Levofloxacin

What it is and how it works

Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of antibacterial agents .

Indications

Levofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). • Pneumonia: Nosocomial and Community Acquired ( 1.2 , 1.3 ) • Skin and Skin Structure Infections (SSSI): Complicated and Uncomplicated • Chronic bacterial prostatitis • Inhalational Anthrax, Post-Exposure in adult and pediatric patients • Plague in adult and pediatric patients • Urinary Tract Infections (UTI): Complicated ( 1.9 , 1.10 ) and Uncomplicated • Acute Pyelonephritis • Acute Bacterial Exacerbation of Chronic Bronchitis • Acute Bacterial Sinusitis 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 bacteria .

Dosage and administration (summary)

• Administer levofloxacin tablets to pediatric patients weighing 30 kg and greater only ( 2.1 , 2.2 ). • Levofloxacin Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg . Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute ( 2.1 .

Contraindications

Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials . Known hypersensitivity to levofloxacin tablets or other quinolones ( 4 , 5.7 )

Warnings and precautions

Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur Clostridium difficile -associated colitis: evaluate if diarrhea occurs Prolongation of the QT interval and isolated cases of torsade de pointes have been reported.

Pregnancy

Pregnancy Risk Summary Published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Storage and supply

Levofloxacin USP is supplied as 250 mg, 500 mg and 750 mg capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: Levofloxacin tablets, USP 250 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed “T4” on one side and plain on other si…

Source: Levofloxacin (Levofloxacin) — US FDA prescribing information, 2025-04-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.