Usual Adult Dose for Gastroesophageal Reflux Disease

Esomeprazole Magnesium: 20 mg orally once a day

• Duration of therapy: 14 days (over-the-counter [OTC] formulations); 4 weeks (prescription formulations)

Esomeprazole Strontium: 24.65 mg orally once a day

• Duration of therapy: 4 weeks

GERD with Erosive Esophagitis (EE):
Esomeprazole Sodium: 20 mg or 40 mg via IV injection (given over at least 3 minutes) OR IV infusion (given over 10 to 30 minutes) once a day

• Duration of therapy: Up to 10 days

Comments:

• Many patients receiving esomeprazole strontium were healed within 4 to 8 weeks.
• If symptoms do not resolve after 4 weeks with a prescription formulation, an additional 4 weeks may be considered.
• Patients may repeat an OTC course of treatment every 4 months.
• Safety and efficacy of esomeprazole sodium IV for Injection for more than 10 days have not been demonstrated.

Uses:

• Short term treatment of heartburn and symptomatic gastroesophageal reflux disease (GERD)
• Treatment of frequent heartburn occurring at least 2 days a week (OTC formulations)
• Alternative to oral therapy for the short-term treatment of GERD with EE in patients unable to use oral route

Usual Adult Dose for Erosive Esophagitis

Esomeprazole magnesium:

• Healing: 20 to 40 mg orally once a day
• Duration of therapy: 4 to 8 weeks
• Maintenance: 20 mg orally once a day

Esomeprazole strontium:

• Healing: 24.65 to 49.3 mg orally once a day
• Duration of therapy: 4 to 8 weeks
• Maintenance: 24.65 mg orally once a daily

Comments:

• An additional 4 to 8-week course of therapy may be considered in patients not healed after initial treatment.
• Maintenance controlled studies did not extend beyond 6 months.

Uses:

• Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed EE
• To maintain symptom resolution and healing of EE

Usual Adult Dose for Helicobacter pylori Infection

Esomeprazole Magnesium:
Triple therapy: 40 mg orally once a day, taken concomitantly with amoxicillin and clarithromycin

• Duration of therapy: 10 days

Esomeprazole Strontium:
Triple therapy: 49.3 mg orally once a day, taken concomitantly with amoxicillin and clarithromycin

• Duration of therapy:10 days

Comments:

• Refer to the manufacturer product information for dosing for amoxicillin and clarithromycin.
• Susceptibility testing should be done in patients who fail therapy.
• If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
• Eradication of H pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Use (as triple therapy): Treatment of H pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H pylori

Usual Adult Dose for NSAID-Induced Gastric Ulcer

Esomeprazole Magnesium: 20 mg to 40 mg orally once a day

• Duration of therapy: Up to 6 months

Esomeprazole Strontium: 24.65 mg to 49.3 mg orally once a day

• Duration of therapy: Up to 6 months

Comments:

• Patients older than 60 years and/or with history of gastric ulcers are considered to be at risk for developing gastric ulcers.
• Controlled studies do not extend beyond 6 months.

Use: Reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers

Usual Adult Dose for Zollinger-Ellison Syndrome

Esomeprazole Magnesium: 40 mg orally 2 times a day

Esomeprazole Strontium: 49.3 mg orally 2 times a day

Comments:

• Doses up to 240 mg daily have been used.
• The dosage in patients with pathological hypersecretory conditions varies with the individual patient; regimens should be adjusted to individual patient needs.

Use: Long term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome

Usual Adult Dose for Pathological Hypersecretory Conditions

Esomeprazole Magnesium: 40 mg orally 2 times a day

Esomeprazole Strontium: 49.3 mg orally 2 times a day

Comments:

• Doses up to 240 mg daily have been used.
• The dosage in patients with pathological hypersecretory conditions varies with the individual patient; regimens should be adjusted to individual patient needs.

Use: Long term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome

Usual Adult Dose for Duodenal Ulcer Prophylaxis

Esomeprazole Sodium:

• Initial dose: 80 mg via IV infusion over 30 minutes
• Maintenance dose: 8 mg/hr given via IV continuous infusion over 71.5 hours (for a total of 72 hours, or 3 days)

Comments:

• IV therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment.
• IV therapy should be followed by oral acid-suppressive therapy.

Use: Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy

Usual Adult Dose for Gastric Ulcer Prophylaxis

Esomeprazole Sodium:

• Initial dose: 80 mg via IV infusion over 30 minutes
• Maintenance dose: 8 mg/hr given via IV continuous infusion over 71.5 hours (for a total of 72 hours, or 3 days)

Comments:

• IV therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment.
• IV therapy should be followed by oral acid-suppressive therapy.

Use: Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy

Usual Pediatric Dose for Gastroesophageal Reflux Disease

Esomeprazole Magnesium:
1 to 11 years: 10 mg orally once a day

• Duration of therapy: Up to 8 weeks

12 to 17 years: 20 mg orally once a day

• Duration of therapy: 4 weeks

Esomeprazole Sodium:
GERD with EE:
1 month to less than 1 year: 0.5 mg/kg IV infused over 10 to 30 minutes

1 to 17 years:

• Body weight less than 55 kg: 10 mg IV infused over 10 to 30 minutes
• Body weight 55 kg or more: 20 mg IV infused over 10 to 30 minutes

Comment: Esomeprazole magnesium doses over 1 mg/kg/day have not been studied in patients 1 to 11 years of age.

