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*
|Type of Infection*||Dose||Frequency||Duration †|
|Inhalational Anthrax (post-exposure) ‡,§|
|Pediatric patients weighing 50 kg or greater||500 mg||every 24 hours||60 days §|
|Pediatric patients weighing 30 kg to less than 50kg||250 mg||every 12 hours||60 days §|
|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|
† 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.
Administer levofloxacin 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 (
. No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50mL/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)
|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|
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)].
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving 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)] .
Levofloxacin tablets, USP
- 250mg pink coloured, capsule shaped, biconvex tablets debossed ‘ML 62′ on one side and plain on other side
- 500 mg peach coloured, capsule shaped, biconvex tablets debossed ‘ML 63′ on one side and plain on other side
- 750 mg white coloured, capsule shaped, biconvex tablets debossed ‘ML 64′ on one side and plain on other side
Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3)].
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