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Actos (pioglitazone)


Thiazolidinediones cause or exacerbate congestive heart failure (CHF) in some patients. After initiation and dose increases, monitor carefully for signs and symptoms of heart failure (HF) and manage accordingly; consider discontinuation or dose reduction. Not recommended in patients with symptomatic HF. Contraindicated with established NYHA Class III or IV HF.


Thiazolidinedione (glitazone)




Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM).


Type 2 Diabetes Mellitus

Initial: 15mg or 30mg qd
Titrate: In increments of 15mg
Max: 45mg qd

W/ CHF (NYHA Class I or II):
Initial: 15mg qd
Titrate: In increments of 15mg
Max: 45mg qd


Concomitant Medications
Insulin Secretagogue:
Reduce dose of insulin secretagogue if hypoglycemia occurs


Decrease insulin dose by 10-25% if hypoglycemia occurs

Gemfibrozil/Other Strong CYP2C8 Inhibitors:
Max: 15mg qd


Oral route

Take w/o regard to meals


Tab: 15mg, 30mg, 45mg


Established NYHA Class III or IV HF.


Not for use in treatment of type 1 DM or diabetic ketoacidosis. Fatal and nonfatal hepatic failure reported. May use with caution in patients with lesser ALT elevations or bilirubin and with an alternate probable cause. Obtain LFTs prior to initiation; caution with liver disease/abnormal LFTs. D/C if ALT >3X ULN; do not restart if cause of abnormal LFTs not established or if ALT remains >3X ULN with total bilirubin >2X ULN without alternative etiologies. Not for use in patients with active bladder cancer; consider benefits versus risks in patients with a prior history of bladder cancer. New onset or worsening of edema reported; caution in patients with edema and in patients at risk for CHF. Increased incidence of bone fractures reported in females. Macular edema reported; refer to an ophthalmologist if visual symptoms develop. Ovulation in premenopausal anovulatory patients may occur; use adequate contraception.


CHF, URTI, hypoglycemia, edema, headache, cardiac failure, pain in extremity, sinusitis, back pain, myalgia, pharyngitis, chest pain.


Increased exposure and T1/2 with CYP2C8 inhibitors (eg, gemfibrozil). Decreased exposure with CYP2C8 inducers (eg, rifampin). Risk of fluid retention and hypoglycemia with insulin and other antidiabetic medications (eg, insulin secretagogues such as sulfonylureas).


Category C, not for use in nursing.


Thiazolidinedione; decreases insulin resistance in the periphery and liver, resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output.


Absorption: Tmax=Within 2 hrs, 3-4 hrs (with food). Distribution: Vd=0.63L/kg; plasma protein binding (>99%). Metabolism: Hydroxylation and oxidation (extensive), CYP2C8, CYP3A4; M-III [keto derivative] and M-IV [hydroxyl derivative] (active metabolites). Elimination: Urine (15-30%), bile and feces; T1/2=3-7 hrs (pioglitazone), 16-24 hrs (metabolites).


Assess for previous hypersensitivity, HF, edema, risk factors for developing HF, liver disease, bone health, active/history of bladder cancer, pregnancy/nursing status, and possible drug interactions. Obtain baseline LFTs.


Monitor for signs and symptoms of HF, edema, weight gain, hematological changes (eg, decreases in Hgb, Hct), liver injury, macular edema, bone fractures, ovulation in premenopausal anovulatory women, and other adverse reactions. Perform periodic measurements of FPG and HbA1c. Periodically monitor LFTs in patients with liver disease. Perform periodic eye exams.


Advise to adhere to dietary instructions and have blood glucose and glycosylated Hgb levels tested regularly. Instruct to seek medical advice promptly during periods of stress and report rapid increase in weight or edema, SOB, or other symptoms of HF to physician. Instruct to d/c and consult physician if unexplained N/V, abdominal pain, anorexia, fatigue, or dark urine occurs. Advise to report any signs of macroscopic hematuria or other symptoms such as dysuria or urinary urgency. Advise to take qd with or without meals. If dose is missed, advise to not double the dose the following day. Inform about the risk of hypoglycemia when using with insulin or other antidiabetic medications. Inform that therapy may result in ovulation in some premenopausal anovulatory women; recommend adequate contraception for all premenopausal women.


25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light, moisture, and humidity.


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