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

Interactions
PK
Renal impairment
References

Cefotaxime (as the sodium salt)

Generic name
Cefotaxime (as the sodium salt)
Brand name
ATC Code
J01DD01

Pharmacokinetics in children

The clearance of cefotaxime in neonates increases noticeably during the first days after birth. It has also been shown that the elimination half-life in neonates is longer than in older children and/or adults as a result of the renal clearance not being fully developed [Kearns 1995]. The dosage for neonates on ECMO does not have to be adjusted despite the greater volume of distribution [Ahsman 2010]. The following pharmacokinetic parameters have been found [Ahsman 2010; Aujard 1989; Kearns 1995]:

  t½ (hours) Cl (ml/min/kg) Vd (l/kg) Cmax (mg/l)
Premature infants (< 7 days) 3.1-5.7 1.07-1.7 0.34-0.56 159.02
Premature infants (≥7 days) 2-3.72 1.17-1.87 0.31-0.32 -
Full-term neonates (< 7 days) 2.77-4.04 0.81-2.25 0.28-0.45 -
Full-term neonates (≥ 7 days) 2.01 2.33 0.36 -
ECMO 3.5 6 ml/min 1.82 l 98
1 month to 18 years 0.8-1.5 0.23-0.63 0.13-1.37 -

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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

Severe bacterial infections
  • intravenous / intramuscular
    • Postnatal age < 1 week
      [1] [17] [24]
      • 100 mg/kg/day in 2 doses. Max: 200 mg/kg/day. Max single dose: 50 mg/kg/dose.

      • Administer the maximum dose in 4 doses

    • Postnatal age 1 week up to 4 weeks
      [1] [17] [24]
      • 150 mg/kg/day in 3 doses. Max: 200 mg/kg/day. Max single dose: 50 mg/kg/dose.

      • Administer the maximum dose in 4 doses.

    • 1 month up to 18 years
      [17]
      • 150 mg/kg/day in 3 doses. Max: 200mg/kg/day, but not exceeding 12 g/day.
Neonatal gonococcal conjunctivitis
  • Intramuscular
    • 0 weeks up to 4 weeks
      [11] [16]
      • 100 mg/kg/day in 1 dose once only.
Perioperative prophylaxis
  • Intravenous
    • 1 month up to 18 years
      [23] [24]
      • Initial dose: 30 - 60 minutes before surgery: 50 mg/kg/dose, once only. Max single dose: 2 g/dose.
      • Maintenance dose: After surgery: 50 mg/kg/dose, once only. Max single dose: 2 g/dose. If surgery exceeds 90 minutes application of an additional dose is indicated..

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment is not required
GFR 30-50 ml/min/1.73 m2
Dose adjustment is not required
GFR 10-30 ml/min/1.73 m2
Dose adjustment is not required
GFR < 10 ml/min/1.73 m2
The first amount given is 100% of the normal dose each time, thereafter 50% of the normal dose each time and the interval between two administrations remains as normal
Patients on dialysis

No generalized recommendations are given.

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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, temporarily elevated liver enzymes. Local reactions after administration, rash, abdominal pain and headaches [Jakobs 1992]. Administering it too rapidly (in less than 1 minute) via a central venous catheter can result in severe arrhythmia. Rare: 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 in children

Cefotaxime should not be mixed with lidocaine (for intramuscular administration) in children aged less than 1 year [SmPC Claforan].

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

Cephalosporins can in general be given to patients who are hypersensitive to penicillin, although cross-reactions have been reported. Special care is indicated in patients who previously had anaphylactic responses to penicillins.
For the treatment of sepsis in the case of Gram-negative bacteria, a combination with another suitable antibiotic such as an aminoglycoside can be considered. When treating infections in the abdominal cavity, be aware that cefotaxime does not give anaerobic coverage.
Pseudomembranous colitis may occur during antibiotic use. If pseudomembranous colitis develops, the cefotaxime treatment should be discontinued and an appropriate therapy started.
In long-term use (longer than 10 days), checks of the blood counts and hepatic and renal function are desirable.

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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
J01DD52
J01DD02
J01DD04
Carbapenems
J01DH02

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References

  1. Fresenius Kabi, SmPC Cefotaxim Fresenius 2 g Pulver zur Herstellung einer Injektionslösung (43128.02.00), 02/2014.
  2. Sanofi-Aventis Deutschland GmbH, SmPC Claforan 1.0/2.0 g (6715.01.00 / 6715.02.00)
  3. Bratzler, DW, et al., Clinical practice guidelines for antimicrobial prophylaxis in surgery, Surg Infect, 2013, 14(1), 73-156
  4. Aujard Y, et al, Pharmacokinetics of cefotaxime and desacetylcefotaxime in the newborn, Diagn Microbiol Infect Dis, 1989, 12, 87-91
  5. Boccazzi A, et al, Clinical and pharmacological evaluation of a modified cefotaxime bid regimen versus traditional tid in pediatric lower respiratory tract infections., Diagn Microbiol Infect Dis, 1998, 32, 265-72
  6. Dellagrammaticas HD, et al, Treatment of gram-negative bacterial meningitis in term neonates with third generation cephalosporins plus amikacin., Biol Neonate., 2000, 77, 139-46
  7. Gouyon JB, et al, Pharmacokinetics of cefotaxime in preterm infants., Dev Pharmacol Ther., 1990, 14, 29-34
  8. Jacobs RF, et al, Safety profile and efficacy of cefotaxime for the treatment of hospitalized children, Clin Infect Dis., 1992, 14, 56-65
  9. Jacobs RF, et al, Cefotaxime and desacetylcefotaxime in neonates and children: a review of microbiologic, pharmacokinetic, and clinical experience, Diagn Microbiol Infect Dis., 1989, 12, 93-9
  10. Kaplan SL, et al, Cefotaxime and aminoglycoside treatment of meningitis caused by gram-negative enteric organisms, Pediatr Infect Dis J, 1990, 9, 810-4
  11. Kearns GL, et al, Cefotaxime and desacetylcefotaxime pharmacokinetics in very low birth weight neonates, J Pediatr, 1989, 114, 461-7
  12. Kearns GL, et al, Pharmacokinetics of cefotaxime and desacetylcefotaxime in the young., Diagn Microbiol Infect Dis., 1995, 22, 97-104
  13. Kearns GL, et al, Cefotaxime dosage in infants and children. Pharmacokinetic and clinical rationale for an extended dosage interval., Clin Pharmacokinet., 1992, 22, 284-97
  14. Lepage P, et al, Treatment of gonococcal conjunctivitis with a single intramuscular injection of cefotaxime, J Antimicrob Chemother., 1990, 26, 23-7
  15. Simon C, et al, Neonatal sepsis in an intensive care unit and results of treatment.., Infection, 1991, 19, 146-9
  16. Spritzer R, et al, Five years of cefotaxime use in a neonatal intensive care unit., Pediatr Infect Dis J, 1990, 9, 92-6
  17. Tunkel AR, et al, Practice guidelines for the management of bacterial meningitis, Clin Infect Dis, 2004, 39, 1267-84
  18. Ahsman MJ et al. , Pharmacokinetics of cefotaxime and desacetylcefotaxime in infants during extracorporeal membrane oxygenation, Antimicrob Agents Chemother, 2010, May;54(5), 1734-41
  19. LCI., LCI-Richtlijn Gonorroe (1-4-2013), www.lci.nl
  20. Eureco-Pharma B.V., SmPC Claforan (RVG RVG 122822//27755) 03/2021, www.geneesmiddeleninformatiebank.nl
  21. Fresenius Kabi, SmPC Cefotaxim Fresenius 0.5 g Pulver zur Herstellung einer Injektionslösung (43128.00.00), 09/2014
  22. Dr. Friedrich Eberth Arzneimittel, SmPC Cefotaxim Eberth 0.5/1/2 g Pulver zur Herstellung einer Injektions- oder Infusionslösung (80067.00.00 / 80068.00.00 / 80069.00.00), 05/2012
  23. Fresenius Kabi, SmPC Cefotaxim Fresenius 1 g Pulver zur Herstellung einer Injektionslösung (43128.01.00), 08/2014
  24. MIP, SmPC Cefotaxim MIP 1 g Inj.-Inf.lsg. (1-31395), 10/2017

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Changes

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