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

Interactions
PK
Renal impairment
References

Daptomycin

Generic name
Daptomycin
Brand name
ATC Code
J01XX09

Pharmacokinetics in children

Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age):

Age Range 1 to <2 years 2-6 years (N=7) 7-11 years (N=2) 12-17 years (N=6)
Dose
Infusion Time		 10 mg/kg
60 minutes		 9 mg/kg
60 minutes		 7 mg/kg
30 minutes		 5 mg/kg
30 minutes
Cmax (µg/ml) 79.2 81.9 (21.6) 64.9, 74.4 62.4 (10.4)
Apparent t1/2 (hr) 5.04 3.8 (0.3) 4.6 5.3 (1.6)
CL/wt (ml/hr/kg) 21.5 21.4 (5.0) 16.0 13.3 (2.9)


Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age):

Age Range 1 to 6 years (N=19) 7-11 years (N=19) 12-17 years (N=13)
Dose
Infusion Time		 12 mg/kg
60 minutes		 9 mg/kg
30 minutes		 7 mg/kg
30 minutes
Cmax (µg/ml) 106 (12.8) 104 (14.5) 104 (35.5)
Apparent t1/2 (hr) 5.1 (0.6) 6.0 (0.8) 7.5 (2.3)
CL/wt (ml/hr/kg) 19.9 (3.4) 15.9 (2.8) 12.4 (3.9)

[EPAR Cubicin]

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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

Infections of the skin and soft tissues without bacteraemia
  • Intravenous
    • 1 year up to 2 years
      • 10 mg/kg/day in 1 dose in 60 minutes.
      • Duration of treatment:

        Maximum 14 days

    • 2 years up to 7 years
      • 9 mg/kg/day in 1 dose in 60 minutes..
      • Duration of treatment:

        Maximum 14 days
Infections of the skin and soft tissues with S. Aureus bacteraemia
  • Intravenous
    • 7 years up to 12 years
      • 9 mg/kg/day in 1 dose let it run in over 30 minutes..
    • 12 years up to 18 years
      • 7 mg/kg/day in 1 dose let it run in over 30 minutes..
    • 1 year up to 7 years
      • 12 mg/kg/day in 1 dose let it run in over 60 minutes..
    • 7 years up to 12 years
      [1]
      • 9 mg/kg/day in 1 dose let it run in over 30 minutes..
    • 12 years up to 18 years
      [1]
      • 7 mg/kg/day in 1 dose let it run in over 30 minutes..

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
No adjustment required
GFR 30-50 ml/min/1.73 m2
No adjustment required
GFR 10-30 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 48 uur
GFR < 10 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 48 uur
Patients on dialysis

On dialysis days, daptomycin should if possible be administered after the 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

No information is present at this moment.

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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

Do not administer to children < 1 year due to possible effects on the musculoskeletal system and/or nervous system, as observed in animals. The clinical relevance of these findings is unknown.

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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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Glycopeptide antibacterials
J01XA04
J01XA02
J01XA01
Polymyxins
J01XB01
Steroid antibacterials
J01XC01
Nitrofuran derivatives
J01XE01
Other antibacterials
J01XX08
J01XX01

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Reference

  1. Novartis Europharm Limited, SmPC Cubicin (EU/1/05/328/001-004) 04-01-2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes