In the U.S.—

• Gastric acid pump inhibitor
• antiulcer agent

Esomeprazole ( e-so-MEP-ra-zole ) is used to treat conditions in which there is too much acid in the stomach. It is used to treat duodenal ulcers and gastroesophageal reflux disease (GERD). This is a condition in which the acid in the stomach washes back up into the esophagus. It also reduces the chance of gastric ulcers in patients who use a group of medicines called NSAIDs and who may be at greater risk (i.e., patients 60 years of age or older or patients who have a history of gastric ulcers). Sometimes esomeprazole is used along with antibiotics to treat ulcers associated with infection caused by the H. pylori bacteria (germ).

Esomeprazole works by decreasing the amount of acid produced by the stomach.

NEXIUM is available only with your doctor's prescription, in the following dosage form:

Oral
• Delayed-release capsules (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For esomeprazole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to esomeprazole. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Esomeprazole has not been studied in pregnant women. However, esomeprazole has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether esomeprazole passes in human breast milk. Since NEXIUM has been shown to cause unwanted effects in animals, it may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on NEXIUM have been done only in adult patients, and there is no specific information comparing the use of esomeprazole in children with use in other age groups.

Older adults—NEXIUM has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Liver disease or a history of liver disease—This condition may cause esomeprazole to build up in the body

Take esomeprazole at least one hour before a meal.

Swallow the capsule whole. Do not crush, break, or chew the capsule. If you cannot swallow the capsule whole, you may open it and sprinkle the granules contained in the capsule on one tablespoonful of applesauce or yogurt and swallow it immediately; or you may mix the granules in some tap water or fruit juice and drink it immediately. The applesauce should not be hot, and the juices you may use include apple or orange juice. Do not chew or crush the granules.

Take NEXIUM for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking NEXIUM.

Dosing—

The dose of esomeprazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of esomeprazole. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you take each day and the length of time you take the medicine depend on the medical problem for which you are taking esomeprazole

• To treat gastroesophageal reflux disease (GERD):
  • Adults—20 or 40 milligrams (mg) taken once a day for 4 to 8 weeks.
  • Children up to 18 years of age—Use and dose must be determined by your doctor.
• To prevent gastroesophageal reflux disease (GERD):
  • Adults—20 mg taken once a day.
  • Children up to 18 years of age—Use and dose must be determined by your doctor.
• To treat ulcers related to infection with H. pylori
  • Adults—40 mg once daily, plus amoxicillin 1000 mg (1 gram) plus clarithromycin 500 mg, taken together before meals twice a day for ten days.
  • Children up to 18 years of age—Use and dose must be determined by your doctor.
• To reduce chance of gastric ulcers in patients who are taking NSAIDs
  • Adults—20 or 40 mg taken once a day.
  • Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of NEXIUM, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store NEXIUM:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store away from heat and direct light.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.