NEXIUM I.V. is approved for more

patients
than any other I.V. 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

NEXIUM I.V. vs. Protonix I.V.

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

  • 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 professional
  • Treatment with NEXIUM I.V. for more than 10 days has not been studied

Dosing

NEXIUM Pediatric Dosing

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, 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 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 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.

2031108-3281229 Last Updated 8/16

Important Safety Information

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • Symptomatic response to therapy does not rule out the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy
  • Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. This diagnosis should be considered for diarrhea that does not improve
  • PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose (multiple daily doses) and long-term (a year or longer) therapy
  • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events included both new onset and exacerbations. If signs or symptoms consistent with CLE or SLE are noted with NEXIUM, discontinue and refer the patient to a specialist. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks
  • Avoid concomitant use of NEXIUM with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using NEXIUM consider alternative anti-platelet therapy
  • Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12). Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy
  • Concomitant use of NEXIUM and St. John’s wort or rifampin can substantially decrease NEXIUM concentrations. Avoid concomitant use
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM is expected to increase the plasma levels of saquinavir. Consider dose reduction of saquinavir
  • Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • NEXIUM may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction of cilastozol
  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate
  • In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain
  • The ARs reported at a frequency of 1% or greater with NEXIUM I.V. in clinical trials were headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation, and pruritus
  • In pediatric patients 1 to 17 years of age, the most frequently reported ARs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
  • In pediatric patients 1 to 11 months the most frequently reported ARs with NEXIUM include abdominal pain, regurgitation, tachypnea, and increased ALT

Approved Uses

NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Prescribing Information with Medication Guide for NEXIUM. (PDF - 303 KB)

Prescribing Information for NEXIUM I.V. (PDF - 72 KB)

Reference

  1. Prescribing Information for NEXIUM I.V., AstraZeneca Pharmaceuticals LP, Wilmington, DE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.