Pioglitazone

PIOGLITAZONE

Manufacturer: RPK Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

Pioglitazone is an oral antidiabetic medication used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is a thiazolidinedione that depends on the presence of insulin for its mechanism of action, decreasing insulin resistance and increasing insulin-dependent glucose disposal. The drug has been shown to have various benefits, including improving insulin sensitivity, reducing hyperglycemia, and increasing high-density lipoprotein (HDL) cholesterol. However, it also carries important safety information, including a warning about congestive heart failure, and contraindications such as initiation in patients with established NYHA Class III or IV heart failure. Common adverse reactions include upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis.

Key Clinical Findings and Indications

Improves insulin sensitivity in insulin-resistant patients
Decreases insulin resistance and increases insulin-dependent glucose disposal
Increases high-density lipoprotein (HDL) cholesterol
Reduces hyperglycemia, hyperinsulinemia, and hypertriglyceridemia
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

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 or any other component of pioglitazone tablets

Adverse Reactions

Upper respiratory tract infection
Headache
Sinusitis
Myalgia
Pharyngitis
Hypoglycemia
Edema
Weight gain
Fractures
Urinary bladder tumors

Dosing Recommendations

General Guidance

Dose adjustments may be necessary when used in combination with other antidiabetic medications or in patients with renal or hepatic impairment

Type 2 diabetes mellitus

Adult Dose

Initiate at 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

Limited data available, but no adverse developmental effects observed in animal studies
Use with caution in pregnant women, as poorly controlled diabetes can increase the risk of congenital malformations and other adverse pregnancy outcomes

Nursing Mothers

Discuss the potential for unintended pregnancy with premenopausal women, as therapy with pioglitazone may result in ovulation in some anovulatory women

Pediatric Use

Not recommended for use in pediatric patients due to lack of safety and efficacy data

Geriatric Use

No significant differences in pharmacokinetic parameters observed between elderly and younger patients
Use with caution in elderly patients, as they may be more susceptible to the adverse effects of pioglitazone