sodium
sesquihydrate
45.1
mg
(corresponding to 40 mg pantoprazole)
PHARMACOTHERAPEUTIC
/
INDICATION
GROUP
/
ACTION MECHANISM
PHARMACODYNAMIC PROPERTIES :
Proton pump inhibitors :
ATC code : A02BC02
Pantoprazole
is
a
substituted
benzimidazole
which inhibits the secretion of hydrochloric acid
in the stomach by specific action on the proton
pumps of the parietal cells.
Pantoprazole is converted to its active form in
the acidic
environment
in
the
parietal
cells
where it
inhibits the H
+
, K
+
-ATPase enzyme, i.e.
the final
stage in the production of hydrochloric
acid in the stomach. The inhibition is dose-
dependent and affects both basal and stimulated
acid
secretion.
As
with
other
proton
pump
inhibitors and H
2
receptor inhibitors, treatment
with pantoprazole
causes a reduced acidity in
the stomach and
thereby an increase in gastrin in
proportion to
the
reduction
in
acidity.
The
increase
in
gastrin
is
reversible.
Since
pantoprazole binds to the enzyme distal to the
cell
receptor
level,
the substance
can
affect
hydrochloric
acid
secretion
independently
of
stimulation by other substances (acetylcholine,
histamine,
gastrin).
The
effect
is
the
same
whether
the
product
is
given
orally
or
intravenously.
PHARMACOKINETIC PROPERTIES :
-
GENERAL PHARMACOKINETICS :
Pantoprazole is rapidly absorbed and the maximal
plasma concentration is achieved even after one
single 40 mg oral dose. On average at about
2.5 p.a. the maximum serum concentrations of
about 2 – 3 µg/ml are achieved, and these values
remain constant after multiple administration.
Volume of distribution is about 0.15 l/kg and
clearance is about 0.1 l/h/kg. Terminal half-
life
is about 1 h. There were a few cases of
subjects with delayed elimination. Because of
the specific
activation of pantoprazole in the
parietal cell the elimination half-life does not
correlate
with
the much
longer
durati