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Levaquin (Levofloxacin) - Summary

 
 



WARNING:

Fluoroquinolones, including LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See Warnings and Precautions].

Fluoroquinolones, including LEVAQUIN®, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid LEVAQUIN® in patients with a known history of myasthenia gravis [See Warnings and Precautions] .

 

LEVAQUIN SUMMARY

LEVAQUIN® is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® 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.

LEVAQUIN® Tablets/Injection and Oral Solution are 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. LEVAQUIN® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

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 ]. Therapy with LEVAQUIN® 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 LEVAQUIN®. 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.

Nosocomial Pneumonia

LEVAQUIN® is indicated for the treatment of 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 anti-pseudomonal β-lactam is recommended [see Clinical Studies ].

Community-Acquired Pneumonia: 7–14 day Treatment Regimen

LEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies] .

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

Community-Acquired Pneumonia: 5-day Treatment Regimen

LEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Dosage and Administration and Clinical Studies ].

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

LEVAQUIN® is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies].

Acute Bacterial Exacerbation of Chronic Bronchitis

LEVAQUIN® 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.

Complicated Skin and Skin Structure Infections

LEVAQUIN® 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 [see Clinical Studies].

Uncomplicated Skin and Skin Structure Infections

LEVAQUIN® 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.

Chronic Bacterial Prostatitis

LEVAQUIN® is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies].

Complicated Urinary Tract Infections: 5-day Treatment Regimen

LEVAQUIN® is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies].

Complicated Urinary Tract Infections: 10-day Treatment Regimen

LEVAQUIN® 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 [see Clinical Studies].

Acute Pyelonephritis: 5 or 10-day Treatment Regimen

LEVAQUIN® is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7 , 14.8) ].

Uncomplicated Urinary Tract Infections

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

Inhalational Anthrax (Post-Exposure)

LEVAQUIN® is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of LEVAQUIN® is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEVAQUIN® has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN® 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 LEVAQUIN® therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1 , 2.2) and Clinical Studies].

Plague

LEVAQUIN® is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of LEVAQUIN® could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [ see Dosage and Administration (2.1, 2.2) and Clinical Studies ].


See all Levaquin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Levaquin (Levofloxacin)

Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI). [2015]
pyelonephritis... INTERPRETATION: Treatment with ceftolozane-tazobactam led to better responses

Effect of levofloxacin on neutrophilic airway inflammation in stable COPD: a randomized, double-blind, placebo-controlled trial. [2014]
study of the effect of levofloxacin in patients with stable COPD... CONCLUSION: In stable COPD, levofloxacin treatment causes a short-term reduction

Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial. [2014]
determine the efficacy of levofloxacin in the treatment of BK viremia... CONCLUSIONS: A 30-day course of levofloxacin does not significantly improve BK

Randomized, double-blind, multicenter phase 2 study comparing the efficacy and safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the treatment of patients with community-acquired bacterial pneumonia. [2013]
Solithromycin, a new macrolide, and the first fluoroketolide in clinical development, with activity against macrolide-resistant bacteria, was tested in 132 patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP) in a multicenter, double-blind, randomized phase 2 study...

Prulifloxacin versus levofloxacin in the treatment of respiratory and urinary tract infections: a multicentre, double-blind, randomized controlled clinical trial. [2012]
respiratory and urinary infections of Chinese patients... CONCLUSION: Prulifloxacin is as effective and well tolerated as levofloxacin in

more studies >>

Clinical Trials Related to Levaquin (Levofloxacin)

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis [Active, not recruiting]
The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients". [Recruiting]
A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation.

Patients over 18 years of age on the waiting list for liver transplantation.

Sample size: n=870 patients.

HYPOTHESIS

Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.

Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients [Recruiting]
Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.

Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections [Completed]
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.

A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects [Completed]
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.

more trials >>

Reports of Suspected Levaquin (Levofloxacin) Side Effects

Tendon Rupture (345)Rotator Cuff Syndrome (289)Tendonitis (286)Arthralgia (136)Tendon Disorder (106)Depression (90)Tenosynovitis (85)Pain in Extremity (78)Pain (76)Stevens-Johnson Syndrome (69)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 12 ratings/reviews, Levaquin has an overall score of 3.75. The effectiveness score is 6.67 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Levaquin review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Sinus infection
Dosage & duration:   750 mg taken 1 per day for the period of 10 days
Other conditions:   None
Other drugs taken:   Multivitamin 1 daily
  
Reported Results
Benefits:   Diminished sinus congestion/drainage and related cough. No hemoptysis or rust stained sputum noted after three days use of Levaquin. Throat irritation diminished third day. Increased feeling of wellbeing on third day.
Side effects:   Mild headache first three days. Increased intake of water and asprin 325 mg, one as needed seemed to help. Headache resolved third day of Levaquin use.
Comments:   Complained of sinus drainage, productive cough, rust stained sputum for two weeks. Chest xray negative to significant findings. Prescribed Levaquin 750mg, 1 by mouth per day, for 10 days. Also taking OTC Mucus Relief Sinus with guaifenesin 400mg and phenylephrine HCL 10mg as need for nasal decongestant and expectorant.

 

Levaquin review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Acute sinusitis/bronchitis
Dosage & duration:   500mg taken 1x day for the period of 10 days
Other conditions:   none
Other drugs taken:   vitamins ibuprofen mucinex anti depresssant
  
Reported Results
Benefits:   Noticeable improvement within 24 hours. Marked improvement within three days. Cleared sinus infection and bronchitis in the ten day prescription time period.
Side effects:   Acute joint and muscle pain to the point of almost not being able to walk. In particular, ankles were so sore I could not put weight on them.
Comments:   Was given Levaquil after a Z Pac did not work.

 

Levaquin review by 24 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Bronchitis
Dosage & duration:   500 mg IV taken iv for the period of 1 day
Other conditions:   None
Other drugs taken:   Steroid, Theophylline
  
Reported Results
Benefits:   Terrible! There are much safer alternatives than this poison. Most fluoroquinolones have been taken off the market. Johnson and Johnson should be ashamed of themselves. They have not warned doctors properly of the serious side effects eventhough the FDA has placed TWO BLACK BOX WARNINGS!
Side effects:   SEVERE shooting, burning pains in all four extremities. Prolonged heart rhythms, hallucinations, nightmares, insomnia. Weakness and pain in all four extremitities. Was a healthy 25 year old PE teacher prior to this poison. Now in a wheelchair.
Comments:   IV 500 mg Levaquin with Solumedrol and Theophylline. NEVER take these three drugs together!!!

See all Levaquin reviews / ratings >>

Page last updated: 2015-08-10

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