Lactic Acidosis

• Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.

• The onset of lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

• Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

• If acidosis is suspected, XIGDUO XR should be discontinued and the patient hospitalized immediately [see Warnings and Precautions (5.1)]