Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment.Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate:pyruvate ratio and metformin plasma levels generally greater than 5 mcg/mL. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.Initiation of ACTOPLUS MET in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.ACTOPLUS MET is not recommended in patients with symptomatic heart failure.If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOPLUS MET must be considered. After initiation of ACTOPLUS MET, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema).Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS MET, cause or exacerbate congestive heart failure in some patients.WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS See full prescribing information for complete boxed warning
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