Posology : מינונים

4.2     Posology and 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 contents of the capsule should not be chewed or crushed.

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.

Acute Duodenal Ulcer

The recommended dosage is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not have 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.

Acute Gastric Ulcer

The recommended dosage is 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not have 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 has been used and healing is usually achieved within 8 weeks.


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


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The recommended alternative treatment regimens for eradication of H pylori are: 
Triple Therapy Regimen

This involves 3 alternatives:
1.    Losec 20 mg, amoxycillin 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 amoxycillin 500 mg and metronidazole 400 mg, both 3 times a day for 1 week.

Dual Therapy Regimen

Losec 40-80 mg daily with amoxicyllin 2 g daily in divided doses for two weeks. In clinical studies daily doses of 1.5-3 g of amoxycillin 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.

Reflux Esophagitis
Treatment

In patients with reflux esophagitis the recommended dosage is 20 mg Losec once daily, given for 4 weeks.

For those patients not fully healed after the initial course, healing usually occurs during a further 4 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 esophagitis the recommended dose is Losec 10 mg 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.

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

Weight                     Dosage
10-20 kg body weight       Losec 10 mg once daily, which may be increased to 20 mg if needed.

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


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.

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.

NSAID-Associated Duodenal Ulcers, Gastric Ulcers, or Gastroduodenal Erosions in Patients with or without Continued NSAID Treatment

Treatment: The recommended dosage of Losec is 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.

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.

Use in the Elderly

No dosage adjustment is necessary in the elderly.
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.


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Use in Patients with Impaired Renal Function
Dose adjustment is not required in patients with impaired renal function.

Method of administration

It is recommended to take Losec capsules in the morning, preferably without food, swallowed whole with half a glass of water. The capsules must not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food

Patients can open the capsule and swallow the contents with half a glass of water or after mixing the contents in a slightly acidic fluid e.g., fruit juice or applesauce, or in non- carbonated water. Patients should be advised that the dispersion should be taken immediately (or within 30 minutes) and always be stirred just before drinking and rinsed down with half a glass of water.

Alternatively patients can suck the capsule and swallow the pellets with half a glass of water.
The enteric-coated pellets must not be chewed.