Recommended Dose/Mode of Administration: The recommended dose of MAGLITIN is 100 mg once daily as monotherapy or as combination therapy with metformin, a sulfonylurea, insulin (with or without metformin), a PPARγ agonist (i.e., thiazolidinediones), metformin plus a sulfonylurea, or metformin plus a PPARγ agonist.
MAGLITIN can be taken with or without food.
When MAGLITIN is used in combination with a sulfonylurea or with insulin, a lower dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea or insulin-induced hypoglycemia (See Hypoglycemia in Combination with a Sulfonylurea or with Insulin under Precautions).
Patients with Renal Impairment: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of MAGLITIN and periodically thereafter.
For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥60 to <90 mL/min/1.73 m2), no dosage adjustment for MAGLITIN is required.
For patients with moderate renal impairment (eGFR ≥45 to <60 mL/min/1.73 m2), no dosage adjustment for MAGLITIN is required.
For patients with moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73 m2), the dose of MAGLITIN is 50 mg once daily.
For patients with severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m2) or with end-stage renal disease (ESRD) (eGFR <15 mL/min/1.73 m2), including those requiring hemodialysis or peritoneal dialysis, the dose of MAGLITIN is 25 mg once daily. MAGLITIN may be administered without regard to the timing of dialysis.
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