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Home>Products & Services> Levofloxacin Hydrochloride Injection 0.5g : 5mL

Levofloxacin Hydrochloride Injection 0.5g : 5mL

Levofloxacin Hydrochloride Injection 0.5g : 5mL

Warning:

Fluoroquinolones, including Levofloxacin hydrochloride, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is future increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Fluoroquinolones, including levofloxacin hydrochloride, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis.

Description:

Levofloxacin is the pure(-)-(S)-enantiomer of the racemic drug substance ofloxacin. Levofloxacin hydrochloride is the hydrochloride salt of levofloxacin, the chemical name is(-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid monohydrochloride

Chemical structure of levofloxacin hydrochloride:

Appearance:

The appearance of levofloxacin hydrochloride may range from a clear light yellow-green to a clear yellow-green solution.

Strength:

           0.5g in 5mL (Calculated by levofloxacin)

Indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin hydrochloride and other antibacterial drugs, levofloxacin hydrochloride should be used 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.

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 hydrochloride. 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 isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin hydrochloride. 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.

Levofloxacin hydrochloride injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin hydrochloride Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

1Nosocomial Pneumonia

Levofloxacin hydrochloride is indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible 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.

2Community-Acquired Pneumonia: 7–14 day Treatment Regimen

Levofloxacin hydrochloride is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumonia.

MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 µg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

3Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

Levofloxacin hydrochloride is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

4Acute Bacterial Exacerbation of Chronic Bronchitis

Levofloxacin hydrochloride is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

5Complicated Skin and Skin Structure Infections

Levofloxacin hydrochloride is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis.

6Uncomplicated Skin and Skin Structure Infections

Levofloxacin hydrochloride is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

7Chronic Bacterial Prostatitis

Levofloxacin hydrochloride is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis.

8Complicated Urinary Tract Infections: 5-day Treatment Regimen

Levofloxacin hydrochloride is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

9Complicated Urinary Tract Infections: 10-day Treatment Regimen

Levofloxacin hydrochloride is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

10Acute Pyelonephritis: 5 or 10-day Treatment Regimen

Levofloxacin hydrochloride is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia.

11Uncomplicated Urinary Tract Infections

Levofloxacin hydrochloride is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

12Inhalational Anthrax

Levofloxacin hydrochloride is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.