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• Virtus Pharmaceuticals
  

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  Vp-pnv-dha | Preferred Pharmaceuticals, Inc.

  

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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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• Virtus Pharmaceuticals
  

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  Vp-pnv-dha | Virtus Pharmaceuticals

  

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  1 softgel capsule daily, or as prescribed by a licensed medical practitioner regardless of lactation status.

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