Reviewed by Carl Kuschel
May 2006
Administration Newborn Drug Protocol Index Newborn Services Home Page

Dose and Administration


  1. 25mg (1.25g of gel, equalling 1.25ml) 4 times daily. The initial prescription should be for a 5 day course.


  1. This has not been studied in children and is not available for use at NWH.


  1. Treatment of oral candidiasis (second-line agent after Nystatin).
  2. Superficial candidal infections.

Contraindications and Precautions

  1. Caution in preterm infants, especially extreme immaturity.
  2. Caution in infants with hepatic dysfunction.
  3. Hypersensitivity to miconazole.
  4. Systemic fungal infections.
  5. Congenital candidiasis.
  6. Caution in infants with poor swallowing (potential for airway obstruction).5

Clinical Pharmacology

An imidazole antifungal agent which has shown fungistatic activity against a number of fungi causing systemic infection. Action depends on its binding to a sterole moiety, ergosterole, present in the membrane of sensitive fungi. May be fungicidal or fungistatic, depending on the drug concentration obtained and the sensitivity of the fungus.

Absorption of miconazole from the gastrointestinal tract is low. Small amounts of miconazole have been detected in saliva.

Possible Adverse Effects

  1. Gastrointestinal disturbances (vomiting and, occasionally, diarrhoea ).
  2. Potential for airway obstruction in infants with poor swallowing.5
  3. Other side effects have been described following IV administration in adults, notably cardiac arrhythmias (with rapid administration), haematological changes (anaemia, aggregation of erythrocytes, thromocytopenia, thrombocytosis), transient hyponatraemia, hyperlipidaemia, fever, rash, pruritus, blurring of vision, dryness of eyes, arthralgia, seizures and transient renal dysfunction.

Special Considerations

  1. No pharmacokinetic studies of miconazole have been performed in neonates and young infants.
  2. Use of the oral gel in infants <6 months of age is not endorsed by the manufacturer, due to the potential for airway obstruction.5
  3. Oral miconazole is not indicated in systemic or congenital candidiasis.
  4. Oral miconazole is not indicated in the treatment of gastrointestinal candidiasis. Nystatin is more effective at eradicating yeasts from the gastrointestinal tract.
  5. Consider topical application of anti-candidal agent to mother’s nipples when infant has oral candidiasis.
  6. If candidal nappy rash is coexistent, a topical agent should also be used.