Levofloxacin

Levofloxacin Manufacturers

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection*
  Dosed Every 24 hours
  Duration (days)†
  *Due to the designated pathogens [see Indications and Usage (1)]. †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 [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 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.
  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 (5.10), 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. a Drug 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.
  

  Nosocomial Pneumonia 
  

  750 mg
  

  7 to 14
  

  Community Acquired Pneumonia‡
  

  500 mg
  

  7 to 14
  

  Community Acquired Pneumonia§
  

  750 mg
  

  5
  

  Acute Bacterial Sinusitis 
  

  750 mg
  

  5
  

  500 mg
  

  10 to 14
  

  Acute Bacterial Exacerbation of Chronic Bronchitis 
  

  500 mg
  

  7
  

  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
  

  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
  

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ, ß
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ, ß
  

  500 mg
  See Table 2 below (2.2)
  

  60 ß
  60 ß
  

  Plague, adult and pediatric patients > 50 kga
  Pediatric patients < 50 kg and ≥ 6 months of age
  

  500 mg
  
  See Table 2 below (2.2)
  

  10 to 14
  
  10 to 14
  

  2.2 Dosage in Pediatric Patients

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

  Table 2Dosage in Pediatric Patients ≥ 6 months of age Type of Infection*
  Dose
  Freq. Once every
  Duration†
  *Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. †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 [see Clinical Studies (14.9)] §The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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. ¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
  

  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
  

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tabletswith 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 [see Use in Specific Populations (8.6)].

  Table 3 shows how to adjust dose based on creatinine clearance.

  Table 3Dosage 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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 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 (2.2)
  60 ß 
  60 ß Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [seeUse in Specific Populations (8.6)].  

  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

   

  Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

   

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

   

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  Levofloxacin | Laboratoires Clarins S.a.

  

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  apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a board spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2p.m. wear long-sleeved shirts, pants, hats and sunglasses. reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating.

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  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 to 14

  Community Acquired Pneumonia

  500 mg

  7 to 14

  Community Acquired Pneumonia

  750 mg

  5

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Plague, adult and pediatric patients > 50 kg

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below (2.2)

  10 to 14

  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

  2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
  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
  Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10-14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI)
  750 mg
  7-14
  Uncomplicated SSSI
  500 mg
  7-10
  Chronic Bacterial Prostatitis
  500 mg
  28
  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
  Inhalation Anthranx (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß
  Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
   
  500mg
  see Table 2 below (2.2)
   
  60ß
  60ß
  Plague, adult and pediatric patients > 50 kgá
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  

  *Due to the designated pathogens [see Indications and Usage (1)].
  †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[see Indications and Usage (1.2)].
  §Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, 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 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.
  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 in adults for duration 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(5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
  áDrug 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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  †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 [see Clinical Studies (14.9)]
  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [see Use in Specific Populations (8.6)].
  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,

  Levofloxacin Tablets
  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets
  Levofloxacin tablets can be administered without regard to food.
  Hydration for Patients Receiving Levofloxacin Tablets
  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1       Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14

  Community Acquired Pneumonia ‡

  500 mg

  7 to 14

  Community Acquired Pneumonia§

  750 mg

  5

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  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 (2.2)

  
  60 ß 
  60 ß

  Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age

  500 mg
  see Table 2 below (2.2)

  10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [seeUse in Specific Populations (8.6)].  

  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 tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

  2.5     Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  1 Due to the designated pathogens [see Indications and Usage (1)].

  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

  3 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)].

  4 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)].

  5 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.

  6 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.

  7 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 [see Clinical Studies (14.9)].

  8 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk.

  9 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.

  Type of Infection1 Dosed Every 24 hours Duration (days)2 Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia3 500 mg 7 to 14 Community Acquired Pneumonia4 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8 Pediatric patients < 50 kg and
  ≥6 months of age7,8 500 mg
  
  see Table 2 below (2.2) 608
  
  608 Plague, adult and pediatric patients
  > 50 kg9
  Pediatric patients < 50 kg and
  ≥6 months of age 500 mg
  
  see Table 2 below (2.2) 10 to 14
  
  10 to 14 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

  1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

  3 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 [see Clinical Studies (14.9)].

  4 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk.

  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

  Type of Infection1 Dose Freq. Once every Duration2 Inhalational Anthrax (post-exposure)3, 4 Pediatric patients
  > 50 kg 500 mg 24 hr 60 days4 Pediatric patients
  < 50 kg and ≥6 months of age 8 mg/kg (not to exceed 250 mg per dose)
  12 hr
  60 days4 Plague5 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 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 [see Use in Specific Populations (8.6)].

  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 Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

  2.5 Administration Instructions

  Levofloxacin Injection

  Caution: Rapid or bolus intravenous infusion of Levofloxacin Injection has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

  Hydration for Patients Receiving Levofloxacin Injection

  Adequate hydration of patients receiving intravenous Levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection in Single-Use Vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.

  LEVOFLOXACIN Injection in Single-Use Vials

  Single-use vials require dilution prior to administration.

  Levofloxacin Injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These Levofloxacin Injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.

  Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:

  Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of Levofloxacin Injection Solution 0.9% Sodium Chloride Injection, USP 4.71 5% Dextrose Injection, USP 4.58 5% Dextrose/0.9% NaCl Injection 4.62 5% Dextrose in Lactated Ringers 4.92 Plasma-Lyte®56/5% Dextrose Injection 5.03 5% Dextrose, 0.45% Sodium Chloride, and 0.15% Potassium Chloride Injection 4.61 Sodium Lactate Injection (M/6) 5.54

  Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].

  Prepare the desired dosage of levofloxacin according to Table 5:

  Table 5: Preparation of Levofloxacin Injection Intravenous Solution Desired Dosage Strength From Appropriate Vial, Withdraw Volume Volume of Diluent Infusion Time 250 mg 10 mL (20 mL Vial) 40 mL 60 min 500 mg 20 mL (20 mL Vial) 80 mL 60 min 750 mg 30 mL (30 mL Vial) 120 mL 90 min

  For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.

  This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.

  Stability of Levofloxacin Injection Following Dilution: Levofloxacin Injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * 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 [ see Clinical Studies (14.9)]. † The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of age*,† 500 mg 60† Pediatric patients < 50 kg and ≥ 6 months of age*,† See Table 2 below (2.2) 60† 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 * The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection Dose Freq. Once Every Duration Inhalational Anthrax (post-exposure) ,* Pediatric patients > 50 kg and ≥ 6 months of age 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* 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † 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 strains [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 strains [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 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 [ see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of ageÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below (2.2) 60ß 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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection* Dose Freq. Once Every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg and ≥ 6 months of age 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§ 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1       Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and
  pediatric patients > 50 kg and ≥ 6 months of age Þ,ß
  Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
  60 ß 
  60 ß

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 strains [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 strains [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]  Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

  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 and ≥ 6 months of age 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§

  *Due to Bacillus anthracis [see Indications and Usage (1.13)]

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

  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 [seeUse in Specific Populations (8.6)].  

  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 tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

  2.5     Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † 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 strains [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 strains [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 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 [ see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of ageÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß See Table 2 below (2.2) 60ß 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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection* Dose Freq. Once Every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg and ≥ 6 months of age 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§ 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablet 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 [see ]. DOSAGE AND ADMINISTRATION ( ) 2.3

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 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 Pediatric patients < 50 kg and ≥6 months of age

  Inhalational Anthrax (Post-Exposure), adult and pediatric

  patients > 50 kg and ≥6 months of age Þ,β

  Þ, β see table below (2.2)

  500 mg

  60

  60 β

  β

  Due to the designated pathogens [see ]. *INDICATIONS AND USAGE ( ) 1

  Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. †

  Due to methicillin-susceptible (including multi-drug-resistant strains [MDRSP]), or [see ]. ‡Staphylococcus aureus, Streptococcus pneumoniaeHaemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila,Mycoplasma pneumoniaeINDICATIONS AND USAGE ( ) 1.2

  Due to (excluding multi-drug-resistant strains [MDRSP]), [see ]. §Streptococcus pneumoniaeHaemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniaeINDICATIONS AND USAGE ( ) 1.3

  This regimen is indicated for cUTI due to and AP due to including cases with concurrent bacteremia. ¶Escherichia coli, Klebsiella pneumoniae, Proteus mirabilisE. coli,

  This regimen is indicated for cUTI due to and for AP due to #Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa;E. coli.

  Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see ]. ÞB. anthracis.CLINICAL STUDIES ( ) 14.9)

  The safety of levofloxacin tablet 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 ] Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. β[WARNINGS AND PRECAUTIONS ( ), USE IN SPECIFIC POPULATIONS ( ), AND CLINICAL STUDIES ( ) 5.108.414.9 )

  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 and ≥6 months of age 500 mg 24 hr 60 days § Pediatric patients < 50 kg and ≥ 6 months of age (not to exceed 250 mg per dose)

  8 mg/kg

  12 hr 60 days §

  Due to (see ] *Bacillus anthracisINDICATIONS AND USAGE (1.13)

  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 This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit. [See ] ‡B. anthracis.CLINICAL STUDIES( ) 14.9

  The safety of levofloxacin tablets 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 [see ]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. §WARNINGS AND PRECAUTIONS ( ), USE IN SPECIFIC POPULATIONS ( ), AND CLINICAL STUDIES ( ) 5.108.414.9)

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablet 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 [see ]. USE IN SPECIFIC POPULATIONS ( ) 8.6

  shows how to adjust dose based on creatinine clearance. Table 3

  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 tablet 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 suspension. [See ]. DRUG INTERACTIONS ( ) AND PATIENT COUNSELING INFORMATION ( ) 7.117.2

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablet can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ]. ADVERSE REACTIONS ( ) AND PATIENT COUNSELING INFORMATION ( ) 6.117.2

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens  [see Indications and Usage (1)]. † 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 strains [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 strains [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 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 [see Clinical Studies (14.9)]. 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of age Þß
  Pediatric patients < 50 kg and ≥ 6 months of ageÞß 500 mg
  
  see Table 2 below (2.2)

  60ß 
  
  

  60ß

   

  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 * Due to Bacillus anthracis [see Indications and Usage (1.13)] † 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 [see Clinical Studies (14.9)] § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. Type of Infection* Dose Freq. Once Every Duration†

  Inhalational Anthrax (post-exposure)‡§
   
      Pediatric patients > 50 kg and ≥ 6 months of age
  

  
  

      Pediatric patients < 50 kg and ≥ 6 months of age

   
  
   500 mg
   
  

  8 mg/kg
  (not to exceed

  250 mg per dose)

   
  24 hr  
   

  12 hr

   
  60 days§
     
  

  60 days§

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 tablets should be administered at least 2 hours before or 2 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † 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 [ 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 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 [ see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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 tablets 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
  (2.2) 60ß Plague, adult and pediatric patients > 50 kgà  500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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. 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 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection*
  Dosed Every 24 hours
  Duration (days)†
  

  *Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.
  

  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 (5.10), 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.

  aDrug 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.
  

  Nosocomial Pneumonia 
  750 mg
  7 to 14
  Community Acquired Pneumonia‡
  500 mg
  7 to 14
  Community Acquired Pneumonia§
  750 mg
  5
  Acute Bacterial Sinusitis 
  750 mg
  5
  
  500 mg
  10 to 14
  Acute Bacterial Exacerbation of Chronic Bronchitis 
  500 mg
  7
  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
  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
  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  500 mg 
  
  
  see Table 2 below (2.2)
  60ß
  
  
  60ß
  Plague, adult and pediatric patients > 50 kga
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  
  See Table 2 below (2.2)
  10 to 14
  
  10 to 14
  2.2 Dosage in Pediatric Patients

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

  Table 2Dosage in Pediatric Patients ≥ 6 months of age Type of Infection*
  Dose
  Freq. Once every
  Duration†
  

  *Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  

  †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 [see Clinical Studies (14.9)]

  §The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.

  ¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
  

  Inhalational Anthrax (post-exposure)‡,§
  Pediatric patients > 50 kg Pediatric patients < 50 kg and ≥ 6 months of age 
  
  500 mg
  
  8 mg/kg 
  (not to exceed 250 mg per dose)
  
  
  24 hr
  
  12 hr
  
  
  60 days§
  
  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
  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tabletswith 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 [see Use in Specific Populations (8.6)].

  Table 3 shows how to adjust dose based on creatinine clearance.

  Table 3Dosage 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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].   

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  * Due to the designated pathogens [see Indications and Usage (1)].

  † 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 [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 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 [see Clinical Studies (14.9)].

  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  Acute Bacterial Sinusitis
  750 mg
  5
  
  500 mg
  10-14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI)
  750 mg
  7-14
  Uncomplicated SSSI
  500 mg
  7-10
  Chronic Bacterial Prostatitis
  500 mg
  28
  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
  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 (2.2)
  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 (2.2)
  10 to 14
  10 to 14
  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

  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  † 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 [see Clinical Studies (14.9)]

  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].   

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  * Due to the designated pathogens [see Indications and Usage (1)].

  † 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 [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 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 [see Clinical Studies (14.9)].

  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  Acute Bacterial Sinusitis
  750 mg
  5
  
  500 mg
  10-14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI)
  750 mg
  7-14
  Uncomplicated SSSI
  500 mg
  7-10
  Chronic Bacterial Prostatitis
  500 mg
  28
  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
  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 (2.2)
  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 (2.2)
  10 to 14
  10 to 14
  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

  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  † 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 [see Clinical Studies (14.9)]

  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/min) Type of Infection* Dosed Every 24 hours Duration (days)† * Due to the designated pathogens [see Indications and Usage (1)] . † 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 pneumonia [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 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 [see Clinical Studies (14.9)]. 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

  Nosocomial Pneumonia

  750 mg

  7-14

  Community Acquired Pneumonia‡

  500 mg

  7-14

  Community Acquired Pneumonia§

  750 mg

  5

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10-14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  Complicated Skin and Skin Structure Infections (SSSI)

  750 mg

  7-14

  Uncomplicated SSSI

  500 mg

  7-10

  Chronic Bacterial Prostatitis

  500 mg

  28

  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

  Inhalational Anthrax (Post-Exposure),
  adult and pediatric patients > 50 kgÞ,ß
  Pediatric patients < 50 kg and ≥ 6 months
  of ageÞ,ß

  500 mg
  
  See Table 2 below (2.2)

  60ß
  
  60ß

  Plague, adult and pediatric patients >50 kgà
  Pediatric patients <50 kg and ≥6 months
  of age

  500 mg

  See Table 2 below (2.2)

  10 to 14

  10 to 14

  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† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † 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 [see Clinical Studies (14.9)] § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 .

  Inhalational Anthrax (post-exposure)‡,§

    Pediatric Patients > 50 kg

  500 mg

  24hr

  60 days§

    Pediatric Patients < 50 kg
    and ≥ 6 months of age
  

  8 mg/kg
  (not to exceed
  250 mg per dose)

  12hr
  
  

  60 days§
  
  

  Plague¶

    Pediatric Patients >50 kg

  500 mg

  24hr

  10 to 14 days

    Pediatric Patients <50 kg

  and ≥ 6 months of age

  8 mg/kg
  (not to exceed
  250 mg per dose)

  12hr

  10 to 14 days

  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 [see Use in Specific Populations (8.6)].

  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 Injection

  Levofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

  2.5 Administration Instructions

  Levofloxacin Injection

  Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

  Hydration for Patients Receiving Levofloxacin Injection

  Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single-Use Flexible Containers, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.

  Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)

  Levofloxacin Injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 150 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.

  Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:

  1. Tear outer wrap at the notch and remove solution container. 2. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. 3. Do not use if the solution is cloudy or a precipitate is present. 4. Use sterile equipment. 5. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration:

  1. Close flow control clamp of administration set. 2. Remove cover from port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. 6. Open flow control clamp to expel air from set. Close clamp. 7. Regulate rate of administration with flow control clamp.

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † 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 [ 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 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 [ see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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 tablets 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
  (2.2) 60ß Plague, adult and pediatric patients > 50 kgà  500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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. 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 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function
  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1 Dosed Every 24 hours Duration (days)2 1 Due to the designated pathogens [see Indications and Usage (1)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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)].
  4 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)].
  5 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.
  6 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.
  7 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 [see Clinical Studies (14.9)].
  8 The 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 (5.10), 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.
  9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
   Nosocomial Pneumonia
  750 mg
  7 to 14
   Community Acquired Pneumonia3
  500 mg
  7 to 14
   Community Acquired Pneumonia4
  750 mg
  5
   Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
   Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
   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
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
  750 mg
  5
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
  250 mg
  10
   Uncomplicated Urinary Tract Infection
  250 mg
  3
   Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
   Pediatric patients < 50 kg and ≥ 6 months of age 7,8
  500 mg
   
  see Table 2 below (2.2)
  608
  608
   Plague, adult and pediatric patients > 50 kg9
   Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  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 Infection1 Dose Freq. Once
  every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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 [see Clinical Studies (14.9)].
  4 The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
   Inhalational Anthrax (post-exposure)3, 4
       Pediatric patients > 50 kg
  500 mg
  24 hr
  60 days4
       Pediatric patients < 50 kg and ≥ 6 months of age
  8 mg/kg
  (not to exceed
  250 mg per dose)
  12 hr
  60 days4
   Plague5
       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
  2.3 Dosage Adjustment in Adults with Renal Impairment
  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
   
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions
  Food and Levofloxacin Tablets
   
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
   
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)  and Patient Counseling Information (17.2)].

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  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1 Dosed Every 24 hours Duration (days)2  Nosocomial Pneumonia
  750 mg
  7 to 14
   Community Acquired Pneumonia3
  500 mg
  7 to 14
   Community Acquired Pneumonia4
  750 mg
  5
   Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
   Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
   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
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
  750 mg
  5
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
  250 mg
  10
   Uncomplicated Urinary Tract Infection
  250 mg
  3
   Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
   Pediatric patients < 50 kg and ≥ 6 months of age 7,8
  500 mg
   
  see Table 2 below (2.2)
  608
  608
   Plague, adult and pediatric patients > 50 kg9
   Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  

   

  
  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 Infection1 Dose Freq. Once
  every Duration2  Inhalational Anthrax (post-exposure)3, 4
       Pediatric patients > 50 kg
  500 mg
  24 hr
  60 days4
       Pediatric patients < 50 kg and ≥ 6 months of age
  8 mg/kg
  (not to exceed
  250 mg per dose)
  12 hr
  60 days4
   Plague5
       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
  

   

  
  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
   
  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
  

   

  
  

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

   

  
  Food and Levofloxacin Tablets
   
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
   
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)  and Patient Counseling Information (17.2)].

   

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablet 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 [see DOSAGE AND ADMINISTRATION (2.3 )].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 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

  Inhalational Anthrax (Post-Exposure), adult and pediatric

  patients > 50 kg and ≥6 months of ageÞ,β

  Pediatric patients < 50 kg and ≥6 months of ageÞ, β

  500 mg

  see table below (2.2)

  60β

  60β

  * Due to the designated pathogens [see INDICATIONS AND USAGE (1)].

