Per 50/500 mg combipack 14 FC tab of sitagliptin phosphate monohydrate 50 mg, 14 FC tab of metformin HCl 500 mg. Per 100/500 mg combipack 14 FC tab of sitagliptin phosphate monohydrate 100 mg, 14 FC tab of metformin HCl 500 mg
Indications/Uses
Sitagliptin: Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM. Metformin: Treatment of type 2 DM.
Sitagliptin FC tab 100 mg once daily. Patient w/ moderate renal insufficiency (CrCl ≥30 to <50 mL/min) 50 mg once daily. Patient w/ severe renal insufficiency (CrCl <30 mL/min), ESRD requiring hemodialysis or peritoneal dialysis 25 mg once daily. Metformin FC tab 500 mg bid or tid, may be gradually increased to a max of 3 g.
Sitagliptin: Discontinue use if pancreatitis occurs. Hypoglycemia. Patients w/ renal insufficiency. Not recommended during pregnancy. Should not be used during lactation. Childn <18 yr. Metformin: Do not use in NIDDM. Heart failure, dehydration, acute or chronic alcoholism, or any condition predisposing to lactic acidosis.
Sitagliptin: Slight increase in AUC & mean peak drug conc of digoxin. Metformin: Increased risk of hypoglycemia w/ other drugs that lower blood-glucose conc & alcohol. Increased lactic acidosis w/ alcohol.
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