pioglitazone and glimepiride
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 )