Levofloxacin is an active pharmaceutical ingredient in the Fluoroquinolones group (J01MA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised January 9, 2026[1]
8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where: • there is resistance to other first-line antibiotics recommended for the infection; • other first-line antibiotics are contraindicated in an individual patient; • other first-line antibiotics have caused side effects requiring treatment to be stopped; • treatment with other first-line antibiotics has failed.
4). • Community-acquired pneumonia • Complicated skin and soft tissue infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.
How to take
CACanada· Health Canada
19 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
APO-LEVOFLOXACIN (levofloxacin tablets) are indicated for the treatment of adults with bacterial infections caused by susceptible strains of the designated microorganisms in the infections listed below. • To reduce the development of drug-resistant bacteria and maintain the effectiveness of APO- LEVOFLOXACIN and other antibacterial drugs, APO-LEVOFLOXACIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
• Upper Respiratory Tract Acute bacterial sinusitis (mild to moderate) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella (Branhamella) catarrhalis. 1 • Lower Respiratory Tract Acute bacterial exacerbations of chronic bronchitis (mild to moderate) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella (Branhamella) catarrhalis.
USUnited States· FDA
9 products
Uses
USOfficial regulatory label· revised March 4, 2025[3]
4). 15). 1 Nosocomial Pneumonia Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae.
Adjunctive therapy should be used as clinically indicated. 1) ]. 2)]. , cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 3)]. 5)]. 5 Uncomplicated Skin and Skin Structure Infections Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.
6 )]. 2)]. The effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised April 9, 2025[4]
1). Consideration should be given to official guidance on the appropriate use of antibacterial medicinal products.
How to take
EU
Drug interactions
Known interactions involving Levofloxacin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 402. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL245980024 · revised January 9, 2026
[2]Health Canada (DPD) · 02284707 · revised March 22, 2025
[3]FDA DailyMed · 05d179f5-b200-85… · revised March 4, 2025 [PDF]
[4]European Medicines Agency · EMEA/H/C/002789 · revised April 9, 2025
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised January 9, 2026[1]
Levofloxacin 5 mg/mL Solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin 5 mg/mL Solution for infusion after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC for the film-coated tablets and as considered appropriate for the individual patient.
Given the bioequivalence of the parenteral and oral forms, the same dosage can be used. Posology The following dose recommendations can be given for Levofloxacin 5 mg/mL Solution for infusion: Dosage in patients with normal renal function (creatinine clearance> 50 mL/min).
Indication Daily dose regimen (according to severity) Total duration of treatment1 (according to severity) Community-acquired pneumonia 500 mg once or twice daily 7 – 14 days Acute pyelonephritis 500 mg once daily 7 – 10 days Complicated urinary tract infections 500 mg once daily 7 – 14 days Chronic bacterial prostatitis 500 mg once daily 28 days Complicated skin and soft tissue infections 500 mg once or twice daily 7 – 14 days Inhalation anthrax 500 mg once daily 8 weeks 1Treatment duration includes intravenous plus oral treatment.
The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days. Special populations Impaired renal function (creatinine clearance ≤ 50 mL/min) Dose regimen 250 mg/24 h 500 mg/24 h 500 mg/12 h Creatinine clearance first dose: 250 mg first dose: 500 mg first dose: 500 mg 50 – 20 mL/min then: 125 mg/24 h then: 250 mg/24 h then: 250 mg/12 h 19 – 10 mL/min then: 125 mg/48 h then: 125 mg/24 h then: 125 mg/12 h < 10 mL/min (including haemodialysis and CAPD)1 then: 125 mg/48 h then: 125 mg/24 h then: 125 mg/24 h 1No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Impaired liver function No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys. 4 “Tendοnitis and tendon rupture” and “QT interval prolongation”).
3). Method of administration Levofloxacin 5 mg/mL Solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. 4). 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 9, 2026[1]
The most commonly reported adverse drug reactions (ADRs) are nausea, diarrhoea, vomiting, transient increase in transaminases, rash, and injection and infusion site reactions. ADRs derived from clinical studies and post-marketing surveillance with ciprofloxacin (oral, intravenous and sequential therapy) sorted by categories of frequency are listed below.
The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin. g. 9). g. 4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression.
