LANSOPAL Capsule

Treatment of duodenal and gastric ulcer

Treatment of reflux oesophagitis, Prophylaxis of reflux oesophagitis, Eradication of Helicobacter pylori concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers, treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment, Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk requiring continued therapy, Symptomatic gastroesophageal reflux disease, Zollinger-Ellison syndrome.

Dosage

Treatment of duodenal ulcer: 30mg once daily for 2 weeks.

Treatment of gastric ulcer: 30mg once daily for 4 weeks.

Reflux oesophagitis: 30mg once daily for 4 weeks.

Prophylaxis of reflux oesophagitis: 15mg once daily. The dose may be increased up to 30mg daily as necessary.

Eradication of Helicobacter pylori: 30mg twice daily for 7 days in combination with one of the following:

clarithromycin 250-500mg twice daily + amoxicillin 1g twice daily.

clarithromycin 250mg twice daily + metronidazole 400-500 mg twice daily.

H.pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with lansoprazole and amoxicillin or metronidazole.

Symptomatic gastro-oesophageal reflux disease: The recommended dose is 15-30mg daily.

Zollinger-Ellison syndrome: The recommended initial dose is 60mg once daily.

Hypersensitivity to the active substance.

Lansoprazole should not be administered with atazanavir.

Headache, dizziness, nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence, dry mouth or throat; increase in liver enzyme levels; urticaria, itching, rash; fatigue; thrombocytopenia, eosinophilia, leucopenia; depression; athralgia, myalgia, fracture of the hip, wrist or spine; oedema.

See the package insert about the details below:

Lansoprazole may interfere with the absorption of drugs where gastric pH is critical to bioavailability.

Atazanavir

Ketoconazole and itraconazole

Digoxin

Theophylline

Tacrolimus

CYP2C19 inhibitor fluvoxamine

Sucralfate/Antacids

Not recommended.

In common with other anti-ulcer therapies, the possibility of malignant gastric tumor should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms ad delay the diagnosis.

Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction

Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a through risk/benefit assessment should regularly be performed in these patients.

As lansoprazole contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ATPase of the parietal cells in the stomach. The inhibition is dose dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.

Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme activity.