Esomeprazole (Lexi-Drugs)

Pronunciation

(es oh ME pray zol)

Brand Names: US

Esomep-EZS; GoodSense Esomeprazole [OTC]; NexIUM; NexIUM 24HR Clear Minis [OTC]; NexIUM 24HR [OTC]; NexIUM I.V.

Brand Names: Canada

ACT Esomeprazole; APO-Esomeprazole; MYLAN-Esomeprazole; NexIUM; PMS-Esomeprazole DR; RAN-Esomeprazole; SANDOZ Esomeprazole

Dosing: Adult

Note: All dosing is expressed in terms of esomeprazole base, regardless of the salt associated with the dosing information. Esomeprazole strontium 24.65 mg is equivalent to 20 mg of esomeprazole base; esomeprazole strontium 49.3 mg is equivalent to 40 mg of esomeprazole base.

Barrett esophagus (off-label use): Oral: Utilize standard doses (20 or 40 mg) once daily (Shaheen 2016; Singh 2014; Spechler 2011); poorly controlled reflux symptoms or esophagitis may require twice daily dosing (Shaheen 2016). The use of 40 mg twice daily (in combination with aspirin) also has been reported (Jankowski 2018).

Dyspepsia (off-label use): Oral: 40 mg once daily for up to 8 weeks (Talley 2007; Pinto-Sanchez 2017; van Zanten 2006).

Erosive esophagitis (healing): Oral: Esomeprazole magnesium, esomeprazole strontium: Initial: 20 to 40 mg once daily for 4 to 8 weeks; if incomplete healing, may continue for an additional 4 to 8 weeks; maintenance: 20 mg once daily (controlled studies did not extend beyond 6 months)

Heartburn (OTC labeling): 20 mg once daily for 14 days (maximum: 20 mg/day); treatment may be repeated after 4 months if needed

Helicobacter pylori eradication: Oral:

American College of Gastroenterology guidelines (Chey 2007; Chey 2017):

Clarithromycin triple regimen: 20 to 40 mg twice daily in combination with clarithromycin 500 mg twice daily and either amoxicillin 1 g twice daily or metronidazole 500 mg 3 times daily; continue regimen for 14 days. Note: Avoid use of clarithromycin triple therapy in patients with risk factors for macrolide resistance (eg, prior macrolide exposure, local clarithromycin resistance rates ≥15%, eradication rates with clarithromycin-based regimens ≤85%) (ACG [Chey 2017]; Fallone 2016).

Bismuth quadruple regimen: 20 mg twice daily in combination with tetracycline 500 mg 4 times daily, metronidazole 250 mg 4 times daily or 500 mg 3 or 4 times daily, and either bismuth subcitrate 120 to 300 mg 4 times daily or bismuth subsalicylate 300 mg 4 times daily; continue regimen for 10 to 14 days.

Concomitant regimen: 20 mg twice daily in combination with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily; continue regimen for 10 to 14 days.

Sequential regimen: 20 mg twice daily plus amoxicillin 1 g twice daily for 5 to 7 days; then continue esomeprazole along with clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 5 to 7 days.

Hybrid regimen: 20 mg twice daily plus amoxicillin 1 g twice daily for 7 days; then continue esomeprazole and amoxicillin along with clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 7 days.

Levofloxacin triple regimen: 20 mg twice daily in combination with amoxicillin 1 g twice daily and levofloxacin 500 mg once daily; continue regimen for 10 to 14 days.

Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice. Esomeprazole magnesium, esomeprazole strontium: 40 mg once daily

Pathological hypersecretory conditions (Zollinger-Ellison syndrome): Oral: Esomeprazole magnesium, esomeprazole strontium: 40 mg twice daily; adjust regimen to individual patient needs; doses up to 240 mg daily have been administered

Prevention of NSAID-induced gastric ulcers: Oral: Esomeprazole magnesium, esomeprazole strontium: 20 to 40 mg once daily for up to 6 months; Note: 40 mg daily did not show additional benefit over 20 mg daily in clinical trials.

Prevention of recurrent gastric or duodenal ulcer bleeding postendoscopy: IV: 80 mg over 30 minutes, followed by 8 mg/hour continuous infusion for a total of 72 hours, then 40 mg orally once daily for 27 additional days (Sung 2009) or may follow continuous infusion with any single daily-dose oral proton pump inhibitor (PPI) for a duration dictated by the underlying etiology (Barkun 2010). Note: The use of intermittent PPIs was found to be comparable with the use of continuous infusion PPIs in patients with high-risk endoscopic findings and may be preferred (Sachar 2014).

Symptomatic gastroesophageal reflux: Oral: Esomeprazole magnesium, esomeprazole strontium: 20 mg once daily for 4 weeks; may consider an additional 4 weeks of treatment if symptoms do not resolve

Treatment of GERD (short-term): IV: 20 mg or 40 mg once daily. Note: Indicated only in cases where oral therapy is inappropriate or not possible; safety/efficacy ≥10 days has not been established.

Treatment of NSAID-induced gastric ulcers (off-label use): Oral: Esomeprazole magnesium: 20 mg once daily for 8 weeks (Goldstein 2007)

Discontinuation of therapy: Oral: Some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One recommendation is to decrease the dose by 50% over 2 weeks to 4 weeks. If the patient is already on the lowest possible dose, alternate day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be re-evaluated (Kim 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

Oral:

Esomeprazole magnesium: Mild-to-severe impairment: No dosage adjustment necessary.

Esomeprazole strontium:

Mild-to-moderate impairment: No dosage adjustment necessary.

Severe impairment: Use is not recommended (has not been studied).

IV: Mild-to-severe impairment: No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Oral:

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Maximum: 20 mg daily.

IV:

Treatment of GERD (short-term):

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Dose should not exceed 20 mg daily

Prevention of recurrent gastric or duodenal ulcer bleeding postendoscopy:

Mild to moderate impairment (Child-Pugh class A or B): 80 mg over 30 minutes, followed by a maximum continuous infusion of 6 mg/hour for a total of 72 hours

Severe impairment (Child-Pugh class C): 80 mg over 30 minutes, followed by a maximum continuous infusion of 4 mg/hour for a total of 72 hour

Dosing: Pediatric

Erosive esophagitis associated with GERD:

Oral:

Infants: Note: Safety and efficacy of doses >1.33 mg/kg/day has not been studied.

3 to 5 kg: 2.5 mg once daily for up to 6 weeks

>5 to 7.5 kg: 5 mg once daily for up to 6 weeks

>7.5 kg: 10 mg once daily for up to 6 weeks

Children 1 to 11 years: Note: Safety and efficacy of doses >1 mg/kg/day has not been studied.

<20 kg: 10 mg once daily for 8 weeks

>20 kg: 10 or 20 mg once daily for 8 weeks

Children ≥12 years and Adolescents: 20 to 40 mg once daily for 4 to 8 weeks

IV: Note: Indicated only in cases where oral therapy is inappropriate or not possible; safety and efficacy >10 days has not been established.

