Indications

Ceftazidime is indicated for the treatment of the infections listed below in adults and children including neonates (from birth).

• Nosocomial pneumonia

• Broncho-pulmonary infections in cystic fibrosis

• Bacterial meningitis

• Chronic suppurative otitis media

• Malignant otitis externa

• Complicated urinary tract infections

• Complicated skin and soft tissue infections

• Complicated intra-abdominal infections

• Bone and joint infections

• Peritonitis associated with dialysis in patients on CAPD.

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing trans-urethral resection of the prostate (TURP).

The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1).

Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum of activity.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Dosage and Administration

Usage: I.V./I.M.

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.

Precautions & Warning:

1. Severe skin reactions (SJS, TEN, DRESS, AGEP) – rare but life-threatening; discontinue immediately if suspected and do not rechallenge.

2. Hypersensitivity – inquire about prior beta-lactam allergies; cross-reactivity possible; severe reactions require immediate withdrawal and emergency measures.

3. Limited spectrum & ESBL susceptibility – not suitable as monotherapy unless pathogen is confirmed susceptible or highly likely; consider local ESBL prevalence.

4. Pseudomembranous colitis (CDAD) – consider in any patient with diarrhea during/after treatment; discontinue ceftazidime and treat C. difficile if confirmed; avoid anti-peristaltic agents.

5. Renal impairment & neurotoxicity – reduce dose in renal dysfunction; failure to do so may cause seizures, encephalopathy, or coma.

6. Other precautions – monitor for superinfection (prolonged use); possible false-positive Coombs' test (≈5%) and urine glucose (copper reduction methods); contains sodium (52 mg/g vial).

Contraindications:

Hypersensitivity to the active substance, to any other cephalosporin or to any of the excipients.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

Adverse Reactions:

The most common adverse reactions are eosinophilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhoea, transient increases in hepatic enzymes, maculopapular or urticarcial rash, pain and/or inflammation following intramuscular injection and positive Coomb's test.

Storage instructions:

Unopened: Do not store above 25°C. Keep the vials in the outer carton.

After reconstitution: Store at 2-8°C (see 6.3 Shelf Life)