Posology : מינונים

4.2    Posology and method of administration
The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.

For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested.

For preparation and administration instructions see section 6.6 
Adults.

Gastroesophageal Reflux Disease (GERD)
- treatment of erosive reflux esophagitis

40 mg once daily for 4 weeks.

An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

- long-term management of patients with healed esophagitis to prevent relapse           20 mg once daily.

- symptomatic treatment of gastroesophageal reflux disease (GERD) 
20 mg once daily in patients without esophagitis. If symptom control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 20 mg once daily, when needed. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.


Adults
In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and

- healing of Helicobacter pylori associated duodenal ulcer and 
- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.

20 mg NEXIUM with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.

Patients requiring NSAID therapy
- healing of gastric ulcers associated with NSAID therapy: The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.

- prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily.

Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.

40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers.

Special Populations

Impaired renal function
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see section 5.2).

Impaired hepatic function

Dose adjustment is not required in patients with mild to moderate liver impairment.
For patients with severe liver impairment, a maximum dose of 20 mg NEXIUM should not be exceeded (see section 5.2).

Elderly

Dose adjustment is not required in the elderly.
Paediatric population
Adolescents from the age of 12 years

Gastroesophageal Reflux Disease (GERD)

-     treatment of erosive reflux esophagitis:
40 mg once daily for 4 weeks.

An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

-     long-term management of patients with healed esophagitis to prevent relapse 
20 mg once daily.

-     symptomatic treatment of gastroesophageal reflux disease (GERD)       20 mg once daily in patients without esophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using         20 mg once daily.


Treatment of duodenal ulcer caused by Helicobacter pylori
When selecting appropriate combination therapy, consideration should be given to official national, regional and 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 treatment should be supervised by a specialist.
The posology recommendation is: