Qualitative and quantitative composition
Each vial contains ceftazidime 1g (as pentahydrate).
Each gram of ceftazidime contains approximately 52mg (2.26mmol) of sodium.
For a full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection (Powder for injection).
White to cream coloured, crystalline powder
Clinical particulars
Therapeutic 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.
4.2 Posology and method of administration
Posology
Table 1: Adults and children ≥ 40 kg
|
Intermittent Administration |
|
Infection |
Dose to be administered |
|
Broncho-pulmonary infections in cystic fibrosis |
100 to 150 mg/kg/day every 8 h, maximum 9 g per day1 |
|
Febrile neutropenia |
2 g every 8 h |
|
Nosocomial pneumonia |
|
Bacterial meningitis |
|
Bacteraemia* |
|
Bone and joint infections |
1-2 g every 8 h |
|
Complicated skin and soft tissue infections |
|
Complicated intra-abdominal infections |
|
Peritonitis associated with dialysis in patients on CAPD |
|
Complicated urinary tract infections |
1-2 g every 8 h or 12 h |
|
Peri-operative prophylaxis for transuretheral resection of prostate (TURP) |
1 g at induction of anaesthesia, and a second dose at catheter removal |
|
Chronic suppurative otitis media |
1 g to 2 g every 8h |
|
Malignant otitis externa |
|
Continuous Infusion |
|
Infection |
Dose to be administered |
|
Febrile neutropenia |
Loading dose of 2 g followed by a continuous infusion of 4 to 6 g every 24 h1 |
|
Nosocomial pneumonia |
|
Broncho-pulmonary infections in cystic fibrosis |
|
Bacterial meningitis |
|
Bacteraemia* |
|
Bone and joint infections |
|
Compli, , cated skin and soft tissue infections |
|
Complicated intra-abdominal infections |
|
Peritonitis associated with dialysis in patients on CAPD |
|
1 In adults with normal renal function 9 g/day has been used without adverse effects.
* When associated with, or suspected to be associated with, any of the infections listed in section 4.1. |
Table 2: Children < 40 kg
|
Infants and toddlers >2 months and children < 40 kg |
Infection |
Usual dose |
|
Intermittent Administration |
|
|
Complicated urinary tract infections |
100-150 mg/kg/day in three divided doses, maximum 6 g/day |
|
|
Chronic suppurative otitis media |
|
|
Malignant otitis externa |
|
|
Neutropenic children |
150 mg/kg/day in three divided doses, maximum 6 g/day |
|
|
Broncho-pulmonary infections in cystic fibrosis |
|
|
Bacterial meningitis |
|
|
Bacteraemia* |
|
|
Bone and joint infections |
100-150 mg/kg/day in three divided doses, maximum 6 g/day |
|
|
Complicated skin and soft tissue infections |
|
|
Complicated intra-abdominal infections |
|
|
Peritonitis associated with dialysis in patients on CAPD |
|
Continuous Infusion |
|
|
Febrile neutropenia |
Loading dose of 60-100 mg/kg followed by a continuous infusion 100-200 mg/kg/day, maximum 6 g/day |
|
|
Nosocomial pneumonia |
|
|
Broncho-pulmonary infections in cystic fibrosis |
|
|
Bacterial meningitis |
|
|
Bacteraemia* |
|
|
Bone and joint infections |
|
|
Complicated skin and soft tissue infections |
|
|
Complicated intra-abdominal infections |
|
|
Peritonitis associated with dialysis in patients on CAPD |
|
Neonates and infants ≤ 2 months |
Infection |
Usual dose |
|
Intermittent Administration |
|
|
Most infections |
25-60 mg/kg/day in two divided doses1 |
|
1 In neonates and infants ≤ 2 months, the serum half life of ceftazidime can be three to four times that in adults.
* Where associated with or suspected to be associated with any of the infections listed in section 4.1. |
Paediatric population
The safety and efficacy of Ceftazidime administered as continuous infusion to neonates and infants ≤ 2 months has not been established.
Elderly
In view of age related reduced clearance of Ceftazidime in elderly patients, the daily dose should not normally exceed 3 g in those over 80 years of age.
Hepatic impairment
Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment. There are no study data in patients with severe hepatic impairment (see also section 5.2). Close clinical monitoring for safety and efficacy is advised.
Renal impairment
Ceftazidime is excreted unchanged by the kidneys. Therefore, in patients with impaired renal function, the dosage should be reduced (see also section 4.4).
An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance:
Table 3: Recommended maintenance doses of Fortum in renal impairment – intermittent infusion
Adults and children ≥ 40 kg
|
Creatinine clearance
(ml/min) |
Approx. serum creatinine
μmol/l (mg/dl) |
Recommended unit dose of Ceftazidime (g) |
Frequency of dosing (hourly) |
|
50-31 |
150-200
(1.7-2.3) |
1 |
12 |
|
30-16 |
200-350
(2.3-4.0) |
1 |
24 |
|
15-6 |
350-500
(4.0-5.6) |
0.5 |
24 |
|
<5 |
>500
(>5.6) |
0.5 |
48 |
In patients with severe infections the unit dose should be increased by 50% or the dosing frequency increased.
In children the creatinine clearance should be adjusted for body surface area or lean body mass.
Children < 40 kg
|
Creatinine clearance
(ml/min)** |
Approx. serum creatinine*
μmol/l (mg/dl) |
Recommended individual dose mg/kg body weight |
Frequency of dosing (hourly) |
|
50-31 |
150-200
(1.7-2.3) |
25 |
12 |
|
30-16 |
200-350
(2.3-4.0) |
25 |
24 |
|
15-6 |
350-500
(4.0-5.6) |
12.5 |
24 |
|
<5 |
>500
(>5.6) |
12.5 |
48 |
|
* The serum creatinine values are guideline values that may not indicate exactly the same degree of reduction for all patients with reduced renal function.
** Estimated based on body surface area, or measured. |
Close clinical monitoring for safety and efficacy is advised.
Table 4: Recommended maintenance doses of Ceftazidime in renal impairment – continuous infusion
Adults and children ≥ 40 kg
|
Creatinine clearance
(ml/min) |
Approx. serum creatinine
μmol/l (mg/dl) |
Frequency of dosing
(hourly) |
|
50-31 |
150-200
(1.7-2.3) |
Loading dose of 2 g followed by 1 g to 3 g /24 hours |
|
30-16 |
200-350
(2.3-4.0) |
Loading dose of 2 g followed by 1 g/24 hours |
|
≤15 |
>350
(>4.0) |
Not evaluated |
Caution is advised in dose selection. Close clinical monitoring for safety and efficacy is advised.
Children < 40 kg
The safety and effectiveness of Ceftazidime administered as continuous infusion in renally impaired children < 40 kg has not been established. Close clinical monitoring for safety and efficacy is advised.
If continuous infusion is used in children with renal impairment, the creatinine clearance should be adjusted for body surface area or lean body mass.
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