OFRAMAX

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OFRAMAX

• Ceftriaxone
• 1gm 250mg
• I.V. I.M.

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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

• Aerobes
• Gram-negative micro-organisms
• H. influenzae, Neisseria meningitidis, N.
  gonorrhoeae, P. mirabilis, Serratia marcescens,
  Salmonella typhi paratyphi, E. coli,
  Klebsiella and Moraxella.
• Gram-positive micro-organisms
• Staph. aureus, Streptococcus pneumoniae and
  Streptococcus viridans
• 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 theCerebrospinal 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 acrossthe 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
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Metabolism Excretion

• OFRAMAX is excreted unchanged in the urine and
  the bile.
• OFRAMAX is excreted as follows
• 2/3 via the kidneys.
• 1/3 via the gallbladder.

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Elimination in renalor 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
• 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
• 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 insurgical 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 drugs 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
• Outstanding efficacy against the major pathogens
  involved in meningitis.
• Good penetration into CSF.
• Treatment period of 4 - 7 days.
• OFRAMAX is considered the drug of choice in the
  treatment of Meningitis.

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OFRAMAX inRespiratory 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 95
• Biliary infection 90
• Typhoid fever 96

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OFRAMAX inUrinary 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 (Aventis) 25.75 L.E.
• Cefotax (T3A) 15.75 L.E.
• Cefotax (Eipico) 12.50 L.E.
• Ceforan (Pharco) 20.00 L.E.
• Cefaxim (El-Nasr) 12.00 L.E.
• Cefoperazone 1gm
• Cefobid (Pfizer) 23.00 L.E.
• Cefazone (Pharco) 13.50 L.E.
• Cefozone (Eipico) 14.20 L.E.
• Peracef (T3A) 12.85 L.E.
• Ceftazidime 1gm
• Fortum (GSK) 37.50 L.E.
• Cetazime (T3A) 25.00 L.E.

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Target Audience

• Target Audience Priority of Calls
• I.V.
• Surg. 1st 100
• I.M.
• Surg. 1st 30
• Chest 2nd 30
• Ped. 3rd 20
• Int./G.P. 4th 20

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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

1. The combination of OFRAMAX with aminoglycosides
   (e.g. gentamycin, tobramycin or amikacin) has a
   marked synergistic effect against Pseudomonas
   aeroginosa .
2. OFRAMAX is safe well tolerated even after
   repeated administration, with no nephrotoxic,
   embryotoxic, teratogenic or mutagenic effects.
3. OFRAMAX is considered the drug of choice in the
   treatment of Meningitis.
4. OFRAMAX offers the physician greater security and
   the patient greater convenience.

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• BEST OF LUCK