Uses:

• Short term treatment of symptomatic GERD
• Alternative to oral therapy for the short-term treatment of GERD with EE when oral administration is not possible/appropriate

Usual Pediatric Dose for Erosive Esophagitis

Esomeprazole Magnesium:
EE due to Acid-Mediated GERD:
1 month to less than 1 year old:
3 kg to 5 kg: 2.5 mg orally once a day
Greater than 5 kg to 7.5 kg: 5 mg orally once a day
Greater than 7.5 kg to 12 kg: 10 mg orally once a day
Duration of therapy: Up to 6 weeks

Healing of EE:
1 to 11 years:
Less than 20 kg: 10 mg orally once a day
20 kg or more: 10 to 20 mg orally once a day
Duration of therapy: 8 weeks

12 to 17 years: 20 or 40 mg orally once a day

• Duration of therapy: 4 to 8 weeks

Comments:

• Esomeprazole magnesium doses for the healing of EE over 1 mg/kg/day have not been studied in patients 1 to 11 years of age.
• Esomeprazole magnesium doses for EE due to acid-mediated GERD over 1.33 mg/kg/day have not been studied.

Uses:

• Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis
• Short term treatment of erosive esophagitis due to acid-mediated GERD in infants

Renal Dose Adjustments

Esomeprazole Magnesium and Sodium: No adjustment recommended.

Esomeprazole Strontium:

• Mild to moderate renal dysfunction: No adjustment recommended.
• Severe renal dysfunction: Not recommended.

Liver Dose Adjustments

Esomeprazole Magnesium:

• Mild to moderate liver dysfunction (Child-Pugh class A and B): No adjustment recommended.
• Severe liver dysfunction (Child-Pugh class C): Maximum daily dose should not exceed 20 mg.

Esomeprazole Sodium:
Bleeding gastric/duodenal ulcers:
Initial dose: 80 mg via IV infusion over 30 minutes
Maintenance dose:

• Mild to moderate liver dysfunction (Child-Pugh class A and B): 6 mg/hr given via continuous IV infusion for 71.5 hours
• Severe hepatic insufficiency (Child-Pugh class C): 4 mg/hr given via continuous IV infusion over 71.5 hours

GERD:

• Mild to moderate liver dysfunction: No adjustment recommended.
• Severe liver dysfunction: A maximum dose of 20 mg/day should not be exceeded.

Esomeprazole Strontium:

• Mild to moderate liver dysfunction (Child-Pugh class A and B): No adjustment recommended.
• Severe liver dysfunction (Child-Pugh class C): The maximum dose should not exceed 24.65 mg/day.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component, other proton pump inhibitors (PPIs), substituted benzimidazoles or any other ingredient of the formulation
• Use with rilpivirine-containing products (IV formulations)

For the treatment of H pylori (as combination therapy): Refer to the contraindications section of the other antibacterial agents for further information.

Safety and efficacy have not been established in patients younger than 1 month (esomeprazole magnesium prescription formulations and esomeprazole sodium) and 18 years (esomeprazole magnesium OTC tablets and esomeprazole strontium).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral Formulations:

• This drug should be taken at least one hour before meals.
• Capsules and tablets should not be chewed or crushed.
• Delayed-release capsules can be opened and mixed with 1 tablespoon of applesauce and swallowed immediately. Any unused mixture should be discarded. Mixing with other foods has not been evaluated and is not recommended. Do not store for future use.

IV:

• The IV injection of esomeprazole should be administered over at least 3 minutes. The IV infusion should be administered over 10 to 30 minutes.
• Treatment with esomeprazole injection is intended for short-term treatment (up to 10 days).

Storage requirements:

• Keep the delayed-release capsules in a tightly closed container.
• The reconstituted IV solution should be stored at temperatures up to 30C (86F) and administered within 12 hours after reconstitution OR within 6 hours if 5% dextrose injection is used after reconstitution. No refrigeration is required.

Reconstitution/preparation techniques:
Delayed-release capsule:

• For patients with a nasogastric tube (NG), the delayed-release capsule can be opened, emptied into a 60 mL catheter tipped syringe, and mixed with 50 mL of water. Shake for 15 seconds, check for granules remaining in the tip, deliver contents through the NG tube, and flush the NG tube with water. Use mixture immediately after preparing. Rinse syringe with water after each use.

Oral suspension:

• Oral administration: Empty contents of 2.5 mg or 5 mg packet into 5 mL of water. Use 15 mL of water for the 10 mg, 20 mg and 40 mg packets. Stir, let thicken for 2 to 3 minutes, stir again, and drink within 30 minutes. Mix any remaining medicine with more water, stir, and drink.
• Nasogastric (NG) or gastric tube: Add 5 mL water to a catheter tipped syringe and add contents of a 2.5 mg or 5 mg packet. Use 10 mL water for the 10 mg, 20 mg and 40 mg packets. Shake the syringe and let thicken for 2 to 3 minutes. Shake syringe prior to injecting through the NG or gastric tube using a French size 6 or larger. Use mixture within 30 minutes. Refill the syringe with equal amount of water originally used, shake, and flush any remaining contents from NG or gastric tube.

General:

• Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
• Triple therapy: Refer to amoxicillin and clarithromycin prescribing information for contraindications, warnings, and dosing in elderly and renally impaired patients.
• Antacids can be used during treatment.
• Patients receiving long-term therapy should be monitored for adverse events and the need for continued use.
• Esomeprazole strontium 44.6 mg is equivalent to 40 mg esomeprazole.

Monitoring:

• METABOLIC: Magnesium levels, especially in patients at risk of hypomagnesemia

Patient advice:

• Patients should communicate if they are taking, or begin taking, other medications, because this drug can interfere with antiretroviral drugs and drugs that are affected by gastric pH changes.
• Patients should be told that full effect may take 1 to 4 days.
• Patients should be instructed to immediately report and seek care for signs/symptoms of cutaneous reactions and/or diarrhea that does not improve.

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