Transcript Proposed Kepler Re-Design

OFRAMAX
Ceftriaxone
1gm & 250mg
I.V. &
I.M.
Introduction
• OFRAMAX is a broad spectrum antibiotic.
• OFRAMAX has all the qualities required in modern treatment of
extremely severe bacterial infections:
• Unequalled antibacterial activity against a large number of microorganisms, including
certain ‘problem’ bacteria responsible for hospital-acquired infections and resistant to
traditional cephalosporins & aminoglycosides.
• Rapid diffusion to the site of infection, into tissue, cerebrospinal fluid & abscesses.
• No metabolism in the body.
• Resistant to B-lactamases.
• Safety.
• Reliability for both the doctor & patient.
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Introduction
• OFRAMAX maintains effective antibacterial
concentrations in the body over a period of 24 hours so
that it can be administered in a single daily dose.
• This is of considerable advantage to both patient and
nursing staff.
• OFRAMAX offers the physician greater security and the
patient greater convenience.
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Antimicrobial Spectrum
1. Aerobes
A.
Gram-negative micro-organisms:
H. influenzae, Neisseria meningitidis, N. gonorrhoeae, P. mirabilis, Serratia marcescens,
Salmonella typhi & paratyphi, E. coli, Klebsiella and Moraxella.
B.
Gram-positive micro-organisms:
Staph. aureus, Streptococcus pneumoniae and Streptococcus viridans
2. Anaerobes
Bacteroids, Clostridium, Fusobacterium, Peptococcus and Peptostreptococcus.
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Mechanism of Action
• OFRAMAX shows a strong affinity for
penicillin-binding proteins.
• Inactivation of these proteins causes lysis of
the bacterial cell wall.
• OFRAMAX is bactericidal in action.
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Synergism
• The combination of OFRAMAX with
aminoglycosides (e.g. gentamycin, tobramycin or
amikacin) has a marked synergistic effect against
Pseudomonas aeroginosa .
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Bioavailability
& Plasma conc.
• Bioavailability of OFRAMAX I.M. = I.V. = 100%.
• Plasma concentrations after I.V. and I.M.
administration are almost identical.
• OFRAMAX retains therapeutic conc. over long
periods of time
(Even after 24 hours, these are several times higher than the MIC of
most pathogens).
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Protein binding
• Ceftriaxone is reversibly bound to albumin.
• The protein-bound OFRAMAX acts as a
reservoir and is one of the factors contributing
to its long elimination half-life (8 hours).
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Distribution in the body
• OFRAMAX diffuses rapidly into the interstitial fluid, and
reaches the site of numerous infections in bactericidal
concentrations after I.V. or I.M. administration.
• OFRAMAX readily crosses the Blood Brain Barrier, and can
be used in the treatment of bacterial meningitis.
• OFRAMAX shows excellent penetration into bone tissue.
• The prolonged contact with microorganisms gives
OFRAMAX the advantage over other cephalosporins.
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Penetration into the
Cerebrospinal fluid (C.S.F.)
Infants & Children:
• OFRAMAX penetrates the inflamed meninges of infants & children.
• The average extent of diffusion in the CSF in bacterial meningitis is
approximately 4 times that in aseptic meningitis.
Adults:
• Administration of OFRAMAX 50 mg/kg leads to CSF conc. several
times higher than the MIC required for the most common causative
organisms of meningitis.
Its long duration and high conc. in the CSF make OFRAMAX the
drug of choice in the treatment of bacterial meningitis.
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Passage across
the placental barrier
• Pregnant women were given 1.5 gm Ceftriaxone
in ½ hour infusion every 24 hours.
• The concentrations of Ceftriaxone in the
amniotic fluid remained fairly constant.
OFRAMAX crosses the placental barrier.
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Penetration into bones
35
30
25
20
15
10
5
0
Ceftriaxone
Cefoperazone
Ceftazidime
Cefotaxime
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Metabolism
& Excretion
•
OFRAMAX is excreted unchanged in the
urine and the bile.
•
OFRAMAX is excreted as follows:
a) 2/3 via the kidneys.
b) 1/3 via the gallbladder.
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Elimination in renal
or hepatic insufficiency
Renal insufficiency:
• Renal insufficiency does not necessitate an adjustment of the dosage as
long as it does not exceed 2 gm / day.
• Assuming normal hepatic function, the reduced excretion via the kidneys is
compensated by increased biliary clearance.
Hepatic insufficiency:
•
In case of severe liver parenchymal damage, increased renal elimination
compensates the hepatic insufficiency.
Dose adjustment is necessary only in case of simultaneous
severe renal & hepatic function disorders.
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Indications
OFRAMAX is indicated in the following severe indications:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Sepsis & severe septic conditions.
Endocarditis.
Meningitis.
GIT & Intra abdominal infections.
Urinary tract infections.
Pneumonia.
Lower RTI.
ENT infections.
Bone & Joint infections.
Skin & soft tissue infections.
Sexually transmitted diseases.
