Levofloxacin

Levofloxacin Injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria. Pneumonia: Nosocomial and Community Acquired. Skin and Skin Structure Infections: Complicated and Uncomplicated. Chronic bacterial prostatitis. Inhalational Anthrax, Post-Exposure. Plague. Urinary Tract Infections: Complicated and Uncomplicated. Acute Pyelonephritis. Acute Bacterial Exacerbation of Chronic Bronchitis.

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

Dosage in patients with normal renal function. Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia 500 mg 7 to 14 Community Acquired Pneumonia 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Inhalational Anthrax (Post-Exposure). Adults and Pediatric Patients > 50 kg Pediatric Patients < 50 kg and ≥ 6 months of age 500 mg 8mg/kg BID (not to exceed 250 mg/dose) 60 60 Plague.

Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials. Known hypersensitivity to levofloxacin or other quinolones

Boxed warning: Fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: Tendinitis and tendon rupture Peripheral neuropathy Central Nervous system effects Discontinue LEVOFLOXACIN INJECTION immediately and avoid use of fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, in patients who experience any of these serious adverse reactions Fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, may exacerbate muscle weakness in patients with myasthenia gravis. Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose. 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.

The most common reactions (≥ 3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness.

Interacting Drug Interaction Multivalent cation-containing products including antacids, metal cations or didanosine Do not co-administer the intravenous formulation in the same IV line with a multivalent cation, e.g., magnesium. Warfarin Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding. Antidiabetic agents Carefully monitor blood glucose

Store at or below 25°C (77°F), however, brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Protect from light.