PANTOPRAZOLE ACT pantoprazole (as pantoprazole sodium) 40 mg/vial powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium, Quantity: 42.29 mg (Equivalent: pantoprazole, Qty 40 mg)

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Pantoprazole sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; nitrogen

Administration route:

Intravenous

Units in package:

Available in carton containing 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For short-term use where oral therapy is not appropriate for the following conditions: 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison Syndrome. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. Note: Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory medicines, whether on first presentation or recurrence.

Product summary:

Visual Identification: White to off white lyophilized powder, in a clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-07-01

Patient Information leaflet

PANTOPRAZOLE ACT
PANTOPRAZOLE (AS PANTOPRAZOLE SODIUM) POWDER FOR INJECTION 40 MG/VIAL
CONSUMER MEDICINE INFORMATION
Version-1.0
2015
Page 1 of 4
Pantoprazole (as sodium)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Pantoprazole ACT.
It
does
not
contain
all
the
available
information.
It
does
not take the place of talking to
your doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
this
medicine
against
the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
WHAT PANTOPRAZOLE
ACT IS USED FOR
This medicine is used to
treat
:

ULCERS
Pantoprazole
ACT
is
used
to
treat and help heal duodenal and
gastric ulcers.
Depending
on
the
position
of
the ulcer it is called a gastric or
duodenal ulcer. A gastric ulcer
occurs
in
the
stomach.
A
duodenal
ulcer
occurs
in
the
duodenum
which
is
the
tube
leading out of the stomach.
These can be caused in part by
too much acid
being made in
the stomach.

REFLUX DISEASE
Pantoprazole ACT is also used
to treat reflux oesophagitis or
reflux
disease.
This
can
be
caused by washing back (reflux)
of
food
and
acid
from
the
stomach into the food pipe, also
known as the oesophagus.
Reflux
can
cause
a
burning
sensation in the chest rising up
to
the
throat,
also
known
as
heartburn.
Pantoprazole ACT is also used
to
prevent
reflux
oesophagitis
from coming back.

ZOLLINGER-ELLISON SYNDROME
Pantoprazole
ACT
is
used
to
treat
a
rare
condition
called
Zollinger-Ellison
syndrome,
where
the
stomach
produces
very
large
amounts
of
acid,
much more than in ulcers and
reflux disease.
This
medicine
contains
the
active
ingredient
pantoprazole
sodium.
Pantoprazole
sodium
belongs to a group of medicines
called
proton
pump
inhibitors
(PPIs).
It
works
by
decreasing
the
amount
of
acid
the
stomach
makes to give relief from the
symptoms and allow healing to
take place.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDI

Summary of Product characteristics

PANTOPRAZOLE ACT
Pantoprazole Sodium for Injection 40 mg/vial
Version 1.0
Page 1 of 11
PRODUCT INFORMATION
PANTOPRAZOLE ACT, PANTOPRAZOLE (AS PANTOPRAZOLE SODIUM) POWDER FOR
INJECTION
40 MG/VIAL
NAME OF THE MEDICINE
Pantoprazole (as sodium)
“(
_RS_
)
‐
6
‐
(Difluoromethoxy)
‐
2
‐
[(3,4
‐
dimethoxypyridin
‐
2
‐
yl)methylsulfinyl]
‐
1
_H-_
benzo
[
_d_
]imidazole sodium salt
pKa of Pantoprazole :
3.96
CAS NUMBER:
138786-67-1 (pantoprazole sodium)
EMPIRICAL FORMULA:
C
16
H
14
F
2
N
3
NaO
4
S
MW: 405
DESCRIPTION
Pantoprazole ACT 40mg powder for injection contains 40mg pantoprazole
(as sodium).
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated gastric secretion.
Pantoprazole sodium is a white to off white lyophilized powder.
Solubility is low at neutral pH
and increases with increasing pH
Pantoprazole ACT powder for injection contains sodium hydroxide
necessary for pH adjustment
to 10.50 – 11.50.
PHARMACOLOGY
Pharmacodynamics
Pantoprazole is a proton pump inhibitor. It inhibits specifically and
dose-proportionately H
+
/K
+
-
ATPase, the enzyme which is responsible for gastric acid secretion in
the parietal cells of the
stomach.
The substance is a substituted benzimidazole which accumulates in the
acidic environment of the
parietal cells after absorption. There, it is converted into the
active form, a cyclic sulfenamide
which binds to the H
+
/K
+
-ATPase, thus inhibiting the proton pump and causing potent and long-
PANTOPRAZOLE ACT
Pantoprazole Sodium for Injection 40 mg/vial
Version 1.0
Page 2 of 11
lasting suppression of basal and stimulated gastric acid secretion. As
pantoprazole acts distal to
the receptor level, it can influence gastric acid secretion
irrespective of the nature of the stimulus
(acetylcholine, histamine, gastrin).
Oral and intravenous pantoprazole 40mg/day for 5 days had equivalent
effect on intra-gastric pH
in 20 healthy adult male volunteers in a randomised, open, 2-period
crossover trial with 14-day
wash-out. The pre-defined equivalence range wa