LANSOPRAZOLE

Posology Adults 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 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 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 four weeks.

In patients not fully healed the treatment may be continued for another four 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 Impaired hepatic or renal function:

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

Elderly patients:

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 under one year of age should be avoided as the available data does not provide any indication of beneficial effects in the treatment of gastroesophageal reflux disease. Method of administration For best results, Lansoprazole 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). Capsules should be swallowed whole with liquid. g. yoghurt, apple puree) to ease administration. 2). After preparing the suspension or mixture, the drug should be administered immediately.

Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from the available data). 4) Psychiatric disorders Depression Insomnia, hallucination, confusion Visual hallucinations Nervous system disorders Headache, dizziness Restlessness, vertigo, paresthesia, somnolence, tremor Eye disorders Visual disturbances.

4) Renal and urinary disorders Tubulointerstitial nephritis (with possible progression to renal failure) Reproductive system and breast disorders Gynaecomastia General Fatigue Oedema Fever, disorders and administration site conditions hyperhidrosis, angioedema, anorexia, impotence Investigations Increase in cholesterol and triglyceride levels, hyponatremia 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.

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). 2). Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract.

Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella, Campylobacter and 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. 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.

Very rare 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. g. g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

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 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.

Subacute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping lansoprazole.

SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Hypomagnesaemia Severe hypomagnesaemia has been reported in patients treated with proton-pump inhibitors (PPI) 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. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.

g. diuretics), healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. 8). Acute tubulointerstitial nephritis can progress to renal failure. Lansoprazole should be discontinued in case of suspected TIN, and appropriate treatment should be promptly initiated.

Impact on vitamin B12 absorption Like any other acid-reducing drug, lansoprazole can result in reduced absorption of vitamin B12 (cyanocobalamin) through hypo- or achlorhydria. This should be taken into consideration with patients with reduced storage capacity or risk factors for inadequate vitamin B12 absorption who are receiving long-term treatment or if corresponding clinical symptoms have been observed.

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.

As Lansoprazole contains sucrose, patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1.