pioglitazone and glimepiride

FDA Drug Profile — pioglitazone and glimepiride, Duetact

Drug Details

Generic Name
pioglitazone and glimepiride
Brand Names
pioglitazone and glimepiride, Duetact
Application Number
NDA021925
Sponsor
Takeda GmbH
NDC Codes
6
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
GLIMEPIRIDE, PIOGLITAZONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE DUETACT is 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. DUETACT 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 )] . DUETACT is 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 )