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Avelox (Moxifloxacin Hydrochloride) - Summary

 
 



WARNING: TEDINOPATHY

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 and Precautions ( 5.1 )].

Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis [see Warnings and Precautions].

 

AVELOX SUMMARY

AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent for oral and 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.

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.

AVELOX   Tablets and IV 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 and Use In Specific Populations ].

Culture and Susceptibility Testing

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 [see Clinical Pharmacology]. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Acute Bacterial Sinusitis

AVELOX is indicated for the treatment of Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies ].

Acute Bacterial Exacerbation of Chronic Bronchitis

AVELOX is indicated for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies].

Community Acquired Pneumonia

AVELOX is indicated for the treatment of Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila 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 (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see Clinical Studies ].

Uncomplicated Skin and Skin Structure Infections

AVELOX is indicated for the treatment of Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies].

Complicated Skin and Skin Structure Infections

AVELOX is indicated for the treatment of Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies ].

Complicated Intra-Abdominal Infections

AVELOX is indicated for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies].


See all Avelox indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Avelox (Moxifloxacin)

Avelox Approved for Plague
Source: MedicineNet Bioterrorism Specialty [2015.05.11]
Title: Avelox Approved for Plague
Category: Health News
Created: 5/8/2015 12:00:00 AM
Last Editorial Review: 5/11/2015 12:00:00 AM

more news >>

Published Studies Related to Avelox (Moxifloxacin)

Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. [2014]
uncomplicated, smear-positive pulmonary tuberculosis... CONCLUSIONS: The two moxifloxacin-containing regimens produced a more rapid

Efficacy and safety of moxifloxacin in hospitalized patients with secondary peritonitis: pooled analysis of four randomized phase III trials. [2014]
bacteria... CONCLUSIONS: The data suggests that once-daily IV (or IV/PO) moxifloxacin has a

Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. [2013]
Antibiotic therapy for complicated intra-abdominal infections (cIAIs) should provide broad-spectrum coverage both Gram-positive and Gram-negative microorganisms... The results show that moxifloxacin is a valuable treatment option for a range of community-acquired cIAIs with mild-to-moderate severity.

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..

more studies >>

Clinical Trials Related to Avelox (Moxifloxacin)

Food and Insulin Effect on QT/QTC Interval of ECG [Completed]
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug. However, there is no published data clarifying this issue. There is also a paucity of data investigating ethnic differences of the effects of medicines on QTc. The aims of the study were to compare the effect of different food contents to placebo on the changes in ECG and to demonstrate the effect of insulin, C-peptide and glucose on the ECG. This was done by giving different treatments on separate days, which included intravenous insulin, a high carbohydrate breakfast [>70%], and a calorie reduced low carbohydrate American FDA standard breakfast. Moxifloxacin 400 mg was used as a positive control and was given with and without food to Caucasian and Japanese volunteers to investigate racial differences.

Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients [Completed]
The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children

Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess [Recruiting]
This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with primary liver abscess based on clinical diagnosis and computed tomography. The trial aims to determine whether the use of moxifloxacin can effectively treat primary pyogenic liver abscess and shorten hospitalization. This regimen has the additional benefit of avoiding nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal tract will also be evaluated using stool cultures.

QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo [Completed]
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.

Greatest International Antiinfective Trial With Avelox [Completed]
The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

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: 2015-08-10

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