- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Candidiasis of the mouth/pharynx, thrush |
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| Candidiasis of the oesophagus and gastro-intestinal tract |
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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
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.
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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 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.
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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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| Antibiotics | ||
|---|---|---|
| A07AA07 | ||
| A07AA12 | ||
| A07AA01 | ||
| A07AA02 | ||
| A07AA06 | ||
| A07AA11 | ||
| A07AA09 | ||
| ANTIBIOTICS | ||
|---|---|---|
| A07AA07 | ||
| A07AA12 | ||
| A07AA01 | ||
| A07AA02 | ||
| A07AA06 | ||
| A07AA11 | ||
| A07AA09 | ||
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References
- Janssen-Cilag BV, SmPC Daktarin ( RVG 07490) 12-07-2023, www.geneesmiddeleninformatiebank.nl
- de Vries TW, et al, Bijna-verstikking van een zuigeling door miconazol orale gel., Nederlands Tijdschrift voor Geneeskunde, 2004, 148, 1598-1600
- Nederlands centrum jeugdgezondheid., Multidisciplinaire richtlijn borstvoeding, www.ncj.nl/richtlijnen, Juni 2015
- Janssen-Cilag, SmPC Daktarin 2% orales Gel (17956-1), 12/2018
- 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
- 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
- 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
- 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
- Casneuf J, et al., Oral thrush in children treated with miconazole gel., Mykosen, 1980, 23(2), 75-8
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Changes
Changes
