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Avelox (Moxifloxacin Hydrochloride) - Summary

 
 



WARNING:

Fluoroquinolones, including AVELOX®, 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).

 

AVELOX SUMMARY

AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl] -6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid.

AVELOX Tablets and I.V. are indicated for the treatment of adults (>/= 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION for specific recommendations. In addition, for I.V. use see PRECAUTIONS, Geriatric Use.)

Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis.

Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains *), Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae.


* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and 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.

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus or Streptococcus pyogenes.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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


See all Avelox indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Avelox (Moxifloxacin)

14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. [2012]
first 14 days of treatment to assess their suitability for future development... INTERPRETATION: PA-824-moxifloxacin-pyrazinamide is potentially suitable for

Neither moxifloxacin nor cefuroxime produces significant attenuation of inflammatory mediator release in patients exposed to cardiopulmonary bypass: a randomized controlled trial. [2011.10.03]
OBJECTIVES: (i) the inflammatory response to CPB may be different from that of infectious disease states that were used to establish the immunomodulatory effects of moxifloxacin; and (ii) a single intravenous dose, which was used in this investigation, may not lead to high enough plasma and intracellular concentrations..

The use of beat-to-beat electrocardiogram analysis to distinguish QT/QTc interval changes caused by moxifloxacin from those caused by vardenafil. [2011.09]
QT correction factors (QTc) can cause errors in the interpretation of drug effects on cardiac repolarization because they do not adequately differentiate changes when heart rate or autonomic state deviates from the baseline QT/RR interval relationship... This study demonstrated that newer methods of electrocardiogram (ECG) analysis can differentiate changes in the QT interval to improve identification of proarrhythmia risk.

Human aqueous humor concentrations of besifloxacin, moxifloxacin, and gatifloxacin after topical ocular application. [2011.06]
PURPOSE: To determine the concentrations of besifloxacin, moxifloxacin, and gatifloxacin in human aqueous humor after topical instillation of commercially available besifloxacin ophthalmic suspension 0.6%, moxifloxacin ophthalmic solution 0.5%, and gatifloxacin ophthalmic solution 0.3%, and to assess these concentrations relative to the minimum inhibitory concentration for 90% of strains (MIC(90)) for each drug against bacterial pathogens identified in recent cases of postoperative endophthalmitis. SETTING: Six clinical sites, United States. DESIGN: Randomized open-label controlled clinical trial... CONCLUSIONS: Based on the aqueous humor drug concentrations measured in this study, it is unlikely that any of the fluoroquinolones tested would be therapeutically effective in the aqueous humor against the most frequently identified drug-resistant staphylococcal isolates from recent cases of postoperative endophthalmitis. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes. Copyright (c) 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Comparative efficacy and safety of moxifloxacin and clindamycin in the treatment of odontogenic abscesses and inflammatory infiltrates: a phase II, double-blind, randomized trial. [2011.03]
Moxifloxacin penetrates well into oromaxillary tissue and covers the causative pathogens that show an increasing resistance to standard antibiotics.No significant differences between groups were found for patients with odontogenic abscesses.

more studies >>

Clinical Trials Related to Avelox (Moxifloxacin)

Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis [Completed]
Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.

- Treatment group 1: Receives moxifloxacin orally once daily for five days.

- Treatment group 2: Receives a matching placebo once daily for five days. In between each

visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

A Study of Avelox® for Treatment of Elderly Patients With Community Acquired Pneumonia [Completed]

TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment [Completed]
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight, duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs.

TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment [Active, not recruiting]
This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.

CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients [Recruiting]
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.

As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

more trials >>

Reports of Suspected Avelox (Moxifloxacin) Side Effects

Dizziness (82)Arthralgia (72)Dyspnoea (63)Nausea (56)Pruritus (55)Rash (53)Hypersensitivity (49)Urticaria (49)Pain in Extremity (46)Anaphylactic Reaction (43)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 10 ratings/reviews, Avelox has an overall score of 3.50. The effectiveness score is 4.20 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.
 

Avelox review by 59 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   sinus infection
Dosage & duration:   400mg taken 1 per day for the period of 10 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Felt better fairly quickly
Side effects:   none
Comments:   I had a terrible sinus infection with very congested lungs. By the end of the 2nd day of treatment I began to feel better. This drug works and I had no side effects. I'm glad I have insurance because without it,10 pills were $181 at Walmart, $192 at Walgreens and $207 at Target.

 

Avelox review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   sinus infection
Dosage & duration:   400 mg taken took 1 for the period of 1/day for 7 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   none
Side effects:   body went into shock - rash all over my entire body, worst stomach I've experienced in my entire life. Had to be carried into the emergency room via ambulance until it cleared enough to return home. It's one day later and I still have the rash and am exhausted. Stay away.
Comments:   don't take it.

 

Avelox review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   sinus infection
Dosage & duration:   400mg po daily taken 1 per day for the period of 1 doses
Other conditions:   hx depression
Other drugs taken:   zoloft
  
Reported Results
Benefits:   none
Side effects:   i ended up in the er, i actually felt like i was dying, tremors to the point i could not walk, tingling in hands and feet, feeling of empending doom, qrs changes on ekg, pvc's on ekg,palpatations in chest. increased heart rate and blood pressure. i will never take this classification of drug again. i had pneumonia in the past and was on levaquin for weeks and had no reaction. i hope i never feel this way again.
Comments:   er did ekg, ct scan, lab work and discharged me home later in the day

See all Avelox reviews / ratings >>

Page last updated: 2013-02-10

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