pioglitazone and metformin hydrochloride

FDA Drug Profile — Actoplus Met

Drug Details

Generic Name
pioglitazone and metformin hydrochloride
Brand Names
Actoplus Met
Application Number
NDA021842
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS & USAGE Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use Pioglitazone and metformin hydrochloride tablets is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. Pioglitazone and metformin hydrochloride tablets are a thiazolidinedione and biguanide 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 metformin is appropriate. ( 1 , 14 ) Limitations of Use : • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )