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Protonix

[pantoprazole sodium]

Renal Impairment

In patients with severe renal impairment, pharmacokinetic parameters for pantoprazole were similar to those of healthy subjects. No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis.

Hepatic Impairment

Text Continues Below



In patients with mild to severe hepatic impairment, maximum pantoprazole concentrations increased only slightly (1. 5-fold) relative to healthy subjects. Although serum half-life values increased to 7-9 hours and AUC values increased by 5-to 7-fold in hepatic-impaired patients, these increases were no greater than those observed in slow CYP2C19 metabolizers, where no dosage frequency adjustment is warranted. These pharmacokinetic changes in hepatic-impaired patients result in minimal drug accumulation following once daily multiple-dose administration. No dosage adjustment is needed in patients with mild to severe hepatic impairment. Doses higher than 40 mg/ day have not been studied in hepatically-impaired patients.


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