Nexium Dosage

Generic name: esomeprazole sodium
Dosage form: injection

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The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

General Information

NEXIUM I.V. for Injection should not be administered concomitantly with any other medications through the same intravenous site and/or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection.

The admixture should be stored at room temperature up to 30°C (86°F) and should be administered within the designated time period as listed in Table 1 below. No refrigeration is required.

Table 1 Storage Time for Final (diluted) Product
Diluent Administer within:

0.9% Sodium Chloride Injection, USP

12 hours

Lactated Ringer’s Injection, USP

12 hours

5% Dextrose Injection, USP

6 hours

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

As soon as oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.

GERD with Erosive Esophagitis

Adult Patients

The recommended adult dose is either 20 mg or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated.

Dosage adjustment is not required in patients with mild to moderate liver impairment (child Pugh Classes A and B). For patients with severe liver impairment (child Pugh Class C), a maximum dose of 20 mg once aily of NEXIUM should not be exceeded [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Pediatric Patients

The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.

1 year to 17 years:

 
Body weight less than 55 kg: 10 mg
 
Body weight 55 kg or greater: 20 mg

1 month to less than 1 year of age: 0.5 mg/kg

Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults

Adult dose is 80 mg administered as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/h for a total treatment duration of 72 hours (i.e., includes initial 30-minute dose plus 71.5 hours of continuous infusion). Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment. Intravenous therapy should be followed by oral acid-suppressive therapy.

For patients with liver impairment, no dosage adjustment of the initial esomeprazole 80 mg infusion is necessary. For patients with mild to moderate liver impairment (Child Pugh Classes A and B), a maximum continuous infusion of esomeprazole 6 mg/h should not be exceeded. For patients with severe liver impairment (Child Pugh Class C), a maximum continuous infusion of 4 mg/h should not be exceeded [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Preparation and Administration Instructions

General Information

The reconstituted solution of Nexium I.V. should be stored at room temperature up to 30°C (86°F) and administered within 12 hours after reconstitution. (Administer within 6 hours if 5% Dextrose Injection is used after reconstitution). No refrigeration is required [see Dosage and Administration (2), Table 1].

Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis

Preparation Instructions for Adult Patients

Intravenous Injection (20 mg or 40 mg vial) over no less than 3 minutes

 
The freeze-dried powder should be reconstituted with 5 mL of 0.9% Sodium Chloride Injection, USP.
 
Withdraw 5 mL of the reconstituted solution and administer as an intravenous injection over no less than 3 minutes.

Preparation Instructions for Pediatric Patients

Intravenous Infusion (20 mg or 40 mg) over 10 minutes to 30 minutes

 
A solution for intravenous infusion is prepared by first reconstituting the contents of one vial* with 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP or 5% Dextrose Injection, USP and further diluting the resulting solution to a final volume of 50 mL. The resultant concentration after diluting to a final volume of 50 mL is 0.8 mg/mL (for 40 mg vial) and 0.4 mg/mL (for 20 mg vial). The solution (admixture) should be administered as an intravenous infusion over a period of 10 minutes to 30 minutes.
 
*For patients 1 month to less than 1 year of age, first calculate the dose (0.5 mg/kg) to determine the vial size needed.

Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults

Preparation Instructions for Loading dose (80 mg) to be given over 30 minutes

The loading dose of 80 mg is prepared by reconstituting two 40 mg vials. Reconstitute each 40 mg vial with 5 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be further diluted in 100 mL 0.9% Sodium Chloride Injection, USP for intravenous use. Administer over 30 minutes.

Preparation Instructions for Continuous Infusion to be given at 8 mg/hour for 71.5 hours

The continuous infusion is prepared by using two 40 mg vials. Reconstitute each 40 mg vial with 5 mL each of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be further diluted in 100 mL 0.9% Sodium Chloride Injection, USP for intravenous use. Administer at a rate of 8 mg/hour for 71.5 hours.

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