WARNING FOR KOMBIGLYZE XR: LACTIC ACIDOSIS
US Full Prescribing Information including Boxed WARNING about lactic acidosis, and Medication Guide
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, KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release) should be discontinued and the patient hospitalized immediately. [See Warnings and Precautions]
Click here for Important Safety Information including complete Boxed WARNING about lactic acidosis
A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE
Once-daily KOMBIGLYZE XR provides the maximum dose of saxagliptin (5 mg) combined with the lowest starting dose of metformin XR (500 mg).
ONCE-DAILY DOSING
5 mg saxagliptin/ 500 mg metformin XR
5 mg saxagliptin/ 1000 mg metformin XR
2.5 mg saxagliptin/ 1000 mg metformin XR
5 mg saxagliptin and 2000 mg metformin XR*
*Can be taken as two 2.5/1000 mg tablets once daily.
Tablets shown are not actual size.
ONCE-DAILY DOSING
5 mg saxagliptin/ 500 mg metformin XR
5 mg saxagliptin/ 1000 mg metformin XR
2.5 mg saxagliptin/ 1000 mg metformin XR
5 mg saxagliptin and 2000 mg metformin XR*
*Can be taken as two 2.5/1000 mg tablets once daily.
Tablets shown are not actual size.
MAXIMUM RECOMMENDED DOSE
5 mg saxagliptin and 2000 mg metformin XR
Consider KOMBIGLYZE XR for patients who:
Drug Interactions