Application Nr Approved Date Route Status External Links
NDA021925 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

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) ] . 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 ) 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) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Comments