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

Interactions
PK
Renal impairment
References

Ceftazidim + Avibactam

Generic name
Ceftazidim + Avibactam
Brand name
ATC Code
J01DD52

Pharmacokinetics in children

In healthy adults, the following pharmacokinetic parameters apply after administration of multiple doses of 2 g/0.5 g of ceftazidim/avibactam every 8 hours for 2 hours via infusion:

  Ceftazidim Avibactam
Vd,ss (l) 17 22
T1/2(hour) 2 2

 

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Complicated intra-abdominal or urinary tract infections, nosocomial pneumonia, other serious infections from susceptible pathogens when other treatment options are limited.
  • Intravenous
    • Postmenstrual age 26 weeks up to 31 weeks

      • Ceftazidim/avibactam: 40/10 mg/kg/dag in 2 doses. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

    • Postmenstrual age 31 weeks up to 45 weeks

      • Ceftazidim/avibactam: 60/15 mg/kg/dag in 3 doses. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

    • Postmenstrual age 45 weeks up to 53 weeks
      [1]

      • Ceftazidim/avibactam: 90/22,5 mg/kg/dag in 3 doses. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

    • Term neonate
      [1]

      • Ceftazidim/avibactam: 60/15 mg/kg/dag in 3 doses. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

    • 1 month up to 3 months
      [1]

      • Ceftazidim/avibactam: 90/22,5 mg/kg/dag in 3 doses. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

    • 3 months up to 6 months
      [1]

      • Ceftazidim/avibactam: 120/30 mg/kg/dag in 3 doses. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

    • 6 months up to 18 years
      [1]

      • Ceftazidim/avibactam: 150/37,5 mg/kg/dag in 3 doses, max: 6000/1500 mg/dag. Infuse over 2 hours

      • Duration of treatment:

        5-14 days depending on type and severity of infection

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Renal impaiment in children > 3 months

CrCl 0 to 3 months 3  to 6 months 6 months to 2 years ≥ 2 years
> 50 ml/min/1,73 m2 No data available Dose adjustment not needed Dose adjustment not needed Dose adjustment not needed
31-50 ml/min/1,73 m2 No data available 60 /15  mg/kg/day in 3 doses 75 /18,75 mg/kg/day in 3 doses, 75 /18,75 mg/kg/day in 3 doses, max 1 g/0,25 g per dose
16-30 ml/min/1,73 m2 No data available 30 / 7,5 mg/kg/dag in 2 doses 37,5 / 9,4 mg/kg/day in 2 doses 37,5 / 9,4 mg/kg/day in 2 doses, max 0,75 g/0,1875 g per dose
6-15 ml/min/1,73 m2 No data available No data available No data available 18,75/ 4,7 mg/kg/ day in 1 dose, max 0,75 g/0,1875 g per dose
Endstage renal disease, including hemodialysis No data available No data available No data available 18,75/ 4,7 mg/kg/ DOSE every 48 hours, max 0,75 g/0,1875 g per dose

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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

Overall, the safety profile in children is similar to the safety profile that was
observed in adult patients with cIAI and cUTI.

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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

Be aware of dosing errors and subsequent overdose when reconstituting the drug. Consult SmPC for specific advice on reconstitution in children < 12 months of age. [SmPC Zavicefta]

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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
J01DD02
J01DD04
Carbapenems
J01DH02

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Reference

  1. Pfizer Ireland Pharmaceuticals, SmPC Zavicefta® (EU/1/16/1109/001) Rev 17, 16-12-2024, www.ema.europa.eu

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Changes

Changes