Pioglitazole and metformin hydrochloride

FDA Drug Profile — Pioglitazole and metformin hydrochloride

Drug Details

Generic Name
Pioglitazole and metformin hydrochloride
Brand Names
Pioglitazole and metformin hydrochloride
Application Number
ANDA204802
Sponsor
Bryant Ranch Prepack
NDC Codes
2
Dosage Forms
TABLET
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 )