Answers to frequently asked questions about NEXIUM

What is NEXIUM indicated for? Are the indications for NEXIUM 24HR and prescription NEXIUM the same?

How is NEXIUM 24HR different from prescription NEXIUM?

Will NEXIUM remain available as a prescription now that NEXIUM 24HR is available?

Once available over the counter, can patients stop taking their prescription heartburn medication and take NEXIUM 24HR?

How can I help my customers get NEXIUM?

How can I help ensure that my customers get their NEXIUM prescription refilled when they return to the pharmacy?

What are the most common side effects with oral NEXIUM?

What are some of the known drug-drug interactions with NEXIUM?

What are the available formulations of NEXIUM?

What is the recommended dosage schedule for oral NEXIUM for adults?

What is the recommended dosage schedule for oral NEXIUM for pediatric patients?

What are the instructions for customers to take oral NEXIUM?

What are the contraindications for NEXIUM?

What is the most important information customers should know about NEXIUM?

Which drugs' absorption is affected by NEXIUM?

How do proton pump inhibitors (PPIs) affect bone health?

What are the storage requirements for NEXIUM?


What is NEXIUM indicated for? Are the indications for NEXIUM 24HR and prescription NEXIUM the same?

Prescription NEXIUM and NEXIUM 24HR have different indications for use.

Prescription NEXIUM is indicated to treat the symptoms of acid reflux disease, or GERD, which typically include persistent heartburn on 2 or more days per week, despite treatment and change of diet. For many people, NEXIUM is also prescribed to help heal damage to the esophagus called erosive esophagitis (EE). Review clinical information for prescription NEXIUM.

NEXIUM 24HR 20 mg delayed‐release capsules are indicated for the treatment of frequent heartburn.*

*Defined as heartburn occurring 2 or more days a week.

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How is NEXIUM 24HR different from prescription NEXIUM?

There are several differences between NEXIUM 24HR and prescription NEXIUM.

Prescription NEXIUM is available in 20 mg and 40 mg delayed‐release capsules. NEXIUM 24HR will only be available in 20 mg delayed‐release capsules.

Prescription NEXIUM is indicated to treat the symptoms of acid reflux disease, or GERD, which typically include persistent heartburn on 2 or more days per week, despite treatment and change of diet. For many people, NEXIUM is also prescribed to help heal damage to the esophagus called EE. Review clinical information for prescription NEXIUM.

NEXIUM 24HR 20 mg delayed‐release capsules are indicated for the treatment of frequent heartburn.*

*Defined as heartburn occurring 2 or more days a week.

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Will NEXIUM remain available as a prescription now that NEXIUM 24HR is available?

Yes, prescription NEXIUM will still be available in both 20 mg and 40 mg delayed‐release capsules.

Other formulations of prescription NEXIUM including NEXIUM I.V. and NEXIUM Oral Suspension will also remain available to patients and physicians.

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Once available over the counter, can patients stop taking their prescription heartburn medication and take NEXIUM 24HR?

Patients should not change or stop taking any prescriptions without first consulting with their health care professional.

We believe the best decisions regarding medications are made between a patient and his or her doctor, and that any changes to a patient’s treatment—including switching to a different medication or treatment—should be made in consultation with a physician.

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How can I help my customers get NEXIUM?

With the useful tools designed just for pharmacists here on NexiumPharmacist.com, you can help your customers get NEXIUM.

You can also help make sure your customers get NEXIUM by telling them to ask their doctor to write “medically necessary,” “may not substitute,” or “dispense as written” on their prescriptions.

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How can I help ensure that my customers get their NEXIUM prescription refilled when they return to the pharmacy?

For your customers who want to ensure they get their NEXIUM prescription refilled when they return to the pharmacy, you can help by putting a note in their records indicating that they want NEXIUM and not a generic PPI or different medication.

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What are the most common side effects with oral NEXIUM?

In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain.

In pediatric patients 1 to 17 years of age, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence.1

In pediatric patients 1 to 11 months, the most frequently reported ARs with NEXIUM include abdominal pain, regurgitation, tachypnea, and increased ALT.

Review the Safety Profile of NEXIUM and read Important Safety Information for NEXIUM.

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What are some of the known drug-drug interactions with NEXIUM?

Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of NEXIUM with clopidogrel. See section 7.3 of the Prescribing Information.

  • NEXIUM may affect plasma levels of antiretroviral drugs—use with atazanavir and nelfinavir is not recommended; if saquinavir is used with NEXIUM, monitor for toxicity and consider saquinavir dose reduction. See section 7.1 of the Prescribing Information.
  • NEXIUM may interfere with drugs for which gastric pH affects bioavailability (eg, ketoconazole, iron salts, erlotinib, and digoxin). See section 7.2 of the Prescribing Information.
  • Combined inhibitors of CYP2C19 and 3A4 may raise esomeprazole levels. See section 7.3 of the Prescribing Information.
  • NEXIUM may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction. See section 7.3 of the Prescribing Information.

Please refer to the full Prescribing Information for NEXIUM for more information.

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What are the available formulations of NEXIUM?

Flexible administration options for NEXIUM include:

  • NEXIUM I.V.
  • NEXIUM Delayed-Release Oral Suspension
  • NEXIUM Delayed-Release Capsules

Find out more about Dosage & Administration for NEXIUM.

