Indications : התוויות

Therapeutic Indications                                                                                                     Peritonitis associated with                                          Creatinine clearance        Approx. serum creatinine           Frequency of dosing               single agent for the treatment of some types of infections unless the pathogen is already Ceftazidime Panpharma is indicated for the treatment of the infections listed below in                                          dialysis in patients on CAPD                                               (ml/min)                  µmol/l (mg/dl)                       (hourly)                    documented and known to be susceptible or there is a very high suspicion that the most adults and children including neonates (from birth).                                                Continuous Infusion                                                                                                                                                                               likely pathogen(s) would be suitable for treatment with ceftazidime. This particularly applies 50-31                         150-200               Loading dose of 2 g followed
- Nosocomial pneumonia                                                                                                                                                                                                                                               by 1-3 g/24 hours                when considering the treatment of patients with bacteraemia and when treating bacterial Febrile neutropenia             Loading dose of 60-100 mg/                                                (1.7-2.3)                                                   meningitis, skin and soft tissue infections and bone and joint infections. In addition,
- Broncho-pulmonary infections in cystic fibrosis                                                                                                               kg followed by a continuous
Nosocomial pneumonia                                                        30-16                         200-350               Loading dose of 2 g followed          ceftazidime is susceptible to hydrolysis by several of the extended spectrum beta-lactamases
- Bacterial meningitis                                                                                                                                          infusion 100-200 mg/kg/day,                                                                                                           (ESBLs). Therefore, information on the prevalence of ESBL-producing organisms should Broncho-pulmonary               maximum 6 g/day                                                           (2.3-4.0)                   by 1 g/24 hours
- Chronic supportive otitis media                                                                                                                                                                                                                                                                     be taken into account when selecting ceftazidime for treatment.
infections in cystic fibrosis                                                ≤15                            >350                         Not evaluated
- Malignant otitis externa                                                                                                                                                                                                                                                                            Pseudomembranous colitis
- Complicated urinary tract infections                                                                                          Bacterial meningitis                                                                                        (>4.0)
Bacteraemia*                                                                                                                                                          Antibacterial agent-associated colitis and pseudomembranous colitis have been reported
- Complicated skin and soft tissue infections                                                                                                                                                    Caution is advised in dose selection. Close clinical monitoring for safety and efficacy is           with nearly all antibacterial agents, including ceftazidime, and may range in severity from - Complicated intra-abdominal infections                                                                                        Bone and joint infections                                        advised.                                                                                             mild to life-threatening. Therefore, it is important to consider this diagnosis in patients - Bone and joint infections                                                                                                     Complicated skin and soft                                                                                                                                             who present with diarrhoea during or subsequent to the administration of ceftazidime Children < 40 kg                                                                                     (see section 4.8). Discontinuation of therapy with ceftazidime and the administration of
- Peritonitis associated with dialysis in patients with CAPD                                                                    tissue infections
The safety and effectiveness of Ceftazidime Panpharma administered as continuous infusion            specific treatment for Clostridium difficile should be considered. Medicinal products that
Treatment of patients with bacteremia that occurs in association with, or is suspected to                                       Complicated intra-abdominal                                      in renally impaired children < 40 kg have not been established. Close clinical monitoring            inhibit peristalsis should not be given.
be associated with, any of the infections listed above.                                                                         infections                                                       for safety and efficacy is advised.
Peritonitis associated with                                                                                                                                           Renal function
Ceftazidime may be used in the management of neutropenic patients with fever that is                                                                                                             If continuous infusion is used in children with renal impairment, the creatinine clearance
suspected to be due to a bacterial infection.                                                                                   dialysis in patients with                                        should be adjusted for body surface area or lean body mass.                                          Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal CAPD                                                                                                                                                                  products such as aminoglycosides or potent diuretics (e.g., furosemide) may adversely
Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for                                                                                                        Haemodialysis                                                                                        affect renal function.
patients undergoing transurethral resection of the prostate (TURP).                                 Neonates and infants        Infection                       Usual dose                       The serum half-life during haemodialysis ranges from 3 to 5 h.
≤2 months                                                                                                                                                                                         Ceftazidime is eliminated via the kidneys; therefore, the dose should be reduced according
The selection of ceftazidime should take into account its antibacterial spectrum, which is                                                                                                       Following each haemodialysis period, the maintenance dose of ceftazidime recommended                 to the degree of renal impairment. Patients with renal impairment should be closely mainly restricted to aerobic Gram-negative bacteria (see sections 4.4 and 5.1).                     Intermittent Administration                                                                  in tables 5 & 6 should be repeated.                                                                  monitored for both safety and efficacy. Neurological sequelae have occasionally been Ceftazidime should be co-administered with other antibacterial agents whenever the                                              Most infections              25-60 mg/kg/day in two                                                                                                                   reported when the dose has not been reduced in patients with renal impairment (see possible range of causative bacteria would not fall within its spectrum of activity.                                                                                                             Peritoneal dialysis                                                                                  sections 4.2 and 4.8).
divided doses1
Consideration should be given to official guidelines on the appropriate use of antibacterial                                                                                                     Ceftazidime may be used in peritoneal dialysis and continuous ambulatory peritoneal
1
In neonates and infants ≤2 months, the serum half-life of ceftazidime can be three         dialysis (CAPD).                                                                                     Overgrowth of non-susceptible organisms
agents.                                                                                               to four times that in adults.
In addition to intravenous use, ceftazidime can be incorporated into the dialysis fluid              Prolonged use may result in the overgrowth of non-susceptible organisms (e.g., Enterococci,