Pioglitazone HCL and Metformin HCL

FDA Drug Profile — Pioglitazone HCL and Metformin HCL

Drug Details

Generic Name
Pioglitazone HCL and Metformin HCL
Brand Names
Pioglitazone HCL and Metformin HCL
Application Number
ANDA202001
Sponsor
Torrent Pharmaceuticals Limited
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 ) 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 are not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis.