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

Interactions
PK
Renal impairment
References

Amphotericin B, liposomal

Generic name
Amphotericin B, liposomal
Brand name
ATC Code
J02AA01

Pharmacokinetics in children

After administration of 2.5-10 mg/kg of Ambisome to children aged 1-17 years, the following kinetic parameters were found:
Cmax: 15-68 µg/ml
Cl: 38-60 ml/kg/hour; Cl steady state: 13 ml/kg/hour
t½: 10 hours

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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

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Dosages

Systemic mycoses
  • Intravenous
    • 0 years up to 18 years
      • 3 - 5 mg/kg/day in 1 dose
Visceral leishmaniasis
  • Intravenous
    • 1 month up to 18 years
      • 3 - 4 mg/kg/day in 1 dose During 10 days
        Alternative         1-1,5 mg/kg/day in 1 dosis during 21 days.

      • In a persistent immunocompromised status, secondary prophylaxis is indicated for preventing recurrences. Consult with an expert about the type, dosage and interval of the secondary prophylaxis
Pulmonary/respiratory mycoses
  • Inhalation
    • 1 month up to 18 years
      • 50 mg/dose once a week.

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary.
GFR 30-50 ml/min/1.73 m2
Adjustment not necessary.
GFR 10-30 ml/min/1.73 m2
Adjustment not necessary.
GFR < 10 ml/min/1.73 m2
No generalized dose 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

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

Ambisome must be nebulized with the I-neb, with the lilac-coloured cup being filled eight times.

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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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Antibiotics
J02AA01
J02AA01
J02AA01
Triazole and tetrazole derivatives
J02AC01
J02AC05
J02AC02
J02AC04
J02AC03
Other antimycotics for systemic use
J02AX06
J02AX04
J02AX01
J02AX05

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References

  1. Gilead Sciences International Limited, SmPC Ambisome (RVG 15610) 13 juli 2018 , www.geneesmiddeleninformatiebank.nl
  2. Hartwig NC et al., Vademecum pediatrische antimicrobiele therapie, 2005
  3. Pana ZD et al, Therapeutic strategies for invasive fungal infections in neonatal and pediatric patients: an update., Expert Opin Pharmacother, 2015, Apr;16(5), 693-710
  4. Hong, Y, et al., Population pharmacokinetics of liposomal amphotericin B in pediatric patiens with malignant diseases, Antimicrob Agents Chemother, 2006, 50(3), 935-42
  5. Gilead, SmPC Ambisome 50 mg Plv. z. Hest. e. Inf.lsg. (1-20606), https://www.univadis.at/, 06/2018
  6. Gilead Sciences International Limited, SmPC Ambisome (RVG 15610) 13 juli 2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes