DUETACT

Absorption and Bioavailability: DUETACT Bioequivalence studies were conducted following a single dose of the DUETACT 30 mg/2 mg and 30 mg/4 mg tablets and concomitant administration of pioglitazone (30 mg) and glimepiride (2 mg or 4 mg) under fasting conditions in healthy subjects. Based on the area under the curve (AUC) and maximum concentration (C max ) of both pioglitazone and glimepiride, DUETACT 30 mg/2 mg and 30 mg/4 mg were bioequivalent to pioglitazone 30 mg concomitantly administered wi...

There have been no clinical efficacy studies conducted with DUETACT. However, the efficacy and safety of the separate components have been previously established. The coadministration of pioglitazone and a sulfonylurea, including glimepiride, has been evaluated for efficacy and safety in two clinical studies. These clinical studies established an added benefit of pioglitazone in glycemic control of patients with inadequately controlled type 2 diabetes while on sulfonylurea therapy. Bioequivalence of DUETACT with coadministered pioglitazone and glimepiride tablets was demonstrated at the 30 mg/...

The following serious adverse reactions are discussed elsewhere in the labeling:

• Congestive Heart Failure [see Boxed Warning and Warnings and Precautions ( 5.1 )]
• Hypoglycemia [see Warnings and Precautions ( 5.2 )]
• Edema [see Warnings and Precautions ( 5.7 )]
• Fractures [see Warnings and Precautions ( 5.8 )]
• Hemolytic Anemia [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (≥5%) are upper respiratory tract infection, accidental injury, and combined edema/peripheral e...

• Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning ] .
• Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of DUETACT [see Warnings and Precautions ( 5.3 )] .
• Use in patients with known history of an allergic reaction to sulfonamide derivatives. Reported hypersensitivity reactions with glimepiride include ...

• Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. ( 5.1 )
• Hypoglycemia: May be severe. When insulin or an insulin secretagogue is used with pioglitazone, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. ( 5.2 )
• Hypersensitivity Reactions:...

7 DRUG INTERACTIONS

• Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone dose to 15 mg daily. ( 2.3 , 7.1 )
• CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.2 )
• Topiramate may decrease pioglitazone concentrations. ( 7.3 )
• Certain medications may affect glucose metabolism, requiring DUETACT dose adjustment and cl...