What is the most pertinent prescribing information for Levofloxacin (Levaquin)?

From the Guidelines

Levaquin (levofloxacin) is a fluoroquinolone antibiotic that should be prescribed at 500-750 mg once daily, with a duration of 5-14 days, depending on the infection type, as it is effective against respiratory tract infections, urinary tract infections, skin infections, and certain community-acquired pneumonia. The dosage of Levaquin should be reduced in patients with renal impairment (CrCl <50 mL/min) 1. It is essential to administer Levaquin with plenty of fluids, and it can be taken with or without food. Important safety concerns associated with Levaquin include tendon rupture risk (especially in older adults, those on corticosteroids, or with kidney, heart, or lung transplants), peripheral neuropathy, CNS effects, exacerbation of myasthenia gravis, and QT interval prolongation 1. Patients should avoid excessive sun exposure during treatment due to photosensitivity risk. Levaquin is contraindicated in patients with known hypersensitivity to fluoroquinolones and should be used cautiously in those with seizure disorders or QT prolongation risk factors. Drug interactions include antacids, metal cations (iron, zinc), sucralfate, and NSAIDs. Levaquin works by inhibiting bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and ultimately causing bacterial cell death.

Some key points to consider when prescribing Levaquin include:

• It is a broad-spectrum antibiotic effective against various bacterial infections
• The dosage may need to be adjusted in patients with renal impairment
• Patients should be monitored for potential side effects, such as tendon rupture and peripheral neuropathy
• Levaquin should be used cautiously in patients with certain medical conditions, such as seizure disorders or QT prolongation risk factors
• It is essential to consider drug interactions when prescribing Levaquin, especially with antacids, metal cations, and NSAIDs. According to the British Infection Society guidelines, Levaquin can be used as an alternative treatment for hospital-treated, non-pneumonic bronchial complications, non-severe pneumonia, and severe pneumonia 1. However, the most recent and highest quality study recommends using Levaquin at a dose of 750 mg daily for 5 days to overcome the most common mechanism for the development of fluoroquinolone resistance 1.

From the FDA Drug Label

These bacterial infections include: nosocomial pneumonia community-acquired pneumonia acute sinus infection acute worsening of chronic bronchitis skin infections, complicated and uncomplicated chronic prostate infection urinary tract infections, complicated and uncomplicated acute kidney infection (pyelonephritis) inhalational anthrax plague Who should not take levofloxacin tablets? Do not take levofloxacin tablets if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to levofloxacin or any of the ingredients in levofloxacin tablets. What should I tell my healthcare provider before taking levofloxacin tablets Before you take levofloxacin tablets, tell your healthcare provider if you: have tendon problems have a problem that causes muscle weakness (myasthenia gravis) have central nervous system problems such as seizures (epilepsy) have nerve problems have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation” have low blood potassium (hypokalemia) have bone problems have joint problems including rheumatoid arthritis (RA) have kidney problems. How should I take levofloxacin tablets Take levofloxacin tablets exactly as your healthcare provider tells you to take them. Take levofloxacin tablets at about the same time each day. Drink plenty of fluids while you take levofloxacin tablets.

The most pertinent prescribing information for Levaquin (levofloxacin) includes:

• Indications: Levaquin is used to treat various bacterial infections, including pneumonia, sinus infection, skin infections, and urinary tract infections.
• Contraindications: Patients with a history of severe allergic reactions to fluoroquinolones or levofloxacin should not take Levaquin.
• Precautions: Before taking Levaquin, patients should inform their healthcare provider about any medical conditions, such as tendon problems, muscle weakness, or nerve problems.
• Administration: Levaquin should be taken exactly as prescribed, at the same time each day, with plenty of fluids.
• Warnings: Levaquin can cause serious side effects, including tendon rupture, worsening of myasthenia gravis, and liver damage. Patients should be monitored for signs of these conditions and seek medical help immediately if they occur 2.

From the Research

Prescribing Information for Levaquin

• Levaquin (levofloxacin) is a fluoroquinolone antibacterial agent with a broad spectrum of activity against Gram-positive and Gram-negative bacteria and atypical respiratory pathogens 3, 4, 5, 6.
• The recommended dosage for Levaquin varies depending on the infection being treated, with common regimens including 500mg once daily for 10 days or 750mg once daily for 5 days 3, 4, 5.
• Levaquin is approved for use in the treatment of community-acquired pneumonia (CAP), acute bacterial sinusitis (ABS), complicated urinary tract infections (UTI), and acute pyelonephritis (AP) 3, 4.
• The high-dose, short-course regimen of Levaquin (750mg once daily for 5 days) has been shown to be noninferior to the 10-day regimen in CAP and ABS, and to have a similar tolerability profile 3, 4.
• Levaquin can be used as monotherapy in patients with CAP, but combination therapy with anti-pseudomonal beta-lactam (or aminoglycoside) should be considered if Pseudomonas aeruginosa is the causative pathogen of the respiratory infection 4.
• Oral Levaquin is rapidly absorbed and is bioequivalent to the intravenous formulation, allowing for sequential intravenous to oral therapy 3, 4, 5.
• Levaquin is generally well tolerated, with the most frequently reported adverse events being nausea and diarrhea 5, 6.
• The prevalence of S. pneumoniae resistance to Levaquin is <1% overall in the US 5.
• Levaquin has good tissue penetration and adequate concentrations can be maintained at the site of infections 3, 4, 5.