COMPOSITION

Each Vial contains: 


Sterile Cefoperazone Sodium IP eq. anhydrous Cefoperazone ...... 1000 mg

Sterile Sulbactum Sodium USP eq. anhydrous Sulbactum ........... 500 mg 


DESCRIPTION

Zefmic S -  Cefoperazone Sodium & Sulbactum Sodium combination consists of a beta-lactam plus a beta-lactamase inhibitor.

PHARMACOLOGY

The antibacterial component of Sulbactum/Cefoperazone is cefoperazone, a third generation  cephalosporin, which acts against sensitive organisms during the stage of active multiplication by inhibiting the biosynthesis of cell wall mucopeptide. Sulbactam does not possess any useful antibacterial activity, except against Neisseriaceae and Acinetobacter. As sulbactam also binds with some penicillin-binding proteins, sensitive strains are also often rendered more susceptible to Sulbactum/Cefoperazone than to Cefoperazone alone.

The combination of Sulbactum and Cefoperazone is active against all organisms sensitive to cefoperazone. In addition, it demonstrates synergistic activity (up to 4-fold reduction in the minimum inhibitory concentrations for the combination versus those for each  component) in a variety of organisms.

Indications

Indicated for the treatment of the following infections when caused by susceptible organisms:

  • Respiratory tract infections (upper and lower)
  • Urinary tract infections
  • Peritonitis, cholecystitis, cholangitis, and other intra-abdominal infections
  • Septicaemia
  • Meningitis
  • Skin and soft tissue infections
  • Bone and joint infections
  • Pelvic inflammatory disease, endometritis, gonorrhoea, and other infections of the genital tract

CONTRAINDICATIONS

It is contraindicated in patients with a known allergy to penicillins, sulbactam, cefoperazone, or any of the cephalosporins.

Warnings And Precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in  patients receiving beta-lactam or cephalosporin therapy. These reactions are more apt to occur in individuals with a history of hypersensitivity reactions to multiple allergens. If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. As with other antibiotics, overgrowth of non-susceptible organisms may occur during the prolonged use of Sulbactum/Cefoperazone. It has not been extensively studied in premature infants or neonates. Therefore, in treating premature infants and neonates, the potential benefits and possible risks involved should be considered before instituting therapy.

Safety & tolerability profile

Sulbactam/cefoperazone is generally well-tolerated. The majority of adverse events are of mild or moderate severity and are tolerated with continued treatment. The most frequent side effects observed with Sulbactum/Cefoperazone have been gastrointestinal. Others include dermatologic reactions, headache, injection pain, chills, and anaphylactoid reactions.

Dosage And Administration

The usual adult dose of the combination is 2 to 4 g/day (i.e, 1-2 g/day each of Cefoperazone and Sulbactam) given IV or IM in equally divided doses every 12 hours.

In severe or refractory infections the daily dosage may be increased to 8g (i.e, 4g/day each of Cefoperazone and Sulbactam) given IV in equally divided doses every 12 hours. The recommended maximum daily dosage of Sulbactam is 4g (8g of the combination).