Avelox (Moxifloxacin Hydrochloride) - Summary

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.

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.

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NEWS HIGHLIGHTS

Published Studies Related to Avelox (Moxifloxacin)

Efficacy and safety of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% for treating bacterial conjunctivitis. [2009.09]
OBJECTIVE: To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of moxifloxacin ophthalmic solution 0.5% for the treatment of bacterial conjunctivitis. DESIGN: Multicenter, randomized, double-masked, parallel-group, active-controlled, noninferiority study. PARTICIPANTS: Patients 1 year of age or older with clinical manifestations of bacterial conjunctivitis... CONCLUSIONS: Besifloxacin ophthalmic suspension was non inferior to moxifloxacin ophthalmic suspension and provided similar safety and efficacy (clinical and microbiological) outcomes when used for the treatment of bacterial conjunctivitis. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis. [2009.08.01]
RATIONALE: Moxifloxacin has potent activity against Mycobacterium tuberculosis in vitro and in a mouse model of antituberculosis (TB) chemotherapy, but data regarding its activity in humans are limited. OBJECTIVES: Our objective was to compare the antimicrobial activity and safety of moxifloxacin versus isoniazid during the first 8 weeks of combination therapy for pulmonary TB... CONCLUSIONS: Substitution of moxifloxacin for isoniazid resulted in a small but statistically nonsignificant increase in Week-8 culture negativity.

Electrocardiographic QTc changes due to moxifloxacin infusion. [2009.06]
Moxifloxacin (400-mg single dose) is a frequent positive control in thorough QT/QTc studies...

Pharmacokinetic, pharmacodynamic, and electrocardiographic effects of dapoxetine and moxifloxacin compared with placebo in healthy adult male subjects. [2009.06]
Selective serotonin reuptake inhibitors (SSRIs) may be associated with electrocardiographic effects. The electrocardiographic pharmacodynamics of dapoxetine, a short-acting SSRI being developed for the treatment of premature ejaculation, are compared with those of placebo and moxifloxacin (positive control) in 2 single-center, randomized, crossover studies in healthy men.

Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested. [2009.05]
This study compares 4 baseline correction methods on the effect of moxifloxacin on the QT/QTc interval: (1) day -1 time-matched baseline electrocardiograms (ECGs), (2) 3 triplicate predose ECGs, (3) 1 triplicate predose ECG, and (4) no baseline correction.Predose baseline methods (3 or 1 triplicate ECGs) are superior to the day -1 time-matched baseline correction or without baseline correction.

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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.

Efficacy and Safety of Sequential IV/PO Moxifloxacin in Comparison to IV Levofloxacin Plus IV Ceftriaxone Followed by PO Levofloxacin, in the Treatment of Patients With Community-Acquired Pneumonia [Completed]
Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.

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PATIENT REVIEWS / RATINGS / COMMENTS

Avelox review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Swollen lymph nodes, sick
Dosage & duration:		400 MG taken 1/day for the period of 5 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Cleared up the infection. I had been on a less effective antibiotic a week earlier, which had not worked.
Side effects:		I got a small rash on my arms right after finishing all the pills.
Comments:		I took 1 400 MG pill per day for 5 days and got plenty of rest and drank plenty of fluids. (My lymph nodes and thyroid glands were swollen and I generally felt ill.)

Avelox review by 24 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Bronchitis
Dosage & duration:		Two pills a day taken once. shock came two hours later. for the period of I had taken Avalox previously.
Other conditions:		5 months later I came down with Rheumetoid Arthritis.
Other drugs taken:		Adderall
		Reported Results
Benefits:		I had taken avalox several times before because I had become immune to other antibiotics. Avalox seemed to work previously.
Side effects:		I almost died. I made it thru the first set of double doors at the emergency room and colapsed. I believe that this triggered me to get Rheumatoid Arthritis five months later.
Comments:		Chemo likely for the rest of my life.

Avelox review by 24 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Bronchitis
Dosage & duration:		Two pills a day taken once. shock came two hours later. for the period of I had taken Avalox previously.
Other conditions:		5 months later I came down with Rheumetoid Arthritis.
Other drugs taken:		Adderall
		Reported Results
Benefits:		I had taken avalox several times before because I had become immune to other antibiotics. Avalox seemed to work previously.
Side effects:		I almost died. I made it thru the first set of double doors at the emergency room and colapsed. I believe that this triggered me to get Rheumatoid Arthritis five months later.
Comments:		Chemo likely for the rest of my life.