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

Interactions
PK
Renal impairment
References

Ceftaroline

Generic name
Ceftaroline
Brand name
ATC Code
J01DI02

Pharmacokinetics in children

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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

Complicated infections of the skin and soft tissues; community-acquired pneumonia (CAP)
  • Intravenous
    • 2 months up to 2 years
      • 24 mg/kg/day in 3 doses. Administer over 60 minutes..
        • Dosage recommendations are based on treatment of S. aureus for which the MIC for ceftaroline is ≤ 1 mg/l.
        •  HIGH DOSE: in S. aureus with MIC of 2 mg / l or 4 mg / l for ceftaroline: 30 mg / kg / day in 3 doses in 120 minutes
    • 12 years up to 18 years and < 33 kg
      • 36 mg/kg/day in 3 doses. Max: 400 mg/dose. Administer over 60 minutes..
        • Dosage recommendations are based on treatment of S. aureus for which the MIC for ceftaroline is ≤ 1 mg/l.
        • HIGH DOSE: in S. aureus with MIC of 2 mg / l or 4 mg / l for ceftaroline: 36 mg / kg / day in 3 doses, max 1800 mg / day; administer over 120 minutes
    • 12 years up to 18 years and ≥ 33 kg
      • 1.200 mg/day in 2 doses. Administer over 60 minutes.  .
      • The dosage recommendations given above are based on treatment of S. aureus, for which the MIC for ceftaroline is ≤ 1 mg/l. For S. aureus with an MIC for ceftaroline of 2 or 4 mg/l, give 36 mg/kg/day in 3 doses, max 1800 mg/day in 3 doses over infusion of 120 minutes

    • 0 months up to 2 months
      • 18 mg/kg/day in 3 doses.
      • Administer in 60 minutes

        Dosage recommendations are based on treatment of S. aureus for which the MIC for ceftaroline is ≤ 1 mg/l.

    • 2 years up to 12 years
      • 36 mg/kg/day in 3 doses. Max: 400 mg/dose. Administer over 60 minutes..
        • Dosage recommendations are based on treatment of S. aureus for which the MIC for ceftaroline is ≤ 1 mg/l.
        • HIGH DOSE: in S. aureus with MIC of 2 mg / l or 4 mg / l for ceftaroline: 36 mg / kg / day in 3 doses, max 1800 mg / day; administer over 120 minutes

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Renal impaiment in children > 3 months

2 months to 2 years:
creatinine clearance > 50 ml/min: adjustment not necessary
creatinine clearance < 50 ml/min: no data known

2 year up to 12 years & > 12 years and < 33 kg:
creatinine clearance 50 ml/min: adjustment not necessary
creatinine clearance 30-50 ml/min: 8 mg/kg bodyweight (max. 300 mg) every 8 hours;
creatinine clearance 15-30 ml/min: 6 mg/kg bodyweight (max. 200 mg) every 8 hours.
in complicated infections of the skin and soft tissues by S. aureus for which the MIC of ceftaroline has to be higher (2 or 4 mg/l instead of 1 mg/l or less),
creatinine clearance 50 ml/min: adjustment not necessary
creatinine clearance 30-50 ml/min: 10 mg/kg bodyweight (max. 400 mg) every 8 hours;
creatinine clearance 15-30 ml/min: 8 mg/kg bodyweight (max. 300 mg) every 8 hours.

> 12 years and >33 kg:
creatinine clearance > 50 ml/min: adjustment not necessary
creatinine clearance 30-50 ml/min: 400 mg every 12 hours;
creatinine clearance 15-30 ml/min: 300 mg every 12 hours
creatinine clearance < 15 ml/min: 200 mg every 12 hours
in complicated infections of the skin and soft tissues by S. aureus for which the MIC of ceftaroline has to be higher (2 or 4 mg/l instead of 1 mg/l or less):
creatinine clearance > 50 ml/min: adjustment not necessary
creatinine clearance 30-50 ml/min: 10 mg/kg bodyweight (max. 400 mg) every 8 hours;
creatinine clearance 15-30 ml/min: 8 mg/kg bodyweight (max. 300 mg) every 8 hours.

Clinical consequences

Nephrotoxic symptoms (renal impairment, tubular necrosis, interstitial nephritis) occur primarily at high doses, with pre-existing renal impairment and with concomitant treatment with other nephrotoxic substances. Convulsions can occur at very high doses. The time above the MIC determines the effect.

Patients on dialysis

AUC and half-life of ceftaroline increase with renal impairment. This increases the risk of side effects. Ceftaroline is removed by hemodialysis. It is unknown whether ceftaroline is removed by peritoneal dialysis.

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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

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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

No information available on specific warnings and precautions in children.

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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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Reference

  1. Pfizer Ireland Pharmaceuticals, SmPC Zinforo (EU/1/12/785/001) Rev 25, 08-09-2021, www.geneesmiddeleninformatiebank.nl

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Changes

Changes