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To reduce the development of drug-resistant bacteria and maintain the effectiveness of CRAVIT (levofloxacin) and other antibacterial drugs, CRAVIT 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.
CRAVIT Tab. / i.v. are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows. CRAVIT i.v. is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). See Dosage & Administration for specific recommendations.
Acute bacterial sinusitis: Due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute bacterial exacerbation of chronic bronchitis: Due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Nosocomial pneumonia: Due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended. (See Pharmacology: Clinical Studies under Actions.)
Community-acquired pneumonia: Due to Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]*), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae. (See Pharmacology: Clinical Studies under Actions.)
* MDRSP (Multi-drug resistant Streptococcus pneumoniae) isolates are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
Complicated skin and skin structure infections: Due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis.
Uncomplicated skin and skin structure infections (mild to moderate): Including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus or Streptococcus pyogenes.
Chronic bacterial prostatitis: Due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis.
Complicated urinary tract infections (mild to moderate): Due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
Acute pyelonephritis (mild to moderate): Caused by Escherichia coli.
Uncomplicated urinary tract infections (mild to moderate): Due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
Inhalation anthrax (post-exposure): To prevent the development of inhalational anthrax following exposure to Bacillus anthracis (see Dosage & Administration, and Pharmacology: Additional Information - Inhalation Anthrax under Actions).
Levofloxacin has not been tested in human for the post-exposure prevention of inhalation anthrax. However, plasma concentration achieved in humans are reasonably likely to predict efficacy (see Pharmacology: Additional Information - Inhalation Anthrax under Actions).
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. Therapy with levofloxacin 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 strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. 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.
