Transcription of CONTRAINDICATIONS ------------------------
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CONTRAINDICATIONS ------------------------
HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese highlights do not include all the information needed to use KOMBIGLYZE XR safely and effectively. See full prescribing information for KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended - release ) tablets, for oral useInitial Approval: 2010 WARNING: LACTIC ACIDOSISSee full prescribing information for complete boxed warning. Post-marketing cases of metformin -associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Following a switch from metformin immediate-release to metformin extended-
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Medication Guide, Metformin hydrochloride extended-release) Tablets, Metformin Hydrochloride Extended-Release, Metformin hydrochloride extended-release tablets, Diaformin XR Diaformin, Diaformin®XR Diaformin, Metformin hydrochloride, Metformin, Indication Date For the treatment, Extended release, Release, RESEARCH AND DEVELOPMENT M. PHARM, RESEARCH AND DEVELOPMENT M. PHARM THESIS 2011