  † 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 strains [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 strains [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 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 [see CLINICAL STUDIES (14.9))].

  β The safety of levofloxacin tablet 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 (5.10), USE IN SPECIFIC POPULATIONS (8.4), AND CLINICAL STUDIES (14.9 ))] Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk.

  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 and ≥6 months of age 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§

  * Due to Bacillus anthracis (see INDICATIONS AND USAGE (1.13)]

  † 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. [See CLINICAL STUDIES(14.9)]

  § The safety of levofloxacin tablets 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 [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), AND CLINICAL STUDIES (14.9))]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk.

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablet 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 tablet 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 suspension. [See DRUG INTERACTIONS (7.1) AND PATIENT COUNSELING INFORMATION (17.2 )].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablet can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) AND PATIENT COUNSELING INFORMATION (17.2)].

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  As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac.

  2.1 Preparation and Handling

  Rhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.

  Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.

  Do not freeze.

  Bring Rhophylac to room temperature before use.

  Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.

  2.2 Suppression of Rh Isoimmunization

  Rhophylac should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac in divided doses at different sites.

  Ensure the site of administration will allow the injection to reach the muscle if Rhophylac is administered intramuscularly. Consider intravenous administration if reaching the muscle is of concern [see Postmarketing Experience (6.2)]. Do not administer Rhophylac subcutaneously into the fatty tissue.

  Table 1 provides dosing guidelines based on the condition being treated.

  Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization Indication Timing of Administration Dose*
  (Administer by Intravenous or Intramuscular Injection) IU, international units; mcg, micrograms. * A 1500 IU (300 mcg) dose of Rhophylac will suppress the immunizing potential of ≥15 mL of Rh 0(D)-positive RBCs. 1 † The dose of Rhophylac must be increased if the patient is exposed to >15 mL of Rh 0(D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage. Rh-incompatible pregnancy   Routine antepartum prophylaxis At Week 28-30 of gestation 1500 IU (300 mcg)   Postpartum prophylaxis
  (required only if the newborn is Rh 0(D)-positive) Within 72 hours of birth 1500 IU (300 mcg)†   Obstetric complications
  (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) Within 72 hours of complication 1500 IU (300 mcg)†   Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) Within 72 hours of procedure 1500 IU (300 mcg)†   Excessive fetomaternal hemorrhage
  (>15 mL) Within 72 hours of complication 1500 IU (300 mcg) plus:
  100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified
  or An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg)
  per 2 mL transfused blood or per 1 mL erythrocyte concentrate 2.3 ITP

  For treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY [see Preparation and Handling (2.1)]. Do not administer intramuscularly.

  A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer:

  Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes

  Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.

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  2.1 Dosage in Adult Patients with Normal Renal Function

  
  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
  

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1 Dosed Every 24 hours Duration (days)2 1 Due to the designated pathogens [see Indications and Usage (1)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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)].
  4 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)].
  5 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.
  6 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.
  7 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 [see Clinical Studies (14.9)].
  8 The 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 (5.10), 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.
  9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
   Nosocomial Pneumonia
  750 mg
  7 to 14
   Community Acquired Pneumonia3
  500 mg
  7 to 14
   Community Acquired Pneumonia4
  750 mg
  5
   Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
   Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
   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
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
  750 mg
  5
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
  250 mg
  10
   Uncomplicated Urinary Tract Infection
  250 mg
  3
   Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
   Pediatric patients < 50 kg and ≥ 6 months of age 7,8
  500 mg
  
  see Table 2 below (2.2)
  608
  608
   Plague, adult and pediatric patients > 50 kg9
   Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  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 Infection1 Dose Freq. Once
  every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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 [see Clinical Studies (14.9)].
  4 The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
   Inhalational Anthrax (post-exposure)3, 4
       Pediatric patients > 50 kg
  500 mg
  24 hr
  60 days4
       Pediatric patients < 50 kg and ≥ 6 months of age
  8 mg/kg
  (not to exceed
  250 mg per dose)
  12 hr
  60 days4
  Plague5
       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
  2.3 Dosage Adjustment in Adults with Renal Impairment

  
  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
  
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  
  Food and Levofloxacin Tablets
  
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
  
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * 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 [ see Clinical Studies (14.9)]. † The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg*,† 500 mg 60† Pediatric patients < 50 kg and ≥ 6 months of age*,† see Table 2 below
  (2.2) 60† Plague, adult and pediatric patients > 50 kg  500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 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 * The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † 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 [ 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 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 [ see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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 tablets 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
  (2.2) 60ß Plague, adult and pediatric patients > 50 kgà  500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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. 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 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † 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 [ 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 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 [ see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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 tablets 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
  (2.2) 60ß Plague, adult and pediatric patients > 50 kgà  500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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. 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 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * 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 [ see Clinical Studies (14.9)]. † The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of age*,† 500 mg 60† Pediatric patients < 50 kg and ≥ 6 months of age*,† See Table 2 below (2.2) 60† 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 * The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection Dose Freq. Once Every Duration Inhalational Anthrax (post-exposure) ,* Pediatric patients > 50 kg and ≥ 6 months of age 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* 2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see DOSAGE AND ADMINISTRATION (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  Type of Infection1

  Dosed Every 24 hours

  Duration
  (days)2

  Nosocomial Pneumonia

  750 mg

  7–14

  Community Acquired Pneumonia3

  500 mg

  7–14

  Community Acquired Pneumonia4

  750 mg

  5

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10–14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  Complicated Skin and Skin Structure Infections (SSSI)

  750 mg

  7–14

  Uncomplicated SSSI

  500 mg

  7–10

  Chronic Bacterial Prostatitis

  500 mg

  28

  Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5

  750 mg

  5

  Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6

  250 mg

  10

  Uncomplicated Urinary Tract Infection

  250 mg

  3

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg 7,8
  Pediatric patients < 50 kg and ≥ 6 months of age 7,8

  500 mg
  see Table 2 below (2.2)

  60 8
  60 8

  Plague, adult and pediatric patients > 50 kg 9
  Pediatric patients < 50 kg and ≥ 6 months of age

   500 mg
  see Table 2 below (2.2)

  10 to 14
  10 to 14

  1 Due to the designated pathogens [see INDICATIONS AND USAGE (1)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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)].
  4 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)].
  5 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.
  6 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.
  7 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 [see CLINICAL STUDIES (14.9)].
  8 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 [see WARNINGS AND PRECAUTIONS (5.10); USE IN SPECIFIC POPULATIONS (8.4); and CLINICAL STUDIES (14.9)] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
  9 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 1

  Dose

  Freq. Once Every

  Duration2

  Inhalational Anthrax (post-exposure)3,4

  Pediatric patients > 50 kg

  500 mg

  24 hr

  60 days4

  Pediatric patients < 50 kg and ≥ 6 months of age

  8 mg/kg (not to exceed 250 mg per dose)

  12 hr

  60 days4

  Plague5 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

  1 Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13) and Yersinia pestis (see INDICATIONS AND USAGE (1.14)]
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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 [see CLINICAL STUDIES (14.9)]
  4 The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10); USE IN SPECIFIC POPULATIONS (8.4); CLINICAL STUDIES (14.9).] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
  5 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 Injection
  Levofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see DOSAGE AND ADMINISTRATION (2.6)].

   

  2.5 Administration Instructions

  Levofloxacin Injection
  Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

  Hydration for Patients Receiving Levofloxacin Injection
  Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1); PATIENT COUNSELING INFORMATION (17.2)].

   

  2.6 Preparation of Intravenous Product

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single Dose Flexible Containers, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.

  Levofloxacin Injection Premix in Single Dose Flexible Containers (5 mg/mL)
  Levofloxacin injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single dose. The 50 mL premixed flexible containers contain 250 mg/50 mL, the 100 mL premixed flexible containers contain 500 mg/100 mL, and the 200 mL premixed flexible containers contain 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single dose only, any unused portion should be discarded.

  Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:

  Tear outer wrap at the notch and remove solution container.  Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. Do not use if the solution is cloudy or a precipitate is present. Use sterile equipment. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration:

  Close flow control clamp of administration set. Remove cover from port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. Open flow control clamp to expel air from set. Close clamp. Regulate rate of administration with flow control clamp.

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance > 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE (1)]. † 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 [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 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 [see CLINICAL STUDIES (14.9)]. ß The 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 (5.10) , USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspented or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß

  500 mg

  60ß

  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß

  see Table 2 below (2.2)

  60ß

  Plague, adult and pediatric patients > 50 kgà

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below (2.2)

  10 to 14

  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 * Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13)] and Yersinia pestis [see INDICATIONS AND USAGE (1.14)]. † 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 [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tablets 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 [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet 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.

  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

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tabletswith 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

  2.5 Administration Instructions

  Food and LevofloxacinTablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving LevofloxacinTablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].   

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)  

  * Due to the designated pathogens [see Indications and Usage (1)].

   

  † 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 [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 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 [see Clinical Studies (14.9)].

   

  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

   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
   Acute Bacterial Sinusitis
   750 mg
   5
   
   500 mg
   10-14
   Acute Bacterial Exacerbation of Chronic Bronchitis
   500 mg
   7
   Complicated Skin and Skin Structure Infections (SSSI)
   750 mg
   7-14
   Uncomplicated SSSI
   500 mg
   7-10
   Chronic Bacterial Prostatitis
   500 mg
   28
   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
   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 (2.2)
   60ß
  60ß
   Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age
   500 mg
  See Table 2 below (2.2)
   10 to 14
  10 to 14
  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  

  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

   

  † 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 [see Clinical Studies (14.9)]

   

  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

   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
  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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1       Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 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 (2.2)
  60 ß 
  60 ß Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [seeUse in Specific Populations (8.6)].  

