For appropriate patients with type 2 diabetes…
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JANUMET XR is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended-release is appropriate.
JANUMET XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUMET XR.
Selected Important Risk Information
WARNING: 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, JANUMET XR should be discontinued and the patient hospitalized immediately [see Warnings and Precautions].
in your state
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