NEXIUM I.V. IS APPROVED FOR MORE PATIENTS THAN ANY OTHER I.V. PROTON-PUMP INHIBITOR (PPI)

Nexium® I.V. (esomeprazole sodium) for injection is approved for patients greater than 1 month old for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis when oral therapy is not possible or appropriate.1

I.V. Treatment Chart
I.V. Treatment Chart

Protonix® (pantoprazole sodium) is a registered trademark of Takeda GmBH. Prevacid® (lansoprazole) is a registered trademark of Takeda Pharmaceuticals America, Inc.

NEXIUM I.V. is the only I.V. PPI approved by the FDA to treat patients 1 month old or greater.1-3

  • NEXIUM I.V. for Injection is an alternative to oral therapy when oral therapy is not possible or appropriate and is administered in the hospital by a health care professional1
  • The safety and effectiveness of NEXIUM I.V. for more than 10 days have not been demonstrated. As soon as oral therapy is possible or appropriate, discontinue intravenous therapy with NEXIUM I.V. and continue with oral NEXIUM therapy1
NEXIUM I.V. for Patients 1 Month Old or Greater

DOSING

Dosing I.V.
Dosing I.V.

ADMINISTRATION

NEXIUM I.V. for Injection for Adult Patients

Prepare and administer in 2 steps—no filter needed.1

3-minute intravenous injection (20 mg or 40 mg) following reconstitution1

To reconstitute: Draw up 5 mL of 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP), into a syringe and inject solution into a 20-mg or 40-mg vial of NEXIUM I.V. Mix thoroughly. Use within 12 hours of reconstitution.

To administer: Withdraw the reconstituted solution (5 mL) into a syringe and inject through an I.V. port over no less than 3 minutes.

10- to 30-minute intravenous infusion (20 mg or 40 mg) following reconstitution1

To reconstitute: Draw up 5 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP, or 5% Dextrose Injection, USP, from a 50-mL bag into a syringe and inject into the vial of NEXIUM I.V. Mix thoroughly.

To administer: Withdraw the reconstituted solution (5 mL) into a syringe and inject back into the 50-mL bag. Administer as an I.V. infusion over 10 to 30 minutes. Stability times: NSS/12 hours, LR/12 hours, and D5W/6 hours.

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.

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

Store unopened vials away from light. Unopened vials may be stored at 77°F with excursions permitted from 59°F to 86°F.

NEXIUM I.V. for Injection for Pediatric Patients

Patients 1 month to <1 year of age, (dose should be infused over 10 minutes to 30 minutes)1:

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

To reconstitute: For patients 1 month to <1 year of age, draw up 5 mL of 0.9% Sodium Chloride Injection, USP, further diluting to a final volume of 50 mL. Resultant concentration after dilution is:

  • 40 mg vial: 0.8 mg/mL
  • 20 mg vial: 0.4 mg/mL

To administer: For patients 1 month to <1 year of age, withdraw appropriate amount of volume for desired dose (0.5 mg/kg) and administer as an I.V. infusion over 10 minutes to 30 minutes.

Patients 1 year to 17 years of age, (dose should be infused over 10 minutes to 30 minutes)1:

  • 1 year to 17 years
    • body weight less than 55 kg: 10 mg
    • body weight 55 kg or greater: 20 mg

To reconstitute: For patients 1 year to 17 years of age, for the 40 mg vial: draw up 5 mL of 0.9% Sodium Chloride Injection, USP, further diluting to a final volume of 50 mL. Resultant concentration after dilution

  • 50 mL: 0.8 mg/mL

To administer: For patients 1 year to 17 years of age, for the 20 mg dose, withdraw 25 mL of the final solution and administer as an I.V. infusion over 10 minutes to 30 minutes. For the 10 mg dose, withdraw 12.5 mL of the final solution and administer as an I.V. infusion over 10 minutes to 30 minutes.

To reconstitute: For patients 1 year to 17 years of age, for the 20 mg vial: draw up 5 mL of 0.9% Sodium Chloride Injection, USP, further diluting to a final volume of 50 mL. Resultant concentration after dilution

  • 50 mL: 0.4 mg/mL

To administer: For patients 1 year to 17 years of age, for the 20 mg dose, withdraw 50 mL of the final solution and administer as an I.V. infusion over 10 minutes to 30 minutes. For the 10 mg dose, withdraw 25 mL of the final solution and administer as an I.V. infusion over 10 minutes to 30 minutes.

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.

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

Store unopened vials away from light. Unopened vials may be stored at 77°F with excursions permitted from 59°F to 86°F.