  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 tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

  2.5     Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  Levofloxacin | Remedyrepack Inc.

  

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  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 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 (2.2)
  60 ß 
  60 ß Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [seeUse in Specific Populations (8.6)].  

  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

   

  Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

   

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

   

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  Levofloxacin | Remedyrepack Inc.

  

  ---

   

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 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 (2.2)
  60 ß 
  60 ß Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [seeUse in Specific Populations (8.6)].  

  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

   

  Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

   

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

   

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  Levofloxacin | American Health Packaging

  

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE (1)]. † 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 [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 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 [see CLINICAL STUDIES (14.9)]. 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 [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. 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 tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß

  500 mg
  see Table 2 below
  (2.2)

  60ß
  60ß

  Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age

  500 mg
  see Table 2 below
  (2.2)

  10 to 14
  10 to 14

  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 * Due to Bacillus anthracis [see INDICATIONS AND USAGE ( 1.13)] and Yersinia pestis [see INDICATIONS AND USAGE ( 1.14)]. † 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 [see CLINICAL STUDIES ( 14.9)] § 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 [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. 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.

  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

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 Clearance20 to 49 mL/min

  Creatinine Clearance10 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 Tablets

  Levofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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  Levofloxacin | Renu Laboratories, Inc.

  

  ---

  Directions:

  clean the affected area and dry thoroughly apply a thin layer over the affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to the spaces between toes..
  Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks. If condition lasts longer, as a doctor to prevent athlete's foot, apply to the feet once or twice daily this product is not effective on the scalp or nails

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  Levofloxacin | Clinical Solutions Wholesale

  

  ---

  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance > 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE (1)]. † 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]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis, Chlamydophilapneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae(excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae[see INDICATIONS AND USAGE(1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiellapneumoniae, 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, Klebsiellapneumoniae, Proteus mirabilis, Pseudomonasaeruginosa; 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 [see CLINICAL STUDIES(14.9)]. ß The safety of levofloxacin tabletsin 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 (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablettherapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspented or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß

  500 mg

  60ß

  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß

  see Table 2 below (2.2)

  60ß

  Plague, adult and pediatric patients > 50 kgà

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below (2.2)

  10 to 14

  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 * Due to Bacillus anthracis[see INDICATIONS AND USAGE (1.13)]and Yersinia pestis[see INDICATIONS AND USAGE (1.14)]. † 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 [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tabletsin 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 [see WARNINGS AND PRECAUTIONS (5.10),USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet 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.

  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

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tabletswith 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

  2.5 Administration Instructions

  Food and LevofloxacinTablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving LevofloxacinTablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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  Levofloxacin | Major Pharmaceuticals

  

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  2.1       Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14  Community Acquired Pneumonia ‡  500 mg  7 to 14  Community Acquired Pneumonia§  750 mg  5  Acute Bacterial Sinusitis  750 mg  5  500 mg  10 to 14  Acute Bacterial Exacerbation of Chronic Bronchitis  500 mg  7  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  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  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 (2.2)  
  60 ß 
  60 ß  Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age  500 mg
  see Table 2 below (2.2)  10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [seeUse in Specific Populations (8.6)].  

  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 tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

  2.5     Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  Levofloxacin | Rite Aid Corporation

  

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  • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age

  age

  dose

  adults and children 12 years and over

  10 mL every 4 hours

  children under 12 years

  do not use

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  Levofloxacin | Remedyrepack Inc.

  

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  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 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 (2.2)
  60 ß 
  60 ß Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [seeUse in Specific Populations (8.6)].  

  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

   

  Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

   

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

   

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function(creatinine clearance ≥ 50 mL/min) Type of Infection* Dosed Every Duration 24 hours (days) † * Due to the designated pathogens [see Indications and Usage (1)]. †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 strains [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 strains [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 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 [see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. Nosocomial Pneumonia 750 mg 7-14 Community Acquired Pneumonia‡ 500 mg 7-14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 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 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50kg and ≥ 6 months of ageÞ,ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß 500 mg
  see Table 2below (2.2) 60ß
  60ß 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† * Due to Bacillus anthracis [see Indications and Usage (1.13)] † 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 [see Clinical Studies (14.9)] § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. Inhalational Anthrax (post-exposure) ‡,§ Pediatric patients > 50 kg and ≥ 6 months of age 500 mg 24 hr 60 days§ 8 mg/kg Pediatric patients < 50 kg and ≥ 6 months of age (not to exceed 250 mg per dose) 2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Creatinine Creatinine Hemodialysis Normal Clearance Clearance or Chronic Renal Function 20 to 49 mL/min 10 to 19 mL/min Ambulatory Every 24 hours Peritoneal Dialysis (CAPD) 750 mg 750 mg 750 mg initial dose, 750 mg initial dose, every 48 hours then 500 mg then 500 mg every 48 hours every 48 hours 500 mg 500 mg initial dose, 500 mg initial dose, 500 mg initial dose, then 250 mg then 250 mg then 250 mg every 24 hours every 48 hours every 48 hours 250 mg No dosage 250 mg No information adjustment every 48 hours. on dosing required If treating uncomplicated UTI, then no dosage adjustment is required 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  Levofloxacin | Remedyrepack Inc.

  

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  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 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 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 (2.2)
  60 ß 
  60 ß Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  1* Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

  §The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

   

  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 [seeUse in Specific Populations (8.6)].  

  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

   

  Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]

   

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

   

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  ---

  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].   

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)  

  * Due to the designated pathogens [see Indications and Usage (1)].

   

  † 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 [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 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 [see Clinical Studies (14.9)].

   

  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

   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
   Acute Bacterial Sinusitis
   750 mg
   5
   
   500 mg
   10-14
   Acute Bacterial Exacerbation of Chronic Bronchitis
   500 mg
   7
   Complicated Skin and Skin Structure Infections (SSSI)
   750 mg
   7-14
   Uncomplicated SSSI
   500 mg
   7-10
   Chronic Bacterial Prostatitis
   500 mg
   28
   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
   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 (2.2)
   60ß
  60ß
   Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age
   500 mg
  See Table 2 below (2.2)
   10 to 14
  10 to 14
  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  

  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

   

  † 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 [see Clinical Studies (14.9)]

   

  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

   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
  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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].   

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)]. † 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 [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 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 [see Clinical Studies (14.9)]. 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 Yersiniapestis. Higher doses of levofloxacin 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
  

  7-14
  

  Community Acquired Pneumonia‡
  

  500 mg
  

  7-14
  

  Community Acquired Pneumonia§
  

  750 mg
  

  5
  

  Acute Bacterial Sinusitis
  

  750 mg
  

  5
  

  500 mg
  

  10-14
  

  Acute Bacterial Exacerbation of Chronic Bronchitis
  

  500 mg
  

  7
  

  Complicated Skin and Skin Structure Infections (SSSI)
  

  750 mg
  

  7-14
  

  Uncomplicated SSSI
  

  500 mg
  

  7-10
  

  Chronic Bacterial Prostatitis
  

  500 mg
  

  28
  

  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
  

  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 (2.2)
  

  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 (2.2)
  

  10 to 14
  10 to 14
  

  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 * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † 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 [see Clinical Studies (14.9)] § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  

  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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * 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 [ 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 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. # 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 [ see Clinical Studies (14.9)]. Þ The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg#,Þ

  Pediatric patients < 50 kg and ≥ 6 months of age#,Þ

  500 mg

  see Table 2 below

  (2.2)

  60Þ

  60Þ

  Plague, adult and pediatric patients > 50 kgß

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below (2.2)

  10 to 14

  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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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.

  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

  2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  ---

  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1:  Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) *   Due to the designated pathogens [see Indications and Usage (1)].
  †   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 [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 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 [see Clinical Studies (14.9)].
  ß   The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.
  á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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
  

   Acute Bacterial Sinusitis
  

  750 mg
  

  5
  

  500 mg
  

  10 to 14
  

   Acute Bacterial Exacerbation of Chronic Bronchitis
  

  500 mg
  

  7
  

   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
  

   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
  

   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 (2.2)
  

  60 ß
  60 ß
  

   Plague, adult and pediatric patients > 50 kgá
  Pediatric patients < 50 kg and ≥ 6 months of age
  

  500 mg
  see Table 2 below (2.2)
  

  10 to 14
  10 to 14
  

  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† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  † 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 [see Clinical Studies (14.9)].
  § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
  

   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
  

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
  
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets
  
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
  
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Important Dosing and Administration Information

  In selecting a LANOXIN dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.

  Consider interruption or reduction in LANOXIN digoxin dose prior to electrical cardioversion [see Warnings and Precautions (5.4)].

  Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.

  2.2 Loading Dosing Regimen in Adults and Pediatric Patients

  For adults and pediatric patients if a loading dosage is to be given, administer half the total loading dose initially, then ¼ the loading dose every 6-8 hours twice, with careful assessment of clinical response and toxicity before each dose. The recommended loading dose is displayed in Table 1.

  Table 1. Recommended LANOXIN Oral Loading Dose mcg = microgram

  Age

       Total Oral Loading Dose (mcg/kg)     

  Administer half the total loading dose initially,
  then ¼ the loading dose every 6 to 8 hours twice

  5 to 10 years

  20-45

  Adults and pediatric patients over 10 years     

  10-15

  2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years Old

  The maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].

  The recommended starting maintenance dose in adults and pediatric patients over 10 years old with normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.

  Table 2. Recommended Starting LANOXIN Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old mcg = microgram

  Age

       Total Oral Maintenance Dose, mcg/kg/day     
  (given once daily)

  Adults and pediatric patients over 10 years     

  3.4-5.1

  Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):

  Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100
  (% Daily Loss = 14 + Creatinine clearance/5)

  Reduce the dose of LANOXIN in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.

