Amphotericin B (oral)

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

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Amphotericin B is hardly absorbed orally

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

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

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.

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.

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

Interactions

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

INTESTINAL ANTIINFECTIVES

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

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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