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

Interactions
PK
Renal impairment
References

Miconazole nitrate with hydrocortisone

Generic name
Miconazole nitrate with hydrocortisone
Brand name
ATC Code
D01AC20

Pharmacokinetics in children

Systemic absorption of miconazole in children is very low or below the limit of detection (which is < 1 ng/ml)

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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

Skin infections by dermatophytes or Candida species
  • Cutaneous
    • 1 month up to 18 years
      • Apply thinly to the affected skin once or twice daily for 5-10 days. After that continue treatment with miconazole (without hydrocortisone)

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

The likelihood of local and systemic effects increases with use in children and with prolonged use: use under occlusion and use on large surfaces

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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

Be careful when using in children  (thinner skin) because of the increased risk of systemic side effects. Use in children can rapidly cause adrenal cortex suppression and also growth hormone suppression. The safety and efficacy of hydrocortisone in children aged < 1 month have not been established.

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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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Reference

  1. Janssen-Cilag BV, SmPC Daktacort (RVG 07342) 14-09-2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes