One tablet, once daily, for proven 24-hour glycemic control
- The recommended dose of JANUVIA is 100 mg once daily with or without food
- 24-hour DPP-4 inhibition with a single daily dose
- No titration needed
The recommended dose of JANUVIA is 100 mg once daily.
Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis. Caution should be used to ensure that the correct dose of JANUVIA is prescribed.
A dosage adjustment is recommended in patients with moderate or severe renal insufficiency or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis.
No dosage adjustment is required for patients with mild renal insufficiency. For patients with moderate renal insufficiency, the dose of JANUVIA is 50 mg once daily. For patients with severe renal insufficiency or with ESRD requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily.
Because there is a need for a dose adjustment, assessment of renal function is recommended before initiation of JANUVIA and periodically thereafter.
There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. A subset of these reports involved patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.
Selected Important Risk Information
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA, such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Angioedema has also been reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a history of angioedema with another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with JANUVIA.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.
JANUVIA® (sitagliptin) tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
JANUVIA 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 of developing pancreatitis while taking JANUVIA.
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