Miconazole, (oro-)mucocal application

Generic name
Miconazole, (oro-)mucocal application
Brand name
ATC Code
A07AC01
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Miconazole, (oro-)mucocal application

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

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

Candidiasis of the mouth/pharynx, thrush
  • Oromucosal
    • Preterm neonates, term neonates and infants < 4 months
      • 0.6 ml/dose 4x daily.

      • The oral gel should be applied thinly to the mucous membrane of the mouth in small quantities with a finger or a cotton swab. Do not apply gel to the mouth or back of the throat all in one go. (see warning section)

    • 4 months up to 2 years
      • 1.25 ml/dose 4x daily.

      • The oral gel should be applied thinly to the mucous membrane of the mouth in small quantities with a finger or a cotton swab. Do not apply gel to the mouth or back of the throat all in one go. (see warning section)

    • 2 years up to 18 years
      • 2.5 ml/dose 4x daily.
Candidiasis of the oesophagus and gastro-intestinal tract
  • Oromucosal
    • 4 months up to 18 years
      • 20 mg/kg/day in 4 doses. Max: 250 mg/dose.

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

Miconazole oral gel can cause closure of the airway in young infants, resulting in suffocation or the threat thereof. 

Very common (> 10%): nausea and vomiting.

Common (1-10%): regurgitation.

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

Contra-indications in children

Children in whom the swallowing reflex is not yet sufficiently developed

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

Use caution in infants and young children (4 months-2 years) because of the risk of (imminent) choking due to closure of the airway; therefore, the gel should not be applied to the back of the throat. Divide each dose into small portions and apply them to the mouth with a clean finger; taking care not to cause the child to choke. Because of this risk of choking, also do not apply the gel to the nipple of a lactating woman before administering to a child. It is important to consider the variability of swallowing function development in this population, especially at 4-6 months of age. Increase the lower limit of this age by 1-2 months for preterm infants or infants with slow neuromuscular development.

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
A07AA07
A07AA12
A07AA01
A07AA02
A07AA06
A07AA11
A07AA09
ANTIBIOTICS
A07AA07
A07AA12
A07AA01
A07AA02
A07AA06
A07AA11
A07AA09

References

  1. Janssen-Cilag BV, SmPC Daktarin ( RVG 07490) 12-07-2023, www.geneesmiddeleninformatiebank.nl
  2. de Vries TW, et al, Bijna-verstikking van een zuigeling door miconazol orale gel., Nederlands Tijdschrift voor Geneeskunde, 2004, 148, 1598-1600
  3. Nederlands centrum jeugdgezondheid., Multidisciplinaire richtlijn borstvoeding, www.ncj.nl/richtlijnen, Juni 2015
  4. Janssen-Cilag, SmPC Daktarin 2% orales Gel (17956-1), 12/2018
  5. Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh), Final Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended, https://www.hma.eu/269.html, Jan 2013
  6. Sriram B, et al., Systemic Candidiasis in Extremely Low Birthweight (ELBW) Neonates Despite the Routine Use of Topical Miconazole Prophylaxis: Trends, Risk Factors and Outcomes over an 11-Year Period, Ann Acad Med Singap, 2014, 43(5), 255-62
  7. Torikai M, et al., Prophylactic efficacy of enteral antifungal administration of miconazole for intestinal perforation, especially for necrotizing enterocolitis: a historical cohort study at a single institution., Surg Today, 2021, 51(4), 568-74
  8. Wainer S, et al, Prophylactic miconazole oral gel for the prevention of neonatal fungal rectal colonization and systemic infection., Pediatr Infect Dis J., 1992, 11(9), 713-6
  9. Casneuf J, et al., Oral thrush in children treated with miconazole gel., Mykosen, 1980, 23(2), 75-8

Changes

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