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Pioglitazone

    Brands

    DEA Class; Rx

    Common Brand Names; Actos

    • Antidiabetics, Thiazolidinediones

    Thiazolidinedione (TZD) oral antidiabetic; targets insulin resistance
    Used in adults with type 2 diabetes mellitus; use with caution in combination with insulin
    Monitor closely; TZDs can cause or exacerbate heart failure (boxed warning)

    Indicated as monotherapy or with insulin or insulin secretagogues

    For the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.

    Hypersensitivity to pioglitazone

    Diabetic ketoacidosis

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

    CHF (NYHA class III, IV)

    Edema when used in combination with sulfonylurea or insulin (<27%)

    Hypoglycemia (<27%)

    Upper respiratory infection (13%)

    Headache (9%)

    Heart failure (up to 8%)

    Sinusitis (6%)

    Fracture of bone (5%)

    Pharyngitis (5%)

    Myalgia (5%)

    Aggravated diabetes

    Diabetic macular edema

    Hepatic failure (rare)

    Increased cholesterol

    Decreased serum triglycerides

    Hematocrit/hemoglobin

    Bladder cancer

    Decreased visual acuity

    Dyspnea

    Increased transaminases

    Pharyngitis

    Sinusitis

    Weight gain

    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

    Adults

    45 mg/day PO.

    Elderly

    45 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Pioglitazone 

    tablet

    • 15mg
    • 30mg
    • 45mg