|
INDICATION AND LIMITATIONS OF USE
JARDIANCE is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease .
JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis .
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
JARDIANCE should not be used in patients with a history of serious hypersensitivity to JARDIANCE or in patients with severe renal impairment , end-stage renal disease , or dialysis .
|
WARNINGS AND PRECAUTIONS Hypotension
JARDIANCE causes intravascular volume contraction and symptomatic hypotension may occur . Before initiating JARDIANCE , assess and correct volume status in the elderly , in patients with renal impairment , low systolic blood pressure , or on diuretics . Monitor for hypotension .
Ketoacidosis
Reports of ketoacidosis , a serious life-threatening condition requiring urgent hospitalization have been identified in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co transporter 2
( SGLT2 ) inhibitors , including JARDIANCE . Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE . Patients who present
|
|||||||
2 ! |
! |
! |
! |
! |
! |
! |
! |
with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis , even if blood glucose levels are less than 250 mg / dL . If suspected , discontinue JARDIANCE , evaluate and treat promptly .
Before initiating JARDIANCE , consider risk factors for ketoacidosis . Patients on JARDIANCE may require monitoring and temporary discontinuation
!
! in situations known to predispose to ketoacidosis .
|