ACTOS(pioglitazone hydrochloride)Tablets

Generic Name and Formulations:
Pioglitazone (as HCl) 15mg, 30mg, 45mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc.
Indications for ACTOS:
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or in combination with metformin, insulin, or a sulfonylurea. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:
≥18yrs: Without CHF: initially 15mg or 30mg once daily; max 45mg once daily. With CHF (NYHA Class I or II): initially 15mg once daily. Concomitant insulin or sulfonylurea: reduce dose of these if needed. Concomitant strong CYP2C8 inhibitors: max 15mg daily.

Children:
<18yrs: not recommended.

Contraindications:
NYHA Class III or IV heart failure.

Warnings/Precautions:
Symptomatic HF: not recommended. Monitor for signs/symptoms of CHF; discontinue or reduce dose if occurs. Hepatic disease. Monitor liver function before initiating therapy; if abnormalities detected, interrupt and assess probable cause; do not restart if ALT >3XULN with total bilirubin >2XULN. Routine monitoring LFTs during therapy without liver disease: not recommended. Active bladder cancer: not recommended. Risk of fractures (esp. females). Perform regular eye exams. 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.

Interactions:
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.

Pharmacological Class:
Thiazolidinedione.

Adverse Reactions:
Upper respiratory tract infection, headache, sinusitis, pharyngitis, myalgia, edema, weight gain, hypoglycemia, dyspnea; changes in serum lipids (may be beneficial), macular edema.

How Supplied:
Tabs—30, 90, 500