per 100 patient-years of exposure,
in the JANUVIA population included nasopharyngitis (12 vs. 9),
hypoglycemia (9 vs. 58), increased blood glucose (5 vs. 9),
osteoarthritis (2 vs. 1), contact dermatitis (1 vs. less than 1),
tremor (1 vs. less than 1), nasal congestion (1 vs. less than 1),
and reduced blood glucose (1 vs. 3) for JANUVIA and non-exposed
patients, respectively.
Dosing of JANUVIA
The recommended dose of JANUVIA is 100 mg once daily, with or
without food, for all approved indications. No dosage adjustment is
needed for patients with mild to moderate hepatic insufficiency or
in patients with mild renal insufficiency (CrCl greater than or
equal to 50 mL/min). To achieve plasma concentrations of JANUVIA
similar to those in patients with normal renal function, lower
dosages are recommended in patients with moderate and severe renal
insufficiency as well as in end-stage renal disease (ESRD) patients
requiring hemodialysis. For patients with moderate renal
insufficiency (CrCl greater than or equal to 30 to less than 50
mL/min), the dose of JANUVIA is 50 mg once daily. For those with
severe renal insufficiency (CrCl less than 30 mL/min) or with ESRD
requiring dialysis, the dose of JANUVIA is 25 mg once daily.
Because there is a need for dosage adjustment based upon renal
function, assessment of renal function is recommended prior to
initiation of JANUVIA and periodically thereafter.
Dosing of JANUMET
JANUMET should be given twice daily with meals, with gradual
dose escalation as needed to reduce the gastrointestinal (GI) side
effects due to metformin. In this formulation, the dose of
sitagliptin remains constant (100 mg daily) and is combined with
the two most widely prescribed doses of metformin (1000 mg daily or
2000 mg daily). The recommended starting dose of JANUMET for
patients not on prior metformin therapy and for those not
adequately controlled on sitagliptin is 50 mg sitagliptin and 500
mg metformin twice-daily with meals.
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Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Related medicine technology :1.
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