pioglitazone and glimepiride
pioglitazone and glimepiride is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including pioglitazone and glimepiride, Duetact. Available dosage form: tablet.
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
- PIOGLITAZONE HYDROCHLORIDE, GLIMEPIRIDE
Indications and Usage
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) ].