Vaxcel Cefobactam

Vaxcel Cefobactam

cefoperazone + sulbactam

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Concise Prescribing Info
Contents
Cefoperazone 500 mg, sulbactam 500 mg
Indications/Uses
Infections caused by susceptible organisms eg, upper & lower resp tract infections, UTI, peritonitis, cholecystitis, cholangitis & other intra-abdominal infections, septicemia, meningitis, skin & soft tissue infections, bone & joint infections, pelvic inflammatory disease, endometritis, gonorrhea & other genital tract infections.
Dosage/Direction for Use
Adult 2-4 g daily in 1:1 ratio in equally divided doses 12 hrly. Severe or refractory infections May be increased up to 8 g of the 1:1 ratio. Patient may require additional cefoperazone administered separately. Administer 12 hrly in equally divided doses. Sulbactam max daily dose: 4 g. Childn 40-80 mg/kg daily in 1:1 ratio 6-12 hrly in equally divided doses. Serious or refractory infections May be increased up to 160 mg/kg daily in 2-4 equally divided doses. Neonate in 1st wk of life Given 12 hrly, max: 80 mg/kg daily of sulbactam dose. Intermittent infusion 1 g/20 mL administered for >15-60 min. IV inj 1 g/20 mL administered for at least 3 min.
Contraindications
Hypersensitivity to penicillin, sulbactam, cefoperazone or cephalosporins.
Special Precautions
History of hypersensitivity reactions to multiple allergens. Severe biliary obstruction, severe hepatic disease or renal dysfunction coexistent w/ either of these conditions. Monitor closely cefoperazone serum conc in patients w/ hepatic dysfunction & concomitant renal impairment. Patients at risk of vit K deficiency eg, patients w/ poor diet, malabsorption states (eg, cystic fibrosis) & on prolonged IV alimentation regimens. Monitor prothrombin time in patients receiving anticoagulant therapy & exogenous vit K. Overgrowth of nonsusceptible organisms during prolonged use. Periodically check for renal, hepatic & hematopoietic system dysfunction during extended therapy especially in neonates, premature & other infants. Pregnancy & lactation. Elderly.
Adverse Reactions
Diarrhea or loose stools, nausea, vomiting; maculopapular rash, urticaria; reversible neutropenia, decreased Hb/hematocrit, transient eosinophilia, thrombocytopenia, hypoprothrombinemia; headache, fever, inj site pain, chills; transient elevations of liver function test; phlebitis at infusion site; anaphylactoid reaction (including shock), hypotension, pseudomembranous colitis, pruritus, Stevens-Johnson syndrome, leucopenia, hematuria.
Drug Interactions
Alcohol & ethanol-containing soln.
MIMS Class
ATC Classification
J01DD62 - cefoperazone and beta-lactamase inhibitor ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Vaxcel Cefobactam powd for inj 1g
Packing/Price
1's
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