Posology : מינונים

4.2 Posology and method of administration

Posology
Adults
Gastric antisecretory treatment when the oral route is not possible.
Patients who cannot take oral medication may be treated parenterally with 20-40 mg once daily. Patients with reflux esophagitis should be treated with 40 mg once daily.
Patients treated symptomatically for reflux disease should be treated with 20 mg once daily.
Usually the IV treatment duration is short and transfer to oral treatment should be made as soon as possible.
Prevention of rebleeding of gastric and duodenal ulcers.

Following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).
The parenteral treatment period should be followed by oral acid-suppression therapy.


Method of administration
Method of administration
For preparation of reconstituted solution, see section 6.6.

Injection (40 mg vial)
A solution for injection is prepared by adding 5 mL of 0.9% sodium chloride for intravenous use to the vial.


40 mg dose
5 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
20 mg dose
2.5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of approximately 3 minutes. Any unused solution should be discarded.


Infusion
40 mg dose
The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
20 mg dose
Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.


80 mg bolus dose
The reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.
8mg/h dose
The reconstituted solution should be given as a continuous intravenous infusion over a period of 71.5 hours (calculated rate of infusion of 8 mg/h. See section `Shelf-life` for shelf- life of reconstituted solution).


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 Pharmacokinetic properties section).


Impaired hepatic function
GERD: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg SOLEZOL should not be exceeded. (See Pharmacokinetic properties section)
Bleeding ulcers: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, following an initial bolus dose of 80 mg SOLEZOL for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5           hours may be sufficient (see section Pharmacokinetic properties).


Elderly
Dose adjustment is not required in the elderly.

  Paediatric population
Posology
Children and adolescents aged 1-18 years
Gastric antisecretory treatment when the oral route is not possible
Patients who cannot take oral medication may be treated parenterally once daily, as a part of a full treatment period for GERD (see doses in table below).


Usually the intravenous treatment duration should be short and transfer to oral treatment should be made as soon as possible.


Recommended intravenous doses of esomeprazole
Age group      Treatment of erosive reflux esophagitis       Symptomatic treatment of GERD
1-11 Years     Weight <20 kg: 10 mg once daily               10 mg once daily Weight≥ 20 kg: 10 mg or 20 mg once d il
12-18 Years 40 mg once daily                                 20 mg once daily 


Method of administration
For preparation of reconstituted solution, see section 6.6.

Injection
40 mg dose
5 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
20 mg dose
2.5 ml or half of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.

10 mg dose
1.25 ml of the reconstituted solution (8 mg/ml) should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.


Infusion
40 mg dose
The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
20 mg dose
Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.
10 mg dose
A quarter of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.