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Pharmacology: Pharmacodynamics: Svoz: Moxifloxacin is a fluoroquinolone antibacterial agent that has activity against a wide range of aerobic gram-positive and gram-negative microorganisms, anaerobes, acid-fast bacteria, and atypicals. It inhibits DNA synthesis via inhibition of topoisomerase II and IV. There are essential bacterial enzymes which control DNA topology and assist in DNA replication, repair and transcription. Moxifloxacin is reported to have greater activity against gram-positive bacteria, including pneumococci, than ciprofloxacin. Moxifloxacin is active in vitro against bacteria such as: Gram-positive bacteria: Streptococcus pneumoniae (multi-drug resistant Streptococcus pneumoniae strains; MDRSP), Streptococcus pyogenes (group A), Streptococcus milleri group (S. anginosus, S. constellatus and S. intermedius), Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus, S. constellatus), Staphylococcus aureus (methicillin susceptible strains), Coagulase negative Staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans) methicillin susceptible strains, Enterococcus faecalis (Vancomycin, Gentamycin, susceptible strains only), Enterococcus avium, Enterococcus faecium, Bacillus spp. and Corynebactrium spp.
Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Citobacter freundii, Enterobacter species (E. aerogenes, E. intermedius, E. sakazaki), Enterobacter cloacae, Pantoea agglomerans, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Morganella morganii, Proteus mirabilis, Neisseria gonorrhoea, Providencia species (P. rettgeri, P. stuartii), Proteus vulgaris, Samonella sp., Serratia sp., Shigella sp., Yersinia sp., H. parainfluenzae, H. influenzae (including β-lactamase negative and positive strains), Moraxella catarrhalis (including β-lactamase negative and positive strains), Bordetella pertussis, Legionella pneumophilia, Acinetobacter baumannii, N. meningitidis, Gardnerella vaginalis, Helicobacter pylori, Pasteurella multocida, Vibrio spp., Brucella melitensis, and Campylobacter spp.
Anaerobic bacteria: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Propionibacterium spp., Peptostreptococcus spp., Bacteroides sp. (B. fragilis, B. distasoni, B. thetaiotaomicron, B. ovatus, B. uniformis, B. vulgaris) and Clostridium perfringens.
Atypical bacteria: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalum, Mycobacterium tuberculosis, M. avium complex (MAC), M. kansasii, M. fortuitum, rickettsias, Ureplasma urealyticum, Legionella pneumophila and Coxiella burnettii.
In vitro, Staphylococcus aureus (methicillin/ofloxacin resistant strains), Coagulase negative Staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans), Pseudomonas aeruginosa, and C. jejuni are resistant to Moxifloxacin.
Svoz Infusion: Moxifloxacin is a 8-methoxy-fluoroquinolone antibacterial agent that has broad spectrum activities. Moxifloxacin inhibits DNA synthesis via inhibition of topoisomerase II and IV. There are essential bacterial enzymes which control DNA topology and assist in DNA replication, repair and transcription. Moxifloxacin has greater activity in vitro against gram-positive bacteria (Streptococcus pneumoniae including penicillin-resistant strains) than many other fluoroquinolones (e.g. ciprofloxacin, levofloxacin, ofloxacin).
Moxifloxacin is active in vitro and in clinical infections against bacteria such as: Gram-positive bacteria: Staphylococcus aureus (methicillin-susceptible [oxacillin-susceptible] strains only), Streptococcus pneumoniae (multi-drug resistant Streptococcus pneumoniae strains; MDRSP), Streptococcus pyogenes (group A β-hemolytic streptococci), Streptococcus agalactiae (group B streptococci), Streptococcus anginosus, Streptococcus constellatus, Streptococcus viridans, Staphylococci epidermidis (methicillin-susceptible [oxacillin-susceptible] strains only) and Enterococcus faecalis.
Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Citrobacter freundii, Enterobacter cloacae, Proteus mirabilis, Shigella sp., Yersinia pestis, Haemophilus parainfluenzae, Haemophilus influenzae, Moraxella catarrhalis and Neisseria meningitidis.
Anaerobic bacteria: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Peptostreptococcus spp., B. fragilis, B. thetaiotaomicron, Clostridium perfringens, Actinomyces, Bilophila wadsworthia, Eubacterium, Lactobacillus and Prevotella species.
Atypical bacteria: Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma genitalum, Mycobacterium tuberculosis, M. avium complex (MAC), M. kansasii, M. fortuitum and Legionella pneumophila.
Pharmacokinetics: Absorption: Moxifloxacin is rapidly absorbed from the gastrointestinal tract after oral doses with an absolute bioavailability of approximately 90%. The maximum (peak) plasma drug concentrations are reached within 1.5-3 hours which increase proportionally. Steady state is reached after 3 days with a 400 mg once-daily regimen. Coadministration with meal does not significantly affect the absorption of Moxifloxacin. (For Svoz only.)
Moxifloxacin plasma concentrations increase proportionally. Steady state is reached after 3 days or longer with a 400 mg once-daily regimen. (For Svoz Infusion only.)
Distribution: Moxifloxacin is widely distributed throughout the body tissue and has the volume of distribution (Vd) ranges from 1.7 to 2.7 L/kg. It accumulates in tissue such as respiratory tissues, alveolar macrophages, abdominal tissues/fluids, uterine tissues (endometrium, myometrium) and sinus tissues as tissue concentrations often exceed plasma concentrations. Moxifloxacin is about 30 to 50% bound to plasma proteins.
Metabolism: Moxifloxacin is metabolized mainly via sulfate and glucuronide conjugation which sulfate conjugate accounts for approximately 38% and glucuronide conjugate accounts for approximately 14%, respectively.
Elimination: Moxifloxacin has an elimination half-life of about 12 hours, allowing once-daily dosing. Moxifloxacin is eliminated in feces (approximately 25% unchanged) and urine (approximately 20% unchanged); sulfate conjugate is excreted in feces and glucuronide conjugate is excreted in urine. The average/mean apparent total body clearance and renal clearance are roughly/approximately 12 L/h and 2.6 L/h, respectively.
