Levofloxacin in 5% Dextrose Injection, USP Dosage and Administration

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2 DOSAGE AND ADMINISTRATION

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 hoursDuration
(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)].
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 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 (5.11), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
Þ
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.
ß
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.
à
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.
Nosocomial Pneumonia750 mg7–14
Community Acquired Pneumonia‡500 mg7–14
Community Acquired Pneumonia§750 mg5
Complicated Skin and Skin Structure Infections (SSSI)750 mg7–14
Uncomplicated SSSI 500 mg7–10
Chronic Bacterial Prostatitis500 mg28
Inhalational Anthrax (Post-Exposure), adult and pediatric patients >50 kg,#500 mg60#
Pediatric patients <50 kg and ≥6 months of age,#see Table 2 below (2.2)60#
Plague, adult and pediatric patients >50 kgÞ500 mg10 to 14
Pediatric patients <50 kg and ≥6 months of agesee Table 2 below (2.2)10 to 14
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)ß750 mg5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)à250 mg10
Uncomplicated Urinary Tract Infection250 mg3
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)500 mg7
Acute Bacterial Sinusitis (ABS)750 mg5
500 mg10 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*DoseFreq. Once everyDuration†
*
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 (5.11), 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

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 hours750 mg initial dose, then 500 mg every 48 hours750 mg initial dose, then 500 mg every 48 hours
500 mg 500 mg initial dose, then 250 mg every 24 hours500 mg initial dose, then 250 mg every 48 hours500 mg initial dose, then 250 mg every 48 hours
250 mg No dosage adjustment required250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is requiredNo 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)].

2.6 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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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

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 hoursDuration
(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)].
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 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 (5.11), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
Þ
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.
ß
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.
à
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.
Nosocomial Pneumonia750 mg7–14
Community Acquired Pneumonia‡500 mg7–14
Community Acquired Pneumonia§750 mg5
Complicated Skin and Skin Structure Infections (SSSI)750 mg7–14
Uncomplicated SSSI 500 mg7–10
Chronic Bacterial Prostatitis500 mg28
Inhalational Anthrax (Post-Exposure), adult and pediatric patients >50 kg,#500 mg60#
Pediatric patients <50 kg and ≥6 months of age,#see Table 2 below (2.2)60#
Plague, adult and pediatric patients >50 kgÞ500 mg10 to 14
Pediatric patients <50 kg and ≥6 months of agesee Table 2 below (2.2)10 to 14
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)ß750 mg5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)à250 mg10
Uncomplicated Urinary Tract Infection250 mg3
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)500 mg7
Acute Bacterial Sinusitis (ABS)750 mg5
500 mg10 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*DoseFreq. Once everyDuration†
*
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 (5.11), 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

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 hours750 mg initial dose, then 500 mg every 48 hours750 mg initial dose, then 500 mg every 48 hours
500 mg 500 mg initial dose, then 250 mg every 24 hours500 mg initial dose, then 250 mg every 48 hours500 mg initial dose, then 250 mg every 48 hours
250 mg No dosage adjustment required250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is requiredNo 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)].

2.6 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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