Moxeza (Moxifloxacin Hydrochloride) - Summary

MOXEZA SUMMARY

MOXEZA™ is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position.

MOXEZA™ solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerococcus viridans*

Corynebacterium macginleyi*

Enterococcus   faecalis*

Micrococcus luteus*

Staphylococcus arlettae*

Staphylococcus aureus

Staphylococcus capitis

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus saprophyticus*

Staphylococcus warneri*

Streptococcus mitis*

Streptococcus pneumoniae

Streptococcus parasanguinis*

Escherichia coli*

Haemophilus influenzae

Klebsiella pneumoniae*

Propionibacterium acnes

Chlamydia trachomatis *

*Efficacy for this organism was studied in fewer than 10 infections.

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NEWS HIGHLIGHTS

Published Studies Related to Moxeza (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

Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. [2011]
convenience of the patient with twice-daily dosing... CONCLUSION: The xanthan gum-based 0.5% moxifloxacin ophthalmic formulation,

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Clinical Trials Related to Moxeza (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

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.

Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection. [Completed]

To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects [Completed]
Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea and vomiting. This study, called a thorough QT study, will characterize the effects of a single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo. Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will be used as a positive control and will be given orally. The cardiac repolarization will be measured by taking consecutive ECGs on a recording device known as a Holter monitor and measuring the QT interval at specified times. In addition, blood samples will also be taken at specified times and will be used to measure the amount of study medication in the body.

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