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HIGHLIGHTS OF PRESCRIBING INFORMATION least annually thereafter, assess renal function and verify as normal.
These highlights do not include all the information needed to use (4, , , , )
JANUMET safely and effectively. See full prescribing information • There have been postmarketing reports of acute pancreatitis,
for JANUMET. including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.
If pancreatitis is suspected, promptly discontinue JANUMET. ()
JANUMET® (sitagliptin/metformin HCl) tablets • Measure hematologic parameters annually. (, )
Initial . Approval: 2007 • Warn patients against excessive alcohol intake. (, )
• May need to discontinue JANUMET and temporarily use insulin
WARNING: LACTIC ACIDOSIS
during periods of stress and decreased intake of fluids and food as
See full prescribing information for complete boxed warning.
may occur with fever, trauma, infection or surgery. (, , ,
)
• Lactic acidosis can occur due to metformin accumulation. The • Promptly evaluate patients previously controlled on JANUMET who
risk increases with conditions such as sepsis, dehydration, develop laboratory abnormalities or clinical illness for evidence of
excess alcohol intake, hepatic insufficiency, renal impa