Levofloxacin Injection Generic Name & Formulations
Legal Class
Rx
General Description
Levofloxacin 5mg/mL; soln for slow IV infusion; preservative-free.
Pharmacological Class
Quinolone.
How Supplied
Contact supplier
Manufacturer
Levofloxacin Injection Indications
Indications
Susceptible bacterial infections including acute bacterial sinusitis (ABS), acute bacterial exacerbations of chronic bronchitis (ABECB), nosocomial or community-acquired pneumonia (CAP), UTIs, acute pyelonephritis, chronic bacterial prostatitis, skin and skin structure infections. Inhalation anthrax (post-exposure): to reduce incidence or progression of disease (see full labeling). Plague. For ABS, ABECB, and uncomplicated UTIs: reserve for those who have no alternative treatment options.
Levofloxacin Injection Dosage and Administration
Adult
≥18yrs (CrCl ≥50mL/min): Regimen depends on pathogen type (see full labeling). Oral soln: take on empty stomach. IV: infuse over 60 mins (250mg or 500mg), or over 90 mins (750mg). ABS: 500mg once daily for 10–14 days or 750mg once daily for 5 days. ABECB: 500mg once daily for 7 days. Nosocomial pneumonia: 750mg once daily for 7–14 days. CAP: 500mg once daily for 7–14 days or 750mg once daily for 5 days. Uncomplicated skin and skin structure: 500mg once daily for 7–10 days; complicated: 750mg once daily for 7–14 days. Prostatitis: 500mg once daily for 28 days. Uncomplicated UTIs: 250mg once daily for 3 days. Complicated UTIs, acute pyelonephritis: 250mg once daily for 10 days or 750mg once daily for 5 days. Postexposure inhalational anthrax: 500mg once daily for 60 days (start as soon as possible after exposure). Plague: 500mg once daily for 10–14 days. Renal impairment (CrCl <50mL/min): adjust dose; see full labeling.
Children
<6mos: not established. ≥6mos: Inhalation anthrax (post–exposure): <30kg: use other forms; 30–<50kg: 250mg every 12hrs for 60 days; ≥50kg: 500mg once daily for 60 days. Plague: <30kg: use other forms; 30–<50kg: 250mg every 12hrs for 10–14 days; ≥50kg: 500mg once daily for 10–14 days.
Levofloxacin Injection Contraindications
Not Applicable
Levofloxacin Injection Boxed Warnings
Boxed Warning
Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects. Exacerbation of myasthenia gravis.
Levofloxacin Injection Warnings/Precautions
Warnings/Precautions
Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS/psychiatric effects); discontinue immediately if signs/symptoms occur. History of depression. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. History of myasthenia gravis; avoid. History of QT prolongation, proarrhythmic conditions (eg, bradycardia, recent MI), or hypokalemia; avoid. Increased risk of aortic aneurysm and dissection (esp. in elderly); reserve use only if no alternatives in patients with history or risk of. Discontinue at 1st sign of skin rash, jaundice, any other hypersensitivity, hepatitis, or photosensitivity. Monitor blood glucose in diabetic patients; discontinue if hypoglycemia occurs. Renal impairment. Maintain adequate hydration. Avoid excessive sun or UV light. Elderly. Pregnancy. Nursing mothers: not recommended (during and for 2 days after last dose).
Levofloxacin Injection Pharmacokinetics
See Literature
Levofloxacin Injection Interactions
Interactions
Avoid drugs that prolong QT interval (eg, Class IA or Class III antiarrhythmics). Oral forms: take at least 2hrs before or 2hrs after magnesium- or aluminum-containing antacids, sucralfate, metal cations, multivitamins containing zinc or iron, or didanosine (buffered forms). Increased risk of tendinitis/tendon rupture with corticosteroids. Concomitant antidiabetics may increase blood glucose disturbances. Increased seizure risk with concomitant NSAIDs. Monitor theophylline, warfarin. May cause false (+) urine screening results for opiates using commercially available immunoassays.
Levofloxacin Injection Adverse Reactions
Adverse Reactions
Nausea, headache, diarrhea, insomnia, constipation, dizziness; tendinitis/tendon rupture, peripheral neuropathy, CNS effects, hypersensitivity reactions, hepatotoxicity, C. difficile-associated diarrhea, torsades de pointes, dysglycemia, phototoxicity, aortic aneurysm/dissection. Children: also musculoskeletal disorders.
Levofloxacin Injection Clinical Trials
See Literature
Levofloxacin Injection Note
Notes
Formerly known under the brand name Levaquin.
Levofloxacin Injection Patient Counseling
See Literature