Pioglitazone

DEA Class; Rx

Common Brand Names; Actos

Hypersensitivity to pioglitazone

Diabetic ketoacidosis

Moderate-severe hepatic impairment (ALT >2.5x ULN)

CHF (NYHA class III, IV)

Do initiate treatment in patients with active liver disease who have ALT levels >2.5 times the upper limit of normal (ULN); if ALT >3 times the ULN, stop treatment; if ALT is 1.5-3 times the ULN, retest qWeek until normal or until it reaches 3 times the ULN and treatment must be discontinued

Not recommended for patients with symptomatic heart failure; may cause or exacerbate congestive heart failure in some patients; monitor patients carefully after initiating therapy; observe for signs and symptoms of heart failure; if signs and symptoms develop, manage heart failure according to current standards of care; consider discontinuing therapy or reducing the dose

New onset or exacerbation of existing edema and dyspnea reported

Macular edema reported; patients should be seen by an ophthalmologist if any visual symptoms arise during therapy; all diabetic patients should have regular eye exams

Delayed related weight gain reported with use; likely associated with fluid retention and fat accumulation

Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin

Risk of hypoglycemia, in combination with insulin or other oral agents

May result in ovulation in some premenopausal, anovulatory women; ensure adequate contraception

May decrease hemoglobin/hematocrit

Increased fracture risk in females

Use with caution in premenopausal/anovulatory females (patient may resume ovulation and increase the risk of pregnancy)

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

Increased risk of CHF; not recommended in symptomatic heart failure

Pregnancy: Limited data with pioglitazone in pregnant women are not sufficient to determine a drug- associated risk for major birth defects or miscarriage

Lactation: There is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production

Pioglitazone 

tablet

• 15mg
• 30mg
• 45mg