  Table 3. Recommended Maintenance Dose (in micrograms given once daily) of LANOXIN in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Functiona a  Doses are rounded to the nearest dose possible using whole LANOXIN tablets. Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.
  b  For adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.
  For pediatric patients, the modified Schwartz equation may be used. The formula is based on height in cm and Scr in mg/dL where k is a constant. Ccr is corrected to 1.73 m2 body surface area. During the first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants. The k is 0.55 for pediatric patients and adolescent girls and 0.7 for adolescent boys.
  GFR (mL/min/1.73 m2) = (k x Height)/Scr
  c  If no loading dose administered.
  d  The doses listed assume average body composition.

  Corrected
  Creatinine
  Clearanceb

  Lean Body Weightd

  Number of Days
  Before Steady
  State Achievedc

  kg

  40

  50

  60

  70

  80

  90

  100

    10 mL/min   62.5*   125   125   187.5   187.5   187.5   250   19   20 mL/min   125   125   125   187.5   187.5   250   250   16   30 mL/min   125   125   187.5   187.5   250   250   312.5   14   40 mL/min   125   187.5   187.5   250   250   312.5   312.5   13   50 mL/min   125   187.5   187.5   250   250   312.5   312.5   12   60 mL/min   125   187.5   250   250   312.5   312.5   375   11   70 mL/min   187.5   187.5   250   250   312.5   375   375   10   80 mL/min   187.5   187.5   250   312.5   312.5   375   437.5   9   90 mL/min   187.5   250   250   312.5   375   437.5   437.5   8   100 mL/min   187.5   250   312.5   312.5   375   437.5   500   7 2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years Old

  The starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)]. The recommended starting maintenance dose for pediatric patients between 5 years and 10 years old is given in Table 4. These recommendations assume the presence of normal renal function.

  Table 4. Recommended Starting LANOXIN Oral Maintenance Dosage in Pediatric Patients between 5 and 10 Years Old

  Age

  Oral Maintenance Dose,
  mcg/kg/dose

  5 years to 10 years

  3.2-6.4   Twice daily

  Table 5 provides average daily maintenance dose requirements for pediatric patients between 5 and 10 years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.

  Table 5. Recommended Maintenance Dose (in micrograms given TWICE daily) of LANOXIN in Pediatric Patients between 5 and 10 Years of Agea Based upon Lean Body Weight and Renal Functiona,b a  Recommended are doses to be given twice daily.
  b  The doses are rounded to the nearest dose possible using whole LANOXIN tablets. Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.
  c  The modified Schwartz equation may be used to estimate creatinine clearance. See footnote b under Table 3.
  d  If no loading dose administered.

  Corrected
  Creatinine
  Clearancec

  Lean Body Weight

  Number of Days
  Before Steady
  State Achievedd

  kg

  20

  30

  40

  50

  60

    10 mL/min   -   62.5   62.5*   125   125   19   20 mL/min   62.5   62.5   125   125   125   16   30 mL/min   62.5   62.5*   125   125   187.5   14   40 mL/min   62.5   62.5*   125   187.5   187.5   13   50 mL/min   62.5   125   125   187.5   187.5   12   60 mL/min   62.5   125   125   187.5   250   11   70 mL/min   62.5   125   187.5   187.5   250   10   80 mL/min   62.5*   125   187.5   187.5   250   9   90 mL/min   62.5*   125   187.5   250   250   8   100 mL/min   62.5*   125   187.5   250   312.5   7 2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

  Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

  Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.

  Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the LANOXIN dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting LANOXIN and correct post-treatment values by the reported baseline level.

  Obtain serum digoxin concentrations just before the next scheduled LANOXIN dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.

  2.6 Switching from Intravenous Digoxin to Oral Digoxin

  When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 6).

  Table 6. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous LANOXIN

  Absolute
     Bioavailability   

     Equivalent Doses (mcg)   

  LANOXIN Tablets

  60-80%

     62.5   

  125

  250

  500

  LANOXIN Intravenous Injection   

  100%

  50

     100   

     200   

     400   

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance≥ 50 mL/min) *  Due to the designated pathogens [see Indications and Usage (1)]. †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 [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 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 [see Clinical Studies (14.9)]. ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 tablets 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
  

  7-14
  

  Community Acquired Pneumonia‡ 
  

  500 mg
  

  7-14
  

  Community Acquired Pneumonia§ 
  

  750 mg
  

  5
  

  Acute Bacterial Sinusitis 
  

  750 mg
  

  5
  

  500 mg
  

  10-14
  

  Acute Bacterial Exacerbation of Chronic Bronchitis 
  

  500 mg
  

  7
  

  Complicated Skin and Skin Structure Infections (SSSI) 
  

  750 mg
  

  7-14
  

  Uncomplicated SSSI 
  

  500 mg
  

  7-10
  

  Chronic Bacterial Prostatitis 
  

  500 mg
  

  28
  

  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
  

  Inhalational Anthrax (Post-Exposure),
  adultand pediatric patients > 50 kg Þ,ß 
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  

  
  500 mg
  see Table 2 below (2.2)
  

  
  60ß
  60ß
  

  Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age
  

    500 mg
  see Table 2 below (2.2)
  

  10 to 14
  
  10 to 14
  

  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 * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage(1.14)]. †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 [see Clinical Studies (14.9)] § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)  and Patient Counseling Information (17.2)].

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  For Treatment of Toxoplasmosis: The dosage of DARAPRIM for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients.

  The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks.

  The pediatric dosage of DARAPRIM is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with DARAPRIM.

  For Treatment of Acute Malaria: DARAPRIM is NOT recommended alone in the treatment of acute malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. However, DARAPRIM at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria. DARAPRIM is only recommended for patients infected in areas where susceptible plasmodia exist. Should circumstances arise wherein DARAPRIM must be used alone in semi-immune persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case.

  For Chemoprophylaxis of Malaria:
  Adults and pediatric patients over 10 years – 25 mg (1 tablet) once weekly
  Children 4 through 10 years – 12.5 mg (1/2 tablet) once weekly
  Infants and children under 4 years – 6.25 mg (1/4 tablet) once weekly.

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  2.1       Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  * Due to the designated pathogens [see Indications and UsageHYPERLINK l "_RefINDICATIONS_AND_USAGE" (1)]. † 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 [see Indications and UsageHYPERLINK l "_Ref_cd55f535-bc4f-26eb-5f98-c25935287e6" (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and UsageHYPERLINK l "_Ref_10fa1391-4861-375e-e722-fda832a596a" (1.3)]. ¶ 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 [see Clinical StudiesHYPERLINK l "_Ref_8b0fe90b-f154-e516-63e6-69d9217a8f0" (14.9)]. 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 [see Warnings and PrecautionsHYPERLINK l "_Ref_9697f448-d255-5ba4-05a0-d00b0688a83" (5.10), Use in Specific PopulationsHYPERLINK l "_RefPEDIATRIC_USE" (8.4), and Clinical StudiesHYPERLINK l "_Ref_8b0fe90b-f154-e516-63e6-69d9217a8f0" (14.9)]. 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.

  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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  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 (2.2)

  
  60 ß
  60 ß

  Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age

  500 mg
  see Table 2 below (2.2)

  10 to 14
  10 to 14

  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

  * Due to Bacillus anthracis [see Indications and UsageHYPERLINK l "_Ref_44e8b8b4-7787-1604-7e7b-4abf6e612f3" (1.13)] and Yersinia pestis [see Indications and UsageHYPERLINK l "_Ref_37b72727-96be-cb93-91f4-bc446d623da" (1.14)]. † 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 toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical StudiesHYPERLINK l "_Ref_8b0fe90b-f154-e516-63e6-69d9217a8f0" (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

  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

  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 [see Use in Specific Populations (8.6)].  

  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 tablets 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 [see DrugInteractions (7.1) and Patient Counseling Information (17.2)]

  2.5     Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.  

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  
  
  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1
  Dosed Every 24 hours
  Duration (days)2
  1   Due to the designated pathogens [see Indications and Usage (1)].
  2   Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3   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)].
  4   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)].
  5   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.
  6   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.
  7   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 [see Clinical Studies (14.9)].
  8   The 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 (5.10), 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.
  9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically inidicated.
  Nosocomial Pneumonia
  750 mg
  7 to 14
  Community Acquired Pneumonia3
  500 mg
  7 to 14
  Community Acquired Pneumonia4
  750 mg
  5
  Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  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
  Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
  750 mg
  5
  Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
  250 mg
  10
  Uncomplicated Urinary Tract Infection
  250 mg
  3
  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
  Pediatric patients < 50 kg and ≥ 6 months of age 7,8
  500 mg
   
  see Table 2 below (2.2)
  608
   
  608
  Plague, adult and pediatric patients > 50 kg9
   
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  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 1  Due to Bacillus anthracis [see Indications and Usage (1.13)]and Yersinia pestis [see Indications and Usage (1.14)].
  2  Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3  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 [see Clinical Studies (14.9)].
  4  The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection1
  Dose
  Freq. Once every
  Duration2
  Inhalational Anthrax (post-exposure)3, 4
  Pediatric patients > 50 kg
  500 mg
  24 hr
  60 days4
  Pediatric patients < 50 kg and ≥ 6 months of age
  8 mg/kg
  (not to exceed
  250 mg per dose)
  12 hr
  60 days4
  Plague5
  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
  2.3 Dosage Adjustment in Adults with Renal Impairment
  

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
  
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions
  

  Food and Levofloxacin Tablets
  
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets 
  
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)]. 

  Table 1:  Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) 1   Due to the designated pathogens [see Indications and Usage (1)].
  2   Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3   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)].
  4   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)].
  5   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.
  6   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.
  7   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 [see Clinical Studies (14.9)].
  8   The 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 (5.10), 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.
  9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection1 Dosed Every 24 hours Duration
   (days)2 Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia3 500 mg 7 to 14 Community Acquired Pneumonia4 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 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 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Plague, adult and pediatric patients > 50 kg9
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14

  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 Infection1 Dose Freq. Once
  every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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 [see Clinical Studies (14.9)].
  4 The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.  Inhalational Anthrax (post-exposure)3, 4      Pediatric patients > 50 kg 500 mg 24 hr 60 days4      Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
  (not to exceed
  250 mg per dose) 12 hr 60 days4  Plague5      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

  2.3 Dosage Adjustment in Adults with Renal Impairment

  
  

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  
  

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  2.2 Dosage in Pediatric Patients

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

  2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  Table 3 shows how to adjust dose based on creatinine clearance.

  2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)]. 

  Table 1:  Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) 1   Due to the designated pathogens [see Indications and Usage (1)].
  2   Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3   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)].
  4   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)].
  5   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.
  6   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.
  7   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 [see Clinical Studies (14.9)].
  8   The 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 (5.10), 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.
  9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
  Type of Infection1
  Dosed Every 24 hours
  Duration
   (days)2
  Nosocomial Pneumonia
  750 mg
  7 to 14
  Community Acquired Pneumonia3
  500 mg
  7 to 14
  Community Acquired Pneumonia4
  750 mg
  5
  Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  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
  Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
  750 mg
  5
  Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
  250 mg
  10
  Uncomplicated Urinary Tract Infection
  250 mg
  3
  Plague, adult and pediatric patients > 50 kg9
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  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 Infection1 Dose Freq. Once
  every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
  3 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 [see Clinical Studies (14.9)].
  4 The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
   Inhalational Anthrax (post-exposure)3, 4
       Pediatric patients > 50 kg
  500 mg
  24 hr
  60 days4
       Pediatric patients < 50 kg and ≥ 6 months of age
  8 mg/kg
  (not to exceed
  250 mg per dose)
  12 hr
  60 days4
   Plague5
       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
  2.3 Dosage Adjustment in Adults with Renal Impairment
  

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
  
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions
  

  Food and Levofloxacin Tablets
  
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
  
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  * Due to the designated pathogens [see INDICATIONS AND USAGE ( 1)]. † 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]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis, Chlamydophilapneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae(excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae [see INDICATIONS AND USAGE(1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiellapneumoniae, 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, Klebsiellapneumoniae, Proteus mirabilis, Pseudomonasaeruginosa; 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 [see CLINICAL STUDIES(14.9)]. ß The safety of levofloxacin tabletsin 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 (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablettherapy 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 tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß

  500 mg

  60ß

  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß

  see Table 2 below (2.2)

  60ß

  Plague, adult and pediatric patients > 50 kgà

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below (2.2)

  10 to 14

  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

  * Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13)] and Yersinia pestis[see INDICATIONS AND USAGE (1.14)]. † 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 [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tablets 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 [see WARNINGS AND PRECAUTIONS (5.10),USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet 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.

  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

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tabletswith 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

  2.5 Administration Instructions

  Food and LevofloxacinTablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving LevofloxacinTablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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  shake well before use measure only with dosing spoon provided read dosing spoon carefully.  Dosing spoon holds 5 mL when filled to the top rim do not use dosing spoon with other products dose as follows or as directed by a doctor mL = milliliter
  
  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  *  Due to the designated pathogens [see Indications and Usage (1)].

  †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 strains [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 strains [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 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 [see Clinical Studies (14.9)].

  ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

  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
  Acute Bacterial Sinusitis
  750 mg
  5
  
  500 mg
  10-14
  Acute Bacterial Exacerbation of Chronic Bronchitis 
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI) 
  750 mg
  7-14
  Uncomplicated SSSI 
  500 mg
  7-10
  Chronic Bacterial Prostatitis 
  500 mg
  28
  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
  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of ageÞ,ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  
  500 mg
  see Table 2 below (2.2)
  
  60ß
  60ß
  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

  * Due to Bacillus anthracis [see Indications and Usage (1.13)]

  † 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 [see Clinical Studies (14.9)]

  § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.

  
  

  Type of Infection*
  Dose
  Freq. Once every
  Duration†
  Inhalational Anthrax (post-exposure) ‡,§
  
  
  
  
  
  
  Pediatric patients > 50 kg and ≥ 6 months of age 
  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§
  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function
  

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  
  Table 1:  Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) *   Due to the designated pathogens [see Indications and Usage (1)].
  †   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 [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 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 [see Clinical Studies (14.9)].
  ß   The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.
  á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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
   Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
   Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
   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
   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
   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 (2.2)
  60 ß
  60 ß
   Plague, adult and pediatric patients > 50 kgá
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  
  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† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  † 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 [see Clinical Studies (14.9)].
  § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
   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
  2.3 Dosage Adjustment in Adults with Renal Impairment
  

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
  
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions
  

  Food and Levofloxacin Tablets
  
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
  
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function
  

  The usual dose of levofloxacin injection

  is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see Dosage and Administration (2.3)].
  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
  Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10-14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI)
  750 mg
  7-14
  Uncomplicated SSSI
  500 mg
  7-10
  Chronic Bacterial Prostatitis
  500 mg
  28
  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
  
  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  500 mg
   
  see Table 2 below (2.2)
  60ß
   
  60ß
  Plague, adult and pediatric patients > 50 kgà
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  

  *

  Due to the designated pathogens [see Indications and Usage (1)].
  †

  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 [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 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 [see Clinical Studies (14.9)].
  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  †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 [see Clinical Studies (14.9)]
  §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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and

  Clinical Studies (14.9)]. 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 [see

  Use in Specific Populations (8.6)].
  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 injection
  Levofloxacin injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see

  Dosage and Administration (2.6)].

  2.5 Administration Instructions
  

  Levofloxacin injection
  Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
  
  Hydration for Patients Receiving Levofloxacin Injection
  Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product
  

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection Premix in Single-Use Flexible Containers and levofloxacin injection in Single-Use Vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.
  
  Levofloxacin Injection in Single-Use Vials
  
  Single-use vials require dilution prior to administration.
  
  Levofloxacin injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of Levofloxacin USP in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin USP/mL. These levofloxacin injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
  
  Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:
  
  Table 4: Compatible Intravenous Solutions

  
  Intravenous Fluids
  Final pH of Levofloxacin Solution
  0.9% Sodium Chloride Injection, USP
  4.71
  5% Dextrose Injection, USP
  4.58
  5% Dextrose/0.9% NaCl Injection
  4.62
  5% Dextrose in Lactated Ringers
  4.92
  Plasma-Lyte® 56/5% Dextrose Injection
  5.03
  5% Dextrose, 0.45% Sodium Chloride, and 0.15% Potassium Chloride Injection
  4.61
  Sodium Lactate Injection (M/6)
  5.54
  
  
  

  Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].

  Prepare the desired dosage of levofloxacin according to Table 5:

  
  

  Table 5: Preparation of Levofloxacin Intravenous Solution

  
  Desired Dosage Strength
  From Appropriate Vial, Withdraw Volume
  Volume of Diluent
  Infusion Time
  500 mg
  20 mL (20 mL Vial)
  80 mL
  60 min
  750 mg
  30 mL (30 mL Vial)
  120 mL
  90 min
  
  

  For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.
  
  This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
  
  Stability of Levofloxacin Injection Following Dilution: Levofloxacin injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.

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  Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches/day. Leave patch on affected area for up to 8 hours. Do not use patches for longer than 5 consecutive days. Children under 12 should consult physician prior to use.

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  2.1 Adults and Adolescents >16 years of age

  The recommended oral dose of Lamivudine in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].

  2.2 Pediatric Patients

  The recommended oral dose of Lamivudine Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.

  2.3 Patients With Renal Impairment

  Dosing of lamivudine is adjusted in accordance with renal function. Dosage adjustments are listed in Table 1 [see Clinical Pharmacology (12.3)].

  Table 1. Adjustment of Dosage of Lamivudine in Adults and Adolescents (≥30 kg) in accordance With Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine ≥50
  150 mg twice daily or 300 mg once daily
  30-49
  150 mg once daily
  15-29
  150 mg first dose, then 100 mg once daily
  5-14
  150 mg first dose, then 50 mg once daily
  less than 5
  50 mg first dose, then 25 mg once daily
  

  No additional dosing of Lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
  
  Although there are insufficient data to recommend a specific dose adjustment of Lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

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  2.1 Dosage in Adult Patients with Normal Renal Function
  

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  
  Table 1:  Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) *   Due to the designated pathogens [see Indications and Usage (1)].
  †   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 [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 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 [see Clinical Studies (14.9)].
  ß   The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.
  á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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
   Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
   Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
   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
   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
   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 (2.2)
  60 ß
  60 ß
   Plague, adult and pediatric patients > 50 kgá
  Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  
  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† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  † 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 [see Clinical Studies (14.9)].
  § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), 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.
  ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
   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
  2.3 Dosage Adjustment in Adults with Renal Impairment
  

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].
  
  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 tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions
  

  Food and Levofloxacin Tablets
  
  Levofloxacin tablets can be administered without regard to food.
  
  Hydration for Patients Receiving Levofloxacin Tablets
  
  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * 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 [ 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 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. # 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 [ see Clinical Studies (14.9)]. Þ The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg#,Þ

  Pediatric patients < 50 kg and ≥ 6 months of age#,Þ

  500 mg

  see Table 2 below

  (2.2)

  60Þ

  60Þ

  Plague, adult and pediatric patients > 50 kgß

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below (2.2)

  10 to 14

  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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † 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 [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet 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.

