Lansoprazole Stella

Lansoprazole Stella

lansoprazole

Manufacturer:

Stellapharm

Distributor:

HK Medical Supplies
/
Health Express
Concise Prescribing Info
Contents
Lansoprazole
Indications/Uses
Treatment of duodenal & gastric ulcer; reflux oesophagitis; NSAID-associated benign gastric & duodenal ulcers in patients requiring continued NSAID treatment. Prophylaxis of reflux oesophagitis; NSAID-associated gastric & duodenal ulcers in patients at risk requiring continued therapy. Eradication of H. pylori concurrently given w/ appropriate antibiotic therapy for H. pylori-associated ulcers. Symptomatic GERD. Zollinger-Ellison syndrome.
Dosage/Direction for Use
Treatment of duodenal ulcer Recommended dose: 30 mg once daily for 2 wk, may be continued for another 2 wk if not fully healed. Treatment of gastric ulcer; reflux oesophagitis; NSAID-associated benign gastric & duodenal ulcers in patients requiring continued NSAID treatment Recommended dose: 30 mg once daily for 4 wk, may be continued for another 4 wk if not fully healed. Treatment of NSAID-associated gastric & duodenal ulcers in patients at risk (eg, >65 yr or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment 15 mg once daily (use other prep for dose <30 mg), may be increased to 30 mg once daily as necessary. Prophylaxis of reflux oesophagitis 15 mg once daily (use other prep for dose <30 mg), may be increased to 30 mg daily as necessary. Eradication of H. pylori Recommended dose: Lansoprazole 30 mg bd for 7 days in combination w/ either clarithromycin 250-500 mg bd + amoxicillin 1 g bd; or clarithromycin 250 mg bd + metronidazole 400-500 mg bd. Symptomatic GERD Recommended dose: 30 mg daily. Zollinger-Ellison syndrome Recommended initial dose: 60 mg once daily. Should be given in 2 divided doses if the required daily dose exceeds 120 mg. Patient w/ moderate or severe liver disease Reduce daily dose to ½. Elderly Should not exceed 30 mg daily.
Administration
Should be taken on an empty stomach: Take 30 min before meals.
Contraindications
Hypersensitivity. Should not be administered w/ atazanavir.
Special Precautions
Can mask symptoms & delay diagnosis of malignant gastric tumour. Slightly increased risk of GI infections eg, Salmonella, Campylobacter & possibly Clostridium difficile. Limited safety data for patients on maintenance treatment for >1 yr. Reports of colitis (very rare); consider discontinuation in case of severe &/or persistent diarrhoea. Treatment for prevention of peptic ulceration in patients requiring continuous NSAID treatment should be restricted to high-risk patients (eg, previous GI bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase likelihood of upper GI adverse events [eg, corticosteroids or anticoagulants], presence of serious co-morbidity factor or prolonged use of NSAID max recommended doses). May modestly increase risk of hip, wrist & spine fracture, predominantly in the elderly or in presence of other recognised risk factors, especially if used in high doses & over long durations (>1 yr). Risk of severe hypomagnesaemia w/ serious manifestations eg, fatigue, tetany, delirium, convulsions, dizziness & ventricular arrhythmia. Consider measuring Mg levels before starting & periodically during treatment if expected to be on prolonged treatment or if concomitantly taking digoxin or drugs that may cause hypomagnesaemia (eg, diuretics). Associated w/ very infrequent cases of subacute cutaneous lupus erythematosus; consider discontinuation if lesions occur, especially in sun-exposed areas of the skin, & if accompanied by arthralgia. Stop treatment for at least 5 days before chromogranin A (CgA) measurements. Co-administration of proton pump inhibitors & high-dose methotrexate may elevate & prolong serum levels of methotrexate &/or its metabolite hydroxymethotrexate. Should not be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May impair ability to drive or operate machinery. Should be used w/ caution in patients w/ moderate & severe hepatic dysfunction. Not recommended during pregnancy. Lactation. Not recommended in childn.
Adverse Reactions
Headache, dizziness; nausea, diarrhoea, stomachache, constipation, vomiting, flatulence, dry mouth or throat, fundic gland polyps (benign); increased liver enzyme levels; urticaria, itching, rash; fatigue.
Drug Interactions
Reduced atazanavir exposure. Sub-therapeutic conc of ketoconazole & itraconazole. Increased digoxin plasma levels. Increased plasma conc of drugs metabolised by CYP3A4; tacrolimus. Reduced theophylline plasma conc. Increased plasma conc w/ fluvoxamine. Reduced plasma conc w/ CYP2C19 & CYP3A4 inducers eg, rifampicin & St. John's wort (Hypericum perforatum). Decreased bioavailability w/ sucralfate/antacids.
ATC Classification
A02BC03 - lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Lansoprazole Stella gastro-resistant cap 30 mg
Packing/Price
3 × 10's
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