Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Ceftazidime

Generic name
Ceftazidime
Brand name
ATC Code
J01DD02

Pharmacokinetics in children

The pharmacokinetic studies (Van den Anker et al., McCracken et al., Mulhall et al., Prinsloo et al.) in neonates show that the clearance of ceftazidime increases with increasing gestational and postnatal age. This is a consequence of the maturation of the kidneys and the increase in glomerular filtration rate. The half-life of ceftazidime is also dependent on the gestational and postnatal age and in premature neonates it can be three to four times the value for adults. The average half-lives for the various age categories are as follows:
Neonates < 1 week, <2 kg: 7-8 hours
Neonates < 1 week, >2 kg: 4 – 6 hours
Neonates 1 – 4 weeks, <2 kg: 3 – 6 hours
Neonates 1 – 4 weeks, >2 kg: 3 – 5 hours
Infants 1 – 2 months: 3 hours
Infants >2 months: 2 hours

In the study by Bradley (2016), the following kinetic parameters were found after a single IV dose of 50 mg/kg (max. 2000 mg):

  3-23 months 2-5 yrs 6-11 yrs 12-17 yrs
Cmax (mg/l) 91.7 80.1 81.3        79.8         
Tmax (hours) - - 2.1 2
t½ (hours) - - 1.6 1.7
Cl (l/kg/hour) - - 0.226 0.169
AUC (hours · mg/l) 286.27 255.32     221.2 230.6

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Infections in cystic fibrosis
  • Intravenous
    • 1 month up to 18 years
      [2] [5] [11] [17] [18]
      • 150 - 200 mg/kg/day in 4 - 6 doses. Max: 12 g/day.

      • Always in combination with tobramycin
        alternative: continuous infusion
Sepsis and severe infection such as febrile neutropenia, respiratory tract infections, bone and joint infections, meningitis, infections of the skin and the soft tissues, urinary tract and the abdomen
Infections (without clinical suspicion of meningitis) caused by microorganisms susceptible at increased exposure ('I')
  • Intravenous
    • 1 month up to 18 years
      [24] [25]
      • 150 mg/kg/day in 3 doses. Max: 6 g/day. ALTERNATIVE: Continuous infusion:
        Loading dose: 100 mg/kg; followed by continuous infusion 200 mg/kg/day, max 6 g/day.

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Renal impaiment in children > 3 months

  • GFR 50-80 ml/min/1.73m²: Dose adjustment is not required
  • GFR 30-50 ml/min/1.73m²: 50-75% of the normal dose each time and the interval between two doses: 12 hours.
    The first amount given is 100% of the normal dose each time; adjust the dosage from the second dose onwards
  • GFR 10-30 ml/min/1.73m²: 50-75% of the normal dose each time and the interval between two doses: 24 hours.
    The first amount given is 100% of the normal dose each time; adjust the dosage from the second dose onwards
  • GFR < 10 ml/min/1.73m²: 25% of the normal dose each time and the interval between two doses: 24 to 48 hours.
    The first amount given is 100% of the normal dose each time; adjust the dosage from the second dose onwards

Clinical consequences:

Nephrotoxic symptoms occur primarily at high dosage, in pre-existing renal function disorders and in concomitant treatment with other nephrotoxic substances. Convulsions can occur at very high doses.

In dialysis:

Haemodialysis: The first amount given is 100% of the normal dose each time; from the second dose onwards: 50% of the normal dose each time and the interval between two doses: 24 hours; administer on dialysis days after the dialysis.
CVVH: The first amount given is 100% of the normal dose each time; from the second dose onwards: 25-75% of the normal dose each time and the interval between two doses: 12 hours

Peritoneal: The first amount given is 100% of the normal dose each time; from the second dose onwards: 25-50% of the normal dose each time and the interval between two doses: 24 hours

 

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Thrombophlebitis, fever, nausea, vomiting, diarrhoea, abnormal blood counts, temporary elevation of liver enzyme, vaginal candidiasis, headaches, dizziness, taste disturbances. Rare: tremor, convulsions, pseudomembranous colitis.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

There is crossover sensitivity and resistance between cephalosporins and penicillins. If severe anaphylactic responses have occurred resulting from penicillins, administration of the first dose of cephalosporins should be under medical supervision. Continued administration of ceftazidime can result in excessive growth of non-susceptible microorganisms. When used for a lengthy period, the blood counts must be checked regularly.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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First-generation cephalosporins
J01DB04
J01DB01
Second-generation cephalosporins
J01DC02
Third-generation cephalosporins
J01DD08
J01DD01
J01DD52
J01DD04
Carbapenems
J01DH02

