Generic name: levofloxacin
Dosage form: tablets, oral solution, injection
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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 [see Dosage and Administration (2.3)].
|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|
|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||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 kg à||500 mg||10 to 14|
|Pediatric patients < 50 kg and ≥ 6 months of age||see Table 2 below (2.2)||10 to 14|
Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
|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§|
|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|
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 (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
|Dosage in Normal Renal Function Every 24 hours||Creatinine Clearance
20 to 49 mL/min
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 (7.1) and Patient Counseling Information (17.2)].
LEVAQUIN® 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)].
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.
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 (6.1) and Patient Counseling Information (17.2)].
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:
|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:
|Desired Dosage Strength||From Appropriate Vial,
|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:
- 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 LEVAQUIN® 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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