Actos (pioglitazone)

ACTOS (pioglitazone) – a thiazolidinedione (TZD) and an agonist for peroxisome proliferator activated receptor (PPAR) gamma commonly used to treat type 2 diabetes mellitus. ACTOS decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is not an insulin secretagogue.

FDA approved uses: Actos is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

Available dosage forms: Tablets – 15, 30, 45 mg.

Usual dosage: Initiate ACTOS at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure. If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. The maximum recommended dose of ACTOS is 15 mg once daily in patients taking strong CYP2C8 inhibitors (e.g., gemfibrozil).

Contraindications: Patients with known hypersensitivity to pioglitazone or to any excipients used in the formulation. Patients with established NYHA Class III or IV heart failure.

Special warnings: WARNING: CONGESTIVE HEART FAILURE -Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients.

  • After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOS must be considered.
  • ACTOS is not recommended in patients with symptomatic heart failure.
  • Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

    • Adverse reactions (side effects) of these medications: The most common side effects of Actos include upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis. Other adverse events reported include flatulence, weight gain, hypoglycemia, urinary tract infection, back pain, dizziness, diarrhea, hypertension, sinusitis, increased CPK, chest pain, and congestive heart failure.

    Common drug interactions: An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life of pioglitazone. An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with ACTOS, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for ACTOS.

    Special instructions for patients: Take this medication exactly as directed by physician. Read the official Medication Guide before starting Actos and when you receive new refills. Call your doctor right away if you have any of the following:

  • swelling or fluid retention, especially in the ankles or legs
  • shortness of breath or trouble breathing, especially when you lie down
  • an unusually fast increase in weight
  • unusual tiredness

    • Full prescribing information may be found at the manufacturer‘s official website Actos.com or at the U.S. Food and Drug Administration’s website at Actos Info at Drugs@FDA

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