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References

  1. Chuang YY, et al, Cefepime versus ceftazidime as empiric monotherapy for fever and neutropenia in children with cancer, Pediatr Infect Dis J, 2002, 21, 203-9
  2. De Boeck K, et al, Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis with high or conventional doses of ceftazidime., J Antimicrob Chemother., 1998, 41, 407-9
  3. De Louvois J, et al, A comparison of ceftazidime and aminoglycoside based regimens as empirical treatment in 1316 cases of suspected sepsis in the newborn. European Society for Paediatric Infectious Diseases--Neonatal Sepsis Study Group, Eur J Pediatr., 1992, 151, 876-84
  4. Fleischhack G, et al, Meropenem versus ceftazidime as empirical monotherapy in febrile neutropenia of paediatric patients with cancer., J Antimicrob Chemother., 2001, Jun;47(6):., 841-53
  5. Latzin P, et al, Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis., J Cyst Fibros., 2008, 7, 142-6
  6. Leiberman A, et al, Medical treatment of chronic suppurative otitis media without cholesteatoma in children--a two-year follow-up., Int J Pediatr Otorhinolaryngol., 1992, 24, 25-33
  7. McCracken GH Jr, et al, Pharmacokinetics of ceftazidime in newborn infants., Antimicrob Agents Chemother, 1984, 26, 583-4
  8. Mulhall A, et al, The pharmacokinetics and safety of ceftazidime in the neonate., J Antimicrob Chemother., 1985, 15, 97-103
  9. Mustafa MM, et al, Comparative study of cefepime versus ceftazidime in the empiric treatment of pediatric cancer patients with fever and neutropenia., Pediatr Infect Dis J., 2001, 20, 362-9
  10. Prinsloo JG, et al, A preliminary pharmacokinetic study of ceftazidime in premature, new born and small infants., J Antimicrob Chemother., 1983, 12, 361-4
  11. Rappaz I, et al, Continuous infusion of ceftazidime with a portable pump is as effective as thrice-a-day bolus in cystic fibrosis children., Eur J Pediatr., 2000, 159, 919-25
  12. Richard DA, et al, Oral ciprofloxacin vs. intravenous ceftazidime plus tobramycin in pediatric cystic fibrosis patients: comparison of antipseudomonas efficacy and assessment of safety with ultrasonography and magnetic resonance imaging. Cystic Fibrosis Study Group., Pediatr Infect Dis J., 1997, 16, 572-8
  13. Rodriguez WJ, et al, Ceftazidime vs. standard therapy for pediatric meningitis: therapeutic, pharmacologic and epidemiologic observations., Pediatr Infect Dis., 1986, 5, 408-15
  14. Schaad UB, et al, Cefepine vs. ceftazidime treatment of pyelonephritis: a European, randomized, controlled study of 300 pediatric cases. European Society for Paediatric Infectious Diseases (ESPID) Pyelonephritis Study Group., Pediatr Infect Dis J, 1998, 17, 639-44
  15. van den Anker JN, et al, Ceftazidime pharmacokinetics in preterm infants: effect of postnatal age and postnatal exposure to indomethacin., Br J Clin Pharmacol., 1995, 40, 439-43
  16. van den Anker JN, et al, Ceftazidime pharmacokinetics in preterm infants: effects of renal function and gestational age, Clin Pharmacol Ther., 1995, 58, 650-9
  17. CBO, Richtlijn Diagnostiek en behandeling Cystic Fibrosis, www.cbo.nl, 2007
  18. GlaxoSmithKline BV. , SmPC Fortum (RVG 12847) 26-4-2014, www.cbg-meb.nl
  19. Bradley JS et al., Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients, Antimicrob Agents Chemother., 2016 , Sep 23;60(10), 6252-9
  20. Fresenius Kabi Deutschland GmbH, SmPC Ceftazidim Kabi 0,5/1 g Pulver zur Herstellung einer Injektionslösung (72303.00.00 / 72304.00.00), 08/2015
  21. Hikma Pharma GmbH, SmPC Ceftazidim Hikma 0,5/1/2 g Pulver zur Herstellung einer Injektions- oder Infusionslösung (89953.00.00 / 89954.00.00 / 89955.00.00), 02/2015
  22. Fresenius Kabi Deutschland GmbH, SmPC Ceftazidim Kabi 2 g Pulver zur Herstellung einer Injektionslösung (72305.00.00), 08/2015
  23. Dr. Friedrich Eberth Arzneimittel GmbH, SmPC Ceftazidim Dr. Eberth 2 g (86055.00.00), 11/2017
  24. Dutch Working Party on Antibiotic Policy (SWAB) - Special Interest Group Pediatrics, Expert opinion on high dosing for infections caused by microorganisms susceptible to increased doses., Dec 6, 2022
  25. European Committee on Antimicrobial Susceptibility Testing - EUCAST, Clinical breakpoints - breakpoints and guidance, https://www.eucast.org/clinical_breakpoints, Jan 2, 2023

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Changes

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