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Levofloxacin

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Last Update: September 23, 2022.

Continuing Education Activity

Levofloxacin is FDA-approved for the treatment of nosocomial pneumonia, community-acquired pneumonia, acute bacterial rhinosinusitis, acute bacterial exacerbation of chronic bronchitis, acute bacterial prostatitis, acute pyelonephritis, urinary tract infection, skin or skin structure infections, prophylaxis, and treatment of plaque due to Yersinia pestis, and to reduce the incidence of disease progression of inhalational anthrax. It is in the fluoroquinolone class of medications. This activity will highlight the indications, mechanism of action, adverse event profile, contraindication, monitoring, toxicity, and relevant interactions pertinent for healthcare team members in treating patients with bacterial infections.

Objectives:

  • Identify the mechanism of action of levofloxacin.
  • Identify the indications of levofloxacin.
  • Recognize the adverse effects of levofloxacin.
  • Outline interprofessional team strategies for improving care coordination and communication to advance levofloxacin and improve outcomes.
Access free multiple choice questions on this topic.

Indications

Levofloxacin is a broad-spectrum, third-generation fluoroquinolone antibiotic used to treat bacterial infections. Levofloxacin is a safe and effective medicine on the World Health Organization's essential medicines list. It was patented in 1987 and subsequently received FDA approval in 1996 for medical use in the United States.[1]

FDA-approved Indications of Levofloxacin

  • Nosocomial Pneumonia
  • Community-Acquired Pneumonia
  • Skin and Skin Structure Infections Complicated and Uncomplicated 
  • Chronic bacterial prostatitis 
  • Acute Bacterial Exacerbation of Chronic Bronchitis 
  • Acute Bacterial Sinusitis
  • Inhalational Anthrax, Post-Exposure in adult and pediatric patients 
  • Plague in adult and pediatric patients 
  • Urinary Tract Infections (UTI)
  • Acute Pyelonephritis
  • Bacterial conjunctivitis(Ophthalmic formulation)

Non-FDA Approved Indications

  • Diabetic foot infection
  • Osteomyelitis[2]

Due to an increased risk of severe side effects (e.g., tendinitis and tendon rupture, peripheral neuropathy, and CNS effects), levofloxacin is used in patients with acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated urinary tract infections who do not have alternative treatment options.[3]

To decrease the development of drug-resistant bacteria, the FDA has recommended using levofloxacin only for strongly suspected bacterial infections. Also, levofloxacin should not be used empirically in patients at risk of multidrug-resistant Escherichia coli.[4] According to Infectious Diseases Society of America (IDSA) 2022 guidelines, levofloxacin is suggested for the infections caused by ESBL-E (extended-spectrum β-lactamase-producing enterobacterales), AmpC-E (AmpC β-lactamase-producing enterobacterales), or stenotrophomonas maltophilia (mild infection).[5]

Mechanism of Action

Levofloxacin is a bactericidal antibiotic of the fluoroquinolone drug class that directly inhibits bacterial DNA synthesis. Levofloxacin promotes the breakage of DNA strands by inhibiting DNA-gyrase in susceptible organisms, which inhibits the relaxation of supercoiled DNA. 

Of the fluoroquinolone class, levofloxacin has the most enhanced activity against gram-positive penicillin-sensitive and resistant organisms, notably, Streptococcus pneumoniae) and reduced action against gram-negative bacilli, notably Pseudomonas aeruginosa, compared to ciprofloxacin. Levofloxacin has effectiveness against other common respiratory organisms, notably Haemophilus influenzaeMoraxella catarrhalis, Legionella sppMycoplasma spp, and Chlamydia pneumoniae.[4]Levofloxacin also has a higher in-vitro activity against mycobacterium tuberculosis and is preferred over the other fluoroquinolones as second-line antitubercular therapy.[6] 

There is a growing concern about drug resistance to fluoroquinolones worldwide, which can occur through chromosome-encoded or plasmid-mediated mechanisms.

Pharmacokinetics

Absorption: Levofloxacin is rapidly absorbed and widely distributed in the body. The bioavailability of levofloxacin is 99%; therefore, levofloxacin's intravenous and oral preparations are used interchangeably. The time to peak plasma concentration (Tmax) is approximately 1.5 hours.[7]

Distribution: The volume of distribution of levofloxacin generally varies from 74 Liters to 112 Liters(single and multiple 500 mg or 750 mg doses), demonstrating extensive distribution in body tissues. Outcomes of the study suggest that levofloxacin is widely distributed in the skin, muscles, liver, kidney, and spleen. Drug concentrations in tissues and fluids are typically higher than in plasma. Levofloxacin has plasma protein binding of  24–38 %; it binds primarily to albumin.[7]

Metabolism: Levofloxacin undergoes little hepatic metabolism in humans and is eliminated unchanged in the urine.[7]

Excretion: Levofloxacin clearance is primarily via the renal route (87%). The mean plasma elimination half-life (t) of levofloxacin is approximately 6 to 8 hours following single or multiple doses of levofloxacin.[8]

Administration

Levofloxacin is available both for oral tablets and solution and intravenous administration. Levofloxacin is not available for administration through intramuscular, intrathecal, or subcutaneous routes. The marketed oral dosage strengths for levofloxacin are 250 mg, 500 mg, and 750 mg.

Oral dosing with tablets can be without regard to meals. However, the oral solution should be taken 1 hour before or 2 hours after meals. Patients should avoid using antacids, or levofloxacin should be administered two hours before or two hours after taking antacids containing magnesium or aluminum. It is essential to maintain proper hydration to prevent crystalluria. 

Levofloxacin injection should be administered for adult and pediatric patients by slow intravenous infusion over 60 minutes (250 to 500 mg) and over 90 minutes (for 750 mg). Due to an increased risk of hypotension, bolus or rapid intravenous administration should be avoided. In addition, the infusion should not use a solution containing multivalent cations. The ophthalmic solution is safe and an effective antibiotic used for seven days to treat bacterial conjunctivitis.  

  • The recommended oral dose regimen is 750 mg once daily to treat nosocomial pneumonia, complicated skin and skin structure infections (7 to 14 days), community-acquired pneumonia, acute bacterial sinusitis, complicated urinary tract infection (UTI), or acute pyelonephritis (five days).
  • The daily dosing of 500 mg once daily is recommended to treat nosocomial pneumonia (7 to 14 days), acute bacterial sinusitis (5 to 14 days), acute bacterial exacerbation of chronic bronchitis (seven days), uncomplicated skin and skin structure infections (7 to 10 days), chronic bacterial prostatitis (28 days), and post-exposure inhalational anthrax (60 days).
  • The daily dosing of 250 mg is recommended for patients with complicated urinary tract infections, acute pyelonephritis (10 days), or uncomplicated urinary tract infections (3 days).[1] 
  • The daily dosing of  750 mg IV or orally once daily (5 days regimen) is recommended for complicated UTIs or acute pyelonephritis.[9]

Use in Specific Patient Populations

Patients with Hepatic Impairment: No dose adjustment is provided in the manufactures labeling. As levofloxacin is eliminated primarily by the kidney and undergoes minimal hepatic metabolism, dose adjustment may not be required. In addition, levofloxacin is used in patients with cirrhosis to prevent spontaneous bacterial peritonitis. The preferred drug for SBP prophylaxis is 3rd generation cephalosporin; levofloxacin can be used in patients allergic to cephalosporins.[10]

Patients with Renal Impairment: A 50% reduction in the total daily dosage is recommended in patients with renal impairment (glomerular filtration rate between 10 and 50 mL/min) and extended to every 48 hours if the glomerular filtration rate falls less than 10 mL/min).[1]

Pregnancy Considerations: Guidelines for acute and recurrent urinary tract infections in women in pregnancy recommends using agents other than levofloxacin, such as amoxicillin/clavulanic acid and cefuroxime. According to joint guidelines published by the American Thoracic Society, CDC, European Respiratory Society, and IDSA, in patients with MDR-TB, levofloxacin can be considered in pregnancy if the benefits of treatment to the mother outweigh the harms.[11] However, the risk-benefit analysis should always be considered, and levofloxacin should be prescribed only when essential. Levofloxacin should generally be avoided during pregnancy.

