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JANUVIA (SITAGLIPTIN): DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of Sitagliptin (Januvia) is 100 mg once daily. This drug can be taken with or without food.

Patients with Renal Insufficiency

For patients with mild renal insufficiency (creatinine clearance [CrCl] >= 50 ml / min, approximately corresponding to serum creatinine levels of <= 1.7 mg / dl in men and <= 1.5 mg / dl in women), no dosage adjustment for Sitagliptin Phosphate (Januvia) is required.

For patients with moderate renal insufficiency (CrCl >= 30 to < 50 ml / min, approximately corresponding to serum creatinine levels of > 1.7 to <= 3.0 mg / dl in men and > 1.5 to <= 2.5 mg / dl in women), the dose of Januvia is 50 mg once daily.

For patients with severe renal insufficiency (CrCl < 30 ml / min, approximately corresponding to serum creatinine levels of > 3.0 mg / dl in men and > 2.5 mg / dl in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Januvia (Sitagliptin Phosphate) is 25 mg once daily. This medicine may be administered without regard to the timing of hemodialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia (Sitagliptin) and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.

Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin

When Sitagliptin (Januvia) is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

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