Commonly susceptible species
 
Aerobic Gram-positive micro-organisms

Staphylococcus aureus*+

Streptococcus agalactiae (Group B)

Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius)

Streptococcus pneumoniae*

Streptococcus pyogenes* (Group A)

Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus)
 
Aerobic Gram-negative micro-organisms

Acinetobacter baumanii

Haemophilus influenzae*

Legionella pneumophila

Moraxella (Branhamella) catarrhalis*
 
Anaerobic micro-organisms

Prevotella spp.
 
“Other” micro-organisms

Chlamydophila (Chlamydia) pneumoniae*

Coxiella burnetii

Mycoplasma pneumoniae*
 
Species for which acquired resistance may be a problem
 
Aerobic Gram-positive micro-organisms

Enterococcus faecalis*

Enterococcus faecium*
 
Aerobic Gram-negative micro-organisms

Enterobacter cloacae*

Escherichia coli*#

Klebsiella oxytoca

Klebsiella pneumoniae*#

Proteus mirabilis*
 
Anaerobic micro-organisms

Bacteroides fragilis*
 
Inherently resistant organisms
 
Aerobic Gram-negative micro-organisms

Pseudomonas aeruginosa
 
*Activity has been satisfactorily demonstrated in clinical studies.

+Methicillin resistant S. aureus have a high probability of resistance to fluoroquinolones. Moxifloxacin resistance rate of > 50% have been reported for methicillin resistant S. aureus.

#ESBL-producing strains are commonly also resistant to fluoroquinolones.
 

5.2 Pharmacokinetic properties
Absorption and Bioavailability

After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/l were observed at the end of the infusion corresponding to a mean increase of approximately 26% relative to those seen after oral administration (3.1 mg/l). The AUC value of approximately 39 mg∙h/l after i.v. administration is only slightly higher than that observed after oral administration (35 mg∙h/l) in accordance with the absolute bioavailability of approximately 91%.

In patients, there is no need for age or gender related dose adjustment on intravenous moxifloxacin.

Pharmacokinetics are linear in the range of 50 - 1200 mg single oral dose, up to 600 mg single intravenous dose and up to 600 mg once daily dosing over 10 days.

Distribution

Moxifloxacin is distributed to extravascular spaces rapidly. The steady-state volume of distribution (Vss) is approximately 2 l/kg. In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug. Moxifloxacin is mainly bound to serum albumin.

Maximum concentrations of 5.4 mg/kg and 20.7 mg/l (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose. The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg. In skin blister fluid concentrations of 1.75 mg/l were observed 10 h after intravenous administration. In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/l (geometri