GlevoPOD Launch Ppt

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Transcript of GlevoPOD Launch Ppt

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    GlevoPOD(Levofloxacin 250 mg+ Cefpodoxime200 mg)

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    Common respiratory pathogens are increasingly becoming

    resistant to antibiotics.

    Penicillin-resistant strains of Strep Pneumoniae account for

    50% or more of isolates in some countries, and the proportionof such strains is rising.

    The worldwide emergence of H Influenzaeand Moraxella

    Catarrhalisthat produce b-lactamase is a major therapeuticproblem.

    There now are strains of Klebsiella, Pseudomonas,and other

    gram negative bacteria that are resistant to most antibiotics.

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    Antibiotic resistance

    Complications and/ortreatment failures

    Increased morbidityand mortality

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    Aggressive approach

    Hit hard, hit early

    Combination therapy

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    FDC of levofloxacin and cefpodoxime

    Levofloxacin is a 3rdgeneration fluoroquinolone.

    Cefpodoxime is a oral , third generation cephalosporin.

    Bactericidal.

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    Levofloxacin

    Levofloxacin

    Levofloxacin enters

    No DNA replication

    No Protein formation

    Bacterial cell death

    DNAGyrase

    & Topo IVInhibited

    DNAGyrase

    Levo actson

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    CEFPODOXIME

    Cefpodoxime

    Cefpodoxime

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    Pathogen GlevoPOD

    Gram positive

    Streptococcus pneumoniae (including MDRSP)

    Staphylococcus aureus

    Gram negative

    Haemophilus influenza Haemophilus parainfluenzae

    Klebsiella pneumonia

    Moraxella catarrhalis

    Legionella pneumophila

    Proteus mirabilis

    Pseudomonas aeruginosa

    Atypical

    Chlamydophila pneumonia

    Mycoplasma pneumonia

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    SynergyERS

    guidelines

    BA studyAntibiotic

    susceptibility

    test

    GlevoPOD

    clinical stidy

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    There exists a synergy between newer quinolones and beta lactamantibiotics like Cefpodoxime.

    Fluroquinolones show a greater bactericidal activity when combined

    with beta lactam antibiotics.

    Combining it with a potent beta lactam antibiotic like Cefpodoxime

    increases its bactericidal activity and hence we get better efficacy.

    The mechanism by which such combinations achieve synergy isbelieved to be the facilitation of entry of beta-lactam antibiotics into

    cells after partial disruption of the cell wall through the action of new

    quinolones.

    SYNERGY

    Journal of Antimicrobial Chemotherapy (1996) 38, 771-776

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    ERS guidelines

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    -

    500.00

    1,000.00

    1,500.00

    2,000.00

    2,500.00

    3,000.00

    3,500.00

    4,000.00

    0 0.5 1 2 4 6 8 10 12 20 24

    Conc(ng/ml)

    Time (hrs)

    Series1

    Series2

    250 MG BID is as effective as 500 mg OD

    With both the formu lat ions, the con centrat ions in

    the plasma were maintained above the MIC for

    the resp iratory pathogens up to 24 hrs

    BIOAVAILABILITY STUDY

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    0

    100

    200

    300

    400

    500

    600

    700

    Levofloxacin 250 mg Levofloxacin 500 mg

    Conc

    (ng/ml)

    At 24 hrs the 250 mg BD dose was found to

    give higher drug concentrations in the

    blood as compared to the 500 mg OD dose

    Trough concentration

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    .S = SENSITIVE: In this case, a clear,

    circular "halo" (zone of inhibition) will

    appear around the antibiotic disk,

    indicating an absence of bacteria.

    I = INTERMEDIATE: A somewhat cloudyplaque indicates that not all the bacteria in

    the area around the disk have been killed.

    R = RESISTANT: In this case, the filter

    paper will have no discernable plaque

    around it, meaning that the bacteria are

    growing normally, even in the presence ofthe antibiotic

    Purpose:To determine susceptibility of bacteria to various antibiotics

    LARGER ZONE OF INHIBITION

    BETTER KILL POWER OF ANTIBIOTIC

    http://en.wikipedia.org/wiki/File:KB_test.jpg
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    Levofloxacin

    Cefpodoxime

    GlevoPOD

    GlevoPOD FDC has larger zone ofinhibition

    Bacteria are more susceptible to GlevoPOD

    GlevoPOD offers a greater kill power

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    GlevoPOD also demonstrated efficacy against bacterial strains

    resistant to individual drugs.

    Thus the chances of antibiotic failure would be higher if levofloxacinor cefpodoxime are used alone. However the combination ensures

    broader coverage thereby minimizing the possibility of treatment

    failure.

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    CAP (40)

    GlevoPOD(10)

    Cefpodoxime(10)

    Levofloxacin(10)

    Amoxiclav(10)

    AECB (40)

    GlevoPOD(10)

    Cefpodoxime(10)

    Levofloxacin(10)

    Amoxiclav(10)

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    PARAMETER DAY 0 DAY 8 DAY 14

    CLINICAL

    Fever Cough

    Dyspnea

    Wheezing Ronchi

    MICROBIOLOGICAL

    Sputum culture RADIOLOGICAL

    Chest X ray

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    0%

    20%

    40%

    60%

    80%

    100%

    120%

    Clinical success Microbiological success

    CAP

    GlevoPOD

    Cefpodoxime

    Levofloxacin

    Amociclav

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    0%

    20%

    40%

    60%

    80%

    100%

    120%

    Clinical success Microbiological success

    AECB

    GlevoPOD

    Cefpodoxime

    Levofloxacin

    Amoxiclav

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    Acute Bacterial Sinusitis

    Acute Exacerbations of Chronic Bronchitis.

    Community Acquired Pneumonia

    1 tablet twice daily or as directed by the physician.

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    LEVOFLOXACIN

    Nausea

    Headache

    Diarrhoea

    Insomnia

    Dizziness

    CEFPODOXIME

    Diarrhoea

    Rashes

    Hypersensitivity

    Patients with known hypersensitivity to levofloxacin or cefpodoxime

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    Widespectrum

    SynergyERS

    guidelines

    BA studyAntibiotic

    susceptibilitytest

    GlevoPOD

    clinical study

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    Gram +ve, Gm ve, Atypical.

    Wide spectrum

    Greater bactericidal efficacy

    Synergy

    Recommend combination of levofloxacin + 3rdgencephalosporins in severe LRTIs

    ERS Guidelines

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    With both the formulations, the concentrations in the plasma weremaintained above the MIC for the respiratory pathogens upto 24 hrs

    At 24 hrs the 250 mg BD dose was found to give higher drugconcentrations in the blood as compared to the 500 mg OD dose

    Bioavailability study

    Larger zone of inhibition with glevopod- better kill power

    Antibiotic susceptibilitytesting

    Glevo POD demonstrated 100% clinical efficacy compared tocefpodoxime in CAP and AECB

    Clinical study

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    TH NK YOU