IPCA PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

pantoprazole sodium sesquihydrate, Quantity: 45.4 mg (Equivalent: pantoprazole, Qty 40 mg)

Dostępny od:

Ipca Pharma (Australia) Pty Ltd

INN (International Nazwa):

Pantoprazole sodium sesquihydrate

Forma farmaceutyczna:

Tablet, enteric coated

Skład:

Excipient Ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Droga podania:

Oral

Sztuk w opakowaniu:

56, 50, 140, 100, 5, 28, 15, 14, 30, 60

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

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. 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.

Podsumowanie produktu:

Visual Identification: Yellow to pale yellow, oval shaped, biconvex enteric-coated tablets plain on both the sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Licence status A

Data autoryzacji:

2010-02-17

Ulotka dla pacjenta

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IPCA PANTOPRAZOLE
Product Information
Pantoprazole (as sodium sesquihydrate) enteric-coated delayed release
tablets
NAME OF THE MEDICINE
Pantoprazole sodium (as pantoprazole sodium sesquihydrate).
Chemical name:
Sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-
2-yl)methyl]sulphinyl]benzimidazol-1-ide sesquihydrate
CAS No:
164579-32-2
Molecular formula:
C
16
H
14
F
2
N
3
NaO
4
S,½H
2
0
MW (sodium salt x 1.5 H
2
O):
432.4
DESCRIPTION
Each Ipca Pantoprazole 40mg enteric coated tablet contains 45.10mg of
pantoprazole
sodium sesquihydrate equivalent to 40mg of pantoprazole.
Each Ipca Pantoprazole 20mg enteric coated tablet contains 22.55mg
pantoprazole
sodium sesquihydrate equivalent to 20mg of pantoprazole.
Pantoprazole is a substituted benzimidazole which inhibits basal and
stimulated gastric
secretion. It is a white to off white crystalline powder. Freely
soluble in water and in ethanol
(96 per cent), practically insoluble in hexane. Solubility is low at
neutral pH and increases
with increasing pH.
In addition to pantoprazole sodium sesquihydrate, these tablets also
contain mannitol,
sodium carbonate , sodium starch glycollate, crospovidone, colloidal
anhydrous silica,
calcium stearate, hypromellose, macrogol 6000, sodium hydroxide,
EUDRAGIT L30-D55
and OPADRY AMB Aqueous Moisture Barrier Coating System
80W52172 Yellow.
Ipca Pantoprazole tablets are gluten free.
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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-lasting suppression of basal and
stimulated gastric acid
secretion. As pantoprazole acts distal to the recepto