CEFTAZIDIME KABI

What it is

CEFTAZIDIME KABI is ceftazidime pentahydrate powder for injection, supplied in vials containing 1 g and 2 g of ceftazidime. It is a white or almost white, crystalline powder. On the addition of water for injections, it dissolves with effervescence to produce a solution for injection.

Approved indications

CEFTAZIDIME KABI is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. — Severe infections in general, for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems such as infected burns. — Respiratory tract infections, for example pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. — Severe ear, nose and throat infections, for example otitis media, mastoiditis. — Urinary tract infections, for example acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. — Skin and soft tissue infections, for example erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. — Gastrointestinal and abdominal infections, for example intra-abdominal abscesses, enterocolitis. — Bone and joint infections, for example osteitis, osteomyelitis, septic arthritis, infected bursitis.

Dosing overview

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity and type of infection and the age, weight and renal function of the patient. For adults, the dosage range is 1 to 6 g per day. In urinary tract infections and in many less serious infections, 500 mg or 1 g 12 hourly is usually adequate. In the majority of infections, 1 g 8 hourly or 2 g 12 hourly should be given. In very severe infections, 2 g 8 or 12 hourly should be administered. The usual dosage range for children aged over 12 months is 25 to 100 mg/kg/day (up to a maximum of 6 g/day) given as two or three divided doses. For neonates and infants up to 12 months, the dosage is 25–100 mg/kg/day in two divided doses. In patients with impaired renal function, the dosage of ceftazidime should be reduced to compensate for its slower excretion, except in mild impairment (glomerular filtration rate greater than 50 mL/min).

Key safety warnings

There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Risk factors for developing neurotoxicity with cephalosporin treatment include being elderly, renal impairment, central nervous system disorders and intravenous administration. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including ceftazidime. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Concurrent treatment with high doses of cephalosporins and nephrotoxic drugs such as aminoglycosides or potent diuretics (for example furosemide) may adversely affect renal function. The development of a positive Coombs test associated with the use of ceftazidime in about 5% of patients may interfere with the cross-matching of blood.

Contraindications

CEFTAZIDIME KABI is contraindicated in persons who have shown hypersensitivity to cephalosporins or who have experienced a major allergy to penicillin (anaphylaxis, angioneurotic oedema, urticaria). Lidocaine (lignocaine) should not be used as a diluent for intramuscular injection in patients who are hypersensitive to lidocaine (lignocaine).

Regulatory history

CEFTAZIDIME KABI was first listed on the Australian Register of Therapeutic Goods on 2 July 2015 for both the 1 g and 2 g powder for injection vial strengths.