Glyxambi

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
NDA206073 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Glyxambi Is A Combination Of Empagliflozin And Linagliptin Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus . Empagliflozin Is Indicated To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease [See Clinical Studies (14.2) ] . However, The Effectiveness Of Glyxambi On Reducing The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Cardiovascular Disease Has Not Been Established. Glyxambi Is A Combination Of Empagliflozin, A Sodium-Glucose Co-Transporter 2 (Sglt2) Inhibitor And Linagliptin, A Dipeptidyl Peptidase-4 (Dpp-4) Inhibitor, Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus Empagliflozin Is Indicated To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease. However, The Effectiveness Of Glyxambi On Reducing The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Cardiovascular Disease Has Not Been Established ( 1 ) Limitations Of Use Not Recommended For Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis ( 1 ) Has Not Been Studied In Patients With A History Of Pancreatitis ( 1 ) Limitations Of Use Glyxambi Is Not Recommended For Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis [See Warnings And Precautions (5.4) ] . Glyxambi Has Not Been Studied In Patients With A History Of Pancreatitis. It Is Unknown Whether Patients With A History Of Pancreatitis Are At An Increased Risk For The Development Of Pancreatitis While Using Glyxambi [See Warnings And Precautions (5.1) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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