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Levaquin

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Levaquin

Indications
Dosage
How Supplied

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

LEVAQUIN® Tablets/Injection and Oral Solution are indicated for the treatment of adults ( ≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. LEVAQUIN® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

Culture and Susceptibility Testing

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology]. Therapy with LEVAQUIN® may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.

As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN®. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

Nosocomial Pneumonia

LEVAQUIN® is indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies].

Community-Acquired Pneumonia: 7–14 Day Treatment Regimen

LEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see DOSAGE AND ADMINISTRATION and Clinical Studies].

MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2ndgeneration cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Community-Acquired Pneumonia: 5-Day Treatment Regimen

LEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see DOSAGE AND ADMINISTRATION and Clinical Studies].

Acute Bacterial Sinusitis: 5-Day And 10–14 Day Treatment Regimens

LEVAQUIN® is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies].

Acute Bacterial Exacerbation Of Chronic Bronchitis

LEVAQUIN® is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Complicated Skin And Skin Structure Infections

LEVAQUIN® is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies].

Uncomplicated Skin And Skin Structure Infections

LEVAQUIN® is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

Chronic Bacterial Prostatitis

LEVAQUIN® is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies].

Complicated Urinary Tract Infections: 5-Day Treatment Regimen

LEVAQUIN® is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies].

Complicated Urinary Tract Infections: 10-Day Treatment Regimen

LEVAQUIN® is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies].

Acute Pyelonephritis: 5 Or 10-Day Treatment Regimen

LEVAQUIN® is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies].

Uncomplicated Urinary Tract Infections

LEVAQUIN® is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Inhalational Anthrax (Post-Exposure)

LEVAQUIN® is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of LEVAQUIN® is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEVAQUIN® has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN® in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEVAQUIN® therapy should only be used when the benefit outweighs the risk [see DOSAGE AND ADMINISTRATION and Clinical Studies].

Plague

LEVAQUIN® is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of LEVAQUIN® could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see DOSAGE AND ADMINISTRATION and Clinical Studies].

DOSAGE AND ADMINISTRATION

Dosage In Adult Patients With Normal Renal Function

The usual dose of LEVAQUIN® Tablets or Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. The usual dose of LEVAQUIN® 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.

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,β 500 mg s 60β
Pediatric patients < 50 kg and ≥ 6 months of age Þ,β ee Table 2 below 60β
Plague, adult and pediatric patients > 50 kg a 500 mg 10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14
* Due to the designated pathogens [see INDICATIONS AND USAGE].
† 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].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE].
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].
βThe safety of LEVAQUIN® 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, Use In Specific Populations, and Clinical Studies]. Prolonged LEVAQUIN® 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 LEVAQUIN® typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

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] and Yersinia pestis [see INDICATIONS AND USAGE].
† 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]
§ The safety of LEVAQUIN® 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, Use in Specific Populations, and Clinical Studies]. Prolonged LEVAQUIN® 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.

Dosage Adjustment In Adults With Renal Impairment

Administer LEVAQUIN® 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].

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

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

LEVAQUIN® Tablets and Oral Solution

LEVAQUIN® Tablets and Oral Solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see DRUG INTERACTIONS and PATIENT INFORMATION].

LEVAQUIN® Injection

LEVAQUIN® Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line.

Administration Instructions

Food and LEVAQUIN® Tablets and Oral Solution

LEVAQUIN® Tablets can be administered without regard to food. It is recommended that LEVAQUIN® Oral Solution be taken 1 hour before or 2 hours after eating.

LEVAQUIN® Injection

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

Hydration for Patients Receiving LEVAQUIN® Tablets, Oral Solution, and Injection

Adequate hydration of patients receiving oral or intravenous LEVAQUIN® should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS and PATIENT INFORMATION].

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 LEVAQUIN® Injection with other intravenous substances, additives or other medications should not be added to LEVAQUIN® Injection Premix in Single-Use Flexible Containers and LEVAQUIN® 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 LEVAQUIN® Injection with an infusion solution compatible with LEVAQUIN® Injection and with any other drug(s) administered via this common line.

LEVAQUIN® Injection in Single-Use Vials

Single-use vials require dilution prior to administration.

LEVAQUIN® 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 LEVAQUIN® 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 LEVAQUIN® 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 LEVAQUIN® Injection Following Dilution].

Prepare the desired dosage of levofloxacin according to Table 5:

Table 5: Preparation of LEVAQUIN® 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 LEVAQUIN® Injection Following Dilution: LEVAQUIN® 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.

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

LEVAQUIN® Injection is also 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 LEVAQUIN® 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 LEVAQUIN® 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.

