Levofloxacin is indicated for the treatment of mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the following conditions:

• Acute maxillary sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
• Acute bacterial exacerbation of chronic bronchitis caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
• Community-acquired pneumonia caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
• Uncomplicated and complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
• Acute pyelonephritis caused by Escherichia coli.
• Uncomplicated and complicated skin and soft tissue infections, including abscesses, cellulitis, furuncles, impetigo, pyoderma, and wound infections, caused by Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis, or Enterococcus faecalis.
• Enteric infections caused by Enterobacter species, Escherichia coli, Campylobacter species, Vibrio cholerae, Shigella species, and Salmonella species.

Levofloxacin is a synthetic, broad-spectrum, third-generation fluoroquinolone antibacterial agent intended for oral administration. Chemically, levofloxacin is a chiral fluorinated carboxyquinolone derivative.

Levofloxacin is a synthetic, broad-spectrum, third-generation fluoroquinolone antibiotic. Chemically, it is a chiral fluorinated carboxyquinolone. Levofloxacin exerts its antibacterial effect by inhibiting bacterial topoisomerase IV and DNA gyrase, enzymes essential for DNA replication, transcription, repair, and recombination. It has in vitro activity against a wide range of Gram-negative and Gram-positive bacteria.

The usual oral dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg once every 24 hours. Levofloxacin tablets may be taken with or without food. Levofloxacin oral solution should be taken 1 hour before or 2 hours after meals.

Levofloxacin injection should be administered only by intravenous infusion. It must not be given by intramuscular, intrathecal, intraperitoneal, or subcutaneous routes. The usual dose of levofloxacin injection is 250 mg or 500 mg infused slowly over 60 minutes every 24 hours, or 750 mg infused slowly over 90 minutes every 24 hours. Since levofloxacin injection is intended for single use only, any unused portion should be discarded. Additives or other medications should not be mixed with levofloxacin injection or infused simultaneously through the same intravenous line.

Adults

• Acute sinusitis: 500 mg once daily for 10–14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days
• Community-acquired pneumonia: 500 mg once daily for 7–14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary tract infections: 250 mg once daily for 3 days
• Complicated urinary tract infections and acute pyelonephritis: 250 mg once daily for 7–10 days; in complicated cases, 750 mg once daily for 5 days
• Uncomplicated skin and soft tissue infections: 500 mg once daily for 7–10 days
• Complicated skin and soft tissue infections: 750 mg once daily for 7–14 days
• Enteric fever: 500 mg once daily for 7–14 days

• Diarrhea, cholera, shigellosis, and enteritis:

• Mild to moderate cases: 500 mg as a single dose
• Moderate to severe cases: 500 mg once daily for 3 days

Children

• Children aged 6 months to less than 5 years: 10 mg/kg every 12 hours
• Children older than 5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be initiated at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion

• Check the container carefully for any small leaks by firmly squeezing the inner bag. If leaks are found, or if the seal is broken, discard the solution.
• Do not use the solution if it is cloudy or if any precipitate is present.
• Do not use flexible containers in series connections.
• Close the flow-control clamp of the administration set.
• Remove the cover from the port at the bottom of the container.
• Insert the piercing pin of the administration set into the port with a twisting motion until it is firmly seated.
• Hang the container appropriately.
• Squeeze and release the drip chamber to establish the proper fluid level during infusion.
• Open the flow-control clamp to expel air from the set, then close the clamp.
• Regulate the rate of administration using the flow-control clamp.

Levofloxacin should not be administered through the same intravenous line with any solution containing multivalent cations, such as magnesium. Antacids, iron preparations, and adsorbent agents may reduce the absorption of levofloxacin. Concomitant use with NSAIDs may increase the risk of central nervous system stimulation, while warfarin may increase the risk of bleeding.

Levofloxacin is contraindicated in patients with known hypersensitivity to levofloxacin, other quinolone antimicrobial agents, or any component of this formulation.

Levofloxacin is generally well tolerated. However, some side effects may occur. These may include nausea, vomiting, diarrhea, abdominal pain, and flatulence. Phototoxicity has been reported rarely. Very rare adverse effects may include tremor, depression, anxiety, and confusion. There is also a risk of retinal detachment.

Levofloxacin is not recommended during pregnancy or while breastfeeding, as its effects on the unborn baby and nursing infant have not been clearly established.

The following precautions should be observed during the administration of levofloxacin:

• Levofloxacin injection should be administered only by slow intravenous infusion over 60 or 90 minutes, depending on the prescribed dose.
• Patients should maintain adequate fluid intake during treatment to help prevent the formation of highly concentrated urine.
• Dose adjustment may be required in patients with renal impairment.

Levofloxacin has a low potential for acute toxicity. However, in the event of acute overdose, the stomach should be emptied, the patient should be kept under close observation, and adequate hydration should be maintained.

4-Quinolone preparation.

Store below 30°C, protected from light and moisture. Keep out of the reach of children.