Glyza 5 mg Tablet

Recommended Dosage: The recommended dosage of Saxagliptin is 2.5 mg or 5 mg once daily taken regardless of meals. Saxagliptin tablets must not be split or cut.

Dosage In Patients With Renal Impairment: No dosage adjustment for Saxagliptin is recommended for patients with mild renal impairment (CrCl >50 mL/min).

The dosage of Saxagliptin is 2.5 mg once daily (regardless of meals) for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (CrCl ? 50 mL/min). Saxagliptin should be administered following hemodialysis. Saxagliptin has not been studied in patients undergoing?peritoneal dialysis.

Because the dosage of Saxagliptin should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of Saxagliptin and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula.

Dosage Adjustment With Concomitant Use Of Strong CYP3A4/5 Inhibitors: The dosage of Saxagliptin is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin)?

Concomitant Use With An Insulin Secretagogue (e.g., Sulfonylurea) Or With Insulin When Saxagliptin 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 minimize the risk of?hypoglycemia