Infants: 0.5 mg/kg/dose once daily

Children and Adolescents ≤17 years:

<55 kg: 10 mg once daily

≥55 kg: 20 mg once daily

GERD, symptomatic:

Fixed dosing: Oral:

Children 1 to 11 years: 10 mg once daily for up to 8 weeks. Note: Safety and efficacy of doses >1 mg/kg/day has not been studied.

Children ≥12 years and Adolescents: 20 mg once daily for 4 to 8 weeks

Weight-directed dosing: Oral: Infants, Children, and Adolescents: 0.7 to 3.3 mg/kg/day (AAP [Lightdale 2013])

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: Oral, IV: No dosage adjustments necessary.

Dosing: Hepatic Impairment: Pediatric

There are no specific pediatric recommendations; based on experience in adult patients, adjustment suggested in severe impairment.

Use: Labeled Indications

Oral:

Esomeprazole magnesium and esomeprazole strontium:

Gastroesophageal reflux disease (Rx only):

Healing of erosive esophagitis: Short-term (4 to 8 weeks) treatment of erosive esophagitis

Maintenance of healing of erosive esophagitis: Maintaining symptom resolution and healing of erosive esophagitis

Symptomatic gastroesophageal reflux disease: Short-term (4 to 8 weeks) treatment of symptomatic gastroesophageal reflux disease (GERD)

Helicobacter pylori eradication (Rx only): As part of a multidrug regimen for Helicobacter pylori eradication in patients with duodenal ulcer disease (active or history of within the past 5 years)

Risk reduction of nonsteroidal anti-inflammatory drug-associated gastric ulcer (Rx only): Prevention of gastric ulcers associated with continuous NSAID therapy in patients at risk (age ≥60 years and/or history of gastric ulcer)

Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (Rx only): Treatment (long-term) of pathological hypersecretory conditions including Zollinger-Ellison syndrome

Esomeprazole magnesium:

Heartburn (OTC labeling): Treatment of frequent heartburn (≥2 days per week).

IV: Esomeprazole sodium:

Gastroesophageal reflux disease (Rx only): Short-term (≤10 days) treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis in pediatric patients 1 month to 17 years of age and adults when oral therapy is not possible or appropriate

Risk reduction of ulcer rebleeding postprocedure (Rx only): Decrease the risk of rebleeding postendoscopy for acute bleeding gastric or duodenal ulcers in adults

Use: Off-Label: Adult

  Barrett esophagusLevel of Evidence [B, G]

Data from a meta-analysis of observational studies evaluating acid suppressive therapy and the risk of esophageal adenocarcinoma or high-grade dysplasia in patients with Barrett esophagus showed that proton pump inhibitors were associated with a reduction in the risk of esophageal adenocarcinoma and high-grade dysplasia associated with Barrett esophagus; a longer duration of PPI use was associated with a greater protective effect Ref. The use of esomeprazole in combination with aspirin for the treatment of Barrett esophagus, including preventing neoplastic progression, has also been reported Ref.

Guidelines from the American College of Gastroenterology for the diagnosis and management of Barrett esophagus and a position statement from the American Gastroenterological Association on the management of Barrett esophagus recommend the use of proton pump inhibitors in the management of Barrett esophagus.

  DyspepsiaLevel of Evidence [A, G]

Data from two randomized, double-blinded, placebo-controlled trials supports the use of esomeprazole for the treatment of dyspepsia Ref. In addition, data from a systematic review support the use of esomeprazole for the treatment of patients with ulcer and reflux-like functional dyspepsia Ref.

Based on the American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines for the management of dyspepsia, the use of esomeprazole is effective and recommended treatment for dyspepsia and functional dyspepsia in patients <60 years of age who are H. pylori negative or who remain symptomatic after H. pylori eradication therapy Ref.

  Stress ulcer prophylaxis in critically ill patientsLevel of Evidence [G]

Based on the Surviving Sepsis Campaign International Guidelines for the Management of Severe Sepsis and Septic Shock, stress ulcer prophylaxis using a proton pump inhibitor or a histamine H2-receptor antagonist is recommended in sepsis or septic shock patients who have GI bleeding risk factors.

  Treatment of NSAID-induced gastric ulcersLevel of Evidence [A]

Data from a multicenter, randomized, double-blind, parallel-group clinical trial supports the use of esomeprazole in the treatment of NSAID-induced gastric ulcers Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Barrett Esophagus:

ACG, “Diagnosis and Management of Barrett’s Esophagus,” January 2016

AGA, “Management of Barrett’s Esophagus,” 2011

Critical Care:

“Surviving Sepsis Campaign: International Guidelines for the Management of Severe Sepsis and Septic Shock: 2016,” March 2017.

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Dyspepsia:

ACG/CAG “Guidelines for the Management of Dyspepsia,” June 2017

Gastroesophageal Reflux Disease:

ACG, “Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease,” March 2013

AGA, “Medical Position Statement on the Management of Gastroesophageal Reflux Disease,” October 2008

Helicobacter pylori Infection:

“ACG Guideline on the Management of Helicobacter pylori Infection,” August 2007

“ACG Guideline on the Treatment of Helicobacter pylori Infection,” February 2017

NSAID-Related Ulcers:

“ACG Guidelines for Prevention of NSAID-Related Ulcer Complications,” February 2009

Proton Pump Inhibitors & Thienopyridines:

ACCF/AHA/SCAI “2011 Guideline for Percutaneous Coronary Intervention,” November 2011

“ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines,” December 2010

Canadian Cardiovascular Society, “The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Upper Gastrointestinal Bleeding:

“International Consensus Recommendations on the Management of Patients with Nonvariceal Upper Gastrointestinal Bleeding,” 2010

Usual Infusion Concentrations: Adult

IV infusion: 20 mg in 50 mL (concentration: 0.4 mg/mL) or 40 mg in 50 mL (concentration: 0.8 mg/mL) of D5W, LR, or NS

Administration: IV

Flush line prior to and after administration with NS, LR, or D5W.

Treatment of GERD: May be administered by injection (≥3 minutes), intermittent infusion (10 to 30 minutes)

Prevention of recurrent gastric or duodenal ulcer bleeding postendoscopy: Administer the loading dose over 30 minutes, followed by the continuous infusion at a rate of 8 mg/hour over 71.5 hours (adjust rate of continuous infusion in patients with hepatic dysfunction)

Administration: Injectable Detail

pH: 9 to 11

Administration: Oral

Capsule: Swallow whole and take at least 1 hour before eating (best if taken before breakfast). Capsule can be opened and contents mixed with 1 tablespoon of applesauce. Swallow immediately; mixture should not be chewed or warmed. For patients with difficulty swallowing, use of granules may be more appropriate.

