Actoplus Met has the following FDA Boxed Warnings: Thiazolidinediones, which is a component of Actoplus Met, can cause or worsen congestive heart failure in some patients. Patients should be monitored for signs and symptoms of heart failure after starting Actoplus Met and after dose changes. If heart failure occurs, it should be managed and Actoplus Met should be stopped or the dose reduced. Actoplus Met should not be used in patients with symptomatic heart failure. Actoplus Met should not be used in patients with established New York Association Class III or IV heart failure. Metformin-associated lactic acidosis can cause death, hypothermia, low blood pressure, and resistant slow heart arrhythmias. Symptoms include general discomfort, muscle pains, breathing problems, drowsiness, and stomach pain. Lab findings may include elevated blood lactate levels, anion gap acidosis, increased lactate:pyruvate ratio, and metformin blood levels greater than 5 mcg/mL. Kidney problems, taking certain drugs, being 65 years old or older, undergoing radiological studies with contrast, undergoing surgery and other procedures, low blood oxygen, excessive alcohol consumption, and liver problems can increase the risk of lactic acidosis. Actoplus Met should be stopped and treatment started if lactic acidosis is suspected. Before you begin treatment with Actoplus Met, consult with your doctor about the following:, All the prescription and over-the-counter medications you take, Your allergies, Your medical history and current health problems, If you are pregnant or breastfeeding, Actoplus Met can cause fluid retention, which can worsen or lead to congestive heart failure. Patients should be monitored for signs and symptoms., Actoplus Met can cause lactic acidosis., Actoplus Met can cause swelling that is dose-related., Actoplus Met can cause low blood sugar levels when used with insulin or an insulin secretagogue. Therefore, a lower insulin or insulin secretagogue dose may be required., Liver failure that can lead to death may be caused by Actoplus Met., Actoplus Met may be associated with a higher risk of bladder cancer., Actoplus Met can increase a female’s incidence of fractures., All diabetic patients are recommended to have regular eye exams, as they are at risk of macular edema with Actoplus Met., Vitamin B12 levels may be decreased by Actoplus Met., There is no evidence that Actoplus Met reduces the risk of macrovascular outcomes. All the prescription and over-the-counter medications you take, Your allergies, Your medical history and current health problems, If you are pregnant or breastfeeding
