Janumet

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
NDA022044 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Janumet Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Limitations Of Use Janumet Should Not Be Used In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis. Janumet 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 For The Development Of Pancreatitis While Using Janumet. [See Warnings And Precautions (5.2) .] Janumet Is A Combination Of Sitagliptin, A Dipeptidyl Peptidase-4 (Dpp-4) Inhibitor, And Metformin Hydrochloride (Hcl), A Biguanide, Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. ( 1 ) Limitations Of Use: Janumet Should Not Be Used In Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis. ( 1 ) Janumet Has Not Been Studied In Patients With A History Of Pancreatitis. ( 1 , 5.2 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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