Generic Name and Formulations:
Pioglitazone (as HCl) 15mg, 30mg, 45mg; tabs.
Company:
Takeda Pharmaceuticals North America, Inc.
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or in combination with metformin, insulin, or a sulfonylurea.
≥18yrs: initially 15mg or 30mg once daily; max 45mg once daily. Reduce insulin or sulfonylurea dose if needed.
<18yrs: not recommended.
Thiazolidinedione.
NYHA Class III or IV heart failure.
Not for treating type 1 diabetes or diabetic ketoacidosis. Symptomatic HF: not recommended. CHF: if NYHA Class II: start at lowest approved dose and titrate carefully. Edema. May increase plasma volume (monitor for signs/symptoms of heart failure); discontinue if cardiac status deteriorates. Hepatic disease. Do not start therapy in active liver disease or if ALT >2.5xULN. Monitor ALT at baseline, then periodically. If ALT 1–2.5xULN, follow-up and monitor closely; discontinue if ALT >3xULN persists or if jaundice occurs. Not for use in patients with history of troglitazone-associated jaundice. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy (Cat.C): consider using insulin instead. Nursing mothers: not recommended.
Potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Antagonizes oral contraceptives, midazolam. Monitor glycemic control more frequently with ketoconazole. Monitor for heart failure with insulin.
Upper respiratory tract infection, headache, sinusitis, pharyngitis, myalgia, anemia, edema, weight gain, hypoglycemia, dyspnea; changes in serum lipids (may be beneficial); also women: risk of fracture.
Tabs—30, 90, 500