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 *||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|
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 (
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 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 ( 17.2)] .
Food and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral 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)] .
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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