Levofloxacindosage

Dosage in patients with normal renal function Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia 750 mg 7-14 Community Acquired Pneumonia 500 mg 7-14 Community Acquired Pneumonia 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 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 8 mg/kg BID (not to exceed 250 mg/dose) 60 60 Plague Adults and Pediatric Patients > 50 kg Pediatric Patients < 50 kg and ≥ 6 months of age 500 mg 8 mg/kg BID (not to exceed 250 mg/dose) 10 to 14 10 to 14 Complicated Urinary Tract Infection or Acute Pyelonephritis 750 mg 5 Complicated Urinary Tract Infection or Acute Pyelonephritis 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Adjust dose for creatinine clearance < 50 mL/min

2.1 Dosage in

Adult Patients with Normal Renal Function The usual dose of levofloxacin oral solution 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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required.

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection * Dosed Every 24 hours Duration (days) † Nosocomial Pneumonia 750 mg 7-14 Community Acquired Pneumonia ‡ 500 mg 7-14 Community Acquired Pneumonia § 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg See Table 2 below 60 ß 60 ß Plague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age 500 mg See Table 2 below 10-14 10-14 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 500 mg 5 10-14 * Due to the designated pathogens. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ 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. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and 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. Þ Drug 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. ß The safety of levofloxacin 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. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

2.2 Dosage in

Pediatric Patients The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection * Dose Freq. Once Every Duration † Inhalational Anthrax (post-exposure) ‡,§ Pediatric patients > 50 kg 500 mg 24 hr 60 days § Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 60 days § Plague ¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days * Due to Bacillus anthracis and Yersinia pestis. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug 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. § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

2.3 Dosage Adjustment in

Adults with Renal Impairment Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced. No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min. In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance. Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min) Dosage in Normal Renal Function Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD) 750 mg 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 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 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

2.4 Drug Interaction

With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins Levofloxacin Oral Solution Levofloxacin oral solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution.

2.5 Administration

Instructions Food and Levofloxacin Oral Solution It is recommended that levofloxacin oral solution be taken 1 hour before or 2 hours after eating. Hydration for Patients Receiving Levofloxacin Oral Solution Adequate hydration of patients receiving oral or intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones.