Страна: Филипини
Език: английски
Източник: FDA (Food And Drug Administration)
Levofloxacin (As Hemihydrate)
Getz Pharma (Phils.) Inc.; Distributor: Getz Pharma (Phils.) Inc.
Levofloxacin (As Hemihydrate)
5mg/ml (750mg/150mL)
Solution For Iv Infusion
USP Type II Clear Glass Vial (150ml) with blue color flip-off seal and grey color rubber stopper (Box of 1’s), USP Type II clear
Getz Pharma (Private.) Ltd., Pakistan
2022-07-18
DESCRIPTION Levofloxacin (Levocin) is a synthetic broad-spectrum antibacterial agent. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-) (S)-enantiomer of the racemic drug substance ofloxacin with a chemical name of: (-)-(S)-9-fluoro-2, 3-dihydro-3- methyl-10- (4-methyl-piperazinyl)-7-oxo-7H pyrido [1,2,3,-de] [1,4] benzoxazine-6-carboxylic acid. The molecular formula is C 18 H 20 FN 3 O 4 and the structural formula is: FORMULATION Levofloxacin (Levocin) IV is available as: Levofloxacin (Levocin) IV Infusion 500mg/100mL Each mL solution for infusion contains: Levofloxacin ... 5mg (as Hemihydrate) Levofloxacin (Levocin) IV Infusion 750mg/150mL Each mL solution for infusion contains: Levofloxacin ... 5mg (as Hemihydrate) CLINICAL PHARMACOLOGY MECHANISM OF ACTION Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The main mechanism of action of levofloxacin involves the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerases), enzymes required for DNA replication, transcription, repair and recombination. Levofloxacin has _in-vitro_ activity against the following gram-negative and gram positive microorganisms. It is often bactericidal at concentrations equal to or slightly greater than inhibitory concentration. It is generally considered to be about twice as active as its isomer, ofloxacin. MICROBIOLOGY Levofloxacin has been shown to be active against most strains of the following micro-organisms. COMMONLY SUSCEPTIBLE SPECIES Aerobic Gram-positive bacteria _Staphylococcus aureus_ methicillin-susceptible. _Staphylococcus saprophyticus._ _Streptococci, group C and G._ _Streptococcus agalactiae._ _Streptococcus pneumoniae._ _Streptococcus pyogenes._ Aerobic Gram-negative bacteria _Burkholderia cepacia._ _Eikenella corrodens._ _Haemophilus influenzae._ _Haemophilus para-influenzae._ _Klebsiella oxytoca._ _Klebsiella pneumoniae._ _Moraxell Прочетете целия документ