Granules: Empty the 2.5 mg or 5 mg packet into a container with 5 mL of water or the 10 mg, 20 mg, or 40 mg packet into a container with 15 mL of water and stir; leave 2 to 3 minutes to thicken. Stir and drink within 30 minutes. If any medicine remains after drinking, add more water, stir and drink immediately.

Tablet: Swallow whole; do not crush or chew; administer with a full glass of water before breakfast in the morning.

Tablet [Canadian product]: Swallow whole with water or may be dispersed in a half a glass of noncarbonated water. Stir until tablets disintegrate, and drink the liquid with pellets immediately or within 30 minutes. Do not chew or crush pellets. After drinking, rinse glass with water and drink.

Administration: Other

Nasogastric tube:

Capsule: Open capsule and place intact granules into a 60 mL catheter-tip syringe; mix with 50 mL of water. Replace plunger and shake vigorously for 15 seconds. Ensure that no granules remain in syringe tip. Do not administer if pellets dissolve or disintegrate. Use immediately after preparation. After administration, flush nasogastric tube with additional water.

Granules: Delayed release oral suspension granules can also be given by nasogastric or gastric tube. If using a 2.5 mg or 5 mg packet, first add 5 mL of water to a catheter-tipped syringe, then add granules from packet. If using a 10 mg, 20 mg, or 40 mg packet, first add 15 mL of water to a catheter-tipped syringe, then add granules from packet. Shake the syringe, leave 2 to 3 minutes to thicken. Shake the syringe and administer through nasogastric or gastric tube (size 6 French or greater) within 30 minutes. Refill the syringe with equal amount (5 mL or 15 mL) of water, shake and flush nasogastric/gastric tube.

Tablet [Canadian product]: Dispersed tablets can also be given by nasogastric tube (size 8 to 20 French) using a 25 to 60 mL disposable syringe. Disperse tablet in 50 mL of water. After administration, flush with additional 25 to 50 mL of water to clear the syringe and tube. In larger nasogastric feeding tubes (ie, size 14 French or greater), the dispersion volume may be reduced to 25 mL.

Administration: Pediatric

Oral: Administer at least 1 hour before food or meals

Capsule: Swallow whole, do not chew or crush. For patients with difficulty swallowing the capsule, capsule may be opened and the enteric coated pellets may be mixed with 1 tablespoon of applesauce (applesauce should not be hot) and swallowed immediately; do not chew or crush granules; do not store mixture for future use.

Nasogastric tube administration: Open capsule and place intact granules into a 60 mL catheter-tipped syringe; mix with 50 mL of water. Replace plunger and shake vigorously for 15 seconds. Ensure that no granules remain in syringe tip. Do not administer if pellets dissolve or disintegrate. Use immediately after preparation. After administration, flush nasogastric tube with additional water.

Granules: Mix contents of the 2.5 mg or 5 mg packet with 5 mL of water or the 10 mg, 20 mg, or 40 mg packet with 15 mL water and stir; leave for 2-3 minutes to thicken; stir and drink within 30 minutes. If any medicine remains after drinking, add more water, stir and drink immediately.

Nasogastric or gastric tube administration: If using a 2.5 mg or 5 mg packet, first add 5 mL of water to a catheter-tipped syringe, then add granules from packet. If using a 10 mg, 20 mg, or 40 mg packet, first add 15 mL of water to a catheter-tipped syringe, then add granules from packet. Shake the syringe, leave 2-3 minutes to thicken. Shake the syringe and administer through nasogastric or gastric tube (French size 6 or greater) within 30 minutes. Refill the syringe with an equal amount (5 mL or 15 mL) of water, shake and flush tube.

IV: Flush line prior to and after administration with NS, LR, or D5W.

Infants, Children, and Adolescents: Administer desired dose by intermittent infusion over 10 to 30 minutes. The manufacturer recommends that children receive intravenous esomeprazole by intermittent infusion only.

Dietary Considerations

Take at least 1 hour before meals; best if taken before breakfast.

Storage/Stability

Capsules:

Esomeprazole magnesium: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Esomeprazole strontium: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Granules: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Powder for injection: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Per the manufacturer, following reconstitution, solution for injection prepared in NS, and solution for infusion prepared in NS or LR should be used within 12 hours; solution for infusion prepared in D5W should be used within 6 hours. Refrigeration is not required following reconstitution.

Additional stability data: Following reconstitution, solutions for infusion prepared in D5W, NS, or LR in PVC bags are chemically and physically stable for 48 hours at room temperature (25°C) and for at least 120 hours under refrigeration (4°C) (Kupiec 2008).

Tablets: Store at 20°C to 25°C (68°F to 77°F).

Preparation for Administration: Adult

Granules for oral administration: Empty the 2.5 mg or 5 mg packet into a container with 5 mL of water or empty the 10 mg, 20 mg, or 40 mg packet into a container with 15 mL of water and stir; leave 2-3 minutes to thicken.

Powder for injection:

For IV injection (≥3 minutes): Adults: Reconstitute powder with 5 mL NS.

For IV infusion (10 to 30 minutes): Initially reconstitute powder with 5 mL of NS, LR, or D5W, then further dilute to a final volume of 50 mL.

For IV infusion (loading dose and continuous infusion): Prepare the 80 mg loading dose by reconstituting two 40 mg vials with NS (5 mL each); the contents of the two vials should then be further diluted in NS 100 mL. To prepare the continuous infusion, also reconstitute two 40 mg vials with NS (5 mL each); the contents of the two vials should then be further diluted in NS 100 mL.

Preparation for Administration: Pediatric

Oral: Granules: Mix contents of the 2.5 mg or 5 mg packet with 5 mL of water or the 10 mg, 20 mg, or 40 mg packet with 15 mL of water and stir; leave 2 to 3 minutes to thicken.

IV: For IV infusion (10 to 30 minutes): Infants, Children, and Adolescents: Reconstitute powder (20 mg or 40 mg) with 5 mL of NS, LR, or D5W; further dilute to a final volume of 50 mL to achieve a final concentration of 0.4 mg/mL or 0.8 mg/mL, respectively

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, fatigue, diarrhea, constipation, flatulence, nausea, or dry mouth. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), severe dizziness, passing out, severe abdominal pain, bone pain, chills, pharyngitis, shortness of breath, excessive weight loss, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), or injection site irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Esomeprazole strontium delayed release capsuleshttps://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202342s005lbl.pdf#page=29

NexIUM capsules, granules for oral suspension: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33

Contraindications

Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to esomeprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Concurrent use with rilpivirine.

OTC labeling: When used for self-medication (OTC), do not use if you have trouble or pain when swallowing food; vomiting with blood, or bloody or black stools; heartburn with lightheadedness, dizziness, or sweating; chest pain or shoulder pain with shortness of breath, sweating, pain spreading to arms, neck or shoulders, or lightheadedness; frequent chest pain

Warnings/Precautions

Concerns related to adverse effects:

• Carcinoma: No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia have occurred.

• Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young adults up to the elderly. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of esomeprazole.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with proton pump inhibitor (PPI) therapy. Patients on high-dose or long-term therapy (≥1 year) should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.

• Fundic gland polyps: Use of proton pump inhibitors (PPIs) increases risk of fundic gland polyps, especially with long-term use >1 year. May occur without symptoms but nausea, vomiting, or abdominal pain may occur; GI bleeding and/or anemia may occur with ulcerated polyps. Diagnosis of polyps may also increase risk for small intestinal blockage. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of proton pump inhibitors may increase risk of these infections.

• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of ≥3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of esomeprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops.

• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

• Hepatic impairment: Patients with severe hepatic impairment may require dosage reductions.

• Renal impairment: Pharmacokinetics of esomeprazole are not expected to be altered in renal impairment; dosage adjustments are not necessary for any degree of renal impairment when using esomeprazole magnesium or esomeprazole sodium. However, since pharmacokinetics of the strontium may be reduced in mild to moderate renal impairment, esomeprazole strontium is not recommended for use in severe impairment (has not been studied).

Concurrent drug therapy issues:

• Clopidogrel: Proton pump inhibitors (PPIs) may diminish the therapeutic effect of clopidogrel, thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Bioavailability may be increased in elderly patients.

• Pediatric: Esomeprazole strontium: Strontium competes with calcium for intestinal absorption and is incorporated into bone; use of esomeprazole strontium in pediatric patients is not recommended.

Dosage form specific issues:

• Intravenous: Safety and efficacy of IV treatment for GERD beyond 10 days have not been established; transition from IV to oral therapy as soon possible.

Other warnings/precautions:

• Appropriate use: Helicobacter pylori eradication: Short-term combination therapy (≤7 days) has been associated with a higher incidence of treatment failure. The American College of Gastroenterology recommends 10 to 14 days of therapy (triple or quadruple) for eradication of H. pylori (Chey 2017).

• Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop esomeprazole treatment ≥14 days before CgA test; if CgA level high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results.

• Self-medication (OTC use): When used for self-medication (OTC), notify health care provider before use if any of the following are present: heartburn for >3 months; frequent wheezing, particularly with heartburn; unexplained weight loss; nausea or vomiting; or stomach pain. Discontinue use and notify health care provider if heartburn continues or worsens; diarrhea occurs; if >14 days of therapy is needed; or if >1 course of therapy is needed every 4 months.

Geriatric Considerations

Dose adjustment is not necessary.

Use has been associated with C. difficile infection, bone loss and fractures, and hypomagnesemia. Refer to Medication Safety Issues for Beers Criteria information.

Pregnancy Considerations

Recommendations for the treatment of GERD in pregnancy are available. As in nonpregnant patients, lifestyle modifications followed by other medications are the initial treatments (Body 2016; Huerta-Iga 2016; Katz 2013; van der Woude 2014). Based on available data, PPIs may be used when clinically indicated (use of an agent with more data in pregnancy may be preferred) (Body 2016; Matok 2012; Pasternak 2010; van der Woude 2014).

Esomeprazole is the s-isomer of omeprazole; refer to the omeprazole monograph for additional information.

Breast-Feeding Considerations

Esomeprazole is the s-isomer of omeprazole. Because omeprazole is present in breast milk (Marshall 1998), it is likely that esomeprazole is present in breast milk.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Refer to omeprazole monograph for additional information.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Unless otherwise specified, percentages represent adverse reactions identified in clinical trials evaluating the oral formulation.

>10%: Central nervous system: Headache (2% to 11%)

1% to 10%:

Central nervous system: Irritability (infants: ≥5%), dizziness (intravenous: ≤3%; oral: <1%), vertigo (intravenous: ≤3%), drowsiness (children: 2%; adults: <1%)

Dermatologic: Pruritus (intravenous: 1%; oral: <1%)

Endocrine & metabolic: Altered thyroid hormone levels (increased thyroxine: ≤1%), decreased serum potassium (≤1%), decreased serum sodium (≤1%), decreased thyroid hormones (thyroxine: ≤1%), increased gastrin (≤1%), increased serum potassium (≤1%), increased serum sodium (≤1%), increased thyroid stimulating hormone level (≤1%), increased uric acid (≤1%)

Gastrointestinal: Flatulence (intravenous: 10%; oral: ≥1%), diarrhea (2% to 4%), abdominal pain (1% to 6%), nausea (intravenous: 6%; oral: ≥1% to 2%), vomiting (infants: 1% to ≥5%; adults: <1%), xerostomia (intravenous: 4%; oral: ≥1%), constipation (intravenous: 3%; oral: ≥1%)

Hematologic & oncologic: Quantitative disorders of platelets (≤1%)

Hepatic: Increased serum alkaline phosphatase (≤1%), increased serum alanine aminotransferase (≤1%), increased serum aspartate aminotransferase (≤1%)

Local: Injection site reaction (intravenous: 2% to 4%)

Renal: Increased serum creatinine (≤1%)

Respiratory: Cough (intravenous: 1%; oral: <1%), tachypnea (infants, oral: 1%)

Miscellaneous: Fever (intravenous: 4%; oral: <1%)

Frequency not defined:

Cardiovascular: Esophageal varices

Gastrointestinal: Barrett esophagus, duodenitis, esophageal stenosis, esophageal ulcer, esophagitis, gastritis, mucosal discoloration

Hematologic & oncologic: Benign polyp

Miscellaneous: Benign nodule

<1%, postmarketing, and/or case reports: Acne vulgaris, acute interstitial nephritis, aggressive behavior, ageusia, agitation, agranulocytosis, albuminuria, alopecia, altered sense of smell, anaphylactic shock, anaphylaxis, anemia, angioedema, anorexia, apathy, aphthous stomatitis, arthralgia, arthropathy, asthenia, back pain, blurred vision, bone fracture, bronchospasm, candidiasis (urogenital), cervical lymphadenopathy, change in bowel habits, chest pain, Clostridioides (formerly Clostridiumdifficile-associated diarrhea, colitis (microscopic), confusion, conjunctivitis, cutaneous lupus erythematosus (including exacerbations), cyanocobalamin deficiency, cystitis, depression, dermatitis, diaphoresis, dysgeusia, dysmenorrhea, dyspepsia, dysphagia, dyspnea, dysuria, edema, enlargement of abdomen, epigastric pain, epistaxis, eructation, erythema multiforme, erythematous rash, exacerbation of arthritis, exacerbation of asthma, facial edema, fatigue, fibromyalgia syndrome, flu-like symptoms, flushing, frequent bowel movements, fungal infection, gastroenteritis, gastrointestinal candidiasis, gastrointestinal dysplasia, gastrointestinal hemorrhage, genital candidiasis, glycosuria, goiter, gynecomastia, hallucination, hematuria, hepatic encephalopathy, hepatic failure, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2014), hernia of abdominal cavity, hiccups, hot flash, hyperbilirubinemia, hyperhidrosis, hypersensitivity reaction, hypertension, hypertonia, hyperuricemia, hypochromic anemia, hypoesthesia, hypomagnesemia (with or without hypocalcemia and/or hypokalemia), hyponatremia, impotence, increased appetite, increased thirst, insomnia, interstitial nephritis, jaundice, laryngeal edema, leukocytosis, leukopenia, maculopapular rash, malaise, melena, menstrual disease, migraine, mouth disease, muscle cramps, myalgia, myasthenia, nervousness, otalgia, otitis media, pain, pancreatitis, pancytopenia, paresthesia, pathological fracture due to osteoporosis, peripheral edema, pharyngeal disease, pharyngitis, polymyalgia rheumatica, polyp (fundic gland), polyuria, pruritus ani, rectal disease, renal disease (chronic; [Lazarus 2016]), rhinitis, rigors, sinusitis, skin photosensitivity, skin rash, sleep disorder, Stevens-Johnson syndrome, stomatitis, systemic lupus erythematosus (including exacerbations), tachycardia, thrombocytopenia, tinnitus, tongue disease, tongue edema, toxic epidermal necrolysis, tremor, urinary frequency, urine abnormality, urticaria, vaginitis, vertigo, visual disturbance, visual field defect, weight gain, weight loss

