pioglitazone and glimepiride

PIOGLITAZONE AND GLIMEPIRIDE

Manufacturer: Prasco Laboratories

Score: 144.0

Quick Summary

Duetact is a combination of pioglitazone and glimepiride used to improve glycemic control in adults with type 2 diabetes mellitus. It is used as an adjunct to diet and exercise to improve blood sugar control in patients who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone. The drug has several important safety considerations, including a boxed warning for congestive heart failure and warnings for hypoglycemia, edema, fractures, and urinary bladder tumors. Duetact should be taken once daily with the first main meal, and the initial dose is based on the patient's current regimen.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes mellitus
Used as an adjunct to diet and exercise
Indicated for patients already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone

Important Safety Information

Warning

Congestive heart failure

Contraindications

Initiation in patients with established NYHA Class III or IV heart failure
Use in patients with known hypersensitivity to pioglitazone, glimepiride, or any other component of Duetact
Use in patients with known history of an allergic reaction to sulfonamide derivatives

Adverse Reactions

Hypoglycemia
Edema
Fractures
Urinary bladder tumors

Dosing Recommendations

General Guidance

Dose adjustments should be made based on effectiveness and tolerability, and should not exceed the maximum recommended daily dose of pioglitazone 45 mg and glimepiride 8 mg

Type 2 diabetes mellitus

Adult Dose

30 mg/2 mg or 30 mg/4 mg once daily

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

Limited data with Duetact or pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage
DUETACT should be discontinued at least two weeks before expected delivery

Nursing Mothers

No data available

Pediatric Use

Not recommended for use in pediatric patients
Safety and effectiveness of Duetact in pediatric patients have not been established

Geriatric Use

To minimize the risk of hypoglycemia, the initial dosing, dose increments, and maintenance dosage of Duetact should be conservative
Geriatric patients should be observed carefully for hypoglycemia