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  • Ceftazidime-VIT
    / Vitamed


    Active Ingredient
    Ceftazidime as pentahydrate 1 g/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    (Powder for solution for IV/IM injection): 10 X 1 g

    not in the basket chart 17058

    Dosage

    Adults and children ≥ 40 kg:
    Broncho-pulmonary infections in cystic fibrosis:
    100 to 150 mg/kg/day every 8 h, maximum 9 g per day1.
    Febrile neutropenia, Nosocomial pneumonia, Bacterial meningitis, Bacteraemia*: 2 g every 8 h.
    Bone and joint infection, Complicated skin and soft tissue infections, complicated intra-abdominal infections, Peritonitis associated with dialysis in patients on CAPD: 1-2 g every 8 h.
    Complicated urinary tract infections: 1-2 g every 8 h or 12 h.
    Per-operative prophylaxis for transurethral resection of prostate (TURP): 1 g at induction of anaesthesia, and a second dose at catheter removal.
    Chronic suppurative otitis media, Malignant otitis externa: 1 g to 2 g every 8 h.
    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: Loading dose of 2 g followed by a continuous infusion of 4 to 6 g every 24 h1.
    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.
    Children < 40 kg
    Infants and toddlers >2 months and children <40 kg (Intermittent Administration):
    Complicated urinary tract infections, Chronic suppurative, otitis media, Malignant otitis externa: 100-150 mg/kg/day in three divided doses, maximum 6 g/day.
    Neutropenic children, Broncho-pulmonary, infections in cystic fibrosis, Bacterial meningitis, Bacteraemia: 150 mg/kg/day in three divided doses maximum 6 g/day.
    Bone and joint infections Complicated skin soft tissue infections, Complicated intra-abdominal infections, Peritonitis associated with dialysis in patients on CAPD: 100 – 150 mg/kg/day in three divided doses, maximum and 6 g/day.
    Continuous Infusion:
    Febrile neutropenia, 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 with CAPD: Loading dose of 60-100 mg/kg followed by a continuous infusion 100-200 mg/kg/day, maximum 6 g/day.
    1-In neonates and infants ≤ 2 months, the serum half-life of ceftazidime can be three to four times than in adults.
    *– Where associated with, or suspects to be associated with, any of the infections.
    See prescribing information for full details.


    Indications

    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 patient 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.
    Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causive bacteria would not fall within its spectrum of activity.
    Consideration should be given to official guidelines on the appropriate use of antibacterial agents.


    Contra-Indications

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


    Special Precautions

    Hypersensitivity: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with ceftazidime must be discontinued immediately and adequate emergency measures must be initiated.
    Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftazidime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
    Spectrum of activity: Ceftazidime has a limited spectrum of antibacterial activity. It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment with ceftazidime. This particularly applies when considering the treatment of patients with bacteraemia and when treating bacterial meningitis, skin and soft tissue infections and bone and joint infections. In addition, ceftazidime is susceptible to hydrolysis by several of the
    extended spectrum beta lactamases (ESBLs). Therefore information on the prevalence of ESBL producing organisms should be taken into account when selecting ceftazidime for treatment.
    Pseudomembranous colitis: Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all anti-bacterial agents, including ceftazidime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftazidime. Discontinuation of therapy with ceftazidime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
    Renal function: Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function.
    Ceftazidime is eliminated via the kidneys; therefore the dose should be reduced
    according to the degree of renal impairment. Patients with renal impairment should be closely monitored for both safety and efficacy. Neurological sequelae have occasionally been reported when the dose has not been reduced in patients with renal impairment.
    Overgrowth of non-susceptible organisms: Prolonged use may result in the overgrowth of non-susceptible organisms (e.g. Enterococci, fungi) which may require interruption of treatment or other appropriate measures. Repeated evaluation of the patient’s condition is essential.
    Test and assay interactions: Ceftazidime does not interfere with enzyme-based tests for glycosuria, but slight interference (false-positive) may occur with copper reduction methods (Benedict’s, Fehling’s, Clinitest).
    Ceftazidime does not interfere in the alkaline picrate assay for creatinine.
    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.
    Sodium content: Important information about one of the ingredients of Ceftazidime-VIT: 1g powder for solution for injection or infusion. Ceftazidime-VIT contains 52 mg of sodium per vial.


    Side Effects

    The most common adverse reactions are eosinphilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhoea, transient increases in hepatic enzymes, maculopapular or uticarcial rash, pain and/or inflammation following intramuscular injection and positive Coomb’s test.
    See prescribing information for full details.


    Drug interactions

    Interaction studies have only been conducted with a probenecid and furosemide.
    Concurrent use of high doses with nephrotoxic medicinal products may adversely affect renal function.
    Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins.
    The clinical relevance of this finding is unknown, but if concurrent administration of ceftazidime with chloramphenicol is proposed, the possibility of antagonism should be considered.
    In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.


    Pregnancy and Lactation

    Pregnancy: There are limited amounts of data from the use of ceftazidime in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Ceftazidime-VIT should be prescribed to pregnant women only if the benefit outweighs the risk.
    Lactation: Ceftazidime is excreted in human milk in small quantities but at therapeutic doses of ceftazidime no effects on the breast-fed infant are anticipated. Ceftazidime can be used during breast-feeding.


    Overdose

    Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma.
    Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment.
    Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal dialysis.


    Manufacturer
    Facta Farmaceutici S.P.A Italy
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