CEFTAZIDIME-AFT

What it is

CEFTAZIDIME-AFT 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 that dissolves with effervescence on addition of water for injections to produce a solution for injection. The 1 g strength is used for intravenous or intramuscular injection, while the 2 g strength is used for intravenous injection or intravenous infusion.

Approved indications

CEFTAZIDIME-AFT 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 concern and other pseudomonal antibiotics cannot be used. Specific indications include: — Severe infections in general, such as septicaemia including neonatal sepsis, bacteraemia, and infections in intensive care unit patients with specific problems such as infected burns. — Respiratory tract infections, such as pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. — Severe ear, nose and throat infections, such as otitis media and mastoiditis. — Urinary tract infections, such as acute and chronic pyelonephritis, pyelitis, cystitis and urethritis. — Skin and soft tissue infections, such as erysipelas, abscesses, cellulitis, infected burns and wounds, and mastitis. — Gastrointestinal and abdominal infections, such as intra-abdominal abscesses and enterocolitis. — Bone and joint infections, such as osteitis, osteomyelitis, septic arthritis and infected bursitis.

Dosing overview

Dosage depends 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 administered by intravenous or intramuscular injection. In urinary tract infections and less serious infections, 500 mg or 1 g every 12 hours is usually adequate. In the majority of infections, 1 g every 8 hours or 2 g every 12 hours should be given. In very severe infections, 2 g every 8 or 12 hours should be administered. Individual doses exceeding 1 g should be administered intravenously. For children aged over 12 months, the usual dosage range is 25 to 100 mg/kg/day up to a maximum of 6 g per day, given as two or three divided doses. For neonates and infants up to 12 months, the dose is 25–100 mg/kg/day in two divided doses. In elderly patients, the daily dosage should be adjusted according to renal function due to reduced clearance of ceftazidime. In patients with impaired renal function, dosage should be reduced to compensate for slower excretion, except in mild impairment where glomerular filtration rate is greater than 50 mL/min.

Key safety warnings

There have been reports of neurotoxicity associated with cephalosporin treatment, with symptoms including encephalopathy, seizures and myoclonus. Risk factors include being elderly, renal impairment, central nervous system disorders and intravenous administration. Withdrawal of the medicine should be considered if there are signs of neurotoxicity. Antibiotic-associated pseudomembranous colitis has been reported with ceftazidime. A toxin produced by Clostridium difficile appears to be the primary cause, and the severity may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis during or after antibiotic use. Mild cases usually respond to drug discontinuation alone, but in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Concurrent treatment with high doses of cephalosporins and nephrotoxic drugs such as aminoglycosides or potent diuretics may adversely affect renal function, although clinical experience has shown this is not likely to be a problem with ceftazidime at recommended dose levels.

Contraindications

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

Regulatory history

CEFTAZIDIME-AFT was first listed on the ARTG in 2017, with two registered variants: the 1 g strength (ARTG 277680) and the 2 g strength (ARTG 277679), both registered on 22 September 2017.