NEXIUM® I.V. for Injection

NEXIUM Provides a Continuum of Care from hospital to home. Flexible administration options include

  • NEXIUM I.V. for Injection
  • NEXIUM for Delayed-Release Oral Suspension
  • NEXIUM Delayed-Release Capsules

In two studies, NEXIUM I.V. demonstrated acid control


NEXIUM I.V. for excellent acid control

NEXIUM I.V. provided faster and more pronounced acid control than pantoprazole I.V.

  • Greater number of hours with pH > 4 after dosing with NEXIUM I.V. 40 mg vs pantoprazole I.V. 40 mg when both given by 15-minute infusion (11.8 vs 5.6 hours, respectively; P <0.0001)2
  • Greater number of hours with pH > 4 after dosing with NEXIUM I.V. 40 mg given by 15-minute infusion vs pantoprazole I.V. 40 mg when both given by 155-minuite bolus (11.8 vs 7.2 hours, respectively; P <0.001)2
  • Data from a randomized, open –label, 3-way crossover study comparing pharmacodynamic parameters in healthy subjects treated with NEXIUM I.V. 40 mg, pantoprazole I.V. 40 mg, both by 15-minute infusion, and pantoprazole I.V. 40 mg given as a 5-minute bolus injection. There was a washout period of at least 14 days between each treatment.2
Adapted from Hartmann et al, 2007.

Proven acid control with NEXIUM I.V. vs NEXIUM oral:
impressive mean duration with intragastric pH >4

  • Day 1: 10.1 hours with NEXIUM I.V. 40 mg vs 8.8 hours with NEXIUM oral 40 mg3
  • Day 5: 15.9 hours with NEXIUM I.V. 40 mg vs 15.3 hours with NEXIUM oral 40 mg3
Data from a randomized, double-blind, 2-way crossover study comparing pharmacodynamic parameters in healthy subjects treated for 5 days with at least a 13-day washout period. All infusions administered over a period of 30 minutes.

Adapted from Wilder-Smith et al, 2005.

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Approved Uses and Important Safety Information about NEXIUM

NEXIUM I.V. for Injection

NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of adult GERD patients with a history of erosive esophagitis (EE) as an alternative to oral therapy when therapy with NEXIUM Delayed-Release Capsules is not possible or appropriate. Treatment with NEXIUM I.V. should be discontinued as soon as the patient is able to continue treatment with NEXIUM Delayed-Release Capsules.

NEXIUM

Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis (EE)

NEXIUM oral 40 mg and NEXIUM 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed EE.

Maintenance of Healing of EE

NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE. Controlled studies did not extend beyond 6 months.

Symptomatic GERD

NEXIUM 20 mg is indicated for the treatment of heartburn and other symptoms associated with GERD.

Pediatric Use

NEXIUM is indicated for the short-term treatment (up to 8 weeks) of GERD (symptomatic GERD and healing of EE) in patients aged 1 to 17 years of age. Pediatric use is supported by extrapolation of results from studies that supported the approval for NEXIUM for adults and safety and pharmacokinetic studies performed in pediatric and adolescent patients.

Safety and effectiveness for the treatment of symptomatic GERD in patients less than 1 year of age have not been established. Safety and effectiveness for other pediatric uses have not been established.

Important Safety Information

  • NEXIUM and NEXIUM I.V. are contraindicated in patients with known hypersensitivity to any component of the formulations or to substituted benzimidazoles
  • In adult patients, the most frequently reported adverse events (AEs) with NEXIUM include headache, diarrhea, and abdominal pain. Injection site reactions have also been reported with NEXIUM I.V.
  • In pediatric patients 1 to 17 years of age, the most frequently reported AEs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
  • Symptomatic response to therapy does not preclude the presence of gastric malignancy
  • Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer
  • As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other PPIs, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced
  • NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
  • NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Dosing for adults and pediatrics is provided in the Prescribing Information
References
  1. Wilder-Smith CH, Rohss K, Bondarov P, et al. Aliment Pharmacol Ther. 2004;20(10):1099-1104.
  2. Hartmann D, Eickhoff A, Damian U, Riemann JF, Schilling D. Eur J Gastroenterol Hepatol. 2007 Feb;19(2):133-7.