RECENT MAJOR CHANGES
Warnings and Precautions
Macrovascular Outcomes (5.4) 07/2008
INDICATIONS AND USAGE
JANUVIA is 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. (1.1)
Important Limitations of Use:
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1.2) JANUVIA has not been studied in combination with insulin. (1.2) DOSAGE AND ADMINISTRATION
Dosage Adjustment in Patients With Moderate, Severe and End Stage Renal Disease (ESRD) (2.2) 50 mg once daily 25 mg once daily Moderate
CrCl >=30 to <50 mL/min~Serum Cr levels [mg/dLMen: >1.7– <=3.0;Women: >1.5– <=2.5
Severe and ESRD
CrCl <30 mL/min~Serum Cr levels [mg/dLMen: >3.0;Women: >2.5;or on dialysis
DOSAGE FORMS AND STRENGTHS
Tablets: 100mg, 50mg, and 25mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema (5.3, 6.2)
WARNINGS AND PRECAUTIONS
Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. (2.2, 5.1) When used with a sulfonylurea, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. (2.3, 5.
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