PANTOZOL

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

متاح من:

TAKEDA INDONESIA - Indonesia

INN (الاسم الدولي):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

جرعة:

20 MG

الشكل الصيدلاني:

TABLET SALUT ENTERIK

الوحدات في الحزمة:

DUS, 1 BLISTER @ 7 TABLET SALUT ENTERIK

المصنعة من قبل:

TAKEDA Gmbh - Germany

تاريخ الترخيص:

2016-01-20

خصائص المنتج

1
Instructions for Use
Pantozol
®
20 mg
Active ingredient:
Pantoprazole sodium sesquihydrate
COMPOSITION
Each
one
gastro-resistant
tablet/enteric
coated
contains
22.6
mg
Pantoprazole
sodium
sesquihydrate
(equivalent
to
pantoprazole 20 mg)
MECHANISM OF ACTION
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 20 mg oral dose. On
average
at
about
2.5
p.a.
the
maximum
serum concentrations of about
1 – 1.5 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 duration of action (inhibition
of acid
secret