Nexium

[Esomeprazole]

Amoxicillin

Pregnancy Category B. See full prescribing information for amoxi-cillin before using in pregnant women.

Clarithromycin

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Pregnancy Category C. See WARNINGS (above) and full prescribing information for clarithromycin before using in pregnant women.

Nursing Mothers

The excretion of esomeprazole in milk has not been studied. However, omeprazole concentrations have been measured in breast milk of a woman following oral administration of 20 mg. Because esomeprazole is likely to be excreted in human milk, because of the potential for serious adverse reactions in nursing infants from esomeprazole, and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been estab-lished.

Geriatric Use

Of the total number of patients who received NEXIUM in clinical trials, 778 were 65 to 74 years of age and 124 patients were 75 years of age.

No overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical expe-rience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

ADVERSE REACTIONS

The safety of NEXIUM was evaluated in over 10,000 patients (aged 18-84 years) in clinical trials worldwide including over 7,400 patients in the United States and over 2,600 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. In general, NEXIUM was well tolerated in both short-and long-term clinical trials.

The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1, 240 patients on NEXIUM 20 mg, 2,434 patients on NEXIUM 40 mg, and 3,008 patients on omeprazole 20 mg daily. The most frequently occurring adverse events ( 1%) in all three groups was headache (5.5, 5.0, and 3.8, respectively) and diarrhea (no differ-ence among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking NEXIUM or omeprazole. Additional adverse events that were reported as possibly or probably related to NEXIUM with an incidence <1% are listed below by body system:

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