LANSOPRAZOLE

Posology Treatment of duodenal ulcer:

The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks.

Treatment of gastric ulcer:

The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication may be continued at the same dose for another 4 weeks.

Reflux oesophagitis:

The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks. Prophylaxis of reflux oesophagitis: 15 mg once daily. The dose may be increased up to 30 mg daily as necessary.

Eradication of Helicobacter pylori:

When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The recommended dose is 30 mg of Lansoprazole orodispersible tablets twice daily for 7 days in combination with one of the following: clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily H.

pylori eradication rates of up to 90% are obtained when clarithromycin is combined with lansoprazole oro-dispersible tablets and amoxicillin or metronidazole. Six months after successful eradication treatment, the risk of re infection is low and relapse is therefore unlikely.

Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined. Lower eradication rates were seen using this combination than in regimens involving clarithromycin.

It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low. Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment: 30 mg once daily for 4 weeks.

In patients not fully healed the treatment may be continued for another 4 weeks. For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used. Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age > 65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment: 15 mg once daily.

If the treatment fails, the dose 30 mg once daily should be used.

Symptomatic gastro-oesophageal reflux disease:

The recommended dose is 15 mg or 30 mg daily. Relief of symptoms is obtained rapidly. Individual adjustment of dosage should be considered. If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.

Zollinger-Ellison syndrome:

The recommended initial dose is 60 mg once daily. The dose should be individually adjusted, and the treatment should be continued for as long as necessary. Daily doses of up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be given in two divided doses.

Special populations Renal impairment:

There is no need for a dose adjustment in patients with impaired renal function. 2).

Elderly:

Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements. A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.

3). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease. Method of administration For optimal effect, Lansoprazole oro-dispersible tablets should be taken once daily in the morning, except when used for H.

pylori eradication when treatment should be twice a day, once in the morning and once in the evening. 2). Lansoprazole oro-dispersible tablets are strawberry flavoured and should be placed on the tongue and gently sucked. The tablet rapidly disperses in the mouth, releasing gastro-resistant microgranules which are swallowed with the patient's saliva.

Alternatively, the tablet can be swallowed whole with a drink of water. The oro-dispersible tablets can be dispersed in a small amount of water and administered via a naso-gastric tube or oral syringe. 6.

4 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5). If co- administration of lansoprazole with HIV protease inhibitors is unavoidable, close clinical monitoring is recommended. Hypomagnesaemia Severe hypomagnesaemia has been rarely reported in patients treated with PPIs like lansoprazole for at least three months, and in most cases for a year.

Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur, but they may begin insidiously and be overlooked. 8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI.

, diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. Interference with laboratory tests Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.

1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment. Influence on vitamin B12 absorption Daily treatment with any acid-suppressing medications over a prolonged period of time (several years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria.

Cyanocobalamin deficiency should be considered in patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, individuals with reduced body stores or risk factors for reduced vitamin B12 absorption (such as the elderly) on long-term therapy or if relevant clinical symptoms are observed.

2). Gastrointestinal infections caused by bacteria Lansoprazole, like all proton pump inhibitors (PPIs), might increase the counts of bacteria normally present in the gastrointestinal tract. This may increase the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and especially in hospitalised patients, Clostridium difficile.

In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered. pylori, then the instructions for the use of these antibiotics should also be followed. Long-term treatment Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.

Gastrointestinal disorders Very rarely cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered. With the exception of patients treated for the eradication of H.

pylori infection, if diarrhoea persists, administration of lansoprazole should be discontinued, due to the possibility of microscopic colitis with thickening of the collagen bundle or infiltration of inflammatory cells noted in the large intestine submucosa.

In majority of cases, symptoms of microscopic colitis resolve on discontinuation of lansoprazole. g. g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

Bone fractures Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.

Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10– 40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.

8). At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, lansoprazole should be withdrawn immediately. Subacute cutaneous lupus erythematosus (SCLE) […]

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