Posology : מינונים

4.2     Posology and method of administration

Posology

Adults
Acute Duodenal Ulcer
The recommended dosage is Losec 20 mg once daily. Symptom resolution is rapid and in most patients, healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period. In patients with poorly responsive duodenal ulcer, Losec 40 mg once daily is recommended and healing is usually achieved within 4 weeks.

The effectiveness of Losec is not affected by concomitant NSAID treatment and the usual duration of treatment is recommended.

Maintenance Treatment for the Prevention of Relapse in Patients with Poorly Responsive Peptic Ulcer
For the prevention of relapse in patients with poorly responsive peptic ulcer,20 mg Losec once daily is recommended. In case of recurrence, the dose can be increased to 40 mg Losec once daily.

Acute Gastric Ulcer
The recommended dosage is Losec 20 mg once daily. Symptom resolution is rapid and in most patients, healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period. In patients with poorly responsive gastric ulcer, 40 mg Losec once daily is recommended and healing is usually achieved within eight weeks.

The effectiveness of Losec is not affected by concomitant NSAID treatment and the usual duration of treatment is recommended.


Helicobacter Pylori-Associated in peptic ulcer disease
The recommended alternative treatment regimens for eradication of H pylori are: 
Triple Therapy Regimen

This involves three alternatives:
1.     Losec 20 mg , amoxicillin 1 g, and clarithromycin 500 mg, all twice a day for 1 week.
2.     Losec 20 mg clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg), all twice a day for 1 week.
3.     Losec 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg, both 3 times a day for 1 week.


Dual Therapy Regimen
Losec 40-80 mg daily with amoxicillin 2 g daily in divided doses for two weeks. In clinical studies daily doses of 1.5-3 g of amoxicillin have been used, with or without addition of metronidazole 400 mg t.i.d.

To ensure healing in patients with active peptic ulcer disease refer to dosage recommendations for duodenal and gastric ulcer.

In each regimen, if the patient is still H. pylori positive, therapy may be repeated.

NSAID-Associated Duodenal Ulcers, Gastric Ulcers, or Gastroduodenal Erosions in Patients with or without Continued NSAID Treatment
Treatment: the recommended dosage is Losec 20 mg once daily.
Symptom resolution is rapid, and in most patients, healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.
Prevention: For the prevention of NSAID-associated duodenal ulcers, gastric ulcers, gastroduodenal erosions, and dyspeptic symptoms, the recommended dosage of Losec is 20 mg once daily.

Reflux Esophagitis
Treatment
In patients with reflux esophagitis, the recommended dose is Losec 20 mg once daily given for 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further four weeks treatment. Losec has also been used in a dose of 40 mg once daily in patients with reflux esophagitis refractory to other therapy. Healing usually occurred within 8 weeks.

Long-Term Management
For the long-term management of patients with healed reflux oesophagitis the recommended dose is 10 mg of omeprazole once daily. If needed, the dose can be increased to Losec 20-40 mg once daily.
Maintenance Treatment for the Prevention of Relapse in Patients with Severe Reflux Esophagitis For the prevention of relapse in patients with severe reflux esophagitis, 20 mg Losec once daily is recommended. In case of recurrence, the dose can be increased to 40 mg Losec once daily.

Zollinger-Ellison Syndrome
The recommended initial dosage is 60 mg Losec once daily. The dosage should be adjusted individually and treatment continued as long as is clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily.

Paediatric population

Severe Reflux Esophagitis in Children from One Year of Age and Older and ≥ 10kg 
The recommended dosage regimen for healing is as follows:

Age                   Weight                                 Dosage
≥ 1 year of          10-20 kg body          Omeprazole 10 mg once daily, which may be age                 weight                    increased to 20 mg if needed.

Over 20 kg body       Losec 20 mg once daily, which may be increased weight                         to 40 mg if needed.


Special populations
Use in the Elderly
No dosage adjustment is necessary in the elderly (see section 5.2).
Hepatic impairment
Use in Patients with impaired hepatic function: as bioavailability and half-life can increase in patients with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg.

Renal impairment
Use in Patients with impaired renal function: dose adjustment is not required in patients with impaired renal function (see section 5.2).

Method of administration

Losec capsules should be taken before meals, and are recommended to be given in the morning and swallowed whole with liquid.

For patients with swallowing difficulties the capsule might be opened and the contents swallowed or suspended in a slightly acidic fluid e.g. fruit juice, yoghurt soured milk, or in non- carbonated water. The suspended contents should be taken within 30 minutes.

Alternatively these patients can suck the capsule and swallow the contents. The enteric-coated pellets must not be chewed.

For children who are unable to swallow the capsule whole, or swallow the contents of the opened capsule, or suck the capsule and swallow its contents, Losec must only be administered by opening the capsules and suspending its contents in a slightly acidic fluid as directed above.