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C19 (major), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2C19 (weak)

Drug Interactions 

Acalabrutinib: Proton Pump Inhibitors may decrease the serum concentration of Acalabrutinib. Risk X: Avoid combination

Amphetamine: Proton Pump Inhibitors may increase the absorption of Amphetamine. Risk C: Monitor therapy

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider therapy modification

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Risk C: Monitor therapy

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Risk D: Consider therapy modification

Cefpodoxime: Proton Pump Inhibitors may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy

Cefuroxime: Proton Pump Inhibitors may decrease the absorption of Cefuroxime. Risk X: Avoid combination

Cilostazol: CYP2C19 Inhibitors may increase the serum concentration of Cilostazol. Management: Consider reducing the cilostazol dose to 50 mg twice daily in patients who are also receiving inhibitors of CYP2C19. Risk D: Consider therapy modification

Citalopram: Esomeprazole may increase the serum concentration of Citalopram. Risk C: Monitor therapy

Clopidogrel: Esomeprazole may diminish the antiplatelet effect of Clopidogrel. Esomeprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Clopidogrel prescribing information recommends avoiding concurrent use with esomeprazole. Rabeprazole or pantoprazole may be lower-risk alternatives to esomeprazole. Risk D: Consider therapy modification

CYP2C19 Inducers (Moderate): May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Cysteamine (Systemic): Proton Pump Inhibitors may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dacomitinib: Proton Pump Inhibitors may decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with proton pump inhibitors. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA. Risk X: Avoid combination

Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Risk X: Avoid combination

Delavirdine: Proton Pump Inhibitors may decrease the serum concentration of Delavirdine. Management: Chronic therapy with proton pump inhibitors (PPIs) should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Dextroamphetamine: Proton Pump Inhibitors may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy

Doxycycline: Proton Pump Inhibitors may decrease the bioavailability of Doxycycline. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Risk X: Avoid combination

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Risk C: Monitor therapy

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Risk D: Consider therapy modification

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Risk C: Monitor therapy

Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Risk C: Monitor therapy

Itraconazole: Proton Pump Inhibitors may increase the serum concentration of Itraconazole. Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any proton pump inhibitors (PPIs). Exposure to Tolsura brand itraconazole may be increased by PPIs; consider itraconazole dose reduction. Risk D: Consider therapy modification

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Risk D: Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Risk D: Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Proton Pump Inhibitors may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor therapy

Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor therapy

Nelfinavir: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Proton Pump Inhibitors may decrease the serum concentration of Nelfinavir. Risk X: Avoid combination

Neratinib: Proton Pump Inhibitors may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Risk D: Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Risk X: Avoid combination

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Risk D: Consider therapy modification

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Esomeprazole. Risk X: Avoid combination

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination

Riociguat: Proton Pump Inhibitors may decrease the serum concentration of Riociguat. Risk C: Monitor therapy

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Risk X: Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy

Secretin: Proton Pump Inhibitors may diminish the diagnostic effect of Secretin. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of proton pump inhibitors (PPIs) and secretin, and discontinue PPIs several weeks prior to secretin administration, with the duration of separation determined by the specific PPI. See full monograph for details. Risk D: Consider therapy modification

St John’s Wort: May decrease the serum concentration of Esomeprazole. Risk X: Avoid combination

Tacrolimus (Systemic): Proton Pump Inhibitors may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose adjustment may be required. Rabeprazole, pantoprazole, or selected H2-receptor antagonists (i.e., ranitidine or famotidine) may be less likely to interact. Genetic testing may predict patients at highest risk. Risk D: Consider therapy modification

Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Esomeprazole may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Voriconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating voriconazole. Risk C: Monitor therapy

Food Interactions

Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam, 2013).

Test Interactions

Esomeprazole may falsely elevate serum chromogranin A (CgA) levels. The increased CgA level may cause false-positive results in the diagnosis of a neuroendocrine tumor. Temporarily stop esomeprazole ≥14 days prior to assessing CgA level; repeat level if initially elevated; use the same laboratory for all testing of CgA levels.

Genes of Interest
Monitoring Parameters

Susceptibility testing recommended in patients who fail H. pylori eradication regimen. Monitor for rebleeding in patients with peptic ulcer bleed. For patients expected to be on prolonged therapy or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (eg, diuretics), consider monitoring magnesium levels prior to initiation of treatment and periodically thereafter.

Advanced Practitioners Physical Assessment/Monitoring

Assess effectiveness and interactions of other medications patient may be taking that are dependent on cytochrome P450 metabolism or on an acid environment for absorption.

Nursing Physical Assessment/Monitoring

Monitor for rebleeding; ongoing diarrhea related to C. difficile; fractures in patients with a history of osteoporosis, tetany, arrhythmias; and seizures related to hypomagnesemia. Monitor for common side effects including headache, nausea, abdominal discomfort, dry mouth, diarrhea, gas, constipation, and drowsiness.

Dosage Forms Considerations

Esomeprazole strontium 49.3 mg is equivalent to 40 mg of esomeprazole base.

