Levores 5mgml Solution for Infusion

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

LEVOFLOXACIN HEMIHYDRATE

可用日期:

AVERROES PHARMACEUTICALS SDN. BHD.

INN（国际名称）:

LEVOFLOXACIN HEMIHYDRATE

每包单位数:

1vial Vials; 1vial Vials

厂商:

PT NOVELL PHARMACEUTICAL LABORATORIES.

资料单张

Not Applicable

产品特点

LEVORES 5MG/ML SOLUTION FOR INFUSION
LEVOFLOXACIN
PRODUCT DESCRIPTION
_Levores Infusion 5mg/ml_
: Clear solution, yellow to greenish yellow, and odorless.
COMPOSITION
_Levores Infusion 5mg/ml_
: Each ml of infusion contains Levofloxacin Hemihydrate equivalent to
5.0 mg
of Levofloxacin Base
PHARMACODYNAMICS
Pharmacotherapeutic group: quinolone antibacterial, fluoroquinolones
ATC code: J01MA12
Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone
class and is the S (-) enantiomer of
the racemic active substance ofloxacin.
Mechanism of action
As a fluoroquinolone antibacterial agent, levofloxacin acts on the
DNA-DNA-gyrase complex and
topoisomerase IV.
PK/PD relationship
The degree of the bactericidal activity of levofloxacin depends on the
ratio of the maximum concentration
in serum (Cmax) or the area under the curve (AUC) and the minimal
inhibitory concentration (MIC).
Mechanism of resistance
Resistance to levofloxacin is acquired through a stepwise process by
target site mutations in both type II
topoisomerases, DNA gyrase and topoisomerase IV. Other resistance
mechanisms such as permeation
barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may
also affect susceptibility to
levofloxacin. Cross-resistance between levofloxacin and other
fluoroquinolones is observed. Due to the
mechanism of action, there is generally no cross-resistance between
levofloxacin and other classes of
antibacterial agents
.
PHARMACOKINETICS
Levofloxacin is rapidly and almost completely absorbed after oral use
with peak plasma concentrations
achieved within 1 hour of a dose. It is distributed into body tissues
including the bronchial mucosa and
lungs, but penetration into CSF is relatively poor. Levofloxacin is
about 30 to 40% bound to plasma
proteins. It is only metabolised to a small degree to inactive
metabolites. The elimination half-life of
Levofloxacin is 6 to 8 hours, although this may be prolonged in
patients with renal impairment.
Levofloxacin is excreted largely unchanged, primarily in the urine. It