pioglitazone

FDA Drug Profile — Actos

Drug Details

Generic Name
pioglitazone
Brand Names
Actos
Application Number
NDA021073
Sponsor
Takeda Pharmaceutical Company Limited
NDC Codes
6
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
PIOGLITAZONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies ( 14 ) ] . Important Limitations of Use Pioglitazone tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone 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 ( 5.3 ) ]. Pioglitazone hydrochloride is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ( 1 , 14 ) Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )