LEVOFLOXACIN (Page 3 of 15)

2.2 Dosage of levofloxacin tablets in Pediatric Patients with Inhalational Anthrax or Plaque

The dosage of levofloxacin tablets for inhalational anthrax (post-exposure) and plague in pediatric patients who weigh 30 kg or greater is described below in Table 2. Levofloxacin tablets cannot be administered to patients who weigh less than 30 kg because of the limitations of the available strength. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg.

Table 2: Levofloxacin Tablets Dosage in Pediatric Patients Weighing 30 kg or greater with Inhalational Anthrax (Post-Exposure) and Plague*

*Due to Bacillus anthracis [see Indications and Usage ( 1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)].

Sequential therapy (intravenous levofloxacin injection to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider.

Begin levofloxacin tablets as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis.

§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. [see Warnings and Precautions ( 5.12), Use in Specific Populations ( 8.4), and Clinical Studies ( 14.9)] .

Begin levofloxacin tablets as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Type of Infection* Dose Frequency Duration†
Inhalational Anthrax (post-exposure) ‡§
Pediatric patients weighing 50 kg or greater 500 mg every 24 hours 60 day§
Pediatric patients weighing 30 kg to less than 50 kg 250 mg every 12 hours 60 day§
Plague¶
Pediatric patients weighing 50 kg or greater 500 mg every 24 hours 10 to 14 days
Pediatric patients weighing 30 kg to less than 50 kg 250 mg every 12 hours 10 to 14 days

2.3 Dosage Adjustment in Adults with Renal Impairment

Administer levofloxacin tablets with caution in patients with renal impairment. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced in these patients.

In patients with renal impairment (creatinine clearance less than 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)] . No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50 mL/minute.

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (Creatinine Clearance less than 50 mL/minute)
Creatinine Clearance greater than or equal to 50 mL/minute Creatinine Clearance 20 to 49 mL/minute Creatinine Clearance 10 to 19 mL/minute Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg every 24 hour 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 every 24 hour 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 every 24 hour 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 Tablets

Levofloxacin tablets 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)] .

2.5 Administration Instructions

Levofloxacin tablets can be administered without regard to food.

If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

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