Multiple dose 500 mg q24h p. o. 3 5.7 ± 1.4 1.1 ± 0. 4 47.5 ± 6. 7 175 ± 25 102 ± 22 7.6 ± 1. 6 116 ± 31 500 mg q24h i. v. 3 6.4 ± 0. 8 ND 54.6 ± 11.1 158 ± 29 91 ± 12 7.0 ± 0. 8 99 ± 28 500 mg or 250 mg q24h i. v., 8.7 ± 4. 0 7 ND 72.5 ± 51.2 7 154 ± 72 111 ± 58 ND ND patients with bacterial infection 6 750 mg q24h p. o. 5 8.6 ± 1. 9 1.4 ± 0. 5 90.7 ± 17.6 143 ± 29 100 ± 16 8.8 ± 1. 5 116 ± 28 750 mg q24h i. v. 5 12.1 ± 4. 1 4 ND 108 ± 34 126 ± 37 80 ± 27 7.9 ± 1. 9 ND 500 mg p. o. single dose, effects of gender and age: Male 8 5.5 ± 1. 1 1.2 ± 0. 4 54.4 ± 18.9 166 ± 44 89 ± 13 7.5 ± 2. 1 126 ± 38 Female 9 7.0 ± 1. 6 1.7 ± 0. 5 67.7 ± 24.2 136 ± 44 62 ± 16 6.1 ± 0. 8 106 ± 40 Young 10 5.5 ± 1. 0 1.5 ± 0. 6 47.5 ± 9. 8 182 ± 35 83 ± 18 6.0 ± 0. 9 140 ± 33 Elderly 11 7.0 ± 1. 6 1.4 ± 0. 5 74.7 ± 23.3 121 ± 33 67 ± 19 7.6 ± 2. 0 91 ± 29 500 mg p. o. single dose, patients with renal insufficiency: CLCR 50-80 mL/ min 7.5 ± 1. 8 1.5 ± 0. 5 95.6 ± 11.8 88 ± 10 ND 9.1 ± 0. 9 57 ± 8 CLCR 20-49 mL/ min 7.1 ± 3. 1 2.1 ± 1. 3 182.1 ± 62.6 51 ± 19 ND 27 ± 10 26 ± 13 CLCR <20 mL/ min 8.2 ± 2. 6 1.1 ± 1. 0 263.5 ± 72.5 33 ± 8 ND 35 ± 5 13 ± 3 Hemodialysis 5.7 ± 1. 0 2.8 ± 2. 2 ND ND ND 76 ± 42 ND CAPD 6.9 ± 2. 3 1.4 ± 1. 1 ND ND ND 51 ± 24 ND 1 clearance/ bioavailability 2 volume of distribution/ bioavailability 3 healthy males 18-53 years of age 4 60 min infusion for 250 mg and 500 mg doses, 90 min infusion for 750 mg dose 5 healthy male and female subjects 18-54 years of age 6 500 mg q48h for patients with moderate renal impairment (CLCR 20-50 mL/ min) and infections of the respiratory tract or skin 7 dose-normalized values (to 500 mg dose), estimated by population pharmacokinetic modeling 8 healthy males 22-75 years of age 9 healthy females 18-80 years of age 10 young healthy male and female subjects 18-36 years of age 11 healthy elderly male and female subjects 66-80 years of age *Absolute bioavailability; F = 0.99 ± 0.08 from a 500-mg tablet and F= 0.99 ± 0.06 from a 750-mg tablet; ND = not determined. | ||||
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