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Pioglitazone

PIOGLITAZONE

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC

Score: 148.0

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

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