Levofloxacin is generally well tolerated, with most adverse effects being mild to moderate in. At the time of the adult approval, pediatric safety and efficacy studies were being conducted by the applicant under their pediatric written. A costminimization analysis comparing azithromycinbased. All studies were randomized, doubleblind, multicenter studies that were designed to compare the clinical efficacy and safety of nemonoxacin with levofloxacin for adult patients with cap. The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience. An initial clinical study 41 assessing the use of levofloxacin in mild to moderate aecb therapy 500 mg once daily for 57 days showed clinical response in 92% of patients. A study to compare the efficacy and safety of levofloxacin.
The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis. Its a type of drug called a fluoroquinolone antibiotic. It has a broad spectrum of in vitro activity against grampositive and gramnegative bacteria, as well as certain other pathogens such as mycoplasma, chlamydia, legionella and mycobacteria spp. It is used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, h. Levofloxacin 500 mg filmcoated tablets summary of product characteristics.
The present study analyzed the efficacy of levofloxacin monotherapy in the. Levofloxacin prophylaxis in patients with newly diagnosed. Levofloxacin has also displayed clinical efficacy in bacterial enteritis 97% of patients cured or improved and in ocular infections 92%, odontogenic infections 83% and biliary tract infections 73% investigated in single clinical trials. Therefore, approval of this indication was based on an efficacy study. Levofloxacin levaquin treatment national hiv curriculum. Levofloxacin is the senantiomer of the fluoroquinolone, ofloxacin. See full prescribing information for complete boxed. Exposure to levofloxacin was significantly associated with successful clinical and microbiological outcomes. Study to demonstrate the clinical efficacy of levofloxacin in the treatment of pneumonia the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Levofloxacin oral tablet is a prescription medication thats used to treat bacterial infections. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests hematology, serum chemistry, and urinalysis and. No information is available on the clinical use of levofloxacin during breastfeeding. In the animals studied, mean plasma concentrations of levofloxacin achieved at. The inputs to the economic analysis utilized details about the hospitalization and information collected via interview at approx.
Levofloxacin, the prodrug of ofloxacin, is indicated for the treatment of mild, moderate, and severe infections caused by a wide variety of susceptible microorganisms. Study 218 was an openlabel, randomized, activecontrolled study that compared levofloxacin with parenteral ceftriaxone andor oral cefuroxime axetil in. Clinical studies have identified the population pk parameters of levofloxacin in patients with tuberculosis and the penetration of levofloxacin into tuberculosis lesions. Comparison of the adverse event profiles of levofloxacin. In addition to the events reported in pediatric patients in clinical trials, events reported in adults during clinical trials or postmarketing experience. Fluoroquinolones, including levaquin, have been associated with disabling and. Fluoroquinolones, including levaquin, are associated with. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These studies usually have reported clinical cure rates 90%. These studies compared tygacil 100 mg intravenous initial dose followed by 50 mg every 12 hours with levofloxacin 500 mg intravenous every 12 or 24 hours. Since moxifloxacin binds the mycobacterium tuberculosis mtb gyrase better than levofloxacin, in theory, it could be a better antituberculosis agent. Efficacy and safety of levofloxacin in the context of. A total of 3 patients with clinical signs and symptoms of bacterial infections.
Safety in pediatric patients treated for more than 14 days has not been studied. Of note, since the 2005 american thoracic societyinfectious diseases society of america guidelines first introduced recommendations for healthcare associated pneumonia hcap, several studies have been published that question the. Levofloxacin had impressive efficacy in clinical studies of community. Levofloxacin treatment was as successful in patients with severe cap as in those with mildtomoderate disease. Levofloxacin pharmacokinetics in children chien 2005. Studies in the mouse showed levofloxacin to have phototoxic activity only at very high doses. Clinical studies in patients with communityacquired pneumonia and acute bacterial sinusitis indicate that levofloxacin levaquin 750mg tablets taken once daily for five days provides comparable efficacy and safety as levofloxacin levaquin 500mg tablets taken once. Levofloxacin injection is also used to treat children who are 6 months of age or older and may have breathed in anthrax germs, have plague, or been exposed to plague germs. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Most of the published trials on grepafloxacin and levofloxacin are of limited value. New fluoroquinolone antibiotics drug and therapeutics. Levofloxacin plasma concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. These response rates included fluoroquinolone problem pathogens, such as streptococcus pneumoniae and staphylococcus aureus.
Pdf levofloxacin is a broadspectrum, thirdgeneration fluoroquinolone antibiotic, used to treat. Levofloxacin is a fluoroquinolone antibacterial indicated in adults. Various japanese studies of levofloxacin 100200 mg thrice daily for 314 da ys suggest rates of clinical efficacy of 85100% in the treatment of uncomplicated and complicated urinary tra ct. In study 1, after at least 3 days of intravenous therapy, a switch to oral levofloxacin 500 mg daily was permitted for both treatment arms. Levofloxacin pharmacokineticspharmacodynamics, dosing. A randomized controlled clinical trial of levofloxacin 750. A study of the safety and effectiveness of levofloxacin compared. Addition of prophylactic levofloxacin to active myeloma treatment during the first 12 weeks of therapy significantly reduced febrile episodes and deaths compared with placebo without increasing health careassociated infections. An initial clinical study assessing the use of levofloxacin in mild to moderate. Comparison of the adverse event profiles of levofloxacin 500 mg and 750 mg in clinical trials for the treatment of respiratory infections. Completing its initial phases of drug development in the mid 1990s as the one of the first fluoroquinolones that could be used with confidence to treat respiratory tract infections, levofloxacin went on to become one of the most widely prescribed antibiotics in the world.
