Levaxela solution for infusion 5 mg/ml bottle 100 ml No. 1




Pharmacological properties
Pharmacodynamics. Levofloxacin is a synthetic antibacterial drug of the fluoroquinolone group, the s (-) enantiomer of the racemic mixture of the drug ofloxacin.
Mechanism of action. Levofloxacin, as an antibacterial drug of the fluoroquinolone group, acts on the DNA gyrase and topoisomerase IV complex.
Pharmacokinetics/pharmacodynamics relationship. The degree of bactericidal activity of levofloxacin depends on the ratio of C max in blood plasma or AUC and the minimum inhibitory concentration (MIC).
Mechanism of resistance. The main mechanism of resistance is due to mutations in the gyr-A genes. In vitro, there is cross-resistance between levofloxacin and other fluoroquinolones. Due to the mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.
Breakpoints. The European Committee on Antimicrobial Susceptibility Testing (EUCAST) recommended MIC breakpoints for levofloxacin that distinguish susceptible from intermediately susceptible (moderately resistant) organisms and intermediately susceptible from resistant organisms are presented in Table 1 MIC testing (mg/L).
Table 1. Clinical MIC breakpoints of levofloxacin, mg/lpathogen | sensitive | resistant |
Enterobacteriaceae | ≤1 | 2 |
Pseudomonas spp. | ≤1 | 2 |
Acinetobacter spp. | ≤1 | 2 |
Staphylococcus spp. | ≤1 | 2 |
S. pneumoniae 1 | ≤2 | 2 |
Streptococcus A, B, C, G | ≤1 | 2 |
H. influenzae 2.3 | ≤1 | 1 |
M. catarrhalis 3 | ≤1 | 1 |
Limit values not related to species 4 | ≤1 | 2 |
1 The cut-off values refer to high-dose therapy.
2 Low-level resistance is possible (levofloxacin MIC 0.12-0.5 mg/L), but there is no evidence that it is of clinical significance for H. influenza.
3 strains with MIC values above the threshold between susceptible and intermediately susceptible (moderately resistant) strains, very rare or not yet reported. Identification and antimicrobial susceptibility testing on any such
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