Levofloxacin (Systemic)

Dosage Forms & Strengths

premix, ready-to-use injection

• 250mg/50mL
• 500mg/100mL
• 750mg/150mL

oral solution

• 25mg/mL

tablet

• 250mg
• 500mg
• 750mg

Community-Acquired Pneumonia

500 mg PO/IV once daily for 7-14 days or 750 mg PO/IV once daily for 5 days

Nosocomial Pneumonia

750 mg PO/IV once daily for 7-14 days

Acute Bacterial Sinusitis

500 mg PO/IV once daily for 10-14 days or 750 mg PO/IV once daily for 5 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis

Acute Bacterial Exacerbation of Chronic Bronchitis

500 mg PO/IV once daily for ≥7 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Inhalational Anthrax

Postexposure therapy

500 mg PO once daily for 60 days, beginning as soon as possible after exposure

Skin/Skin Structure Infections

Uncomplicated: 500 mg PO/IV once daily for 7-10 days

Complicated: 750 mg PO/IV once daily for 7-14 days

Chronic Bacterial Prostatitis

500 mg PO/IV once daily for 28 days

Complicated Urinary Tract Infections & Acute Pyelonephritis

250 mg PO/IV once daily for 10 days or 750 mg PO/IV once daily for 5 days

Uncomplicated Urinary Tract Infections

250 mg PO/IV once daily for 3 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections

Plague

Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older

500 mg PO/IV once daily for 10-14 days

Acne Vulgaris (Off-label)

100 mg PO q8hr for 4 weeks

Epididymitis (Off-label)

500 mg PO qDay for 10 days

Pseudomonas aeruginosa Pulmonary Infections (Orphan)

Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis

Orphan indication sponsor

• Mpex Pharmaceuticals, Inc, 11535 Sorrento Valley Road, San Diego, CA 92121

Dosage Modifications

Renal impairment (normal dosage, 750 mg/day)

• CrCl 20-49 mL/min: 750 mg every other day
• CrCl 10-19 mL/min or hemodialysis (HD)/peritoneal dialysis (PD): 750 mg initially, then 500 mg every other day

Renal impairment (normal dosage, 500 mg/day)

• CrCl 20-49 mL/min: 500 mg initially, then 250 mg once daily
• CrCl 10-19 mL/min or HD/PD: 500 mg initially, then 250 mg every other day

Renal impairment (normal dosage, 250 mg/day)

• CrCl 20-49 mL/min: No dosage adjustment required
• CrCl 10-19 mL/min: 250 mg every other day; no dosage adjustment required for uncomplicated urinary tract infection (UTI)
• HD/PD: No data

Dosing Considerations

Susceptible organisms

• Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Chlamydia pneumoniae, Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, Proteus mirabilis, Providencia spp, Pseudomonas aeruginosa, Serratia spp, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Ureaplasma urealyticum
• First-line therapy: C jejuni, C freundii, Enterobacter spp; no unanimity on others (eg, A hydrophila, L pneumophila, M morganii)

Dosage Forms & Strengths

premix, ready-to-use injection

• 250mg/50mL
• 500mg/100mL

oral solution

• 25mg/mL

tablet

• 250mg
• 500mg

Inhalational Anthrax

Postexposure therapy

≥6 months and <50 kg: 8 mg/kg PO q12hr for 60 days, beginning as soon as possible after exposure; individual dose not to exceed 250 mg  

≥6 months and >50 kg: 500 mg PO once daily for 60 days, beginning as soon as possible after exposure

Safety in children for treatment duration >14 days has not been established

Plague

Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older

≥6 months and <50 kg: 8 mg/kg PO/IV q12hr for 10-14 days; individual dose not to exceed 250 mg 

≥50 kg: 500 mg PO/IV once daily for 10-14 days

Acute Bacterial Rhinosinusitis (Off-label)

10-20 mg/kg/day PO qDay or divided q12hr

Community Acquired Pneumonia (Off-label)

S. pneumonia

• 6 months - 5 years: 16-20 mg/kg/day PO qDay for 10 days
• 5-16 years: 8-10 mg/kg/day PO qDay for 10 days; not to exceed 750 mg/da

M. pneumoniae, C. trachomatis, C. pneumoniae

• Adolescents with skeletal maturity: 500 mg PO qDay for 10 days; not to exceed 750 mg/day

Cl is reduced and half-life prolonged in patients with CrCl less than 50 mL/minute.

Treatment of community-acquired pneumonia, including multidrug resistant strains of S. pneumoniae (MDRSP); nosocomial pneumonia; acute bacterial exacerbation of chronic bronchitis; acute bacterial rhinosinusitis (ABRS); prostatitis (chronic bacterial), urinary tract infection (uncomplicated or complicated); acute pyelonephritis; skin or skin structure infections (uncomplicated or complicated); reduce incidence or disease progression of inhalational anthrax (postexposure); prophylaxis and treatment of plague (pneumonic and septicemic) due to Y. pestis

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve levofloxacin for use in patients who have no alternative treatment options for acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated urinary tract infections.

Refer to adult dosing.

Solution for injection: Single-use vials must be further diluted in compatible solution (eg, D5W, NS) to a final concentration of 5 mg/mL prior to infusion.