Actos

[Pioglitazone]

Ethnicity:

Pharmacokinetic data among various ethnic groups are not available.

Drug-Drug Interactions

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The following drugs were studied in healthy volunteers with a co-administration of ACTOS 45 mg once daily. Listed below are the results:

Fexofenadine HCI:
Co-administration of ACTOS for 7 days with 60 mg fexofenadine administered orally twice daily resulted in no significant effect on pioglitazone pharmaco-kinetics. ACTOS had no significant effect on fexofenadine pharmacokinetics.

Glipizide:
Co-administration of ACTOS and 5 mg glipizide administered orally once daily for 7 days did not alter the steady-state pharmacokinetics of glipizide.

Digoxin:
Co-administration of ACTOS with 0.25 mg digoxin administered orally once daily 7 days did not alter the steady-state pharmacokinetics of digoxin.

Warfarin:
Co-administration of ACTOS for 7 days with warfarin did not alter the steady-state pharmacokinetics of warfarin. ACTOS has no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin therapy.

Metformin:
Co-administration of a single dose of metformin (1000 mg) and ACTOS after 7 days of ACTOS did not alter the pharmacokinetics of the single dose of metformin.

Midazolam:
Administration of ACTOS for 15 days followed by a single 7.5 mg dose of midazolam syrup resulted in a 26% reduction in midazolam Cmax and AUC.

Ranitidine HCI:
Co-administration of ACTOS for 7 days with ranitidine administered orally twice daily for either 4 or 7 days resulted in no significant effect on pioglitazone pharmacokinetics. ACTOS showed no significant effect on ranitidine pharmacokinetics. ER: Co-administration of ACTOS for 7 days with 30 mg nifedipine ER adminis-tered orally once daily for 4 days to male and female volunteers resulted in least square mean (90% Cl) values for unchanged nifedipine of 0.83 (0.73-0.95) for Cmax and 0.88 (0.80-0.96) for AUC. In view of the high variability of nifedipine pharmacokinetics, the clinical significance of this finding is unknown.

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