PIOGLITAZONEHYDROCHLORIDE

Manufacturer: Proficient Rx LP

Score: 148.0

Quick Summary

Pioglitazone hydrochloride 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 recommended starting dose is 15 mg or 30 mg once daily, with a maximum dose of 45 mg once daily. Important safety information includes a boxed warning for congestive heart failure, and contraindications for patients with established NYHA Class III or IV heart failure and known hypersensitivity to pioglitazone or any other component of the drug. Common adverse reactions include upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis.

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

Important Safety Information

Warning

Congestive heart failure

Contraindications

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

Adverse Reactions

Upper respiratory tract infection
Headache
Sinusitis
Myalgia
Pharyngitis

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with congestive heart failure or those taking strong CYP2C8 inhibitors

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

Category C
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

It is not known whether pioglitazone hydrochloride is secreted in human milk
A decision should be made to discontinue nursing or discontinue pioglitazone hydrochloride

Pediatric Use

Safety and effectiveness have not been established in pediatric patients
Not recommended for use in pediatric patients based on adverse effects observed in adults

Geriatric Use

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

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