The rationale is that whilst there are no studies comparing aztreonam and levofloxacin, those comparing aztreonam and tobramycin against which levofloxacin has been compared showed a much more convincing benefit for aztreonam. Listing a study does not mean it has been evaluated by the u. An effectiveness and safety study for levofloxacin in. The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia. The aspectcuti phase 3 clinical trial clinicaltrials. Find, read and cite all the research you need on researchgate. It is not known if levofloxacin injection is safe and effective in children under 6 months of age. Such excellent results are to be expected with agents that penetrate well into the site of.
A randomized controlled clinical trial of levofloxacin 750 mg versus 500 mg intravenous infusion in the. Efficacy and safety of levofloxacin in the context of other. Because these patients are often seriously ill with a number of comorbid conditions, regular monitoring of individual serum drug concentrations is often required. Levofloxacin is a fluoroquinolone antibiotic and is the optical s.
This study is registered with the isrctn registry, number isrctn51731976, and the eu clinical trials register, number 206635. Cumulative clinical trial experience with levofloxacin for patients. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Twentytwo enrolling universityaffiliated medical centers.
Levofloxacin 750mg tablet ministry of health and long. The national hiv curriculum is an aids education and training center aetc program supported by the health resources and services administration hrsa of the u. Quinsair, innlevofloxacin european medicines agency. These results suggest that prophylactic levofloxacin could be used for patients with newly diagnosed myeloma undergoing antimyeloma therapy. Data from six clinical trials encompassing 1,997 total patients have been analyzed to determine the efficacy of levofloxacin 500 mg qd or 750 mg qd in treating patients with communityacquired pneumonia cap due to legionella.
The trial was stopped early, with 110 patients in the azithromycin group and 102 patients in the levofloxacin group, at the point when clinical equivalency was demonstrated. However, amounts in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. A subset of pediatric patients in the clinical trials 40 levaquin treated and 893 nonfluoroquinolone treated enrolled in a prospective, longterm surveillance study to assess the incidence of protocoldefined musculoskeletal disorders arthralgia, arthritis, tendinopathy, gait abnormality during 60 days and 1 year following the first. Clinical studies that determine the predictive value of pkpd parameters have been carried out in hospitalized patients with acute respiratory tract infections. A subset of children in the clinical trials 40 levofloxacintreated and 893 nonfluoroquinolonetreated enrolled in a prospective, longterm surveillance study to assess the incidence of protocoldefined musculoskeletal disorders arthralgia, arthritis, tendinopathy, gait abnormality during 60 days and 1 year following the first dose of the study drug. Therefore, approval of this indication was based on an efficacy study conducted in animals see clinical studies.
Streptococcus pyogenes, or proteus mirabilis see clinical studies 14. The optimal duration of treatment for chronic prostatitis remains unclear. In phase 3 clinical trials, 1,190 levofloxacintreated patients 25% were 65 years of age. Outcomes of highdose levofloxacin therapy remain bound to.
In general, comparative studies have looked primarily for equivalent rather than greater efficacy than comparator drugs. Levofloxacin fda label injection solution aidsinfo. Based on the the cumulative clinical trial exposure data available from the mah sanofi, the frequency of the event can be estimated as rare. In this analysis, we report on the efficacy of levofloxacin in the treatment of communityacquired pneumonia cap and nosocomial pneumonia caused by p. For most of their licensed indications, the newer fluoroquinolones have not been compared with the current standard uk. Studies assessing levofloxacin for cap therapy show significant advantages over. Levofloxacin fda prescribing information, side effects. Levaquin fda prescribing information, side effects and uses. Therefore, approval of this indication was based on an efficacy study conducted in animals see dosage and administration 2. As with other drugs in this class, some strains of. Levofloxacin efficacy in the treatment of community.
To evaluate the safety and efficacy of the higher dose and shorter course of levaquin, 528 outpatient and hospitalized adults with clinically and radiologically determined mild to severe communityacquired pneumonia were evaluated in a doubleblind, randomized, prospective, multicenter study comparing levaquin 750 mg, iv or orally, every day for five days or levaquin 500 mg iv or orally, every day for 10 days. Levofloxacin generated clinical and microbiological response rates of 95% and 96%, respectively. Elderly patients may be more susceptible to drugassociated effects on the qt interval. Finally, three studies 1618 fulfilling the inclusion criteria were included in this metaanalysis. There are no adequate reports or wellcontrolled studies of levofloxacin in pregnant women. Levofloxacin prophylaxis in patients with newly diagnosed myeloma. Efficacy studies of levofloxacin injection could not be conducted in humans with plague for ethical and feasibility reasons. Additional phase iii clinical studies were also being conducted in the us and europe at the time this article was prepared.
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