esomeprazole

Pronunciation

Generic Name: esomeprazole (ee so MEP ra zol)
Brand Name: Esomeprazole Strontium, NexIUM, NexIUM I.V., NexIUM OTC

What is esomeprazole?

Esomeprazole is in a group of drugs called proton pump inhibitors. Esomeprazole decreases the amount of acid produced in the stomach.

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

Esomeprazole may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Esomeprazole is not for immediate relief of heartburn symptoms.

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

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

Esomeprazole is not for immediate relief of heartburn symptoms.

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What should I discuss with my healthcare provider before taking esomeprazole?

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 take this medication if you are allergic to esomeprazole or to any other benzimidazole medication such as albendazole or mebendazole.

To make sure you can safely take esomeprazole, tell your doctor if you have any of these other conditions:

  • severe liver disease; or

  • low levels of magnesium in your blood.

Taking 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 taken the medication 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. Before you take this medication, tell your doctor if you have osteoporosis or osteopenia (low bone mineral density).

Some conditions are treated with a combination of esomeprazole and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

FDA pregnancy category B. Esomeprazole is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether esomeprazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take esomeprazole?

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

This medicine is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.

Take each dose with a full glass (8 ounces) of water.

Esomeprazole should be taken at least one hour before a meal.

Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole.

To make swallowing easier, you may open the esomeprazole capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Esomeprazole can be given through a nasogastric (NG) feeding tube. Open the capsule and sprinkle the medicine into a 60-milliliter syringe. Mix in 50 milliliters of water. Place the plunger into the syringe and shake the mixture well. Make sure there are no medicine granules stuck in the tip of the syringe. Attach the syringe to the NG tube and push the plunger down to empty the syringe into the tube. Then flush the tube with more water to wash the contents down.

Take this medication for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include confusion, headache, drowsiness, blurred vision, fast heartbeat, nausea, dry mouth, sweating, flushing, shortness of breath, tremor, loss of coordination, or seizure (convulsions).

What should I avoid while taking esomeprazole?

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

Esomeprazole side effects

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

Stop using esomeprazole and call your doctor at once if you have:

  • dizziness, confusion;

  • fast or uneven heart rate;

  • jerking muscle movements;

  • jittery feeling;

  • diarrhea that is watery or bloody;

  • muscle cramps, muscle weakness or limp feeling;

  • cough or choking feeling; or

  • seizure (convulsions).

Common side effects may include:

  • headache, drowsiness;

  • mild diarrhea;

  • nausea, stomach pain, gas, constipation; or

  • dry mouth.

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 for 4 weeks

Esomeprazole Strontium:
-24.65 mg orally once a day for 4 to 8 weeks.

Comment:
-If symptoms do not resolve after 4 weeks, an additional 4 weeks may be considered.

GERD with Erosive Esophagitis:
Esomeprazole Sodium:
-20 mg or 40 mg IV injection once a day, over no less than 3 minutes; or IV infusion once a day, over no less than 10 to 30 minutes

Comment: 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; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route

Usual Adult Dose for Erosive Esophagitis:

Healing:
-Esomeprazole Magnesium: 20 to 40 mg orally once a day for 4 to 8 weeks
-Esomeprazole Strontium: 24.65 to 49.3 mg orally once a day for 4 to 8 weeks
-An additional 4 to 8 week course of therapy may be considered in patients not healed after initial treatment.

Maintenance of healing:
-Esomeprazole Magnesium: 20 mg orally once a day
-Esomeprazole Strontium: 24.65 mg orally once a daily

Comments:
-Esomeprazole Sodium injection may be used as an alternative to oral therapy, if unable to use oral route.
-Maintenance of healing: 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 for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days

Esomeprazole Strontium:
Triple therapy:
-49.3 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days

Comments:
-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: Triple therapy (esomeprazole plus amoxicillin and clarithromycin): 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 for up to 6 months

Esomeprazole Strontium:
-24.65 mg to 49.3 mg orally once a day for up to 6 months

Comment:
-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

Comment: Doses up to 240 mg daily have been used.

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

Comment: Doses up to 240 mg daily have been used.

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.
-Intravenous 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.
-Intravenous 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:
Less than 1 year:
-Data not available

1 to 11 years:
-10 mg once a day for up to 8 weeks
-Comment: Doses over 1 mg/kg/day have not been studied.

12 to 17 years:
-20 mg once a day for 4 weeks

Esomeprazole Sodium:
GERD with Erosive Esophagitis:
Less than 1 month:
-Not recommended.

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

Esomeprazole Strontium: Not recommended.

Uses: Short term treatment of symptomatic GERD; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route

Usual Pediatric Dose for Erosive Esophagitis:

Esomeprazole Magnesium:
Healing:
Less than 1 year:
-Data not available

1 to 11 years:
-Less than 20 kg: 10 mg once a day for 8 weeks
-20 kg or more: 10 mg or 20 mg once a day for 8 weeks

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

Comment: Doses over 1 mg/kg/day have not been studied.

Erosive Esophagitis due to acid-mediated GERD:
Less than 1 month:
-Data not available

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: For up to 6 weeks

Comment: Doses over 1.33 mg/kg/day have not been studied.

1 year and older:
-Data not available

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?

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

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • cilostazol;

  • clopidogrel;

  • diazepam;

  • digoxin;

  • erlotinib;

  • iron supplements;

  • methotrexate;

  • rifampin;

  • St. John's wort;

  • tacrolimus;

  • antifungal medication--ketoconazole, voriconazole; or

  • HIV/AIDS medication--atazanavir, nelfinavir, saquinavir (Invirase).

This list is not complete and other drugs may interact with esomeprazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about esomeprazole.
  • 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: 12.05. Revision Date: 2014-04-16, 10:15:58 AM.

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