DOSAGE & ADMINISTRATION

FOR NEXIUM

NEXIUM Delayed-Release Capsules1 Available in 20-mg and 40-mg doses
APPROVED USES DOSE FREQUENCY & DURATION
Gastroesophageal Reflux Disease (GERD)

Healing of erosive esophagitis (EE)

Maintenance of healing of EE

Symptomatic GERD
20 mg or 40 mg

20 mg

20 mg
Once daily for 4 to 8 weeks*

Once daily

Once daily for 4 weeks
Pediatric GERD

12 to 17 year olds

Healing of EE

Symptomatic GERD
20 mg or 40 mg

20 mg

Once daily for 4 to 8 weeks

Once daily for 4 weeks
Risk reduction of NSAID-associated gastric ulcer 20 mg or 40 mg Once daily for up to 6 months
Helicobacter pylori eradication to reduce the risk

of duodenal ulcer recurrence


Triple Therapy:

NEXIUM

Amoxicillin

Clarithromycin
40 mg

1000 mg

500 mg
Once daily for 10 days

Twice daily for 10 days

Twice daily for 10 days
Pathological hypersecretory conditions including

Zollinger-Ellison Syndrome
40 mg§ Twice daily//
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NEXIUM for Delayed-Release Oral Suspension1 Available in 2.5-mg, 5-mg, 10-mg, 20-mg and 40-mg single-dose packets
APPROVED USES DOSE FREQUENCY & DURATION
Same as Delayed-Release Capsules (above), as well as the following:
Pediatric GERD

1 month to <1 year old


EE due to acid-mediated GERD only

Weight 3 kg to 5 kg

Weight >5 kg to 7.5 kg

Weight >7.5 kg to 12 kg
2.5 mg

5 mg

10 mg
Once daily for up to 6 weeks

Once daily for up to 6 weeks

Once daily for up to 6 weeks
1 to 11 year olds#    
Short-term treatment of symptomatic GERD 10 mg Once daily for up to 8 weeks
Healing of EE

Weight <20 kg

Weight ≥20 kg
10 mg

10 mg or 20 mg
Once daily for 8 weeks

Once daily for 8 weeks
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*The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered.

Controlled studies did not extend beyond 6 months.

If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

§The dosage of NEXIUM in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.

//Doses up to 240 mg daily have been administered.

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

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

FORMULATION ROUTE OPTIONS
NEXIUM Delayed‐Release Capsules

Oral Capsule can be swallowed whole.

Capsule can be opened and

mixed with applesauce.
NEXIUM Delayed‐Release Capsules Nasogastric (NG) Tube Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric (NG) tube.
NEXIUM for Delayed‐Release Oral Suspension Oral For the 2.5 mg and 5 mg strengths, mix the contents of packet with 5 mL of water, leave 2 to 3 minutes to thicken, stir and drink within 30 minutes.

For the 10 mg, 20 mg and 40 mg strengths, mix contents of packet with 15 mL of water, and follow the instructions above.
NEXIUM for Delayed‐Release Oral Suspension NG or Gastric Tube For the 2.5 mg and 5 mg strengths, add 5 mL of water to a syringe and then add contents of packet. Shake the syringe; leave 2 to 3 minutes to thicken. Shake the syringe and inject through the NG or gastric tube within 30 minutes.

For the 10 mg, 20 mg and 40 mg strengths, add 15 mL of water, and follow the instructions above.

Please refer to the full Prescribing Information  for NEXIUM for more information. (PDF – 303 KB)

1891304-3111914 Last Updated 4/15

Important Safety Information

  • 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
  • Atrophic gastritis has occasionally been noted with long-term therapy with omeprazole
  • Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops
  • 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
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea
  • 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
  • Long-term and multiple daily dose proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine
  • 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
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
  • 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
  • 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 with Medication Guide for NEXIUM. (PDF – 303 KB)

Prescribing Information for NEXIUM I.V. (PDF - 72 KB)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Reference

  1. Prescribing Information for NEXIUM. AstraZeneca Pharmaceuticals LP, Wilmington, DE.