Vaxcel Esomeprazole Dosage/Direction for Use

Adults: Gastric Antisecretory Treatment When The Oral Route Is Not Possible: Patients who cannot take oral medication may be treated parenterally with 20-40mg once daily. Patients with reflux esophagitis should be treated with 40mg once daily. Patients treated symptomatically for reflux disease should be treated with 20mg once daily. For healing of gastric ulcers associated with NSAID therapy the usual dose is 20mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20mg once daily. Usually the intravenous 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, 80mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8mg/h given over 3 days (72 hours). The parenteral treatment period should be followed by oral acid suppression therapy.
Method of Administration: For preparation of reconstituted solution, see Instruction for Use and Handling as follows.
Injection: 40mg dose: 5ml of the reconstituted solution (8mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
20mg dose: 2.5ml or half of the reconstituted solution (8mg/ml) should be given as an intravenous injection over a period of at least 3 minutes.
Infusion: 40mg dose: The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
20mg dose: Half of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
80mg 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 8mg/h).
Special Populations: Patients with 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 Pharmacology: Pharmacokinetics under Actions).
Patients with 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 20mg Vaxcel Esomeprazole 40mg Powder for Injection I.V. should not be exceeded (see Pharmacology: Pharmacokinetics under Actions).
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 80mg Vaxcel Esomeprazole 40mg Powder for Injection for infusion, a continuous intravenous infusion dose of 4mg/h for 71.5 hours may be sufficient (see Pharmacology: Pharmacokinetics under Actions).
Older People: Dose adjustment is not required in the elderly.
Instruction for Use and Handling: The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used. The degradation of reconstituted solution is highly pH dependent and the product must therefore only be reconstituted in the specified volume of 0.9% sodium chloride for intravenous use. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug. From a microbiological point of view, the product is recommended to be used immediately.
Injection: Injection 40mg: A solution for injection (8mg/ml) is prepared by adding 5 ml of 0.9% sodium chloride for intravenous use to the esomeprazole 40 mg vial. The reconstituted solution for injection is clear and colourless to very slightly yellow. The reconstituted solution should be given as an intravenous injection over a period of at least 3 minutes. Half of the volume should be given if 20mg should be administered. Any unused solution after 24 hours should be discarded.
Infusion: Infusion 40mg: A solution for infusion is prepared by dissolving the content of one vial with esomeprazole 40mg in up to 100ml of 0.9% sodium chloride for intravenous use. Half of the volume should be given if 20mg should be administered. Any unused solution after 24 hours should be discarded.
Infusion 80mg: A solution for infusion is prepared by dissolving the contents of two vials of esomeprazole 40mg in up to 100ml of 0.9% sodium chloride for intravenous use.
The reconstituted solution for infusion is clear and colourless to very slightly yellow. The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
Route of Administration: for intravenous injection & infusion only.