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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: PHARMACOKINETICS
In 6 fasting healthy male volunteers, approximately 95% to 98% of a single oral dose of lomefloxacin was absorbed. Absorption was rapid following single doses of 200 and 400 mg (Tmax 0.8 to 1.4 hours). Mean plasma concentration increased proportionally between 100 and 400 mg as shown below:
||Mean Peak Plasma Concentration (mcg/mL)
||Area Under Curve (AUC) (mcg·h/mL)
In 6 healthy male volunteers administered 400 mg of lomefloxacin on an empty stomach qd for 7 days, the following mean pharmacokinetic parameter values were obtained:
Cmax 2.8 mcg/mL
Cmin 0.27 mcg/mL
AUC0.24 h 25.9 mcg·h/mL
Tmax 1.5 h
t1/2 7.75 h
The elimination half-life in 8 subjects with normal renal function was approximately 8 hours. At 24 hours postdose, subjects with normal renal function receiving single doses of 200 or 400 mg had mean plasma lomefloxacin concentrations of 0.10 and 0.24 mcg/mL, respectively. Steady-state concentrations were achieved within 48 hours of initiating therapy with one-a-day dosing. There was no drug accumulation with single-daily dosing in patients with normal renal function.
Approximately 65% of an orally administered dose was excreted in the urine as unchanged drug in patients with normal renal function. Following a 400-mg dose of lomefloxacin administered qd for 7 days, the mean urine concentration 4 hours postdose was in excess of 300 mcg/mL. The mean urine concentration exceeded 35 mcg/mL for at least 24 hours after dosing.
Following a single 400-mg dose, the solubility of lomefloxacin in urine usually exceeded its peak urinary concentration 2- to 6-fold. In this study, urine pH affected the solubility of lomefloxacin with solubilities ranging from 7.8 mg/mL at pH 5.2, to 2.4 mg/mL at pH 6.5, and 3.03 mg/mL at pH 8.12.
The urinary excretion of Maxaquin (Lomefloxacin Hydrochloride) was virtually complete within 72 hours after cessation of dosing, with approximately 65% of the dose being recovered as parent drug and 9% as its glucuronide metabolite. The mean renal clearance was 145 mL/min in subjects with normal renal function (GFR = 120 mL/min). This may indicate tubular secretion.
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