Composition
Each vial contains :
Cefoperazone (as cefoperazone sodium)           500 mg or 1 g

Properties and Mode of Action
CEFOZON, cefoperazone is a parenteral third generation cephalosporin with a broad spectrum of activity against most G-ve aerobic bacteria e.g. E. coli, Proteus mirabilis and vulgaris, Klebsiella sp.,Citrobacter sp., Enterobacter sp., Morganella morganii, Providentia rettgeri, Serratia sp., Haemophilus influenzae and Neisseria gonorrhoeae (including some beta-lactamase-producing strains), Acinetobacter sp. (some strains are resistant) and especially Pseudomonas aeruginosa.
CEFOZON is active against G+ve aerobic bacteria eg. Staphylococci (including penicillinase-producing strains), beta-haemolytic streptococci, Streptococcus pneumoniae.
CEFOZON is active against some anaerobic bacteria eg. Bacteroides sp. (including B.fragilis),Clostridium sp.,Peptococcus sp.,and Peptostreptococcus sp..
In-vitro activity has also been demonstrated against Salmonella sp.(including S.typhi),Shigella sp., Neisseria meningitidis, Eubacterium sp., Fusobacterium sp. and Clostridium difficile sp..
CEFOZON is widely distributed in body tissues and fluids. High concentrations are achieved in bile. Up to 30% of a dose is excreted unchanged in urine within 12 - 24 hours.

Indications
Treatment of infections due to susceptible organisms :
Urinary tract infections.
Peritonitis, and other intra-abdominal infections.
Skin and soft tissue infections.
Bone and joint infections.
Pelvic inflammatory disease,endometritis and other infections of the female genital tract.
Respiratory tract infections.
Bacterial septicaemia and typhoid fever.

Dosage and Administration
CEFOZON is administered by deep I.M. injection or I.V. by slow injection over 3 - 5 minutes or by infusion over 15 - 30 minutes.
Usual Adult Dose:
1 g every 12 hours.
In severe infections or infections caused by less sensitive organisms, the total daily dose or frequency may be increased as follows:
2 g every 4 hours or 3 g every 6 hours or 4 g every 8 hours.

Children Dose:
25 -100 mg/kg every 12 hours.

Duration of therapy:
Continue administration for a minimum of 48 - 72 hours after fever abates or other evidence of bacterial eradication has been obtained.

Precautions
Cross-sensitivity and/or related problems:
Patients intolerant of one cephalosporin may be intolerant of other cephalosporins. Patients allergic to penicillins or penicillin derivatives may be allergic to cephalosporins, so, caution is recommended when cephalosporins are administered to patients with a history of penicillin anaphylaxis.
Pregnancy and Lactation:
Use only when potential benefits outweigh potential hazards to the fetus. CEFOZON is excreted in breast milk, usually in low concentrations. However problems in humans have not been documented.
Renal or Hepatic Function Impairment: Patients with renal failure require no dose adjustment when usual doses are administered.
In haemodialysis patients,schedule dosing to follow a dialysis period.
In general,the dose should not exceed 4 g daily in patients with liver disease or biliary obstruction, or 2 g daily in those with both liver and renal impairment.
If higher doses are used, plasma concentrations of CEFOZON should be monitored.
Hypoprothrombinaemia has been reported with cefoperazone and has rarely been associated with bleeding episodes. Prothrombin time should be monitored in patients at risk of hypoprothrombinaemia and vitamin K administered if necessary.
Care should be taken in patients receiving anticoagulants.
Direct and Indirect Coomb's tests may become positive.
A false-positive reaction for urine glucose may occur with Benedict’s or Fehling’s solutions.
A disulfiram-like reaction with alcohol has occurred with cefoperazone,therefore alcohol should be avoided during and for at least several days after treatment.

Drug Interactions
Dosage adjustment of anticoagulants may be necessary during and after therapy with cefoperazone.
Concurrent use of thrombolytic agents,with CEFOZON is not recommended.

Contra_indications
Previous allergic reactions (anaphylaxis) to penicillins, penicillin derivatives, penicillamine, or cephalosporins.

Side effects
As with other cephalosporins,hypersensitivity reactions (e.g.allergic rashes) and gastrointestinal reactions (e.g.diarrhoea) may occasionally occur.

Presentation
CEFOZON 500 mg Vials : Box of 1 vial + 1 ampoule solvent.
CEFOZON 1 g Vials : Box of 1 vial + 2 ampoules solvent.