PANTOPRAZOLE SANDOZ pantoprazole (as sodium sesquihydrate) 20mg enteric coated tablet bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

pantoprazole sodium sesquihydrate, Quantity: 22.55 mg (Equivalent: pantoprazole, Qty 20 mg)

Disponible depuis:

Sandoz Pty Ltd

DCI (Dénomination commune internationale):

Pantoprazole sodium sesquihydrate

forme pharmaceutique:

Tablet, enteric coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; sodium carbonate; triethyl citrate; calcium stearate; hyprolose; crospovidone; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4R aluminium lake

Mode d'administration:

Oral

Unités en paquet:

30 tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: Duodenal ulcer; Gastric ulcer; Gastro-oesophageal reflux disease (GORD) i. Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD ii. Reflux oesophagitis; Gastrointestinal lesions refractory to H2 blockers ; 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: Clarithromycin and amoxicillin or; Clarithromycin and metronidazole or; 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 micro-organism. 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.

Descriptif du produit:

Visual Identification: Yellow oval coated tablet.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Licence status A

Date de l'autorisation:

2009-04-21

Résumé des caractéristiques du produit

_Product Information _
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_Page 1 _
_Pantoprazole Sandoz 20 mg & 40 mg Enteric Coated Tablets _
_10/2017 _
_Sandoz Pty Ltd _
_ _
_Version 02 _
PRODUCT INFORMATION
PANTOPRAZOLE SANDOZ 20 MG/40 MG ENTERIC COATED TABLETS
NAME OF THE MEDICINE
_ _
Pantoprazole (as sodium sesquihydrate)
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1
_H_
-
benzimidazole, sodium salt, sesquihydrate
CAS Number: 164579-32-2 (pantoprazole sodium sesquihydrate)
Empirical formula: C
16
H
14
F
2
N
3
NaO
4
S. 1.5H
2
O
_ _
MW: 432
_ _
DESCRIPTION
_ _
Each Pantoprazole Sandoz 40 mg enteric coated tablet contains 45.10 mg
of
pantoprazole sodium sesquihydrate equivalent to 40 mg of pantoprazole.
Each Pantoprazole Sandoz 20 mg enteric coated tablet contains 22.55 mg
pantoprazole sodium sesquihydrate equivalent to 20 mg of pantoprazole.
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated
gastric secretion.
Pantoprazole sodium sesquihydrate is a white to off-white crystalline
powder.
Solubility is low at neutral pH and increases with increasing pH.
In addition to pantoprazole sodium sesquihydrate, these tablets also
contain sodium
carbonate, microcrystalline cellulose, crospovidone, hyprolose,
colloidal anhydrous
silica, calcium stearate, Opadry complete film coating system 03B22011
Yellow,
Eudragit L30D-55, and triethyl citrate.
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_Product Information _
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_Page 2 _
_Pantoprazole Sandoz 20 mg & 40 mg Enteric Coated Tablets _
_10/2017 _
_Sandoz Pty Ltd _
_ _
_Version 02 _
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 sulphenamide which binds to the H
+
/K
+
-ATPase, thus inhibiting the
proton pump and causing potent and long-