Nystatin

Generic name
Nystatin
Brand name
ATC Code
A07AA02
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Is not absorbed after administration via the skin or mucous membranes.
Is hardly absorbed at all after oral administration.

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

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Candidiasis of the mouth/pharynx, thrush
  • Oral
    • Premature infants Gestational age < 37 weeks
      [2]
      • 400.000 IU/day in 4 doses.
    • Term neonate
      [2] [3]
      • 400.000 - 800.000 IU/day in 4 doses. ALTERNATIVELY: after each feeding 50,000-100,000 IU, maximum 800,000 IU/day.
      • Duration of treatment:

        For thrush, treat until 1 week after visible lesions have disappeared (source: NHG/Dutch College of General Practitioners)

    • 1 month up to 1 year
      [2] [3]
      • 400.000 - 800.000 IU/day in 4 doses. ALTERNATIVELY: after each feeding 50.000-100.000 IU/dose, maximum 800.000 IU/day.
      • Duration of treatment:

        For thrush, treat until 1 week after visible lesions have disappeared (source: NHG/Dutch College of General Practitioners)

    • 1 year up to 18 years
      [2]
      • 1.600.000 - 2.400.000 IU/day in 4 doses.
      • Directions for administration:

        Distribute the total amount of oral suspension over both sides of the oral cavity and (if possible) keep in the mouth for several minutes before swallowing.

Candidiasis of the esophagus and gastro-intestinal tract (Treatment)
  • Oral
    • Term neonate
      [2] [4]
      • 300.000 - 400.000 IU/day in 3 - 4 doses.
    • 1 month up to 18 years
      [2] [4]
      • 1.500.000 - 3.000.000 IU/day in 3 doses.
Prophylaxis candidiasis of the mouth/pharynx (thrush)
  • Oral
    • Term neonate
      [2]
      • 100.000 IU/day in 1 dose
Prophylaxis of candidiasis of the esophagus and gastro-intestinal tract
  • Oral
    • 1 month up to 2 years
      [4]
      • 450.000 - 600.000 IU/day in 3 - 4 doses.
    • Term neonate
      • 450.000 - 600.000 IU/day in 3 - 4 doses.

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

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

No information available on specific warnings and 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
A07AA06
A07AA09
ANTIBIOTICS
A07AA06
A07AA09

References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
  2. Sanofi-Aventis BV, SPC Nystatine,(RVG 06771) 14-06-2023, www.geneesmiddeleninformatiebank.nl
  3. Beentjes MM et al., NHG-Standaard Zwangerschap en kraamperiode (tweede herziening)., Huisarts Wet , 2012, 55(3), 112-25
  4. Dermapharm AG, Nystaderm S (6863327.00.00), 02/2014

Changes

Therapeutic Drug Monitoring


Overdose