HOW SUPPLIED

Dosage Forms And Strengths

TABLETS, Film-coated, capsule-shaped
  • 250 mg terra cotta pink tablets, imprinted with “250” on one side and “LEVAQUIN” on the other
  • 500 mg peach tablets, imprinted with “500” on one side and “LEVAQUIN” on the other
  • 750 mg white tablets, imprinted with “750” on one side and “LEVAQUIN” on the other
ORAL SOLUTION, 25 mg/mL, clear yellow to clear greenish-yellow color
INJECTION, Single-Use Vials of concentrated solution for dilution for intravenous infusion, clear yellow to clear greenish-yellow in appearance
  • 20 mL vial of 25 mg/mL levofloxacin solution, equivalent to 500 mg of levofloxacin
  • 30 mL vial of 25 mg/mL levofloxacin solution, equivalent to 750 mg of levofloxacin
INJECTION (5 mg/mL in 5% Dextrose) Premix in Single-Use Flexible Containers, for intravenous infusion
  • 100 mL container, fill volume 50 mL (equivalent to 250 mg levofloxacin)
  • 100 mL container, fill volume 100 mL (equivalent to 500 mg levofloxacin)
  • 150 mL container, fill volume 150 mL (equivalent to 750 mg levofloxacin)

Storage And Handling

LEVAQUIN® Tablets

LEVAQUIN® Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. LEVAQUIN® Tablets are packaged in bottles and in unit-dose blister strips in the following configurations:

  • 250 mg tablets are terra cotta pink and are imprinted: “LEVAQUIN” on one side and “250” on the other side
    • bottles of 50 (NDC 50458-920-50)
    • unit-dose/100 tablets (NDC 50458-920-10)
  • 500 mg tablets are peach and are imprinted: “LEVAQUIN” on one side and “500” on the other side
    • bottles of 50 (NDC 50458-925-50)
    • unit-dose/100 tablets (NDC 50458-925-10)
  • 750 mg tablets are white and are imprinted “LEVAQUIN” on one side and “750” on the other side
    • bottles of 20 (NDC 50458-930-20)
    • unit-dose/100 tablets (NDC 50458-930-10)

LEVAQUIN® Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers.

LEVAQUIN® Tablets are manufactured for Janssen Pharmaceuticals, Inc., Titusville, NJ 08560 by Janssen Ortho LLC, Gurabo, Puerto Rico 00778.

LEVAQUIN® Oral Solution

LEVAQUIN® Oral Solution is supplied in a 16 oz. multi-use bottle (NDC 50458-170-01). Each bottle contains 480 mL of the 25 mg/mL levofloxacin oral solution.

LEVAQUIN® Oral Solution should be stored at 25°C (77°F); excursions permitted to 15° – 30°C (59° to 86°F) [refer to USP controlled room temperature].

LEVAQUIN® Oral Solution is manufactured for Janssen Pharmaceuticals, Inc., Titusville, NJ 08560 by Janssen Pharmaceutica N.V., Beerse, Belgium.

LEVAQUIN® Injection, Single-Use Vials

LEVAQUIN® Injection is supplied in single-use vials. Each vial contains a concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials and 750 mg of levofloxacin in 30 mL vials.

  • 25 mg/mL, 20 mL vials (NDC 50458-164-20)
  • 25 mg/mL, 30 mL vials (NDC 50458-165-30)

LEVAQUIN® Injection in Single-Use Vials should be stored at controlled room temperature and protected from light.

LEVAQUIN® Injection in Single-Use Vials is manufactured for Janssen Pharmaceuticals, Inc., Titusville, NJ 08560 by Janssen Pharmaceutica N.V., Beerse, Belgium.

LEVAQUIN® Injection Pre-Mixed Solution, Single-Use In Flexible Container

LEVAQUIN® (levofloxacin in 5% dextrose) Injection is supplied as a single-use, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W).

  • 5 mg/mL (250 mg), 100 mL flexible container, 50 mL fill (NDC 50458-167-01)
  • 5 mg/mL (500 mg), 100 mL flexible container, 100 mL fill (NDC 50458-168-01)
  • 5 mg/mL (750 mg), 150 mL flexible container, 150 mL fill (NDC 50458-166-01)

LEVAQUIN® Injection Premix in Flexible Containers should be stored at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat and protect from freezing and light. LEVAQUIN® Injection Premix in Flexible Containers is manufactured for Janssen Pharmaceuticals, Inc., Titusville, NJ 08560 by Hospira, Inc., Austin, TX 78728.

Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Revised: May 2014

Last reviewed on RxList: 6/5/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
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How Supplied
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