Breastfeeding Considerations:  Levofloxacin has not been used in infants because of consideration of adverse consequences on the infants' developing joints. Clinical data indicate that breast milk has a low concentration of levofloxacin, which is unlikely to cause damaging effects in breastfed babies. Using levofloxacin with breastfeeding mothers is acceptable with monitoring the infant for possible GI adverse effects (diarrhea or candidiasis). Additionally, pregnant women should be counseled not to breastfeed during treatment with levofloxacin and for two days after taking the last dose of levofloxacin.[12] According to the American Academy of Pediatrics use of levofloxacin should be reserved only for the management of infections for which no effective alternative is available due to the risk of tendinopathy and musculoskeletal toxicity.[13]

Adverse Effects

The primary adverse effects of levofloxacin include photosensitivity, nausea, diarrhea, headache, tendinitis, tendon rupture, hyper-hypoglycemia, seizures, prolonged QT interval, and peripheral neuropathy. Clinicians should carefully prescribe levofloxacin to patients with a history of prolonged QT intervals.[14] 

It is advisable to minimize or avoid exposure to natural or artificial sunlight while taking levofloxacin to reduce the occurrence of phototoxicity.

Research has determined prolonged levofloxacin is associated with an increased risk of fungal or bacterial superinfection (e.g., pseudomembranous colitis).[15] 

Levofloxacin can cause hepatotoxicity. The pattern of enzyme elevation is hepatocellular, cholestatic, or mixed. The case of jaundice and vanishing bile duct syndrome have been described. Hepatotoxicity can be associated with immunoallergic presentations such as fever, rash, and eosinophilia. The latency to onset is usually short (1 to 3 weeks), and the onset is often abrupt with enzyme elevation, jaundice, and sometimes hepatic failure. Hence the likelihood score for hepatotoxicity is A (well-established cause of clinically apparent liver injury).[16]

FDA has warned that fluoroquinolones, including levofloxacin, can increase the risk of aortic aneurysm and aortic dissection. Avoid prescribing levofloxacin in elderly patients and patients with a history of Marfan syndrome or Ehlers-Danlos syndrome.[17]

Drug-Drug Interactions

Concomitant administration of oral hypoglycemic agents such as glimepiride increases the risk of hypoglycemia. Careful monitoring of blood glucose is recommended for patients taking concurrent antidiabetic agents due to the risk of glucose dysregulation.[18] Unlike ciprofloxacin, levofloxacin does not inhibit the drug-metabolizing enzyme CYP1A2; however, its weak inhibiting potential on the CYP2C9 enzyme, bleeding can occur with concurrent administration of warfarin.[19] A study indicates that simultaneous administration of levofloxacin with NSAIDs such as diclofenac can cause seizures. Concomitant administration of oral hypoglycemic agents such as glimepiride increases the risk of hypoglycemia. Careful monitoring of blood glucose is recommended for patients taking concurrent antidiabetic agents due to the risk of glucose dysregulation. There is a risk of QTc prolongation when levofloxacin and thioridazine are administered. The combination should be avoided.[20] Cations in aluminum hydroxide, magnesium oxide, ferrous sulfate, and calcium carbonate can chelate and reduce the absorption of levofloxacin. Consequently, these drugs should be administered at least two hours before or after levofloxacin.[21]

Contraindications

The concurrent administration of levofloxacin with drugs that prolong the QT interval is contraindicated.[22]

It is also contraindicated in patients with documented hypersensitivity to the drug or excipients, as cases of anaphylaxis have been reported.[23]

Fluoroquinolones, including levofloxacin, are contraindicated in pregnancy. Research has suggested that risk is highest during the first trimester; levofloxacin administration should typically be discouraged during pregnancy and lactation unless a safer alternative is not available. More research is needed to establish the role of fluoroquinolone during pregnancy.[24]

It is recommended to avoid levofloxacin and other fluoroquinolone antibiotics in patients with myasthenia gravis due to an increased risk of exacerbation of existing muscle weakness.[25]

Boxed Warning: FDA has alerted a boxed warning for using levofloxacin and other fluoroquinolones due to increased risk of disabling and irreversible side effects, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects (e.g., seizures, increased intracranial pressure) in all ages. Older patients > 60 years, those taking corticosteroids and with kidney, heart, or lung transplants, are at increased risk of severe tendon disorders.[26]

Monitoring

Providers should monitor patients taking levofloxacin for crystalluria, signs and symptoms of tendonitis, disordered glucose regulation, altered mental status, white blood cells, and signs of infections.

During treatment, it is also essential to periodically evaluate organ system functions (hepatic, renal). It is also necessary to monitor for evidence of bleeding because of the drug interaction of levofloxacin with warfarin, which acts on the CYP2C9 enzyme and raises warfarin levels.[27]

Unlike ciprofloxacin, monitoring patients concurrently taking theophylline is unnecessary as levofloxacin does not inhibit the enzyme CYP1A2.[19]

Monitor complete blood count (CBC) as agranulocytosis and thrombocytopenia have been reported.[28]

Toxicity

The elimination half-life of levofloxacin ranges from 27 to 35 hours in adults with renal impairment, depending on severity, compared with six to eight hours in healthy adults. This prolonged half-life indicates that dosing adjustment is necessary for these patients. Neurotoxicity, including non-convulsive status epilepticus, has been reported with levofloxacin.[29] Levofloxacin has a low potential for acute toxicity; however, the stomach needs to be emptied during an acute overdose. The patient should be under observation with adequate maintenance of hydration. It is important to note that hemodialysis or peritoneal dialysis can not adequately remove levofloxacin. The role of enhancing drug elimination with forced dilution is not clear. Activated oral charcoal administration is also a recommended approach with appropriate conditions.[12]

Enhancing Healthcare Team Outcomes

Levofloxacin is a widely prescribed respiratory fluoroquinolone by many healthcare professionals for a broad spectrum of bacterial infections. Levofloxacin is well-known to increase the risk of tendinitis and tendon rupture in all ages, especially in patients over 60 years old, taking corticosteroids, and with a history of kidney, heart, or lung transplants. It not only extends hospital stays but increases the cost of healthcare. All healthcare workers who prescribe this agent should stratify patients earlier for risk of these complications and should sparely use the drug for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections. Healthcare staff should counsel patients to maintain adequate hydration to prevent crystalluria and avoid antacids to enhance bioavailability. As levofloxacin excretion is primarily via the kidney, providers should carefully adjust the dose in the presence of renal insufficiency to prevent levofloxacin accumulation. Consultation with an infectious diseases specialist is required to treat resistant infections.

Clinicians should monitor patients for changes in bowel frequency, fever, abdominal cramps, loss of appetite, nausea, vomiting, right upper quadrant tenderness, jaundice, dark-colored urine, or palpitations. Levofloxacin is well-known to cause pseudomembranous colitis, hepatotoxicity, and QT prolongation; therefore, patients should receive education to discontinue treatment when the clinical features develop. If diarrhea develops, it is essential to adequately manage fluid and electrolyte replacement in this patient population. Healthcare workers should limit the duration of levofloxacin therapy and abstain from the empirical prescribing of this agent due to the growing worldwide concern of drug resistance to levofloxacin and other fluoroquinolones.

Clear communication between clinicians (MD, DO, NP,  PA) and nurses is necessary to administer levofloxacin by slow infusion to avoid the risk of hypotension. Pharmacists need to verify dosing and treatment duration and check for drug-drug interactions. Nursing is on the front lines of observing adverse effects and promptly reporting these to the rest of the team. A concerted and collaborative interprofessional team effort between patients, clinicians, nurses, pharmacists, and other healthcare providers is necessary to achieve improved patient outcomes with reduced risk of adverse drug reactions and increased patient satisfaction related to levofloxacin therapy. [Level 5]

Review Questions

References

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Disclosure: Vivek Podder declares no relevant financial relationships with ineligible companies.

Disclosure: Nazia Sadiq declares no relevant financial relationships with ineligible companies.

Copyright © 2024, StatPearls Publishing LLC.

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