  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

  2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function
  

  The usual dose of Levofloxacin Tablet 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)>

  
  * Due to the designated pathogens [see Indications and Usage (1)]. † 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 strains [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 strains [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 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 [see Clinical Studies (14.9)]. 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin therapy in adults 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 <em>Yersinia pestis</em>. Higher doses of levofloxacin 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
  7–14
  Community Acquired Pneumonia‡
  500 mg
  7–14
  Community Acquired Pneumonia§
  750 mg
  5
  Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10–14
  Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI)
  750 mg
  7–14
  Uncomplicated SSSI
  500 mg
  7–10
  Chronic Bacterial Prostatitis
  500 mg
  28
  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
  Inhalational Anthrax (Post-Exposure), adult and
  pediatric patients > 50 kg and ≥ 6 months of ageÞ,ß
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  500 mg
  
  
  see Table 2 below (2.2) 60ß
  
  60ß
   Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age
   500 mg
  see Table 2 below (2.2)  10 to 14
  10 to 14
  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
  

  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † 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 [see Clinical Studies (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9).] 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. 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
  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 [see Use in Specific Populations (8.6)].
  
  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)] .

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

   

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE ( 1)]. † 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 [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 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 [see CLINICAL STUDIES ( 14.9)]. 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 [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. 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 tablets 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
  Acute Bacterial Sinusitis
  750 mg
  5
  
  500 mg
  10 to 14
  Acute Bacterial Exacerbation of 
  Chronic Bronchitis
  500 mg
  7
  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
  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
  Inhalational Anthrax (Post-Exposure), 
  adult and pediatric patients > 50 kgÞ,ß Pediatric patients < 50 kg  and ≥ 6 months 
  of ageÞ,ß
  500 mg see Table 2  below (2.2) 60ß
  
  60ß
  Plague, adult and pediatric  patients 
  > 50 kgà Pediatric patients < 50 kg 
  and ≥ 6 months of age
  500 mg see Table 2  below (2.2) 10 to 14
  
  10 to 14
  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 * Due to Bacillus anthracis [see INDICATIONS AND USAGE ( 1.13)] and Yersinia pestis [see INDICATIONS AND USAGE ( 1.14)]. † 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 [see CLINICAL STUDIES ( 14.9)] § 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 [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. 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. 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
  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see USE IN SPECIFIC POPULATIONS (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function
  

  The usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see Dosage and Administration (2.3)].

  
  

  Table 1:  Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  * Due to the designated pathogens [see Indications and Usage (1)].
  † 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 [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 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 [see Clinical Studies (14.9)].
  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
    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
    Acute Bacterial Sinusitis
  750 mg
  5
  500 mg
  10 to 14
    Acute Bacterial Exacerbation of Chronic Bronchitis
  500 mg
  7
    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
    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
    Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß
    Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  500 mg
   see Table 2 below (2.2)
  60ß
   60ß
    Plague, adult and pediatric patients > 50 kg à
    Pediatric patients < 50 kg and ≥ 6 months of age
  500 mg
  see Table 2 below (2.2)
  10 to 14
  10 to 14
  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 [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  † 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 [see Clinical Studies (14.9)]

  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 injection 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 [see Use in Specific Populations (8.6)].
  
  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 injection should not be coadministered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

  2.5 Administration Instructions
  

  Caution: Rapid or bolus intravenous infusion of levofloxacin injection has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
  
  Hydration for Patients Receiving Levofloxacin Injection
  
  Adequate hydration of patients receiving intravenous levofloxacin injection should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product
  

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  
  Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection in single-use vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.
  
  Levofloxacin Injection in Single-Use Vials
  
  Single-use vials require dilution prior to administration.
  
  Levofloxacin injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These levofloxacin injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
  
  Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:

  
  
  Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of
  Levofloxacin Solution    0.9% Sodium Chloride Injection, USP
  4.71
     5% Dextrose Injection, USP
  4.58
     5% Dextrose/0.9% NaCl Injection
  4.62
     5% Dextrose in Lactated Ringers
  4.92
     Plasma-Lyte® 56/5% Dextrose Injection
  5.03
     5% Dextrose, 0.45% Sodium Chloride, and
     0.15% Potassium Chloride Injection
  4.61
     Sodium Lactate Injection (M/6)
  5.54
  
  

  Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].

  Prepare the desired dosage of levofloxacin according to Table 5:

                                              Table 5: Preparation of Levofloxacin Intravenous Solution

    Desired Dosage Strength
  From Appropriate Vial, Withdraw Volume
  Volume of Diluent
  Infusion Time
    250 mg
  10 mL (20 mL Vial)
  40 mL
  60 min
    500 mg
  20 mL (20 mL Vial)
  80 mL
  60 min
    750 mg
  30 mL (30 mL Vial)
  120 mL
  90 min
  

  For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.

  This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.

  Stability of Levofloxacin Injection Following Dilution: Levofloxacin injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.

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  2.1 Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance≥ 50 mL/min)

  *  Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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 [see Clinical Studies (14.9)].

  ß The 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 tablets 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
  7-14
  Community Acquired Pneumonia‡ 
  500 mg
  7-14
  Community Acquired Pneumonia§ 
  750 mg
  5
  Acute Bacterial Sinusitis 
  750 mg
  5
  
  500 mg
  10-14
  Acute Bacterial Exacerbation of Chronic Bronchitis 
  500 mg
  7
  Complicated Skin and Skin Structure Infections (SSSI) 
  750 mg
  7-14
  Uncomplicated SSSI 
  500 mg
  7-10
  Chronic Bacterial Prostatitis 
  500 mg
  28
  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
  Inhalational Anthrax (Post-Exposure),
  adultand pediatric patients > 50 kg Þ,ß 
  Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
  
  500 mg
  see Table 2 below (2.2)
  
  60ß
  60ß
  Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age
    500 mg
  see Table 2 below (2.2)
  10 to 14
  
  10 to 14
  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

  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage(1.14)].

  †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 [see Clinical Studies (14.9)]

  § The safety of levofloxacin tablets 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.
  

  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
  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets 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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)  and Patient Counseling Information (17.2)].

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  2.1    Dosage in Adult Patients with Normal Renal Function

  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/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

   Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)  Type of Infection*  Dosed Every 24 hours  Duration (days)†  * Due to the designated pathogens [see Indications and Usage (1)].  † 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 [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 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 [see Clinical Studies (14.9 )].

  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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 treatm

   Nosocomial Pneumonia  750 mg  7–14  Community Acquired Pneumonia‡  500 mg  7–14  Community Acquired Pneumonia§  750 mg  5  Acute Bacterial Sinusitis  750 mg  5  500 mg  10–14  Acute Bacterial Exacerbation of Chronic Bronchitis  500 mg  7  Complicated Skin and Skin Structure Infections (SSSI)  750 mg  7–14  Uncomplicated SSSI  500 mg  7–10  Chronic Bacterial Prostatitis  500 mg  28  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 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 (2.2) 

  60ß 

  60ß 

  Plague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age

  500 mg

  see Table 2 below (2.2)

  10 to 14

  10 to 14

  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†  * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].  † 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 [see Clinical Studies (14.9)]

  § 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.<</html>

   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  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 [see Use in Specific Populations (8.6)].

  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 Tablets 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 [see Drug Interactions (7.1)and Patient Counseling Information (17.2)].

  2.5    Administration Instructions

  Food and Levofloxacin Tablets
  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin tablets
  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets are 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 [see Dosage and Administration (2.3)].   

  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
  

   Acute Bacterial Sinusitis
  

   750 mg
  

   5
  

   
  

   500 mg
  

   10-14
  

   Acute Bacterial Exacerbation of Chronic Bronchitis
  

   500 mg
  

   7
  

   Complicated Skin and Skin Structure Infections (SSSI)
  

   750 mg
  

   7-14
  

   Uncomplicated SSSI
  

   500 mg
  

   7-10
  

   Chronic Bacterial Prostatitis
  

   500 mg
  

   28
  

   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
  

   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 (2.2)
  

   60ß
  60ß
  

   Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age
  

   500 mg
  See Table 2 below (2.2)
  

   10 to 14
  10 to 14
  

   

   

   

   

   

   

   

   

   

  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
  

   

   

   

   

   

  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 [see Use in Specific Populations (8.6)].

  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 Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  Levofloxacin | Hospira Worldwide, Inc.

  

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  Oxaliplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

  2.1 Dosage

  Administer Oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):

  Day 1: Oxaliplatin 85 mg/m2 intravenous infusion in 250-500 mL 5% Dextrose injection, USP and leucovorin 200 mg/m2 intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.

  Day 2: Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.

  The administration of Oxaliplatin does not require prehydration. Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.

  For information on 5-fluorouracil and leucovorin, see the respective package inserts.

  2.2 Dose Modification Recommendations

  Prior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory tests [see Warnings and Precautions (5.6)]. Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.

  Adjuvant Therapy in Patients with Stage III Colon Cancer

  Neuropathy and other toxicities were graded using the NCI CTC scale version 1 [see Warnings and Precautions (5.2)].

  For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.

  A dose reduction of Oxaliplatin to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.

  Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer

  Neuropathy was graded using a study-specific neurotoxicity scale [see Warnings and Precautions (5.2)]. Other toxicities were graded by the NCI CTC, Version 2.0.

  For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.

  A dose reduction of Oxaliplatin to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.