There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using available data, but the reporting incidence from adverse drug reaction reports indicates the frequency is at minimum between 1/1,000 and 1/10,000 (corresponding to the Rare frequency category).
4). The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment: Common Vomiting, Transient increase in […]
GBOfficial regulatory label· Warnings and precautions· revised January 9, 2026[1]
8). 3). Prolonged, disabling and potentially irreversible serious adverse drug reactions Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Levofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.
aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).
Resistance to fluoroquinolones of E. coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.
Inhalation Anthrax Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.
Infusion Time The recommended infusion time of at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin 5 mg/mL Solution for infusion should be observed. It is known for ofloxacin that during infusion tachycardia and a temporary decrease in blood pressure may develop.
In rare cases, as a consequence of a profound drop in blood pressure, circulatory collapse may occur. Should a conspicuous drop in blood pressure occur during infusion of levofloxacin, (l- isomer of ofloxacin) the infusion must be halted immediately.
Tendοnitis and tendon rupture Tendοnitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
The risk of tendοnitis and tendon rupture is increased in patients receiving daily doses of 1000 mg levofloxacin, in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 9, 2026[1]
1, • in patients with epilepsy, • in patients with history of tendon disorders related to fluoroquinolone administration, • in children or growing adolescents, • during pregnancy, • in breast-feeding women.
This is not medical advice. Consult a qualified healthcare professional.
2 Community-acquired pneumonia (mild, moderate and severe infections) due to Staphylococcus aureus, Streptococcus pneumoniae (including penicillin-resistant strains), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae (see 4 DOSAGE AND ADMINISTRATION, and 14 CLINICAL TRIALS).
Nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated.
Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended. 1 Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Desrosiers et al.
Allergy, Asthma and Clinical Immunology, 2011, 7:2 2 Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2008 update – highlights for primary care. O’Donnell et al. Can Respir J 2008; 15 (Suppl A): 1A-8A.
APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 5 of 76 APO-LEVOFLOXACIN is not indicated for acute bronchitis. • Skin and Skin Structure Uncomplicated skin and skin structure infections (mild to moderate) due to Staphylococcus aureus or Streptococcus pyogenes.
Complicated skin and skin structure infections (mild to moderate), excluding burns, due to Enterococcus faecalis, methicillin-sensitive Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis, or Streptococcus agalactiae. • Urinary Tract Complicated urinary tract infections (mild to moderate) due to Enterococcus (Streptococcus) faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae or Staphylococcus saprophyticus. Acute pyelonephritis (mild to moderate) caused by Escherichia coli (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis. In cases of uncomplicated acute bacterial cystitis, limit the use of APO-LEVOFLOXACIN to circumstances where no other treatment options are available.
A urine culture should be obtained prior to treatment to ensure levofloxacin susceptibility. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing the infection, and to determine their susceptibility to levofloxacin.
Therapy with levofloxacin may be initiated before the results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin.
Culture and susceptibility testing performed periodically during therapy, will reveal not only the therapeutic effect of the antimicrobial agent, but also the possible emergence of bacterial resistance. 3 Pediatrics). 2 Geriatrics Geriatrics (≥ 65 years of age): Drug absorption appears to be unaffected by age.
3 Pharmacokinetics, Special Populations and Conditions). APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 6 of 76
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
, and 14 CLINICAL TRIALS). Nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae or Streptococcus pneumoniae.
Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended. 1 Canadian clinical practice guidelines for acute and chronic rhinosinusitis.
Desrosiers et al. Allergy, Asthma and Clinical Immunology, 2011, 7:2 2 Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2008 update – highlights for primary care. O’Donnell et al. Can Respir J 2008; 15 (Suppl A): 1A-8A.
APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 5 of 76 APO-LEVOFLOXACIN is not indicated for acute bronchitis. • Skin and Skin Structure Uncomplicated skin and skin structure infections (mild to moderate) due to Staphylococcus aureus or Streptococcus pyogenes.
Complicated skin and skin structure infections (mild to moderate), excluding burns, due to Enterococcus faecalis, methicillin-sensitive Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis, or Streptococcus agalactiae. • Urinary Tract Complicated urinary tract infections (mild to moderate) due to Enterococcus (Streptococcus) faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae or Staphylococcus saprophyticus. Acute pyelonephritis (mild to moderate) caused by Escherichia coli (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis. In cases of uncomplicated acute bacterial cystitis, limit the use of APO-LEVOFLOXACIN to circumstances where no other treatment options are available.
A urine culture should be obtained prior to treatment to ensure levofloxacin susceptibility. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing the infection, and to determine their susceptibility to levofloxacin.
Therapy with levofloxacin may be initiated before the results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin.
Culture and susceptibility testing performed periodically during therapy, will reveal not only the therapeutic effect of the antimicrobial agent, but also the possible emergence of bacterial resistance. 3 Pediatrics). 2 Geriatrics Geriatrics (≥ 65 years of age): Drug absorption appears to be unaffected by age.
3 Pharmacokinetics, Special Populations and Conditions). APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 6 of 76 2 CONTRAINDICATIONS • APO-LEVOFLOXACIN tablets are contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
). 4 Drug-Drug Interactions). Sexually Transmitted Diseases Levofloxacin is not indicated for the treatment of syphilis or gonorrhea. Levofloxacin is not effective in the treatment of syphilis. Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis.
All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with antimicrobial agents with limited or no activity against Treponema pallidum should have a follow-up serologic test for syphilis after 3 months.
Cardiovascular Aortic Aneurysm and Aortic Dissection Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones.
Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones. , infective endocarditis).
The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids. In case of sudden severe abdominal, chest or back pain, acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities, patients should be advised to immediately consult a physician in an emergency department.
QT Prolongation Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. During post-marketing surveillance, very rare cases of torsades de pointes have been reported in patients taking levofloxacin.
These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. , amiodarone, sotalol) antiarrhythmic agents, and cisapride. 2 Pharmacodynamics, Studies Measuring Effects on QT and Corrected QT (QTc) Intervals).
Driving and Operating Machinery Neurologic adverse effects such as dizziness and lightheadedness may occur. Therefore, patients should know how they react to levofloxacin before operating an automobile or machinery or engaging in other activities requiring mental alertness and coordination.
, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. SEVERE CASES OF HYPOGLYCEMIA RESULTING IN COMA OR DEATH HAVE BEEN REPORTED. If a hypoglycemic reaction occurs, discontinue APO-LEVOFLOXACIN immediately and initiate appropriate therapy.
4 Drug-Drug Interactions, Antidiabetic Agents). Hypoglycemic coma has been observed in diabetic patients with the use of levofloxacin. Fatal outcomes have been reported. All cases of hypoglycemic coma had multiple confounding factors; a temporal relationship with the use of levofloxacin was identified (onset of altered APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 12 of 76 consciousness occurred within 3 days in most cases).
4 Drug-Drug Interactions, Antidiabetic Agents). Gastrointestinal Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including levofloxacin. CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
, Cardiovascular 02/2025 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
1 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
8 5 OVERDOSAGE............................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
• APO-LEVOFLOXACIN tablets are contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING . • Levofloxacin is also contraindicated in persons with a history of tendinitis or tendon rupture associated with the use of any member of the quinolone group of antimicrobial agents.
This is not medical advice. Consult a qualified healthcare professional.
The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. 9 )]. 8 Plague Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y.
2 )]. Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. 10)]. 7 )]. 8) ]. 8 )]. 12 Uncomplicated Urinary Tract Infections Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
15 )] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 13 Acute Bacterial Exacerbation of Chronic Bronchitis Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
15 )] and for some patients ABECB is self-limiting, reserve levofloxacin tablets for treatment of ABECB in patients who have no alternative treatment options. 4)]. 15 )] and for some patients ABS is self-limiting, reserve levofloxacin tablets for treatment of ABS in patients who have no alternative treatment options.
15 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
4)] . Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets.
Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.
How to take
USOfficial regulatory label· revised March 4, 2025[3]
2). • Levofloxacin Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. 2). 1. 1 Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥ 50 mL/minute The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/minute. 3 )]. 2) 10 to 14 10 to 14 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) # 250 mg # 10 # Uncomplicated Urinary Tract Infection 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 500 mg 7 Acute Bacterial Sinusitis (ABS) 750 mg 5 500 mg 10 to 14 * Due to the designated pathogens [see Indications and Usage ( 1)].
† Sequential therapy (intravenous levofloxacin to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider. 2 )]. 3 )]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E.
coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E.
coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. 9 )]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied.
9 )]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
2 Dosage of Levofloxacin Tablets in Pediatric Patients with Inhalational Anthrax or Plague The dosage of levofloxacin tablets for inhalational anthrax (post-exposure) and plague in pediatric patients who weigh 30 kg or greater is described below in Table 2.
levofloxacin tablets cannot be administered to patients who weigh less than 30 kg because of the limitations of the available strength. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg.
14)]. † Sequential therapy (intravenous levofloxacin injection to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider. ‡ Begin levofloxacin tablets as soon as possible after suspected or confirmed exposure to aerosolized B.
anthracis. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. 9)] . Begin levofloxacin tablets as soon as possible after suspected or confirmed exposure to Yersinia pestis.
3 Dosage Adjustment in Adults with Renal Impairment Administer levofloxacin tablets with caution in patients with renal impairment. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced in these patients.
6 )]. No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50 mL/minute. Table 3 shows how to adjust dose based on creatinine clearance.
Table 3:
Dosage Adjustment in Adult Patients with Renal Impairment (Creatinine Clearance less than 50 mL/minute) Creatinine Clearance greater than or equal to 50 mL/minute Creatinine Clearance 20 to 49 mL/minute Creatinine Clearance 10 to 19 mL/minute Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD) 750 mg every 24 hours 750 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 500 mg every 24 hours 500 mg initial dose, then 250 mg every 24 hours 500 mg initial dose, then 250 mg every 48 hours 500 mg initial dose, then 250 mg every 48 hours 250 mg every 24 hours No dosage adjustment required 250 mg every 48 hours.
1) and Patient Counseling Information (17)]. 5 Administration Instructions Levofloxacin tablets can be administered without regard to food. Hydration for Patients Receiving Levofloxacin Tablets Adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine.
1 ) and Patient Counseling Information ( 17)].
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 3,252 reports total. [5]
Off Label Use 288
Drug Ineffective 256
Nausea 190
Dyspnoea 172
Fatigue 161
Diarrhoea 157
Arthralgia 152
Death 123
Pain 116
Rash 110
Condition Aggravated 109
Pneumonia 105
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised March 4, 2025[3]
2 ). gov/medwatch . 15 )] Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. 5 )]. 2 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to levofloxacin in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black.
Patients were treated with levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)]. Patients received levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.
The overall incidence, type and distribution of adverse reactions was similar in patients receiving levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. 4% of patients treated with the 750 mg dose.
2%). 3%). 1 to <1% of levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness. 3 )] vertigo hypertonia hyperkinesias abnormal gait somnolence * syncope Respiratory, Thoraic and Mediastinal Disorders epistaxis Cardiac Disorders cardiac arrestpalpitation ventricular tachycardia ventricular arrhythmia Vascular Disorders phlebitis Gastrointestinal Disorders gastritisstomatitis pancreatitis esophagitis gastroenteritis glossitis pseudomembranous/ C.
6 )] * N = 7274 In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including levofloxacin.
The relationship of the drugs to these events is not presently established. 3 Postmarketing Experience Table 6 lists adverse reactions that have been identified during post-approval use of levofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
6 )] General Disorders and Administration Site Conditions multi-organ failure pyrexia Investigations prothrombin time prolonged international normalized ratio prolonged muscle enzymes increased
USOfficial regulatory label· Warnings and precautions· revised March 4, 2025[3]
6 ) Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. 10 ) Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. 1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient.
Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting levofloxacin.
4 )]. Discontinue levofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including levofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
2)]. This adverse reaction most frequently involves the Achilles tendon and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites. Tendinitis or tendon rupture can occur within hours or days of starting levofloxacin or as long as several months after completion of fluoroquinolone therapy.
Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors.
Discontinue levofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised March 4, 2025[3]
3 )]. 7 )
This is not medical advice. Consult a qualified healthcare professional.
2). The doses should be inhaled as close as possible to 12 hours apart. Quinsair is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment. Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
If a dose is missed, it should be taken as soon as the patient remembers providing that at least an 8- hour interval is allowed before inhaling the next dose. Patients should not inhale the contents of more than one ampoule to compensate for the missed dose.
8). Elderly patients (≥ 65 years old) The safety and efficacy of Quinsair in elderly patients with CF have not been established. Renal impairment Doses do not need to be adjusted in patients with mild to moderate renal impairment . Quinsair is not recommended for use in patients with severe renal impairment.
2). Paediatric population The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established. 3 but no recommendation on a posology can be made. Method of administration Inhalation use. 6). For patients taking multiple inhaled therapies, the recommended order of administration is as follows: 1.
Bronchodilators; 2. Dornase alfa; 3. Airway clearance techniques; 4. Quinsair; 5. Inhaled steroids. 6). The Manufacturer’s Instructions for Use of the Zirela Nebuliser System should be reviewed prior to the first use of Quinsair.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised April 9, 2025[4]
Summary of the safety profile The most frequently reported adverse reactions were cough/productive cough (54%), dysgeusia (30%) and fatigue/asthenia (25%). Tabulated list of adverse reactions reported with Quinsair The adverse reactions with at least a reasonable possibility of a causal relationship with Quinsair are presented according to the MedDRA System Organ Classification.
The adverse drug reactions are ranked by frequency with the most frequent reactions first. The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
4). * Adverse events with uncertain relatedness to Quinsair but which are known to be associated with systemic administration of levofloxacin and/or are plausibly associated with Quinsair and were reported more frequently than with placebo in clinical studies.
4). *** See paragraph below for further details. Tabulated list of additional adverse reactions reported following systemic administration of levofloxacin The adverse reactions with at least a reasonable possibility of a causal relationship with levofloxacin are presented according to the MedDRA System Organ Classification.
The adverse drug reactions are ranked by frequency with the most serious reactions first. The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data).
g. hallucination, paranoia), Agitation, Abnormal dreams, Nightmares Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt Nervous system disorders1 Tremor Convulsion, Paraesthesia Peripheral sensory neuropathy, Peripheral sensory motor neuropathy, Dyskinesia, Extrapyramidal disorder, Syncope, Benign intracranial hypertension Eye disorders1 Transient vision loss Ear and labyrinth disorders1 Vertigo Cardiac disorders** Palpitation Ventricular tachycardia, Ventricular arrhythmia and torsade de pointes Vascular disorders** Hypotension Respiratory, thoracic and mediastinal disorders Pneumonitis allergic Hepatobiliary disorders Jaundice and severe liver injury, including cases with fatal acute liver failure Skin and subcutaneous tissue disorders Hyperhidrosis Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Fixed drug eruption Toxic epidermal necrolysis, Stevens-Johnson syndrome, Erythema multiforme, Photosensitivity reaction, Leukocytoclastic vasculitis, Stomatitis Musculoskeletal and connective tissue disorders1 Muscular […]
EUOfficial regulatory label· Warnings and precautions· revised April 9, 2025[4]
8). 3). g. including angioedema and anaphylactic shock). 8). g. 8). 4 Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
9) such as, for example: • Congenital long QT syndrome. g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics). g. hypokalaemia, hypomagnesaemia). g. heart failure, myocardial infarction, bradycardia).
Elderly patients and women may be more sensitive to QTc-prolonging medicinal products. Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations. 8). 5). Psychotic reactions Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.
8). Caution is recommended if levofloxacin is used in psychotic patients or in patients with a history of psychiatric disease. Peripheral neuropathy Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
8). Exacerbation of myasthenia gravis Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and the requirements for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
Levofloxacin is not recommended in patients with a known history of myasthenia gravis. Tendinitis and tendon rupture Tendinitis and tendon rupture (especially, but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, patients receiving daily doses of 1,000 mg levofloxacin, and those treated concurrently with corticosteroids.
Therefore, concomitant use of corticosteroids should be avoided. g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered. g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised April 9, 2025[4]
1; • History of tendon disorders related to fluoroquinolone administration; • Epilepsy; • Pregnancy; • Breast-feeding.
This is not medical advice. Consult a qualified healthcare professional.
Therefore, concomitant use of corticosteroids should be avoided. g. painful swelling, inflammation) the treatment with levofloxacin should be discontinued and alternative treatment should be considered. g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.
Clostridium difficile-associated disease Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD).
8). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with levofloxacin. If CDAD is suspected or confirmed, levofloxacin should be stopped immediately and appropriate treatment initiated without delay.
