pioglitazone
Drug Details
- Generic Name
- pioglitazone
- Brand Names
- Actos, Pioglitazone
- Application Number
- NDA021073
- Sponsor
- Takeda Pharmaceutical Company Limited
- NDC Codes
- 7
- 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 exert 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 ] . Pioglitazone 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. ( 14) Important Limitations of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ()