Levofloxacin
Dosing in kidney impairment
Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥ 50 mL/minute The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. These recommendations apply to patients with creatinine clearance ≥ 50 mL/minute.
For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration] . [See table below.] 10 to 14 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) # 250 mg 10 # Uncomplicated Urinary Tract Infection 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 500 mg 7 Acute Bacterial Sinusitis (ABS) 750 mg 5 500 mg 10 to 14
Dosage Adjustment in Adults with Renal Impairment Administer levofloxacin tablets with caution in patients with renal impairment. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced in these patients. In patients with renal impairment (creatinine clearance less than 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations] .
No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50 mL/minute. Table 3 shows how to adjust dose based on creatinine clearance. [See table below.]
| Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute ( 2.1, 2.2) | ||
| Type of Infection | Dose Every 24 hours | Duration (days) |
| Nosocomial Pneumonia ( 1.1) | 750 mg | 7 to 14 |
| Community Acquired Pneumonia ( 1.2) | 500 mg | 7 to 14 |
| Community Acquired Pneumonia ( 1.3) | 750 mg | 5 |
| Complicated SSSI ( 1.4) | 750 mg | 7 to 14 |
| Uncomplicated SSSI ( 1.5) | 500 mg | 7 to 10 |
| Chronic Bacterial Prostatitis ( 1.6) | 500 mg | 28 |
| Inhalational Anthrax (Post-Exposure) ( 1.7) | ||
| Adults and Pediatric Patients 50 kg or greater | 500 mg | 60 |
| Pediatric Patients 30 kg to less than 50 kg (2.2) | 250 mg every 12 hours | 60 |
| Plague ( 1.8) | ||
| Adults and Pediatric Patients 50 kg or greater | 500 mg | 10 to 14 |
| Pediatric Patients 30 kg to less than 50 kg (2.2) | 250 mg every 12 hours | 10 to 14 |
| Complicated UTI ( 1.9) or Acute Pyelonephritis ( 1.11) | 750 mg | 5 |
| Complicated UTI ( 1.10) or Acute Pyelonephritis ( 1.11) | 250 mg | 10 |
| Uncomplicated UTI ( 1.12) | 250 mg | 3 |
| Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) | 500 mg | 7 |
| Acute Bacterial Sinusitis ( 1.14) | 750 mg | 5 |
| 500 mg | 10 to 14 | |
| *Due to the designated pathogens [see Indications and Usage ( 1)] . | ||
| †Sequential therapy (intravenous levofloxacin to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider. | ||
| ‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae(including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila,or Mycoplasma pneumoniae [see Indications and Usage ( 1.2)]. | ||
| §Due to Streptococcus pneumoniae(excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae,or Chlamydophila pneumoniae [see Indications and Usage ( 1.3)]. | ||
| ¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilisand AP due to E. coli,including cases with concurrent bacteremia. | ||
| #This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. | ||
| ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized | ||
| B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies ( 14.9)] . | ||
| ßThe safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions ( 5.12), Use in Specific Populations ( 8.4), and Clinical Studies ( 14.9)] Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk. | ||
| àDrug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablet typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. | ||
| Type of Infection * | Dosed 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), adult and pediatric patients weighing 50 kg Þ, ßor greater Pediatric patients weighing 30 kg to less than 50 kg Þ, ß | 500 mg see Table 2 below (2.2) | 60 ß 60 ß |
| Plague, adult and pediatric patients weighing 50 kg àor greater Pediatric patients weighing 30 kg to less than 50 kg à | 500 mg see Table 2 below (2.2) | 10 to 14 10 to 14 |
| Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ¶ | 750 mg | 5 |
| Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) # | 250 mg | 10 # |
| Uncomplicated Urinary Tract Infection | 250 mg | 3 |
| Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) | 500 mg | 7 |
| Acute Bacterial Sinusitis (ABS) | 750 mg | 5 |
| 500 mg | 10 to 14 | |
| Creatinine Clearance greater than or equal to 50 mL/minute | Creatinine Clearance 20 to 49 mL/minute | Creatinine Clearance 10 to 19 mL/minute | Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD) |
| 750 mg every 24 hours | 750 mg every 48 hours | 750 mg initial dose, then 500 mg every 48 hours | 750 mg initial dose, then 500 mg every 48 hours |
| 500 mg every 24 hours | 500 mg initial dose, then 250 mg every 24 hours | 500 mg initial dose, then 250 mg every 48 hours | 500 mg initial dose, then 250 mg every 48 hours |
| 250 mg every 24 hours | No dosage adjustment required | 250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required | No information on dosing adjustment is available |
Dosing in liver impairment
Hepatic Impairment Pharmacokinetic studies in patients with hepatic impairment have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.
Preparation and administration
Important Administration Instructions Levofloxacin tablets can be administered without regard to food. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.