Application Nr Approved Date Route Status External Links
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Indications and Purposes

1 Indications And Usage Pioglitazone And Glimepiride Tablets Are Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus Who Are Already Treated With A Thiazolidinedione And Sulfonylurea Or Who Have Inadequate Glycemic Control On A Thiazolidinedione Alone Or A Sulfonylurea Alone [See Clinical Studies ( 14 )]. Important Limitations Of Use Pioglitazone Exerts Its Antihyperglycemic Effect Only In The Presence Of Endogenous Insulin. Pioglitazone And Glimepiride Tablets Should Not Be Used To Treat Type 1 Diabetes Or Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. Use Caution In Patients With Liver Disease [See Warnings And Precautions ( 5.5 )]. Pioglitazone And Glimepiride Tablets Are A Thiazolidinedione And A Sulfonylurea Combination Product Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus When Treatment With Both Pioglitazone And Glimepiride Is Appropriate. ( 1 ) Important Limitations Of Use: • Not For Treatment Of Type 1 Diabetes Or Diabetic Ketoacidosis. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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