  Dose Modifications in Therapy for Patients with Renal Impairment

  In patients with normal renal function or mild to moderate renal impairment, the recommended dose of Oxaliplatin is 85 mg/m2. In patients with severe renal impairment, the initial recommended Oxaliplatin dose should be reduced to 65 mg/m2 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

   

  2.3 Preparation of Infusion Solution

  Reconstitution or final dilution must never be performed with a sodium chloride solution or other chloride containing solutions.

  The lyophilized powder is reconstituted by adding 10 mL (for the 50 mg vial) or 20 mL (for the 100 mg vial) of Water for Injection, USP or 5% Dextrose Injection, USP. Do not administer the reconstituted solution without further dilution. The reconstituted solution must be further diluted in an infusion solution of 250-500 mL of 5% Dextrose Injection, USP.

  After reconstitution in the original vial, the solution may be stored up to 24 hours under refrigeration [2-8°C (36-46°F)]. After final dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under refrigeration [2-8°C (36-46°F)].

  Oxaliplatin for Injection, USP is not light sensitive.

  Oxaliplatin Injection, USP is incompatible in solution with alkaline medications or media (such as basic solutions of 5-fluorouracil) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with 5% Dextrose Injection, USP prior to administration of any concomitant medication.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.

  Needles or intravenous administration sets containing aluminum parts that may come in contact with Oxaliplatin Injection, USP should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.

  2.2 Dose Modification Recommendations

  Prior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory tests [see Warnings and Precautions (5.6)]. Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.

  Adjuvant Therapy in Patients with Stage III Colon Cancer

  Neuropathy and other toxicities were graded using the NCI CTC scale version 1 [see Warnings and Precautions (5.2)].

  For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.

  A dose reduction of Oxaliplatin to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.

  Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer

  Neuropathy was graded using a study-specific neurotoxicity scale [see Warnings and Precautions (5.2)]. Other toxicities were graded by the NCI CTC, Version 2.0.

  For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.

  A dose reduction of Oxaliplatin to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.

  Dose Modifications in Therapy for Patients with Renal Impairment

  In patients with normal renal function or mild to moderate renal impairment, the recommended dose of Oxaliplatin is 85 mg/m2. In patients with severe renal impairment, the initial recommended Oxaliplatin dose should be reduced to 65 mg/m2 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

   

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  do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor 

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

  *Due to the designated pathogens [see Indications and Usage (1)].

  †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 [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 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.

  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)].

  βThe 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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin 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 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 7-14 Community Acquired Pneumonia‡ 500 mg 7-14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 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 Inhalational Anthrax (Post-Exposure), adult and
  pediatric patients > 50 kg Þ,β
  pediatric patients < 50 kg and ≥ 6 months of ageÞ,β 500 mg
  
  see Table 2 below (2.2) 60 β
  
  60 β Plague, adult and pediatric patients > 50 kg à
  Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
  see Table 2 below (2.2) 10 to 14
  10 to 14 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

  *Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

  †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 [see Clinical Studies (14.9)]

  §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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

  Type of Infection* Dose Freq. Once every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 500 mg 24hr 60 days§ Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
  (not to exceed
  250 mg per dose) 12hr 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 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 [see Use in Specific Populations (8.6)].

  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 Injection

  Levofloxacin injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

  2.5 Administration Instructions

  Levofloxacin Injection

  Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

  Hydration for Patients Receiving Levofloxacin Injection

  Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection in single-use vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.

  Levofloxacin Injection in Single-Use Vials

  Single-use vials require dilution prior to administration.

  Levofloxacin injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These levofloxacin injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.

  Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:

  Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of Levofloxacin
  Solution 0.9% Sodium Chloride Injection, USP 4.71 5% Dextrose Injection, USP 4.58 5% Dextrose/0.9% NaCl Injection 4.62 5% Dextrose in Lactated Ringers 4.92 Plasma-Lyte® 56/5% Dextrose Injection 5.03 5% Dextrose, 0.45% Sodium Chloride,
  and 0.15% Potassium Chloride Injection 4.61 Sodium Lactate Injection (M/6) 5.54

  Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].

  Prepare the desired dosage of levofloxacin according to Table 5:

  Table 5: Preparation of Levofloxacin Intravenous Solution Desired Dosage
  Strength From Appropriate Vial,
  Withdraw Volume Volume of Diluent Infusion Time 500 mg 20 mL (20 mL Vial) 80 mL 60 min 750 mg 30 mL (30 mL Vial) 120 mL 90 min

  For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.

  This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.

  Stability of Levofloxacin Injection Following Dilution: Levofloxacin injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C(- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.

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  2.1 Dosing in Mild to Moderate Alzheimer's Disease

  The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

  2.2 Dosing inModerate to Severe Alzheimer's Disease

  The recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with moderate to severe Alzheimer’s disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months.

  2.3 Administration Information

  Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food.
  
  The donepezil hydrochloride 23 mg tablet should not be split, crushed, or chewed.

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  • take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs

  adults & children 12 yrs & over

  30 mL (2 TBSP) every 6 hrs

  children 4 to under 12 yrs

  ask a doctor

  children under 4 yrs

  do not use

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of Levofloxacin Tablet 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)>

  Due to the designated pathogens [see Indications and Usage (1)].
  †
  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 strains [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 strains [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 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 [see Clinical Studies (14.9)].
  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 [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin therapy in adults 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 <em>Yersinia pestis</em>. 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.

  Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
  †
  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 [see Clinical Studies (14.9)]
  §
  The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9).] 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 [see Use in Specific Populations (8.6)].

  Table 3 shows how to adjust dose based on creatinine clearance.

  2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin Tablets

  Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)] .

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin Tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

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  Levofloxacin | Hospira, Inc.

  

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes 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 [see Dosage and Administration (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)].  † 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 [ 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 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 [ see Clinical Studies (14.9)]. 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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.

  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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10-14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  Complicated Skin and Skin Structure Infections (SSSI)

  750 mg

  7-14

  Uncomplicated SSSI

  500 mg

  7-10

  Chronic Bacterial Prostatitis

  500 mg

  28

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients >50 kgÞ,ß
  Pediatric patients <50 kg and ≥6 months of ageÞ,ß

  500 mg
  See Table 2 below (2.2)

  60ß
  60ß

  Plague, adult and pediatric patients >50 kgà
  Pediatric patients <50 kg and ≥6 months of age

  500 mg
  See Table 2 below (2.2)

  10 to 14
  10 to 14

  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 * Due to Bacillus anthracis [ see Indications and Usage (1.13)].  † 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 [ see Clinical Studies (14.9)].  § 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 [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. 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. 

  Type of Infection* 

  Dose

  Freq. Once Every

  Duration†

  Inhalational Anthrax (post-exposure)‡,§ 

      Pediatric patients >50 kg 

  500 mg

  24 hours

  60 days§

      Pediatric patients <50 kg and ≥6 months of age

  8 mg/kg
  (not to exceed
  250 mg per dose)

  12 hours

  60 days§

  Plague¶ 

      Pediatric patients >50 kg 

  500 mg

  24 hours

  10 to 14 days

      Pediatric patients <50 kg and ≥6 months of age

  8 mg/kg
  (not to exceed
  250 mg per dose)

  12 hours

  10 to 14 days

  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 [see Use in Specific Populations (8.6)].

  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 Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

  2.5 Administration Instructions

  Levofloxacin Injection
  Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

  Hydration for Patients Receiving Levofloxacin Injection
  Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

  2.6 Preparation of Intravenous Product

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single-Use Flexible Containers or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.

  Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)
  Levofloxacin Injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 250 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.

  Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:

  1. Tear outer wrap at the notch and remove solution container. 2. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. 3. Do not use if the solution is cloudy or a precipitate is present. 4. Use sterile equipment. 5. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration:

  1. Close flow control clamp of administration set. 2. Remove cover from port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. 6. Open flow control clamp to expel air from set. Close clamp. 7. Regulate rate of administration with flow control clamp.

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  2.1 Dosage in Adult Patients With Normal Renal Function

  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/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [ see Dosage and Administration ( 2.3) ].

  Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * 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 [ 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 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. # 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 [ see Clinical Studies ( 14.9) ]. Þ The 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 ( 5.10), Use in Specific Populations ( 8.4), and Clinical Studies ( 14.9) ]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets 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

  Acute Bacterial Sinusitis

  750 mg

  5

  500 mg

  10 to 14

  Acute Bacterial Exacerbation of Chronic Bronchitis

  500 mg

  7

  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

  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

  Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg #,Þ

  Pediatric patients < 50 kg and ≥ 6 months of age #,Þ

  500 mg

  see Table 2 below

  ( 2.2)

  60 Þ

  60 Þ

  Plague, adult and pediatric patients > 50 kg ß

  500 mg

  10 to 14

  Pediatric patients < 50 kg and ≥ 6 months of age

  see Table 2 below ( 2.2)

  10 to 14

  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 * Due to Bacillus anthracis [ see Indications and Usage ( 1.13) ] and Yersinia pestis [see Indications and Usage ( 1.14) ]. † 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 [ see Clinical Studies ( 14.9) ]. § The safety of levofloxacin tablets 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 [ see Warnings and Precautions ( 5.10), Use in Specific Populations ( 8.4), and Clinical Studies ( 14.9) ]. Prolonged levofloxacin tablet 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.

  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

  2.3 Dosage Adjustment in Adults With Renal Impairment

  Administer levofloxacin tablets 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 [ see Use in Specific Populations ( 8.6) ].

  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 Tablets

  Levofloxacin tablets 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 [ see Drug Interactions ( 7.1) and Patient Counseling Information ( 17.2) ].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [ see Adverse Reactions ( 6.1) and Patient Counseling Information ( 17.2) ].

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  Levofloxacin | Deseret Biologicals, Inc.

  

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  1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

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