LANSOPRAZOLE ODT GENERICHEALTH lansoprazole 15 mg orally disintegrating tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
26-03-2018
Public Assessment Report
(PAR)
26-11-2017
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Active ingredient:
lansoprazole, Quantity: 15 mg
Available from:
Lupin Australia Pty Limited
INN (International Name):
Lansoprazole
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: glyceryl monostearate; citric acid; hyprolose; purified water; purified talc; aspartame; polysorbate 80; methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; polyacrylate dispersion (30 per cent); titanium dioxide; crospovidone; macrogol 6000; microcrystalline cellulose; iron oxide yellow; iron oxide red; mannitol; triethyl citrate; magnesium stearate; magnesium carbonate hydrate; xylitol; calcium hydrogen phosphate; Flavour
Administration route:
Oral
Units in package:
Cold form dessicant blister (with push through Al foil) 7's and 28's, Alu/Alu blister (with push through Al foil) 7's and 28's, Cold form dessicant blister (with Peelable Al foil) 7's and 28's, Alu/Alu blister (with Peelable Al foil) 7's and 28's
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Adults:,1.Healing and long-term management of reflux oesophagitis.,2.Healing and long-term management for patients with duodenal ulcer.,3.Healing of benign gastric ulcer. Patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,4.Lansoprazole is also effective in patients with benign peptic lesions that do not respond to H2-receptor antagonists.,5.Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see Clinical Trials).,6.Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.,Paediatric patients 6 to 17 years of age.,1.Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis.,2.Healing of erosive oesophagitis.
Product summary:
Visual Identification: White to yellowish white uncoated tablets,speckled with orange to dark brown pellets debossed with 'I5' on one side and plain on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2014-11-19
Summary of Product characteristics
Lansoprazole ODT generichealth PI V3.0
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PRODUCT INFORMATION
LANSOPRAZOLE ODT GENERICHEALTH
NAME OF THE MEDICINE
Non-proprietary name: lansoprazole
The structural formula of lansoprazole is shown below:
CAS Registry Number: CAS No. 103577-45-3
Chemical name: 2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]
methyl] sulphinyl]-1H-benzimidazole
Molecular formula: C
16
H
14
F
3
N
3
O
2
S
Molecular weight: MW 369.4
DESCRIPTION
Lansoprazole is a substituted benzimidazole. It is a white or brownish
powder, Freely soluble in
dimethylformamide soluble in methanol, very slightly soluble in
acetonitrile and practically insoluble
in water. Lansoprazole is a racemic mixture of R and S enantiomers.
Lansoprazole has a pKa of 4.29
and 8.8.
Each Lansoprazole ODT generichealth contains 15 mg or 30 mg of
lansoprazole and the following
inactive ingredients:
ENTERIC
COATED
PELLETS:
Microcrystalline
cellulose,
magnesium
carbonate
hydrate,
hyprolose,
hypromellose, titanium dioxide, purified talc, mannitol, methacrylic
acid-ethyl acrylate copolymer
dispersion (1:1) 30 per cent, polyacrylate dispersion 30 per cent,
macrogol 6000, citric acid, glyceryl
monostearate, polysorbate 80, triethyl citrate, iron oxide yellow
(E172) and iron oxide red (E172).
OTHER EXCIPIENTS: F-Melt Type C (ARTG no. 106551), Crospovidone,
magnesium stearate, strawberry
flavor (ARTG no. 105990) and aspartame.
PHARMACOLOGY
ACTIONS
Lansoprazole reduces gastric acid secretions by inhibiting the
H+/K+-ATPase (proton pump) of the
parietal cells in the gastric mucosa, the terminal phase of acid
secretion. The drug is effective in the
treatment of acid-related disorders of the upper gastrointestinal
tract.
Lansoprazole ODT generichealth PI V3.0
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A single dose of 30 mg lansoprazole inhibits stimulated acid secretion
by approximately 80%. Basal
acid secretion and basal and stimulated secretion volumes are affected
to a lesser degree.
After repeated dosing (for 7 days) 90% inhibition of stimulated acid
secretion is achieved. Despite its
short elimina
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