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Pioglitazone HCl/Metformin HCl Extended-Release Tablets (ACTOplus met XR) for Type 2 Diabetes

On May 12, the FDA approved pioglitazone HCl and metformin HCl extended-release tablets (ACTOplus met XR; Takeda Pharmaceutical Co, Ltd) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already receiving pioglitazone and metformin or who have inadequate glycemic control with either drug alone.

According to a company news release, it is the first and only prescription once-daily oral antidiabetic fixed-dose combination product available with the extended-release form of metformin.

The recommended starting dose for pioglitazone-metformin extended-release tablets is one 15-mg/1000-mg or 30-mg/1000-mg tablet administered once daily with the evening meal; this dose may be gradually uptitrated to a maximum of 45 mg/2000 mg depending on clinical response and tolerance. Patients initiating therapy or receiving dose increases should be monitored carefully for signs and symptoms of heart failure, including excessive and rapid weight gain, dyspnea, and/or edema. Use of the product in the setting of New York Heart Association class III or IV heart failure is contraindicated.

Patients receiving pioglitazone-metformin therapy should be informed that the extended-release tablets must be swallowed whole and not chewed, cut, or crushed, and that inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.

Because metformin is substantially excreted by the kidneys and its accumulation has been linked to a risk for potentially fatal lactic acidosis, pioglitazone-metformin products should not be used in patients with kidney disease or renal impairment.

Similarly, treatment with pioglitazone-metformin should not be initiated in patients with clinical evidence of active liver disease or increased serum transaminase levels (alanine aminotransferase > 2.5 the upper limit of normal). Liver enzyme monitoring is recommended before initiation of therapy and periodically thereafter.

A pioglitazone and immediate-release metformin combination product (ACTOplus met) previously was approved by the FDA for the adjunctive treatment of type 2 diabetes mellitus.