New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2...(val: 2006 RECENT MAJOR CHANGES ...),Health

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

• recommended dose of JANUVIA is 100mg once daily. JANUVIA can be taken with or without food. (2.1)

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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