TOPRA 40 pantoprazole (as sodium sesquihydrate) 40mg enteric coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate, Quantity: 45.1 mg (Equivalent: pantoprazole, Qty 40 mg)

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: triethyl citrate; sodium carbonate; hyprolose; iron oxide yellow; calcium stearate; crospovidone; hypromellose; mannitol; methacrylic acid - ethyl acrylate copolymer (1:1)

Administration route:

Oral

Units in package:

100, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:- i) duodenal ulcer, ii) gastric ulcer, iii) gastro-oesophageal reflux disease (GORD): Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; Reflux oesophagitis iv) gastrointestinal lesions refractory H2 blockers v) Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics; i) Clarithromycin and amoxicillin, or ii) Clarithromycin and metronidazole, or iii) Amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. 4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.

Product summary:

Visual Identification: Yellow colored, enteric coated, oval biconvex tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-12-14

Patient Information leaflet

TOPRA™ 40
CONSUMER MEDICINE INFORMATION
Pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TOPRA.
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 TOPRA
against the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TOPRA IS USED FOR
The name of your medicine is TOPRA. It contains the active ingredient
called pantoprazole.
ULCERS
TOPRA 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.
Most people who have a peptic ulcer also have bacteria called
_Helicobacter pylori _in their stomach.
When TOPRA is taken with antibiotics the combination therapy will kill
the _Helicobacter pylori _and
let your ulcer heal.
TOPRA may also be used to prevent ulcers associated with the use of
non-steroidal anti-
inflammatory drugs (NSAIDs). These are medicines used to relieve pain,
swelling and other
symptoms of inflammation, including arthritis (inflammation of the
joints).
REFLUX DISEASE
TOPRA 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.
TOPRA is also used to prevent reflux oesophagitis from coming back.
ZOLLINGER-ELLISON SYNDROME
TOPRA is used to treat a rare condition called Zollinger-Ellison
syndrome, w

Summary of Product characteristics

Page 1 of 20
PRODUCT INFORMATION
TOPRA™ 40
ENTERIC-COATED DELAYED RELEASE TABLETS
NAME OF THE MEDICINE
Active ingredient:
Pantoprazole (as sodium sesquihydrate)
Chemical name:
Sodium 5-(difluoromethoxy)-2-[(_RS_)-[(3,4-dimethoxypyridin-2-
yl)methyl]sulphinyl]benzimidazol-1-ide sesquihydrate
CAS number:
164579-32-2
Molecular weight:
432.4
Molecular formula:
C
16
H
14
F
2
N
3
NaO
4
S, 1½ H
2
O
Chemical structure:
DESCRIPTION
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated gastric
secretion. Pantoprazole sodium sesquihydrate is a white to off-white
crystalline powder. It
is freely soluble in water, soluble in methanol and practically
insoluble in methylene
chloride.
TOPRA 40 is available as enteric coated-tablets containing 40 mg
pantoprazole (as
sodium sesquihydrate).
TOPRA
enteric-coated
tablets
contain
the
following
inactive
ingredients:
sodium
carbonate anhydrous, mannitol, crospovidone, calcium stearate,
hypromellose, iron oxide
yellow, hydroxypropylcellulose, methacrylic acid - ethyl acrylate
copolymer (1:1), triethyl
citrate.
PHARMACOLOGY
PHARMACODYNAMICS
Pantoprazole
is
a
proton
pump
inhibitor
(PPI).
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 sulphenamide which binds to the H
+
/K
+
-ATPase, thus inhibiting the proton
Page 2 of 20
pump and causing potent and long-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).
Pantoprazole's selectivity is due to the fact that it only exerts its
full effect in a strongly
acidic environment (pH < 3), remaining mostly inactive at higher pH
values. As a re