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Drug dosage identifier

Miconazole

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Dose and administration

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

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

Indications

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

Contraindications and precautions

  • Caution in preterm infants, especially extreme immaturity.
  • Caution in infants with hepatic dysfunction.
  • Hypersensitivity to miconazole.
  • Systemic fungal infections.
  • Congenital candidiasis.
  • 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

  • Gastrointestinal disturbances (vomiting and, occasionally, diarrhoea).
  • Potential for airway obstruction in infants with poor swallowing.5

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

  • No pharmacokinetic studies of miconazole have been performed in neonates and young infants.
  • 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
  • Oral miconazole is not indicated in systemic or congenital candidiasis.
  • Oral miconazole is not indicated in the treatment of gastrointestinal candidiasis. Nystatin is more effective at eradicating yeasts from the gastrointestinal tract.
  • Consider topical application of anti-candidal agent to mother's nipples when infant has oral candidiasis.
  • If candidal nappy rash is coexistent, a topical agent should also be used.

Management of Miconazole administration

Description

Oral: Milky white gel 2% (20mg per gram of gel) in 40 gm tubes.
Topical: White cream 2% (20mg per gram of gel) in 20 gm tubes.

Prescription

Charted on prescription chart in ml/dose.

Administration

Oral

  • Gel can be drawn up in a syringe.
  • Apply gel to all areas in the mouth with a syringe.
  • Administer after a feed.

Topical

Apply cream to mycotic lesions with a swab or applicator.

Nursing considerations

  • Observe for signs of adverse effects.
  • Provide frequent oral care.
  • Observe for signs of airway obstruction.
  • If dummy is used, change daily to avoid reinfection.
  • Treatment should be reviewed at 5 days. If there has been a clinical success, treatment should be discontinued. Otherwise, treatment should be continued for up to a total of 12 days. If treatment has been unsuccessful at this point, an alternative treatment should be considered.

Storage

  • Gel - store <25°C
  • Cream - store <25°C

References

  1. Hoppe JE, and the antifungals study group. Treatment of oropharyngeal candidiasis in immunocompetent infants: a randomized multicenter study of miconazole gel vs. nystatin suspension. Pediatr Infect Dis J 1997;16:288-93
  2. Hoppe JE, Hahn H, and the antimycotics study group. Randomized comparison of two nystatin oral gels with miconazole oral gel for treatment of oral thrush in infants. Infection 1996;24(2):136-139
  3. Saunders R (ed). New Ethicals Compendium. Auckland, Adis Press 1992. 4th edition. Pages 898-900
  4. Koldin MH, Medoff G. Antifungal chemotherapy. Pediatr Clin North Am 1983; 30:49-61.
  5. Jansen-Cilag Pty Ltd. Datasheet and communication. 27 April, 2006.

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Document Control

  • Date last published: 31 May 2006
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years