Surgical infections: prophylaxis & treatment.
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Dose
•
Once Daily.
•
This offers the following privileges:
1.
2.
3.
4.
5.
6.
Patient compliance.
Easier for the nursing staff.
Earlier discharge from hospital.
Lowered risk of infections.
Considerable social benefit.
Saving in health costs.
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OFRAMAX in
surgical prophylaxis
• A single 1 – 2 gm dose of OFRAMAX is an
effective prophylactic measure against infection at
surgery, and its long duration of action enhances
the drug’s reliability.
• OFRAMAX is recommended in a single dose of
1gm (in surgery with low risk of infection), or 2gm (in surgery with
high risk of infection) for prophylaxis of perioperative
infections.
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OFRAMAX in Sepsis
& Septic conditions
(including Endocarditis)
• OFRAMAX can be used for treating sepsis
& septic conditions in a daily dose of 2 gm.
• The once daily dosage can help in
discharging the patient from hospital
sooner, and hence reduce the health care
costs.
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OFRAMAX in Meningitis
•
OFRAMAX is characterized by:
1.
Outstanding efficacy against the major pathogens involved in
meningitis.
2.
Good penetration into CSF.
3.
Treatment period of 4 - 7 days.
OFRAMAX is considered the drug of choice in
the treatment of Meningitis.
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OFRAMAX in
Respiratory Tract Infections
• OFRAMAX is significantly superior to other
antimicrobials in the treatment of Pneumonia
and Severe Bronchitis.
• A further advantage is the Once Daily dosage of
OFRAMAX.
• OFRAMAX is effective even where other
antimicrobials have failed to cure very seriously ill
patients.
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OFRAMAX in E.N.T.
and Jaw Infections
• OFRAMAX, administered once daily at a
dose of 1 gm, can be recommended for
severe jaw and ear, nose & throat infections.
• The duration of treatment is 5 – 10 days.
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OFRAMAX in
G.I.T. Infections
• Peritonitis
• Biliary infection
• Typhoid fever
95%
90%
96%
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OFRAMAX in
Urinary Tract Infections
• OFRAMAX shows very good Cure rates with 1-2 gm
once daily dose for one week.
• Patients previously treated unsuccessfully with other
antibiotics respond well to OFRAMAX.
OFRAMAX is superior to comparable
antimicrobials even when administered in low
doses and once daily.
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Safety
• OFRAMAX is safe & well tolerated even
after repeated administration.
• OFRAMAX shows no nephrotoxic.
• OFRAMAX shows no embryotoxicity,
teratogenicity or mutagenic effects.
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Side Effects
• OFRAMAX is very well tolerated.
• The incidence of occurrence of undesirable
side effects is only 0.6%.
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Competition
• Ceftriaxone 1gm:
OFRAMAX (RANBAXY)
22.50 L.E.
Rocephin
(Roche)
46.00 L.E.
Cefotrix
(T3A)
30.00 L.E.
Epicephin
(Eipico)
20.00 L.E.
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Competition (…cont.)
• Cefotaxime 1gm:
Claforan
Cefotax
Cefotax
Ceforan
Cefaxim
(Aventis)
(T3A)
(Eipico)
(Pharco)
(El-Nasr)
25.75 L.E.
15.75 L.E.
12.50 L.E.
20.00 L.E.
12.00 L.E.
• Cefoperazone 1gm:
Cefobid
Cefazone
Cefozone
Peracef
(Pfizer)
(Pharco)
(Eipico)
(T3A)
23.00 L.E.
13.50 L.E.
14.20 L.E.
12.85 L.E.
• Ceftazidime 1gm:
Fortum
Cetazime
(GSK)
(T3A)
37.50 L.E.
25.00 L.E.
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Target Audience
•
•
Target Audience
Priority
% of Calls
Surg.
1st
100 %
Surg.
Chest
Ped.
Int./G.P.
1st
30 %
30 %
20 %
20 %
I.V.
I.M.
2nd
3rd
4th
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Major Selling Points
1.
OFRAMAX maintains effective antibacterial
concentrations in the body over a period of 24 hours,
hence given Once daily.
2.
3rd generation ceph. with Unequalled antibacterial
activity against large number of microorganisms, thus,
suitable for wide range of infections.
3.
Rapid diffusion to the site of infection, into tissue,
cerebrospinal fluid & abscesses, hence high & rapid cure
rate.
4.
OFRAMAX is bactericidal in action, thus offering high
& rapid cure rate, with no recurrence of infection.
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Major Selling Points
5.
The combination of OFRAMAX with aminoglycosides
(e.g. gentamycin, tobramycin or amikacin) has a marked
synergistic effect against Pseudomonas aeroginosa .
6.
OFRAMAX is safe & well tolerated even after repeated
administration, with no nephrotoxic, embryotoxic,
teratogenic or mutagenic effects.
7.
OFRAMAX is considered the drug of choice in the
treatment of Meningitis.
8.
OFRAMAX offers the physician greater security and
the patient greater convenience.
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BEST OF LUCK
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