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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 and or lung transplants [ See Warnings and Precautions (5.1) ].

 

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® (levofloxacin) 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 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 below. 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). Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Acute maxillary 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 anti-pseudomonal (beta)-lactam is recommended. (See CLINICAL STUDIES.)

Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae (including penicillin-resistant strains, MIC value for penicillin >/=2 µg/mL), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae. (See CLINICAL STUDIES.)

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.

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.


See all Levaquin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Levaquin (Levofloxacin)

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

Second-line levofloxacin-based triple therapy's efficiency for Helicobacter pylori eradication in patients with peptic ulcer. [2011.08]
OBJECTIVES: First-line standard eradication efficacy with lansoprazole, amoxicillin and clarithromycin regressed over 10 years. The aim of this study was to evaluate the efficacy and tolerability of a levofloxacin-based regimen in patients with peptic ulcer after failure of the standard first-line H.pylori eradication therapy in a country with a high rate of infection... CONCLUSION: OLA regimen eradication rate was successful only in 40% of patients who failed in the first-line eradication. New eradication treatment strategies must be performed, at least in Turkey.

Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. [2011.06.01]
RATIONALE: Lower respiratory tract infection with Pseudomonas aeruginosa (PA) is associated with increased morbidity in patients with cystic fibrosis (CF). Current treatment guidelines for inhaled antibiotics are not universally followed due to the perception of decreased efficacy, increasing resistance, drug intolerance, and high treatment burden with current aerosol antibiotics. New treatment options for CF pulmonary infections are needed. OBJECTIVES: This study assessed the efficacy and safety of a novel aerosol formulation of levofloxacin (MP-376, Aeroquin) in a heavily treated CF population with PA infection... CONCLUSIONS: Nebulized MP-376was well tolerated and demonstrated significant clinical efficacy in heavily treated patients with CF with PA lung infection. Clinical trial registered with www.clinicaltrials.gov (NCT00677365).

Efficacy of levofloxacin and rifaximin based quadruple therapy in Helicobacter pylori associated gastroduodenal disease: a double-blind, randomized controlled trial. [2011.06]
The aim of this study was to evaluate the efficacy of levofloxacin and rifaximin based quadruple regimen as first-line treatment for Helicobacter pylori infection. A prospectively randomized, double-blinded, parallel group, comparative study was performed...

Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects. [2011.06]
The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects. Ten CF subjects received single 180-mg doses of two formulations of MP-376, followed by a multiple-dose phase of 240 mg once daily for 7 days...

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: 2013-02-10

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