Esomep-EZS Kit contains delayed release capsules, packaged with Pill Swallowing Spray

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Delayed Release, Oral, as magnesium [strength expressed as base]:

GoodSense Esomeprazole: 20 mg [gluten free; contains brilliant blue fcf (fd&c blue #1)]

NexIUM: 20 mg, 40 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

NexIUM 24HR: 20 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

NexIUM 24HR Clear Minis: 20 mg [contains corn starch, fd&c blue #2 (indigotine), fd&c blue #2 aluminum lake, fd&c red #40]

Generic: 20 mg, 40 mg

Capsule Delayed Release, Oral, as strontium:

Generic: 24.65 mg [DSC], 49.3 mg

Kit, Oral, as magnesium [strength expressed as base]:

Esomep-EZS: 20 mg [contains brilliant blue fcf (fd&c blue #1), sodium benzoate]

Packet, Oral, as magnesium [strength expressed as base]:

NexIUM: 2.5 mg (30 ea); 5 mg (30 ea); 10 mg (30 ea); 20 mg (30 ea); 40 mg (30 ea)

Solution Reconstituted, Intravenous, as sodium [strength expressed as base]:

NexIUM I.V.: 40 mg (1 ea) [contains edetate disodium]

Generic: 20 mg (1 ea); 40 mg (1 ea)

Solution Reconstituted, Intravenous, as sodium [strength expressed as base, preservative free]:

Generic: 40 mg (1 ea)

Tablet Delayed Release, Oral, as magnesium [strength expressed as base]:

NexIUM 24HR: 20 mg [contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Delayed Release, Oral, as magnesium [strength expressed as base]:

Generic: 40 mg

Packet, Oral, as magnesium [strength expressed as base]:

NexIUM: 10 mg (28ea, 30ea)

Tablet Delayed Release, Oral:

NexIUM: 40 mg

Generic: 40 mg

Tablet Delayed Release, Oral, as magnesium [strength expressed as base]:

NexIUM: 20 mg

Generic: 20 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A02BC05
Generic Available (US)

May be product dependent

Pricing: US

Capsule, delayed release (Esomeprazole Magnesium Oral)

20 mg (per each): $1.02 – $9.02

40 mg (per each): $1.02 – $9.02

Capsule, delayed release (Esomeprazole Strontium Oral)

49.3 mg (per each): $9.67

Capsule, delayed release (GoodSense Esomeprazole Oral)

20 mg (per each): $0.25

Capsule, delayed release (NexIUM 24HR Clear Minis Oral)

20 mg (per each): $0.65

Capsule, delayed release (NexIUM 24HR Oral)

20 mg (per each): $0.70

Capsule, delayed release (NexIUM Oral)

20 mg (per each): $10.04

40 mg (per each): $10.04

Kit (Esomep-EZS Oral)

20 mg (per each): $3,610.00

Pack (NexIUM Oral)

2.5 mg (per each): $10.84

5 mg (per each): $10.84

10 mg (per each): $10.84

20 mg (per each): $10.84

40 mg (per each): $10.84

Solution (reconstituted) (Esomeprazole Sodium Intravenous)

20 mg (per each): $41.88

40 mg (per each): $41.88 – $60.00

Solution (reconstituted) (NexIUM I.V. Intravenous)

40 mg (per each): $53.58

Tablet, EC (NexIUM 24HR Oral)

20 mg (per each): $0.65

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Proton pump inhibitor suppresses gastric acid secretion by inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole is the S-isomer of omeprazole.

Pharmacodynamics/Kinetics

Distribution: Vdss: 16 L

Protein binding: 97%

Metabolism: Hepatic via CYP2C19 primarily and (to a lesser extent) via 3A4 to hydroxy, desmethyl, and sulfone metabolites (all inactive)

Bioavailability: Oral: 64 after a single dose; 90% with repeat dosing

Half-life elimination:

Infants: 0.93 hours

Children 1 to 5 years: 0.42 to 0.74 hours (Zhao 2006)

Children 6 to 11 years: 0.73 to 0.88 hours (Zhao 2006)

Children ≥12 years and Adolescents ≤17 years: 0.82 to 1.22 hours (Li 2006)

Adults: ~1 to 1.5 hours

Time to peak: Oral:

Infants: Median: 3 hours

Children 1 to 5 years: 1.33 to 1.44 hours (Zhao 2006)

Children 6 to 11 years: 1.75 to 1.79 hours (Zhao 2006)

Children ≥12 years and Adolescents ≤17 years: 1.96 to 2.04 hours (Li 2006)

Adults: 1.5 to 2 hours

Excretion: Urine (80%, primarily as inactive metabolites; <1% as active drug); feces (20%)

Clearance (with repeated dosing):

Children 1 to 5 years: 6 to 19.44 L/hour (Zhao 2006)

Children 6 to 11 years: 7.84 to 9.22 L/hour (Zhao 2006)

Children ≥12 years and Adolescents ≤17 years: 8.36 to 15.88 L/hour (Li 2006)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: AUC was 2 to 3 times higher in patients with severe hepatic impairment.

Geriatric: AUC and Cmax were increased by 25% and 18%, respectively, following administration of esomeprazole magnesium.

Gender: AUC and Cmax were 13% higher in women than men following administration of esomeprazole magnesium.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation)

Effects on Bleeding

No information available to require special precautions

Index Terms

Esomeprazole Magnesium; Esomeprazole Sodium; Esomeprazole Strontium; Nexium 24HR

FDA Approval Date
February 20, 2001
References

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Kupiec TC, Aloumanis V, Ben M, et al, “Physical and Chemical Stability of Esomeprazole Sodium Solutions,” Ann Pharmacother, 2008, 42(9):1247-51.[PubMed 18614750]

Lam JR, Schneider JL, Zhao W, Corley DA. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA. 2013;310(22):2435-2422.[PubMed 24327038]

Lanza FL, Chan FK, and Quigley EM, “Guidelines for Prevention of NSAID-Related Ulcer Complications,” Am J Gastroenterol, 2009, 140(3):728-38.[PubMed 19240698]

Lau JY, Leung WK, Wu JC, et al, “Omeprazole Before Endoscopy in Patients With Gastrointestinal Bleeding,” N Engl J Med, 2007, 356(16):1631-40.[PubMed 17442905]

Lau JY, Sung JJ, Lee KK, et al, “Effect of Intravenous Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers,” N Engl J Med, 2000, 343(5):310-6.[PubMed 10922420]

Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016:238-246.[PubMed 26752337]

Levine GN, Bates ER, Blankenship JC, et al, “2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions,” Circulation, 2011, 124(23):e574-651.[PubMed 22064601]

Lin HJ, Lo WC, Lee FY, et al, “A Prospective Randomized Comparative Trial Showing That Omeprazole Prevents Rebleeding in Patients With Bleeding Peptic Ulcer After Successful Endoscopic Therapy,” Arch Intern Med, 1998, 158(1):54-8.[PubMed 9437379]

Li J, Zhao J, Hamer-Maansson JE, et al, “Pharmacokinetic Properties of Esomeprazole in Adolescent Patients Aged 12 to 17 Years With Symptoms of Gastroesophageal Reflux Disease: A Randomized, Open-Label Study,” Clin Ther, 2006, 28(3):419-27.[PubMed 16750456]

Li X-Q, Anderson TB, Ahlstrom M, et al, “Comparison of Inhibitory Effects of the Proton Pump-Inhibiting Drugs Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, and Rabeprazole on Human Cytochrome P450 Activities,” Drug Metab Disp, 2004, 32(8):821-7.[PubMed 15258107]

Marshall JK, Thompson AB, Armstrong D. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol. 1998;12(3):225-227.[PubMed 9582548]

Matok I, Levy A, Wiznitzer A, et al, “The Safety of Fetal Exposure to Proton-Pump Inhibitors During Pregnancy,” Dig Dis Sci, 2012, 57(3):699-705.[PubMed 22038541]

Moayyedi PM, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG clinical guideline: management of dyspepsia. Am J Gastroenterol. 2017;112(7):988-1013. doi: 10.1038/ajg.2017.154.[PubMed 28631728]

Natsch S, Vinks MH, Voogt AK, et al, “Anaphylactic Reactions to Proton-Pump Inhibitors,” Ann Pharmacother, 2000, 34(4):474-6.[PubMed 10772433]

Nexium (esomeprazole magnesium) [prescribing information]. Wilmington, DE: AstraZeneca; June 2018.

