Renal Impairment:The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function. Following a single dose of 500 mg or 1000 mg dalbavancin, the mean plasma clearance (CLT) was reduced 11%, 35%, and 47% in subjects with mild (CLCR 50 to 79 mL/min), moderate (CLCR 30 to 49 mL/min), and severe (CLCR less than 30 mL/min), renal impairment, respectively, compared to subjects with normal renal function. The clinical significance of the decrease in mean plasma CLT, and the associated increase in AUC0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with severe renal impairment has not been established [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].
No dosage adjustment is necessary for patients with CLCR greater than 30 mL/min or patients receiving hemodialysis. The recommended two-dose regimen for dalbavancin in patients with severe renal impairment who are not receiving regularly scheduled hemodialysis is 750 mg followed one week later by 375 mg.
Dalbavancin pharmacokinetic parameters in subjects with end-stage renal disease receiving regularly scheduled hemodialysis (three times/week) are similar to those observed in subjects with mild to moderate renal impairment, and less than 6% of an administered dose is removed after three hours of hemodialysis. Therefore, no dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalbavancin may be administered without regard to the timing of hemodialysis in such patients [see Dosage and Administration (2.1) and Overdosage (10)].
Renal Impairment:The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function. Following a single dose of 500 mg or 1000 mg dalbavancin, the mean plasma clearance (CLT) was reduced 11%, 35%, and 47% in subjects with mild (CLCR 50 to 79 mL/min), moderate (CLCR 30 to 49 mL/min), and severe (CLCR less than 30 mL/min), renal impairment, respectively, compared to subjects with normal renal function. The clinical significance of the decrease in mean plasma CLT, and the associated increase in AUC0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with severe renal impairment has not been established [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].
No dosage adjustment is necessary for patients with CLCR greater than 30 mL/min or patients receiving hemodialysis. The recommended two-dose regimen for dalbavancin in patients with severe renal impairment who are not receiving regularly scheduled hemodialysis is 750 mg followed one week later by 375 mg.
Dalbavancin pharmacokinetic parameters in subjects with end-stage renal disease receiving regularly scheduled hemodialysis (three times/week) are similar to those observed in subjects with mild to moderate renal impairment, and less than 6% of an administered dose is removed after three hours of hemodialysis. Therefore, no dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalbavancin may be administered without regard to the timing of hemodialysis in such patients [see Dosage and Administration (2.1) and Overdosage (10)].
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