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Levaquin - Clinical Pharmacology

[Levofloxacin]



Race

The effect of race on levofloxacin pharmacokinetics was exam-ined through a covariate analysis performed on data from 72 subjects: 48 white and 24 non-white. The apparent total body clearance and apparent volume of distribution were not affected by the race of the subjects.

Renal insufficiency

Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with impaired renal function (creatinine clearance <50 mL/ min), requiring dosage adjustment in such patients to avoid accumulation. Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin are not required following hemodialysis or CAPD. (See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION.)

Hepatic insufficiency

Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.

Bacterial infection

The pharmacokinetics of levofloxacin in patients with serious community-acquired bacterial infections are comparable to those observed in healthy subjects. Drug-drug interactions: The potential for pharmacokinetic drug inter-actions between levofloxacin and theophylline, warfarin, cyclosporine, digoxin, probenecid, cimetidine, sucralfate, and antacids has been evaluated. (See PRECAUTIONS: Drug Interactions.)

Table 1. Mean SD Levofloxacin PK Parameters Cmax Tmax AUC CL/ F 1 Vd/ F 2 t1/ 2 CLR

Regimen (g/ mL) (h) (g h/ mL) (mL/ min) (L) (h) (mL/ min)
Single dose
250 mg p. o. 3 2.8 0. 4 1.6 1. 0 27.2 3. 9 156 20 ND 7.3 0. 9 142 21
500 mg p. o. 3 * 5.1 0. 8 1.3 0. 6 47.9 6. 8 178 28 ND 6.3 0. 6 103 30
500 mg i. v. 3 6.2 1. 0 1.0 0. 1 48.3 5. 4 175 20 90 11 6.4 0. 7 112 25
750 mg p. o. 5 * 9.3 1. 6 1.6 0. 8 101 20 129 24 83 17 7.5 0. 9 ND
750 mg i. v. 5 11.5 4. 0 4 ND 110 40 126 39 75 13 7.5 1. 6 ND
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