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

Interactions
PK
Renal impairment
References

Amphotericin B (oral)

Generic name
Amphotericin B (oral)
Brand name
ATC Code
A07AA07

Pharmacokinetics in children

Amphotericin B is hardly absorbed orally

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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

Selective bowel decontamination, mycotic stomatitis and intestinal fungal infections (or prophylaxis thereof)
  • Oral
    • Suspension for oral use
      • 5 up to 10 kg
        • 75 mg/day in 3 doses.
        • Directions for administration:

          Keep the suspension in the mouth for as long as possible

      • 10 up to 20 kg
        • 150 mg/day in 3 doses.
        • Directions for administration:

          Keep the suspension in the mouth for as long as possible

      • 20 up to 30 kg
        • 200 mg/day in 4 doses.
        • Directions for administration:

          Keep the suspension in the mouth for as long as possible

      • 0 years up to 18 years
        • 400 mg/day in 4 doses.
        • Directions for administration:

          Keep the suspension in the mouth for as long as possible

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Even in high doses of up to 3 g/day side effects are uncommon because amphotericin B is barely absorbed.

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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

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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
A07AA12
A07AA01
A07AA02
A07AA06
A07AA11
A07AA09
Imidazole derivatives
A07AC01
ANTIBIOTICS
A07AA12
A07AA01
A07AA02
A07AA06
A07AA11
A07AA09

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References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
  2. Nath CE, et al, Amphotericin B in children with malignant disease: a comparison of the toxicities and pharmacokinetics of amphotericin B administered in dextrose versus lipid emulsion, Antimicrob Agents Chemother, 1999, Jun;43(6), 1417-23
  3. Benson JM, et al, Pharmacokinetics of amphotericin B in children, Antimicrob Agents Chemother, 1989, Nov;33(11), 1989-93
  4. Koren G, et al, Pharmacokinetics and adverse effects of amphotericin B in infants and children, J Pediatr, 1988, Sep;113(3), 559-63
  5. Kintzel PE, et al, Practical guidelines for preparing and administering amphotericin B, Am J Hosp Pharm, 1992, May;49(5), 1156-64
  6. Singh UK, et al, Amphotericin B therapy in children with visceral leishmaniasis: daily vs. alternate day, a randomized trial, J Trop Pediatr, 2010, Oct;56(5), 321-4
  7. Thakur CP, et al, Daily versus alternate-day regimen of amphotericin B in the treatment of kala-azar: a randomized comparison, Bull World Health Organ, 1994, 72(6), 931-6
  8. Koh LP, et al, Randomized trial of fluconazole versus low-dose amphotericin B in prophylaxis against fungal infections in patients undergoing hematopoietic stem cell transplantation., Am J Hematol, 2002, Dec;71(4), 260-7
  9. Riley DK, et al, The prophylactic use of low-dose amphotericin B in bone marrow transplant patients, Am J Med., 1994, Dec;97(6), 509-14
  10. Bowden R, et al, A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients, Clin Infect Dis, 2002, Aug 15;35(4), 359-66
  11. Herbrecht R, et al, Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis, N Engl J Med, 2002, Aug 8;347(6), 408-15
  12. Pappas PG,, A phase II randomized trial of amphotericin B alone or combined with fluconazole in the treatment of HIV-associated cryptococcal meningitis, Clin Infect Dis, 2009, Jun 15;48(12), 1775-83
  13. CHEPLAPHARM Arzneimittel GmbH, SmPC Fungizone (RVG 06065) 17-11-2020, www.geneesmiddeleninformatiebank.nl

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Changes

Changes