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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: PHARMACOKINETICS IN SPECIFIC POPULATIONS

Pharmacokinetics in the geriatric population

In 16 healthy elderly volunteers (61 to 76 years of age) with normal renal function for their age, the half-life of lomefloxacin (mean of 8 hours) and its peak plasma concentration (mean of 4.2 mcg/mL) following a single 400-mg dose were similar to those in 8 younger subjects dosed with a single 400-mg dose. Thus, drug absorption appears unaffected in the elderly. Plasma clearance was, however, reduced in this elderly population by approximately 25%, and the AUC was increased by approximately 33%. This slower elimination most likely reflects the decreased renal function normally observed in the geriatric population.

Pharmacokinetics in renally impaired patients

In 8 patients with creatinine clearance (ClCr) between 10 and 40 mL/min/1.73 m2, the mean AUC after a single 400-mg dose of lomefloxacin increased 335% over the AUC demonstrated in patients with a ClCr > 80 mL/min/1.73 m2. Also, in these patients, the mean t1/2 increased to 21 hours. In 8 patients with ClCr < 10 mL/min/1.73 m2, the mean AUC after a single 400-mg dose of lomefloxacin increased 700% over the AUC demonstrated in patients with a ClCr > 80 mL/min/1.73 m2. In these patients with ClCr < 10 mL/min/1.73 m2, the mean t1/2 increased to 45 hours. The plasma clearance of lomefloxacin was closely correlated with creatinine clearance, ranging from 31 mL/min/1.73 m2 when creatinine clearance was zero to 271 mL/min/1.73 m2 at a normal creatinine clearance of 110 mL/min/1.73 m2. Peak lomefloxacin concentrations were not affected by the degree of renal function when single doses of lomefloxacin were administered. Adjustment of dosage schedules for patients with such decreases in renal function is warranted.

Pharmacokinetics in patients with cirrhosis

In 12 patients with histologically confirmed cirrhosis, no significant changes in rate or extent of lomefloxacin exposure (Cmax, Tmax, t1/2, or AUC) were observed when they were administered 400 mg of Maxaquin (Lomefloxacin) tablets as a single dose. No data are available in cirrhotic patients treated with multiple doses of lomefloxacin. Cirrhosis does not appear to reduce the nonrenal clearance of lomefloxacin. There does not appear to be a need for a dosage reduction in cirrhotic patients, provided adequate renal function is present.



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