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Cefosub 1gm/2gm Injection

COMPOSITION:
Each 1 g vial contains:
Cefoperazone (as sodium) USP......500mg
Sulbactam (as sodium) USP..............500mg
Each 2g vial contains:
Cefoperazone (as sodium) USP......1g
Sulbactam (as sodium) USP..............1g

CLINICAL PHARMACOLOGY:
Cefosub  is a combination of Cefoperazone, a third generation of cephalosporin and Sulbactam, - lactamase inhibitor Cefoperazone is bactericidal agent, with broad spectrum of activity against most of the gram positive & gram negative pathogens. It also shows a good activity against the difficult to treat pathogens such as Bacteroides fragilis clostridium diffcile and pseudomonas. Sulbactam is -lactamase inhibitor, which confers the following advantages:
1.    It inhibits -lactamase produced by bacteria & protects Cefoperazone.
2.    Enhances the bactericidal activity by a synergistic action with Cefoperazone.
3.    Decreases the MIC values of organisms susceptible to Cefoperazone due to increased affinity to PBPs.
4.    Cefoperazone resistant bacteria becomes susceptible by the addition of Sulbactam.
      Thus, Cefosub  is a unique combination with extensive spectrum of activity.
INDICATIONS:
For the treatment and management of:
       Respiratory tract infections (Upper & Lower)
       Urinary track infections (Upper & Lower)
       Intra-abdominal infections, Peritonitis, Cholecystitis etc.
       Septicemia
       Infections in Burns & Wounds
       Skin & Soft tissue infections
       Bone & Joint Tissue infections
       Pelvic Inflammatory Disease, Endometritis, Gonorrhoea, Other  infections of genital track
       Infections in immunocompromised patients
       Febrile neutropenic patients
       For Prophylaxis:
       Laparoscopic surgery
       Cholecystectomy & other colorectal surgery
       Plastic surgery
       Multiple fractures & complicated orthopaedic surgery.
ADVERSE EFFECTS:
Generally, Cefosub  is well tolerated. However, mild and transient side effects such as:  Hypersensitivity reactions, gastrointestinal effects, viz;diarrhoea, vomiting &nausea may be seen. Incidence of super infection is also observed as with other cephalosporins.
PRECAUTIONS & WARNINGS:
Hypersensitivity or allergy to penicillin.
Patients with renal/hepatic dysfunction.
Renal and hematological status should be monitored, especially during prolonged & high-dose therapy.
DOSAGE & ADMINISTRATIONS:
Cefosub  is available as a dry powder for reconstitution. Sterile water for injection should be used for reconstitution.
Adults:
The usual dosage of Cefosub  is 2-4g/day (i.e 1-2g/day of Cefoperazone activity) given I.M./I.V in equally divided doses every 12 hours. The initial dose preferably, should be 2g followed by 1g b.i.d. in severe or refractory infections, the daily dosage may be increased to 8g.
Children:
The usual dose in children is 40-80mg/kg/day (i.e 20-40mg/kg/day Cefoperazone activity) in 2-4 equally divided doses. In serious infections, these dosages may be increased to 60mg/kg/day in 2 - 4 equally divided doses.
I.V. Dose:
For intermittent infusion, each vial should be reconstituted .with the appropriate amount of 5% dextrose in water, 0.9% sodium chloride injection, or sterile water for injection & then diluted to 20mL with the same solution followed by administration over 15-60 mins. For I.V. Injection, each vial should be reconstituted as above and administered over a minimum of 3 min.
I.M. Dose:
Sterile water for injection should be used for reconstitution. For a reconstitution of Cefoperazone of 250mg/mL a two step dilution is required using sterile water followed by 2% lidocaine to approximate 0.5% lidocaine solution.
STORAGE:
Store below 25o C(77oF) excursion permitted to 15-30oC (59-86oF) Protect from light and humidity. Keep out of the reach of Children.