Levofloxacin (Page 3 of 16)

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 1

Dose

Freq. Once Every

Duration2

Inhalational Anthrax (post-exposure)3,4

Pediatric patients > 50 kg

500 mg

24 hr

60 days4

Pediatric patients < 50 kg and ≥ 6 months of age

8 mg/kg (not to exceed 250 mg per dose)

12 hr

60 days4

Plague5
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

1 Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13)] and Yersinia pestis [(see INDICATIONS AND USAGE (1.14)]
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
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)]
4 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); CLINICAL STUDIES (14.9).] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

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 FunctionEvery 24 hours

Creatinine Clearance20 to 49 mL/min

Creatinine Clearance10 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

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

ADVERSE REACTIONS (6.1); 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 Dose 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 Dose 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 dose. The 50 mL premixed flexible containers contain 250 mg/50 mL, the 100 mL premixed flexible containers contain 500 mg/100 mL, and the 200 mL premixed flexible containers contain 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 dose 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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