General Information

Nexium (esomeprazole magnesium) is a proton pump inhibitor. It is formulation as delayed-release capsule, delayed-release suspension and as an injection for intravenous use. 

Nexium delayed-release capsule and delayed-release suspension are indicated for:

• Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.
• Maintenance of healing of EE in adults.
• Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.
• Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.
• Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.
• Long-term treatment of pathological hypersecretory conditions, including Zollinger Ellison syndrome in adults.

Nexium for delayed-release oral suspension is indicated for the:

• Short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.
• Short-term treatment of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age

Nexium IV is indicated for

• Short-term treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients 1 month to 17 years of age, as an alternative to oral therapy when oral NEXIUM is not possible or appropriate.
• Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults

Nexium delayed-release capsule and delayed-release suspension Recommended Dosing:

Healing of EE (1 year and older) EE due to Acid-Mediated GERD (1 month to less than 1 year)

• Adults 20 mg or 40 mg1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks
• 12 years to 17 years 20 mg or 40 mg once daily for 4 to 8 weeks
• 1 month to 11 years see full prescribing information for weight-based dosing and duration of treatment 

Maintenance of Healing of EE

• Adults 20 mg once daily. Controlled studies do not extend beyond 6 months

Treatment of Symptomatic GERD

• Adults 20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks
• 12 years to 17 years 20 mg once daily for 4 weeks
• 1 year to 11 years 10 mg once daily for up to 8 weeks

Risk Reduction of NSAID-Associated Gastric Ulcer

• Adults 20 mg or 40 mg1 once daily for up to 6 month

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

• Adults Nexium 40 mg1 once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days Clarithromycin 500 mg twice daily for 10 days

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

• Adults Starting dosage is 40 mg twice daily (varies with the individual patient) as long as clinically indicated.

Nexium IV Recommended Dosing

GERD with Erosive Esophagitis

The recommended adult dosage is either 20 mg or 40 mg once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes) for up to 10 days.

• The recommended pediatric dosage is based upon age and weight. See full prescribing information.

Risk Reduction of Rebleeding of Gastric and Duodenal Ulcers

• The recommended adult dosage is 80 mg administered as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for a total treatment duration of 72 hours.

Mechanism of Action

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion. 

Side Effects

Side effects reported with Nexium use include (but are not limited to) the following:

• Headache
• Diarrhea
• Abdominal pain

Clinical Trial Results

Four multicenter, double-blind, randomized trials evaluated the healing rates of Nexium 40 mg, Nexium 20 mg, and omeprazole 20 mg in subjects with endoscopically diagnosed erosive esophagitis. Healing rates were evaluated at week four and eight. At week eight, healing rates were higher with Nexium treatment compared to omeprazole in all four studies.

Two multicenter, randomized, double-blind, placebo-controlled 4-arm trials evaluated the long-term maintenance of healing of erosive esophagitis. The trials included subjects with endoscopically confirmed, healed erosive esophagitis, and they evaluated Nexium 40 mg, 20 mg and 10 mg once-daily over six months of treatment. Subjects remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in subjects treated with Nexium compared to placebo.

Nexium's effectiveness in the resolution of GERD symptoms was evaluated in two multicenter, randomized, double-blind, placebo-controlled trials. These trials were conducted in a total of 717 subjects, and they compared four weeks of treatment with Nexium 20 mg or 40 mg once daily versus placebo. The percentage of subjects who were symptom-free of heartburn was significantly higher in the Nexium groups compared to placebo at all follow-up visits (weeks 1, 2 and 4).

In three European symptomatic GERD trials, no significant treatment related differences were observed between Nexium 20 mg and 40 mg and omeprazole 20 mg.

Nexium in combination with amoxicillan and clarithromycin was tested in two multicenter, randomized, double-blind trials for the eradication of Helicobacter pylori (H. pylori) in subjects with duodenal ulcer disease. H. pylori eradication rates at four weeks post-therapy were significantly higher in the Nexium plus amoxicillin and clarithromycin group than in a Nexium plus clarithromycin or Nexium alone group.