Indications

This product is indicated for the treatment of severe infections in adults caused by susceptible strains, including hospital-acquired pneumonia (late-onset hospital-acquired pneumonia; community-acquired pneumonia requiring ICU admission for critically ill patients); bronchiectasis with infection; intra-abdominal infections; bloodstream infections; skin and soft tissue infections; bone and joint infections; reproductive system infections; urinary system infections. It can also be used for acute exacerbations of moderate to severe chronic obstructive pulmonary disease with a risk of Pseudomonas aeruginosa infection.

Dosage and Administration

Usage: I.V./I.M.

Adults: The usual adult dose is 2 to 4 g per day (i.e. 1 to 2 g per day cefoperazone activity) given intravenously or intramuscularly in equally divided doses every 12 hours.

In severe or refractory infections the daily dosage may be increased up to 8 g (i.e., 4 g cefoperazone activity) given intravenously in equally divided doses or 12 g of the 1:2 ratio. The recommended maximum daily dosage of sulbactam is 4 g (i.e., 8 g of sulbactam/cefoperazone).

In febrile neutropenia, total daily dose can be administered twice or thrice a day in equally divided doses.

Precautions & Warning:

1. Before initiating sulbactam/cefoperazone, carefully inquire about any history of hypersensitivity to cephalosporins, penicillins, or other drugs; if serious allergic or severe skin reactions occur, discontinue the drug immediately and institute appropriate emergency treatment.

2. In patients with severe hepatic disease, biliary obstruction, or combined hepatic and renal impairment, dose adjustment or monitoring of cefoperazone serum concentrations is recommended, with a maximum daily dose of 2 g if both hepatic and renal dysfunction coexist.

3. Cefoperazone/sulbactam may cause bleeding (related to vitamin K deficiency, especially in at-risk patients), superinfection, organ dysfunction, and Clostridium difficile-associated diarrhea (CDAD); therefore, monitor at-risk patients, supplement vitamin K as needed, discontinue if unexplained persistent bleeding occurs, and consider CDAD in any patient presenting with diarrhea during or up to two months after treatment.

4. Limited data in premature infants/neonates; use only after weighing risks and benefits.

Contraindications:

Hypersensitivity to the active substances (sulbactam, cefoperazone), to beta-lactams or to any of the excipients.

Adverse Reactions:

1. Neutropenia, Leukopenia, Coombs direct test positive, Haemoglobin decreased, Haematocrit decreased, Thrombocytopenia, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased (Very Common ≥1/10)

2. Coagulopathy, Eosinophilia, Diarrhea Nausea Vomiting, Blood bilirubin increased (Common ≥1/100 to <1/10)

3. Headache, Pruritus Urticaria, Infusion site phlebitis Injection site pain Pyrexia Chills (Uncommon ≥1/1000 to < 1/100)

4. Hypoprothrombinaemia, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid reaction, including shock, Hypersensitivity, Pseudomembranous colitis, Jaundice, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Dermatitis exfoliative, Maculopapular rash, Haematuria (Frequency Not Known (cannot be estimated from available data))

Storage instructions:

Store in a cool and dry place. Keep away from the direct sunlight.