Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
lansoprazole, Quantity: 30 mg
Lupin Australia Pty Limited
Lansoprazole
Tablet, orally disintegrating
Excipient Ingredients: iron oxide yellow; hyprolose; crospovidone; microcrystalline cellulose; iron oxide red; titanium dioxide; polyacrylate dispersion (30 per cent); methacrylic acid - ethyl acrylate copolymer (1:1); polysorbate 80; magnesium stearate; aspartame; triethyl citrate; mannitol; citric acid; glyceryl monostearate; magnesium carbonate hydrate; hypromellose; macrogol 6000; purified talc; purified water; Flavour; xylitol; calcium hydrogen phosphate
Oral
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, Alu/Alu blister (with Peelable Al foil) 7's and 28's, Cold form dessicant blister (with Peelable Al foil) 7's and 28's
(S4) Prescription Only Medicine
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.
Visual Identification: White to yellowish white uncoated tablets,speckled with orange to dark brown pellets debossed with '30' 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
Licence status A
2014-11-19
Lansoprazole ODT generichealth PI V3.0 Page 1 of 13 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 Page 2 of 13 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 Izlasiet visu dokumentu