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MAXAQUIN (LOMEFLOXACIN HYDROCHLORIDE) TABLETS: CLINICAL PHARMACOLOGY

Metabolism

Lomefloxacin is minimally metabolized although 5 metabolites have been identified in human urine. The glucuronide metabolite is found in the highest concentration and accounts for approximately 9% of the administered dose. The other 4 metabolites together account for < 0.5% of the dose.

Pharmacodynamics

Approximately 10% of an oral dose was recovered as unchanged drug in the feces.

Serum protein binding of lomefloxacin is approximately 10%.

The following are mean tissue- or fluid-to-plasma ratios of Maxaquin (Lomefloxacin HCl) following oral administration. Studies have not been conducted to assess the penetration of lomefloxacin into human cerebrospinal fluid.

Tissue or Body Fluid Mean Tissue- or Fluid to-Plasma Ratio
Bronchial mucosa 2.1
Bronchial secretions 0.6
Prostatic tissue 2.0
Sputum 1.3
Urine 140.0


In two studies including 74 healthy volunteers, the minimal dose of UVA light needed to cause erythema (MED-UVA) was inversely proportional to plasma lomefloxacin concentration. The MED-UVA values (16 hours and 12 hours postdose) were significantly higher than the MED-UVA values 2 hours postdose at steady state. Increasing the interval between lomefloxacin dosing and exposure to UVA light increased the amount of light energy needed for photoreaction. In a study of 27 healthy volunteers, the steady state AUC values and Cmin values were equivalent whether the drug was administered in the morning or in the evening.

Food effect

When Maxaquin (Lomefloxacin) and food were administered concomitantly, the rate of drug absorption was delayed (Tmax increased to 2 hours [delayed by 41%], Cmax decreased by 18%), and the extent of absorption (AUC) was decreased by 12%.



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