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What is the recommended dosage schedule for oral NEXIUM for adults?

Healing of erosive esophagitis (EE): NEXIUM 20 mg or NEXIUM 40 mg, once daily for 4 to 8 weeks, is recommended for short-term treatment for healing and symptomatic resolution of diagnostically confirmed EE.1

Maintenance of healing of EE: NEXIUM 20 mg, once daily, is recommended to maintain symptom resolution and healing of EE.1 Controlled studies did not extend beyond 6 months.

Symptomatic GERD: NEXIUM 20 mg, once daily for 4 to 8 weeks, is recommended for the short-term treatment of heartburn and other symptoms associated with GERD.1

For the full recommended dosing schedule of NEXIUM, see Dosage & Administration.

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What is the recommended dosage schedule for oral NEXIUM for pediatric patients?

For the short-term treatment (up to 8 weeks) of symptomatic GERD in patients 1 to 11 years of age: the recommended dose of NEXIUM is 10 mg once daily.1

For the short-term treatment in the healing of EE in patients 1 to 11 years of age: for children whose weight is less than 20 kg, the recommended dose is 10 mg once daily for 8 weeks; for children whose weight is 20 kg or greater, the recommended dose is 10 mg or 20 mg once daily for 8 weeks.1

For the short-term treatment of GERD in patients 12 to 17 years of age: the recommended dose is 20 mg once daily for 4 weeks.1

For the short-term treatment in the healing of EE in patients 12 to 17 years of age: the recommended dose of NEXIUM is 20 mg or 40 mg once daily for 4 to 8 weeks.1

For the short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in patients 1 month to less than 1 year of age: the recommended dose of NEXIUM is 2.5 mg, 5 mg or 10 mg, based on weight, once daily for up to 6 weeks.

Swallow the capsules whole. Do not chew or crush them. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the NEXIUM Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. The granules/applesauce mixture should not be stored for future use.1

For customers who have a nasogastric tube in place, NEXIUM Delayed-Release Capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube in the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated. The suspension must be used immediately after preparation.1

Find out more about Dosage & Administration for NEXIUM.

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What are the instructions for patients to take oral NEXIUM?

Customers should follow these instructions for taking NEXIUM:

  • Take NEXIUM exactly as prescribed by your doctor
  • Do not change your dose or stop NEXIUM without talking to your doctor
  • Take NEXIUM at least 1 hour before a meal
  • Swallow the capsules whole. Do not chew or crush them. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the NEXIUM Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. The granules/applesauce mixture should not be stored for future use
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for the missed dose
  • If you take too much NEXIUM, consult with your doctor right away
  • If you take NEXIUM Delayed-Release Oral Suspension:
    • Empty the contents of a packet into a container with 1 tablespoon of water
    • Stir
    • Leave for 2 to 3 minutes to thicken
    • Stir and drink within 30 minutes
    • If any medicine remains after drinking, add more water, stir, and drink right away

Find out more about Dosage & Administration for NEXIUM and please refer to the full Prescribing Information for NEXIUM for more information.

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What are the contraindications for NEXIUM?

NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

Review the Safety Profile of NEXIUM and read Important Safety Information for NEXIUM.

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What is the most important information customers should know about NEXIUM?

Advise customers that NEXIUM may increase their risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in the intestines. Customers should call their doctor right away if they have watery stool, stomach pain, and fever that does not go away.

Review the Safety Profile of NEXIUM and read Important Safety Information for NEXIUM.

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Which drugs' absorption is affected by NEXIUM?

Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, atazanavir, iron salts, erlotinib, and digoxin).1

Please refer to the full Prescribing Information for NEXIUM for more information.

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How do proton pump inhibitors (PPIs) affect bone health?

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.1

Read the Important Safety Information and refer to the full Prescribing Information for NEXIUM for more information.

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What are the storage requirements for NEXIUM?

NEXIUM should be stored at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.1

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Important Safety Information for NEXIUM

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • Symptomatic response to therapy does not rule out the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy
  • Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. This diagnosis should be considered for diarrhea that does not improve
  • PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose (multiple daily doses) and long-term (a year or longer) therapy
  • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events included both new onset and exacerbations. If signs or symptoms consistent with CLE or SLE are noted with NEXIUM, discontinue and refer the patient to a specialist. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks
  • Avoid concomitant use of NEXIUM with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using NEXIUM consider alternative anti-platelet therapy
  • Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12). Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy
  • Concomitant use of NEXIUM and St. John’s wort or rifampin can substantially decrease NEXIUM concentrations. Avoid concomitant use
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM is expected to increase the plasma levels of saquinavir. Consider dose reduction of saquinavir
  • Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • NEXIUM may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction of cilastozol
  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate
  • In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain
  • The ARs reported at a frequency of 1% or greater with NEXIUM I.V. in clinical trials were headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation, and pruritus
  • In pediatric patients 1 to 17 years of age, the most frequently reported ARs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
  • In pediatric patients 1 to 11 months the most frequently reported ARs with NEXIUM include abdominal pain, regurgitation, tachypnea, and increased ALT

Approved Uses

NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Prescribing Information (PDF – 303 KB)