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Avelox

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Avelox

Absorption

Moxifloxacin, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90 percent. Co-administration with a high fat meal (i.e., 500 calories from fat) does not affect the absorption of moxifloxacin. Consumption of 1 cup of yogurt with moxifloxacin does not significantly affect the extent or rate of systemic absorption (AUC).

The mean (± SD) Cmax and AUC values following single and multiple doses of 400 mg moxifloxacin given orally are summarized below.


  Cmax(mg/L) AUC (mg•h/L) Half-life (hr)
Single Dose Oral      
  Healthy (n = 372) 3.1 ± 1.0 36.1 ± 9.1 11.5 - 15.6*
Multiple Dose Oral      
  Healthy young male/female
(n = 15)		 4.5 ± 0.5 48.0 ± 2.7 12.7 ± 1.9
  Healthy elderly male
(n = 8)		 3.8 ± 0.3 51.8 ± 6.7  
  Healthy elderly female
(n = 8)		 4.6 ± 0.6 54.6 ± 6.7  
  Healthy young male
(n = 8)		 3.6 ± 0.5 48.2 ± 9.0  
  Healthy young female
(n = 9)		 4.2 ± 0.5 49.3 ± 9.5  
* Range of means from different studies

The mean (± SD) Cmax and AUC values following single and multiple doses of 400 mg moxifloxacin given by 1 hour I.V. infusion are summarized below.


  Cmax(mg/L) AUC (mg•h/L) Half-life (hr)
Single Dose I.V.      
  Healthy young male/female
(n = 56)		 3.9 ± 0.9 39.3 ± 8.6 8.2 - 15.4*
  Patients (n = 118)      
    Male (n = 64) 4.4 ± 3.7    
    Female (n = 54) 4.5 ± 2.0    
    < 65 years (n = 58) 4.6 ± 4.2    
    ≥ 65 years (n = 60) 4.3 ± 1.3    
Multiple Dose I.V.      
  Healthy young male (n = 8) 4.2 ± 0.8 38.0 ± 4.7 14.8 ± 2.2
  Healthy elderly
(n =12; 8 male, 4 female)		 6.1 ± 1.3 48.2 ± 0.9 10.1 ± 1.6
  Patients** (n = 107)      
    Male (n = 58) 4.2 ± 2.6    
    Female (n = 49) 4.6 ± 1.5    
    < 65 years (n = 52) 4.1 ± 1.4       
    ≥ 65 years (n = 55) 4.7 ± 2.7    
* Range of means from different studies
** Expected Cmax (concentration obtained around the time of the end of the infusion) Plasma concentrations increase proportionately with dose up to the highest dose tested (1200 mg single oral dose). The mean (± SD) elimination half-life from plasma is 12 ± 1.3 hours; steady-state is achieved after at least three days with a 400 mg once daily regimen.
Brand Name: Avelox
Generic Name: Moxifloxacin HCL
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