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

Interactions
PK
Renal impairment
References

Miconazole, cutaneous

Generic name
Miconazole, cutaneous
Brand name
ATC Code
D01AC02

Pharmacokinetics in children

Pharmacokinetic parameters have not been studied in children.

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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

Fungal infections of the skin
  • Cutaneous
    • Premature and Term neonate
      [6]

      • 2%: Apply thinly to the affected skin twice daily

      • Duration of treatment:

        2-6 weeks.
        Continue treatment after eradication of infection up to at least 5-7 days.

    • 1 month up to 18 years
      [5]

      • 2%: Apply thinly to the affected skin twice daily

      • Duration of treatment:

        2-6 weeks.
        Continue treatment after eradication of infection up to at least 7 days.
Nappy rash with secondary Candida infection
  • Cutaneous
    • Preterm neonates, term neonates and infants < 2 years
      [1] [2]

      • 2%: Apply twice daily, thinly to affected skin

      • Duration of treatment:

        1-2 weeks

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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

Hypersensitivity

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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

Neonatal nappy rash often goes together with oral candidiasis, which should be treated too.
Do not clean the skin affected by nappy eczema with perfumed soap or wet wipes. Expose the nappy area to the air as much as possible.

Excipients: Benzoic acid (in some preparations) may exacerbate jaundice in neonates (< 4 wk) due to absorption through immature skin.

 

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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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Other antifungals for topical use
D01AE13
D01AE15
OTHER ANTIFUNGALS FOR TOPICAL USE
D01AE13
D01AE15

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References

  1. Concannen P et al, Diaper dermatitis: a therapeutic dilemma. Results of a double-blind placebo controlled trial of miconazole nitrate 0,25%, Pediatr. Dermatol, 2001, Mar-Apr;18(2):, 149-55
  2. Spraker MK et al, Topical miconazole nitrate ointment in the treatment of diaper dermatitis complicated by candidiasis., Cutis, 2006, Feb;77(2):, 113-20
  3. Degreef H et al, Miconazole nitrate in the treatment of dermatomycoses, Dermatologica, 1975, 150(2), 103-10
  4. NHG. , Standaard Dermatomycosen (M64) Versie 3.0, Februari 2022
  5. Dermapharm, SmPC Micotar 20 mg/g (35633.00.00) , 04-2020
  6. Workgroup Neonatal Pharmacology, Expert opinion on the use of miconazole in neonates - 5 march 2024

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Changes

Changes