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.
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 Zoton FasTab 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 Zoton FasTab 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.
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.
There is no need for a dose adjustment in patients with impaired renal function.
Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).
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.
The use of Zoton FasTab is not recommended in children as clinical data are limited (see also section 5.2). 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, Zoton FasTab 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. Zoton FasTab should be taken at least 30 minutes before food (see section 5.2). Zoton FasTab is 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 orodispersible tablets can be dispersed in a small amount of water and administered via a naso-gastric tube or oral syringe.