Pioglitazone Hydrochloride

PIOGLITAZONE HYDROCHLORIDE

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC

Score: 148.0

Quick Summary

Pioglitazone is a thiazolidinedione used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It works by decreasing insulin resistance in the periphery and liver, resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. The drug is available in 15 mg, 30 mg, and 45 mg tablets and should be taken once daily with or without meals. The recommended starting dose is 15 mg or 30 mg once daily, with a maximum dose of 45 mg once daily. Pioglitazone is contraindicated in patients with established NYHA Class III or IV heart failure and in patients with known hypersensitivity to the drug. Important safety information includes the risk of congestive heart failure, edema, and fractures, as well as potential liver damage and bladder cancer. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes mellitus
Decreases insulin resistance in the periphery and liver
Increases insulin-dependent glucose disposal and decreases hepatic glucose output
Available in 15 mg, 30 mg, and 45 mg tablets

Important Safety Information

Warning

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

Contraindications

Established NYHA Class III or IV heart failure
Known hypersensitivity to pioglitazone or any other component of Pioglitazone tablets

Adverse Reactions

Congestive heart failure
Edema
Fractures
Liver damage
Bladder cancer

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with congestive heart failure, liver disease, or renal impairment

Type 2 diabetes mellitus

Adult Dose

15 mg or 30 mg once daily, with a maximum dose of 45 mg once daily

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Abnormal blood glucose concentrations during pregnancy are associated with a higher incidence of congenital anomalies, as well as increased neonatal morbidity and mortality

Nursing Mothers

It is not known whether pioglitazone is secreted in human milk
A decision should be made to discontinue nursing or discontinue pioglitazone, taking into account the importance of pioglitazone to the mother

Pediatric Use

Safety and effectiveness of pioglitazone in pediatric patients have not been established
Pioglitazone is not recommended for use in pediatric patients based on adverse effects observed in adults

Geriatric Use

No significant differences were observed in pharmacokinetic parameters between elderly and younger patients
Clinical experiences have not identified differences in effectiveness and safety between the elderly (> 65 years) and younger patients