INDICATIONS AND USAGE

Healing of Erosive Esophagitis (EE)

Adults

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of NEXIUM may be considered.

Pediatric Patients 12 Years to 17 Years of Age

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.

Pediatric Patients 1 Year to 11 Years of Age

NEXIUM for delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age.

Pediatric Patients 1 Month to Less Than 1 Year of Age

NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.

Maintenance of Healing of EE

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

Treatment of Symptomatic GERD

Adults

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

Pediatric Patients 12 Years to 17 Years of Age

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

Pediatric Patients 1 Year to 11 Years of Age

NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.

Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the reduction in

the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric

ulcers. Controlled studies do not extend beyond 6 months.

Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Triple Therapy

NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.

DOSAGE

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.

Antacids may be taken with NEXIUM.

Swallow NEXIUM capsules whole. Never chew or crush NEXIUM.

If you have difficulty swallowing NEXIUM capsules, you may open the capsule and empty the granules into 1 tablespoon of applesauce. The applesauce used should not be hot and should be soft enough to swallow without chewing. Do not mix the NEXIUM granules with any other food.

Do not crush or chew the granules. Be sure to swallow the applesauce right away. Throw away any remaining mixture. Do not store it for later use.

If you forget to take a dose of NEXIUM, 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 a missed dose.

ADVERSE REACTIONS

Acute Tubulointerstitial Nephritis

Clostridium difficile-Associated Diarrhea

Bone Fracture

Cutaneous and Systemic Lupus Erythematosus

Cyanocobalamin (Vitamin B-12) Deficiency

Hypomagnesemia

Fundic Gland Polyps

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f4853677-1622-4037-688b-fdf533a11d96/spl-doc?hl=esomeprazole

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