Pioglitazone hydrochloride and glimepiride

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE

Manufacturer: Sandoz Inc

Score: 148.0

Quick Summary

Pioglitazone and glimepiride is a combination medication used to treat type 2 diabetes. It combines pioglitazone, a thiazolidinedione, and glimepiride, a sulfonylurea, to improve glycemic control. The medication is indicated for adults with type 2 diabetes who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone. However, it is not recommended for patients with symptomatic heart failure or for initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure. The medication has several important safety considerations, including the risk of congestive heart failure, hypoglycemia, edema, and fractures. Dosing recommendations vary based on the patient's current regimen and renal function. Special population considerations include use during pregnancy, nursing, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes
Indicated for patients already treated with a thiazolidinedione and sulfonylurea or with inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone
Not recommended for patients with symptomatic heart failure or for initiation in patients with established NYHA Class III or IV heart failure

Important Safety Information

Warning

Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients

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 pioglitazone and glimepiride tablets
Use in patients with known history of an allergic reaction to sulfonamide derivatives

Adverse Reactions

Hypoglycemia
Edema
Fractures
Hemolytic anemia
Urinary bladder tumors

Dosing Recommendations

General Guidance

Dose adjustments should be made based on effectiveness and tolerability, with a maximum daily dose of pioglitazone 45 mg and glimepiride 8 mg

Type 2 diabetes

Adult Dose

30 mg/2 mg or 30 mg/4 mg once daily, titrated as needed

Pediatric Dose

Special Population Considerations

Pregnancy

Limited data available
Use during pregnancy not recommended due to potential risks to the fetus

Nursing Mothers

Use during nursing not recommended due to potential risks to the infant

Pediatric Use

Safety and efficacy not established in pediatric patients
Not recommended for use in pediatric patients due to potential risks

Geriatric Use

Use with caution in geriatric patients due to increased risk of hypoglycemia and other adverse reactions
Dose adjustments may be necessary based on renal function and other factors

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