Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies (14.4)].
Because fluoroquinolones, including levofloxacin have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.15)] and for some patients ABS is self-limiting, reserve levofloxacin tablets for treatment of ABS in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Culture and susceptibility testing
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4) ]. Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance
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/minute. For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3) ].
Table 1: Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance greater than or equal to 50 mL/minute)
|Type of Infection*||Dosed Every 24 hours||Duration (days)†|
|Nosocomial Pneumonia||750 mg||7 to 14|
|Community Acquired Pneumonia‡||500 mg‡||7 to 14‡|
|Community Acquired Pneumonia§||750 mg§||5§|
|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|
|Inhalational Anthrax (Post-Exposure), adult and pediatric patients weighing 50 kg Þ,ß or greater Pediatric patients weighing 30 kg to less than 50 kg Þ,ß||500 mg see Table 2 below (2.2)||60ß 60ß|
|Plague, adult and pediatric patients weighing 50 kg à or greater Pediatric patients weighing 30 kg to less than 50 kg||500 mg see Table 2 below (2.2)||10 to 14 10 to 14|
|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|
|Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)||500 mg||7|
|Acute Bacterial Sinusitis (ABS)||750 mg||5|
|500 mg||10 to 14|
* Due to the designated pathogens [see Indications and Usage (1) ].
† Sequential therapy (intravenous levofloxacin to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider.
‡ 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.
Þ 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) ].
ß The 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 (5.12), 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.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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.
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