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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