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)].
| 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 |
| Complicated Skin and Skin Structure Infections (SSSI) | 750 mg | 7–14 |
| Uncomplicated SSSI | 500 mg | 7–10 |
| Chronic Bacterial Prostatitis | 500 mg | 28 |
| Inhalational Anthrax (Post-Exposure), adult and pediatric patients >50 kg¶,# | 500 mg | 60# |
| Pediatric patients <50 kg and ≥6 months of age¶,# | see Table 2 below (2.2) | 60# |
| Plague, adult and pediatric patients >50 kgÞ | 500 mg | 10 to 14 |
| Pediatric patients <50 kg and ≥6 months of age | see Table 2 below (2.2) | 10 to 14 |
| Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)ß | 750 mg | 5 |
| Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)à | 250 mg | 10 |
| Uncomplicated Urinary Tract Infection | 250 mg | 3 |
| Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) | 500 mg | 7 |
| Acute Bacterial Sinusitis (ABS) | 750 mg | 5 |
| 500 mg | 10 to 14 | |
2.2 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† |
|---|---|---|---|
| |||
Pediatric patients >50 kg | 500 mg | 24 hours | 60 days§ |
Pediatric patients <50 kg and ≥6 months of age | 8 mg/kg | 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 | 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.
| 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 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:
- 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 Levofloxacin Injection Premix in Flexible Containers.
- Open flow control clamp to expel air from set. Close clamp.
- Regulate rate of administration with flow control clamp.