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esomeprazole (injection)

Pronunciation

Generic Name: esomeprazole (injection) (EE soe MEP ra zole)
Brand Name: NexIUM I.V.

What is esomeprazole injection?

Esomeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Esomeprazole is sometimes given as an injection when you cannot take medicine by mouth.

Esomeprazole injection is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Esomeprazole injection is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Esomeprazole injection is also used to lower the risk of a stomach ulcer bleeding again after an endoscopy treatment.

Esomeprazole injection may also be used for purposes not listed in this medication guide.

What is the most important information I should know about esomeprazole injection?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before using esomeprazole injection?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medicine if you are allergic to esomeprazole or to any other benzimidazole medicine such as albendazole or mebendazole.

To make sure esomeprazole injection is safe for you, tell your doctor if you have:

  • severe liver disease;

  • low levels of magnesium in your blood;

  • osteoporosis;

  • low bone mineral density (osteopenia);

  • if you are taking clopidogrel (Plavix); or

  • if you take medicine to treat tuberculosis.

Tell your doctor if you have osteoporosis or osteopenia (low bone mineral density). Using a proton pump inhibitor such as esomeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have used the medicine long-term or at high doses, and in those who are age 50 and older. It is not clear whether esomeprazole is the actual cause of an increased risk of fracture.

It is not known whether esomeprazole injection will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Esomeprazole injection can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is esomeprazole injection given?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Esomeprazole is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Esomeprazole is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Do not use the mixed medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

This medicine is usually given once daily for up to 10 days to treat GERD or erosive esophagitis.

To prevent re-bleeding after endoscopy treatment, esomeprazole injection may be given around-the-clock for 72 hours. You may then be instructed to take a medicine by mouth to reduce stomach acid.

Use esomeprazole injection for the full prescribed length of time. Your symptoms may improve before your infection is completely cleared.

Call your doctor if your symptoms do not improve or if they get worse while you are using this medicine.

This medicine can cause unusual results with certain medical tests, and you may need to stop using the medicine for a short time before a test. Tell any doctor who treats you that you are using esomeprazole injection.

Store the powder medicine at room temperature away from moisture, heat, and light. After mixing esomeprazole injection, store at room temperature and use the medicine as soon as possible. The mixture will be good for only 6 to 12 hours depending on the type of liquid diluent used.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Call your doctor for instructions if you miss a daily dose of esomeprazole injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using esomeprazole injection?

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid taking an herbal supplement containing St. John's wort at the same time you are using esomeprazole injection.

Esomeprazole injection side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;

  • kidney problems--urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or

  • low magnesium--dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure.

Common side effects may include:

  • nausea, stomach pain, gas;

  • diarrhea, constipation;

  • headache, dizziness;

  • dry mouth;

  • itching; or

  • pain, itching, swelling, redness, or bruising around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Esomeprazole dosing information

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:
Esomeprazole Sodium:
-IV injection: 20 mg or 40 mg once a day, over no less than 3 minutes

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
-Alternative to oral therapy for the short-term treatment of GERD with erosive esophagitis 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 six months.

Uses:
-Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis
-To maintain symptom resolution and healing of erosive esophagitis

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 daily
-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 twice a day

Esomeprazole Strontium: 49.3 mg orally twice 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 twice a day

Esomeprazole Strontium: 49.3 mg orally twice 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 IV infusion over 30 minutes
-Maintenance dose: 8 mg/hr IV continuous infusion for a total of 72 hours (includes initial 30 minute dose plus 71.5 hours of continuous infusion)

Comments:
-Intravenous 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 IV infusion over 30 minutes
-Maintenance dose: 8 mg/hr IV continuous infusion for a total of 72 hours (includes initial 30 minute dose plus 71.5 hours of continuous infusion)

Comments:
-Intravenous 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 once a day
-Duration of therapy: Up to 8 weeks

12 to 17 years: 20 mg once a day
-Duration of therapy: 4 weeks

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

1 to 17 years:
-Less than 55 kg: 10 mg IV infused over 10 to 30 minutes
-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 erosive esophagitis in patients unable to use oral route

Usual Pediatric Dose for Erosive Esophagitis:

Esomeprazole Magnesium:
Healing of Erosive Esophagitis:
1 to 11 years:
Less than 20 kg: 10 mg once a day
20 kg or more: 10 mg or 20 mg once a day
Duration of therapy: 8 weeks

12 to 17 years: 20 or 40 mg once a day
-Duration of therapy: 4 to 8 weeks

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

Comments:
-Esomeprazole magnesium doses for the healing of erosive esophagitis over 1 mg/kg/day have not been studied in patients 1 to 11 years of age.
-Esomeprazole magnesium doses for erosive esophagitis 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

What other drugs will affect esomeprazole injection?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with esomeprazole injection, especially:

  • cilostazol;

  • clopidogrel;

  • digoxin;

  • erlotinib;

  • iron-containing medicines (ferrous fumarate, ferrous gluconate, ferrous sulfate, and others);

  • methotrexate;

  • mycophenolate mofetil;

  • rifampin;

  • tacrolimus;

  • antifungal medication--ketoconazole, voriconazole;

  • a blood thinner--warfarin, Coumadin, Jantoven; or

  • HIV/AIDS medication--atazanavir, nelfinavir, saquinavir.

This list is not complete. Other drugs may interact with esomeprazole injection, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about esomeprazole injection.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02.

Date modified: July 24, 2017
Last reviewed: January 20, 2015

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