OFRAMAXOFRAMAXCeftriaxoneCeftriaxone

1gm & 250mg1gm & 250mgI.V.I.V. && I.M.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 dosesingle daily dose.

• This is of considerable advantage to both patientpatient and nursing staffnursing staff.

• OFRAMAX offers the physician greater securitysecurity and the patient greater convenienceconvenience.

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Antimicrobial Spectrum1.1. AerobesAerobes

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

2.2. AnaerobesAnaerobesBacteroids, 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 bactericidalbactericidal in action.

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Synergism

• The combination of OFRAMAXOFRAMAX with aminoglycosides (e.g.

gentamycin, tobramycin or amikacin) has a marked synergistic effect against PseudomonasPseudomonas aeroginosa 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 reservoirreservoir 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.)(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 times4 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 Its long duration and high conc. in the CSF make OFRAMAX the OFRAMAX the drug of choicedrug of choice in the treatment of in the treatment of

bacterial meningitis.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.OFRAMAX crosses the placental barrier.

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Penetration into bones

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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 renalor hepatic insufficiency

Renal 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:Hepatic insufficiency:• In case of severe liver parenchymal damage, increased

renal elimination compensates the hepatic insufficiency.

Dose adjustment is necessary only in case of Dose adjustment is necessary only in case of simultaneoussimultaneous severe renal & hepatic severe renal & hepatic

function disorders.function disorders.

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Indications

OFRAMAX is indicated in the following severe indications:

1. Sepsis & severe septic conditions.2. Endocarditis.3. Meningitis.4. GIT & Intra abdominal infections.5. Urinary tract infections.6. Pneumonia.7. Lower RTI.8. ENT infections.9. Bone & Joint infections.10. Skin & soft tissue infections.11. Sexually transmitted diseases.12. Surgical infections: prophylaxis & treatment.

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Dose

• Once DailyOnce Daily.

• This offers the following privileges:1. Patient compliance.2. Easier for the nursing staff.3. Earlier discharge from hospital.4. Lowered risk of infections.5. Considerable social benefit.6. 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 drug’s reliability.

• OFRAMAX is recommended in a single single dosedose 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 efficacy against the major pathogens

involved in meningitis.

2. Good penetrationpenetration into CSF.

3. Treatment period of 4 - 7 days4 - 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 PneumoniaPneumonia and Severe BronchitisSevere Bronchitis.

• A further advantage is the Once DailyOnce Daily dosage of OFRAMAX.

• OFRAMAX is effectiveeffective even where other antimicrobials have failed to cure very seriouslyseriously 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 goodvery good Cure ratesCure rates with 1-2 gm once daily dose for one week.

• Patients previously treated unsuccessfully with other antibiotics respond wellwell to OFRAMAX.

OFRAMAX is superior to comparable OFRAMAX is superior to comparable antimicrobials even when administered antimicrobials even when administered

in low doses and once daily.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:

OFRAMAXOFRAMAX (RANBAXY)(RANBAXY)22.50 L.E.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 OnceOnce daily.

2. 3rd generation ceph. with Unequalled antibacterial activityactivity against large number of microorganisms, thus, suitable for wide rangewide range of infections.

3. Rapid diffusion to the site of infection, into tissue, cerebrospinal fluid & abscesses, hence high & high & rapidrapid cure ratecure rate.

4. OFRAMAX is bactericidalbactericidal in action, thus offering high & rapid cure rate, with nono recurrencerecurrence 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 safesafe & well tolerated even after repeated administration, with nono nephrotoxic, embryotoxic, teratogenic or mutagenic effects.

7. OFRAMAX is considered the is considered the drug of choicedrug of choice in the in the treatment of treatment of MeningitisMeningitis..

8. OFRAMAX offers the physician greater securitysecurity and the patient greater convenienceconvenience.

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BEST OF LUCK