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Type 2 diabetes, as monotherapy or as an adjunct to diet and exercise; also may be used in conjunction with a sulfonylurea, metformin, or insulin when diet, exercise, and a single agent alone does not result in adequate glycemic control in patients with type 2 diabetes mellitus.


Established New York Heart Association class III or IV heart failure; hypersensitivity to any component of the product.

Adverse reactions:

Cardiovascular CHF. CNS Headache (9%). EENT Pharyngitis (5%); macular edema (postmarketing). GI Tooth disorders (5%). Hepatic Elevated ALT. Hematologic Anemia (less than 2%); decrease in hemoglobin and hematocrit. Lab Tests Decreased hemoglobin and hematocrit levels, elevated ALT, elevated CPK levels. Metabolic-Nutritional Hypoglycemia. Musculoskeletal Bone fractures, myalgia (5%). Respiratory Upper respiratory tract infection (13%); sinusitis (6%). Miscellaneous Edema (5%).


Contraceptives, oral Oral contraceptives may decrease both hormone components about 30%, potentially reducing contraceptive effectiveness. CYP2C8 enzyme inhibitors (eg, azole antifungal agents [eg, ketoconazole], fluvoxamine, gemfibrozil, trimethoprim) Pioglitazone plasma levels may be elevated, increasing the pharmacologic effects and adverse reactions. CYP2C8 inducers (eg, rifampin) Pioglitazone plasma concentrations may be reduced, decreasing the efficacy. Midazolam Plasma concentrations may be reduced by pioglitazone, decreasing the efficacy.


Warnings Pioglitazone can cause or exacerbate CHF in some patients. Consider discontinuing or reducing the dose if symptoms of heart failure occur. Treatment of patients with symptomatic heart failure is not recommended. Monitor After starting treatment or increasing the dose, carefully observe patients for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema). Monitor liver enzymes prior to the start of therapy and periodically thereafter. Fasting blood glucose and hemoglobin A 1c (HbA 1c ) measurements should be performed periodically to monitor glycemic control and therapeutic response. Pregnancy Category C . Lactation Undetermined. Children Safety and efficacy not established. Hepatic Function Use with caution. Do not initiate therapy in patients with clinical evidence of active liver disease or baseline ALT more than 2.5 × ULN. Discontinue therapy if ALT increases to more than 3 × ULN and persists. Related drugs have reported rare hepatotoxicity. Bone Fractures Increased incidence of bone fractures noted in women but not men. Diabetic Ketoacidosis Not recommended. Edema Use caution; can cause fluid retention. Hematologic Decreases in Hgb and Hct (2% to 4%) have been reported and may be related to increases in plasma volume associated with pioglitazone therapy. Hyperglycemia May increase the risk of hypoglycemia when used in combination with other hypoglycemic agents; may need dose reduction of concomitant agents. Ovulation May result in ovulation in premenopausal anovulatory women; recommend contraception. Type 1 diabetes Not recommended. Weight gain Dose-related weight gain has been seen alone and in combination with other hypoglycemic agents.



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