GlevoPOD Launch Ppt
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 Influenzae and Moraxella
Catarrhalis that 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 3rd generation 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
C o n c ( n g / m l )
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
C o n c
( n g / m l )
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
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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 + 3rd gencephalosporins 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