Nexium (esomeprazole magnesium) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; November 2017.

Nexium 24HR (esomeprazole sodium) [prescribing information]. Madison, NJ: Pfizer; received February 2018.

Nexium IV (esomeprazole sodium) [prescribing information]. Wilmington, DE: AstraZeneca; August 2018.

Pasternak B and Hviid A, “Use of Proton-Pump Inhibitors in Early Pregnancy and the Risk of Birth Defects,” N Engl J Med, 2010, 363(22):2114-23.[PubMed 21105793]

Paoluzi P, Iacopini F, Crispino P, et al, “2-Week Triple Therapy for Helicobacter pylori Infection is Better Than 1-Week in Clinical Practice: a Large Prospective Single-Center Randomized Study,” Helicobacter, 2006, 11(6):562-8.[PubMed 17083378]

Pinto-Sanchez MI, Yuan Y, Bercik P, Moayyedi P. Proton pump inhibitors for functional dyspepsia [update published in Cochrane Database Syst Rev. 2017;11:CD011194]. Cochrane Database Syst Rev. 2017;3:CD011194. doi: 10.1002/14651858.CD011194.pub2.[PubMed 28271513]

Rhodes A, Evans LE, Alhazzani W, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43(3):304-377.[PubMed 28101605]

Sachar H, Vaidya K, Laine L. Intermittent vs continuous proton pump inhibitor therapy for high-risk bleeding ulcers: a systematic review and meta-analysis. JAMA Intern Med. 2014;174(11):1755-1762.[PubMed 25201154]

Shaheen NJ, Falk GW, Iyer PG, et al. ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus. Am J Gastroenterol. 2016;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322.[PubMed 26526079]

Singh S, Garg SK, Singh PP, et al. Acid-suppressive medications and risk of oesophageal adenocarcinoma in patients with Barrett’s oesophagus: a systematic review and meta-analysis. Gut. 2014;63(8):1229-37. doi: 10.1136/gutjnl-2013-305997.[PubMed 24221456]

Spechler SJ, Sharma P, Souza RF, et al; American Gastroenterological Association. American Gastroenterological Association medical position statement on the management of Barrett’s esophagus. Gastroenterology. 2011;140(3):1084-1091. doi: 10.1053/j.gastro.2011.01.030.[PubMed 21376940]

Sung JJ, Barkun A, Kuipers EJ, et al, “Intravenous Esomeprazole for Prevention of Recurrent Peptic Ulcer Bleeding: A Randomized Trial,” Ann Intern Med, 2009, 150(7):455-64.[PubMed 19221370]

Talley NJ and Vakil N, “Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the Management of Dyspepsia,” Am J Gastroenterol, 2005, 100(10):2324-37.[PubMed 16181387]

Talley NJ, Vakil N, Lauritsen K, et al; STARS I Study Group. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning: does a 1-week trial of acid suppression predict symptom response? Aliment Pharmacol Ther. 2007;26(5):673-682.[PubMed 17697201]

van der Woude CJ, Metselaar HJ, Danese S. Management of gastrointestinal and liver diseases during pregnancy. Gut. 2014;63(6):1014-1023.[PubMed 24429582]

van Zanten SV, Armstrong D, Chiba N, et al. Esomeprazole 40 mg once a day in patients with functional dyspepsia: the randomized, placebo-controlled “ENTER” trial [published correction appears in Am J Gastroenterol. 2006;101(9):2171]. Am J Gastroenterol. 2006;101(9):2096-2106.[PubMed 16817845]

Wolfe MM and Sachs G, “Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, and Stress-Related Erosive Syndrome,” Gastroenterology, 2000,118(2 Suppl 1):9-31.

Zargar SA, Javid G, Khan BA, et al, “Pantoprazole Infusion as Adjuvant Therapy to Endoscopic Treatment In Patients With Peptic Ulcer Bleeding: Prospective Randomized Controlled Trial,” J Gastroenterol Hepatol, 2006, 21(4):716-21[PubMed 16677158]

Zhao J, Li J, Hamer-Maansson JE, et al, “Pharmacokinetic Properties of Esomeprazole in Children Aged 1 to 11 Years With Symptoms of Gastroesophageal Reflux Disease: A Randomized, Open-Label Study,” Clin Ther, 2006, 28(11): 1868-76.[PubMed 17213007]

Brand Names: International

Aesopra (PH); Almiprazole (EG); Alton (LK); Ameprazole (VN); Axiago (ES); Carbum (CR, DO, GT, HN, NI, PA, SV); Ceso (IN); Emanera (SG, UA); Emazole (IE); Emep (PH); Emess (LK); Emozul (GB); Empel (LK); Escadra (LV); Esmopump (EG); Esofag (IN); Esofax (CR, DO, GT, HN, NI, PA, SV); Esoflux (PH); Esoget DRT (PH); Esola (ID); Esomax (ID); Esomep (BD, LB, PH); Esonexa (UA); Esopra (BD); Esoragim 40 (VN); Esorest (IN); Esoroxen (KR); Esotec (PH); Esoxium (UA, VN); Esoz-20 (ET, ZW); Esoz-40 (ZW); Esozid (ID); Esural (BH); Exmezol (KR); Exocid (ID); Exozole (KR); Exzium (LK); Ignis (IN); Inexium (FR); Jubium-20 (SG); Jubium-40 (SG); Lanxium (ID); Maxima (BD); Nedox (CO, PE); Neksium (IN); Nemeol (KR); Neopral (PE); Nepramel (IE); Nexazol (KR); Nexazole (IE); Nexiam (LU); Neximash (EG); Nexipra (KR); Nexird (KR); Nexium (AE, AR, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BO, BR, BS, BZ, CH, CI, CL, CN, CO, CU, CY, CZ, DE, DK, EE, EG, ES, ET, FI, GB, GH, GM, GN, GR, GY, HK, HR, ID, IE, IL, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LR, LT, LV, MA, ML, MR, MT, MU, MW, MY, NE, NG, NL, NO, NZ, PE, PH, PL, PR, PT, PY, QA, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SR, TH, TN, TR, TT, TW, TZ, UA, UG, UY, VE, VN, ZA, ZM, ZW); Nexium IV (MX); Nexium-MUPS (MX); Nexmezol (LV, ZW); Nexpa (KR); Nexpro (IN, PH, ZW); Nexpro-20 (ET, TZ); Nexpro-40 (TZ); Nexum (PK); Pamezone (CR, DO, GT, HN, NI, PA, SV); Peprazom (PH); Prazia (BD); Proxium (ID); Raciper (IN); S-Omipin (PH); Solezol (IL); Sompraz (IN); Sompraz IV (TZ); Ulcium (EC); Xsom (PH); Zoleric (LK); Zutura (EC)

Esomeprazole (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(es oh ME pray zol)

Brand Names: US

Esomep-EZS; GoodSense Esomeprazole [OTC]; NexIUM; NexIUM 24HR Clear Minis [OTC]; NexIUM 24HR [OTC]; NexIUM I.V.

