Complete Allergy Antihistamine

2.1 Dosage in Adult Patients with Normal Renal Function

The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally 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)].

Table 1Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection*
Dosed Every 24 hours
Duration (days)†

*Due to the designated pathogens [see Indications and Usage (1)].

†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].

¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

ÞDrug 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)].

ßThe safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.

a Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablet typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

Nosocomial Pneumonia 
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis 
750 mg
5

500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis 
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI) 
750 mg
7 to 14
Uncomplicated SSSI 
500 mg
7 to 10
Chronic Bacterial Prostatitis 
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection 
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ, ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ, ß
500 mg
See Table 2 below (2.2)
60 ß
60 ß
Plague, adult and pediatric patients > 50 kga
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg

See Table 2 below (2.2)
10 to 14

10 to 14
2.2 Dosage in Pediatric Patients

The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

Table 2Dosage in Pediatric Patients ≥ 6 months of age Type of Infection*
Dose
Freq. Once every
Duration†

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

†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡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)]

§The safety of levofloxacin tablets 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 (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.

¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

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§
Plague¶



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
2.3 Dosage Adjustment in Adults with Renal Impairment

Administer levofloxacin tabletswith 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 3Dosage 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
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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

2.5 Administration Instructions

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)].