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Prevacid

[Lansoprazole]

Dual Therapy:

PREVACID/ amoxicillin The most frequently reported adverse events for patients who received PREVACID t. i. d. plus amoxicillin t. i. d. dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with PREVACID t. i. d. plus amoxicillin t. i. d. dual therapy than with PREVACID alone. For more information on adverse reactions with amoxicillin or clarithromycin, refer to their package inserts, ADVERSE REACTIONS sections.
Laboratory Values

The following changes in laboratory parameters for lansoprazole were reported as adverse events:

Text Continues Below



Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/ decreased/ abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, eosinophilia, hyperlipemia, increased/ decreased electrolytes, increased/ decreased cholesterol, increased glucocorticoids, increased LDH, increased/ decreased/ abnormal platelets, and increased gastrin levels. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0. 4% (4/ 978) placebo patients and 0. 4% (11/ 2677) lansoprazole patients had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these lansoprazole patients reported jaundice at any time during the study. In clinical trials using combination therapy with PREVACID plus amoxicillin and clarithromycin, and PREVACID plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed. For more information on laboratory value changes with amoxicillin or clarithromycin, refer to their package inserts, ADVERSE REACTIONS section.

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