Anti- peristaltic medicinal products are contraindicated in this clinical situation. Patients predisposed to seizures Quinolones may lower the seizure threshold and may trigger seizures. 5). 8), treatment with levofloxacin should be discontinued.
Patients with G-6- phosphate dehydrogenase deficiency Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents. Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.
2). 8). Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures. Severe cutaneous adverse […]
3 ) and Patient Counseling Information ( 17 )]. 3 Peripheral Neuropathy Fluoroquinolones, including levofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including levofloxacin.
2 )]. Discontinue levofloxacin immediately if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation.
Avoid fluoroquinolones, including levofloxacin, in patients who have previously experienced peripheral neuropathy [see Adverse Reactions ( 6) and Patient Counseling Information ( 17)]. 4 Central Nervous System Effects Psychiatric Adverse Reactions Fluoroquinolones, including levofloxacin, havebeenassociated with an increased risk of psychiatric adverse reactions, including: toxic psychoses, hallucinations, or paranoia; depression, or suicidal thoughts; anxiety,agitation, restlessness, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment.
Attempted or completed suicide have been reported, especially in patients with a medical history of depression, or an underlying risk factor for depression. These reactions may occurfollowingthe first dose. If these reactions occur in patients receiving levofloxacin, discontinue levofloxacin and institute appropriate measures.
Central Nervous SystemAdverseReactions Fluoroquinolones, including levofloxacin, have beenassociated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), tremors, and lightheadedness.
, certain drug therapy, renal dysfunction). 5), and Patient Counseling Information (17)]. 5 Exacerbation of Myasthenia Gravis Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Postmarketing serious adverse reactions including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. 3) and Patient Counseling Information ( 17 )]. 6 Other Serious and Sometimes Fatal Adverse Reactions Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including levofloxacin.
These events may be severe and generally occur following the administration of multiple doses. , toxic epidermal necrolysis, Stevens-Johnson Syndrome); • vasculitis; arthralgia; myalgia; serum sickness; • allergic pneumonitis; • interstitial nephritis; acute renal insufficiency or failure; • hepatitis; jaundice; acute hepatic necrosis or failure; • anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
Discontinue levofloxacin immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures [see Adverse Reactions ( 6 ) and Patient Counseling Information ( 17)]. 7 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including levofloxacin.
These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions.
Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated [see Adverse Reactions ( 6) and Patient Counseling Information ( 17) ].
8 Hepatotoxicity Post-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with levofloxacin. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients.
Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. 6 )]. The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity.
Levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see Adverse Reactions ( 6 ) and Patient Counseling Information ( 17)]. 9 Risk of Aortic Aneurysm and Dissection Fluoroquinolones,includinglevofloxacin, have been associated with aortic aneurysm and dissection.
Findings from epidemiologic studies show a consistently increased risk of hospitalizationfor aortic aneurysm or dissection within two months following use of a fluoroquinolone antibacterial drug. , age greater than 85 years). The evidence shows the potential for a 2-fold increasedrisk over the background risk following fluoroquinolone exposure and was based on a small number of cases, mostly in older patients.
The cause for the risk of aortic aneurysm ordissectionhas not been identified, but the available data suggest that use of fluoroquinolones may contribute in the short term to aneurysm progression. Inpatientswith a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve levofloxacin for use only when there are no alternative antibacterial treatmentsavailable.
10 Clostridium difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including levofloxacin, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. 2 ) and Patient Counseling Information ( 17)].
11 Prolongation of the QT Interval Some fluoroquinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including levofloxacin.
Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents.
5), and Patient Counseling Information ( 17 )]. 8 )]. 4 )]. In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage.
2 )]. , glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death havebeen reported. 3) and Patient Counseling Information ( 17) ]. , burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure.
Therefore, excessive exposure to these sources of light should be avoided. 3) and Patient Counseling Information ( 17)]. 15 Development of Drug Resistant Bacteria Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Patient Counseling Information (17)].
8). 8). 2). Haemoptysis The use of inhaled medicinal products may induce a cough reflex. Administration of Quinsair in patients with clinically significant haemoptysis should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Patients with glucose-6-phosphate dehydrogenase deficiency Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone medicinal products. Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.