Hetlioz

Hetlioz Manufacturers

• Vanda Pharmaceuticals Inc.
  

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  Hetlioz | Blenheim Pharmacal, 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 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)
  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 
  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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