Brand Names: Canada

Nexium

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It is used to treat syndromes caused by lots of stomach acid.
  • It is used to treat or prevent NSAID-associated gastric ulcers in patients with a history of ulcers.
  • It is used to treat heartburn.
  • It is used to lower the chance of bleeding ulcers after a certain procedure (endoscopy).
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to esomeprazole or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, or St. John’s wort.
  • If you have any of these health problems: Black or bloody stools; heartburn with light-headedness, sweating, or dizziness; chest pain; shoulder pain with shortness of breath; pain that spreads to the arms, neck, or shoulders; light-headedness; sweating a lot; throwing up blood; or trouble or pain swallowing food.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take this drug in high doses or for longer than a year, or if you are older than 50 years old. Talk with your doctor.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. You will need to have your blood work checked if you will be taking this drug for a long time or if you take certain other drugs like digoxin or water pills. Talk with your doctor.
  • Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Very bad dizziness or passing out.
  • Very bad belly pain.
  • Bone pain.
  • Fever or chills.
  • Sore throat.
  • Shortness of breath.
  • A big weight loss.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Injection:
  • Irritation where the shot is given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Feeling sleepy.
  • Belly pain.
  • Diarrhea.
  • Constipation.
  • Gas.
  • Dry mouth.
  • Upset stomach.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Tablets and capsules:
  • Take 1 hour before a meal.
  • Take with a full glass of water.
  • Tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Capsules:
  • Swallow whole. Do not chew or crush.
  • If you cannot swallow this drug whole, you may sprinkle the contents on applesauce. If you do this, swallow the mixture right away without chewing.
  • If mixing on applesauce, the applesauce should not be warm. Do not sprinkle on other liquids or foods.
  • Those who have feeding tubes may make a liquid. Empty contents of capsule into a 60 mL syringe with 50 mL of water. Replace plunger and shake for 15 seconds. Flush feeding tube before and after this drug is taken.
  • Powder for suspension:
  • Take 1 hour before a meal.
  • Mix 2.5 mg or 5 mg granules with 1 teaspoon (5 mL) and the 10 mg, 20 mg, or 40 mg granules with 1 tablespoon (15 mL) of water; let them sit for a few minutes. Mix and drink.
  • Rinse cup with more water and drink.
  • Take your dose within 30 minutes after mixing. Throw away any part not used within 30 minutes of mixing.
  • Those who have feeding tubes may make a liquid. Empty contents of packet into syringe with 1 teaspoon or 1 tablespoon (5 or 15 mL) of water. Replace plunger and shake. Let sit for a few minutes. After taking this drug, refill syringe with water, shake, and flush feeding tube.
  • All oral products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Injection:
  • This drug is given as a shot into a vein or into a vein nonstop for a period of time.
What do I do if I miss a dose?
  • All oral products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Tablets and capsules:
  • Keep lid tightly closed.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Esomeprazole (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(es oh ME pray zol)

Brand Names: US

Esomep-EZS; GoodSense Esomeprazole [OTC]; NexIUM; NexIUM 24HR Clear Minis [OTC]; NexIUM 24HR [OTC]; NexIUM I.V.

Brand Names: Canada

Nexium

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It is used to treat syndromes caused by lots of stomach acid.
  • It is used to treat or prevent NSAID-associated gastric ulcers in patients with a history of ulcers.
  • It is used to treat heartburn.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to esomeprazole or any other part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, or St. John’s wort.
  • If your child has any of these health problems: Black or bloody stools; heartburn with lightheadedness, sweating, or dizziness; chest pain; shoulder pain with shortness of breath; pain that spreads to the arms, neck, or shoulders; lightheadedness; sweating a lot; throwing up blood; or trouble or pain swallowing food.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. Your child will need to have their blood work checked if they will be taking this drug for a long time or if they take certain other drugs like digoxin or water pills. Talk with the doctor.
  • Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if this drug is taken in high doses or for longer than a year. Talk with the doctor.
  • Use care if your child has risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your child’s doctor about your child’s risks of osteoporosis.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your child’s doctor if your child has lupus. Call your child’s doctor right away if your child has signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Do not give more than what the doctor told you to give. Do not give more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Very bad dizziness or passing out.
  • Very bad belly pain.
  • Shortness of breath.
  • A big weight loss.
  • Bone pain.
  • Fever or chills.
  • Sore throat.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your child’s doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Injection:
  • Irritation where the shot is given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Feeling sleepy.
  • Belly pain.
  • Diarrhea.
  • Constipation.
  • Gas.
  • Dry mouth.
  • Upset stomach.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Tablets and capsules:
  • Give 1 hour before a meal.
  • Give this drug with a full glass of water.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Capsule:
  • You may sprinkle contents of capsule on applesauce. Have your child swallow without chewing.
  • If mixing on applesauce, the applesauce should not be warm. Do not sprinkle on other liquids or foods.
  • For children who have feeding tubes, you may make a liquid. Empty contents of capsule into a 60 mL syringe with 50 mL of water. Replace plunger and shake for 15 seconds. Flush feeding tube before and after this drug is taken.
  • Powder for suspension:
  • Give 1 hour before a meal.
  • Mix 2.5 mg or 5 mg granules with 1 teaspoon (5 mL) and the 10 mg, 20 mg, or 40 mg granules with 1 tablespoon (15 mL) of water; let them sit for a few minutes. Mix and have your child drink.
  • Rinse cup with more water and have your child drink.
  • Give your child the dose within 30 minutes after mixing. Throw away any part not used within 30 minutes of mixing.
  • For children who have feeding tubes, you may make a liquid. Empty contents of packet into syringe with 5 or 15 mL of water. Replace plunger and shake. Let sit for a few minutes. Refill syringe with water, shake, and flush feeding tube.
  • All products:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Injection:
  • It is given as a shot into a vein.
What do I do if my child misses a dose?
  • All oral products:
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Tablets and capsules:
  • Keep lid tightly closed.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.