Amphotericin B, liposomal

Generic name
Amphotericin B, liposomal
Brand name
ATC Code
J02AA01
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Amphotericin B, liposomal

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

Interactions
PK
Renal impairment
References

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

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

No information is present at this moment.

Available formulations

No information is present at this moment.

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.

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

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.

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.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIMYCOTICS FOR SYSTEMIC USE

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

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

Changes

Therapeutic Drug Monitoring


Overdose