title: Contraindications - Neonatal Intensive Care Drug Manual
text: |
  Neonatal Intensive Care Drug Manual
  |
  bet | 405/654 | Sana | 03.01.2022 | Hajmi | 1,5 Mb. | | #14803 |
  Contraindications
  |
  Known hypersensitivity to nystatin or any other ingredients (sucrose, methyl hydroxybenzoat, propyl hydroxybenzoate)
  |
  Precautions
  |
  None
  |
  Drug Interactions
  |
  Not applicable
  |
  Adverse Reactions
  |
  Generally well tolerated. Large doses may produce gastrointestinal upset (vomiting, diarrhoea). Rarely, may lead to rashes e.g. urticaria. Type 4 hypersensitivity reactions have been reported in adults.
  |
  Compatibility
  |
  No information
  |
  Incompatibility
  |
  Do not mix in the syringe with any other medication.
  |
  Stability
  |
  Stable until expiry date on the bottle/tube.
  |
  Storage
  |
  At room temperature
  |
  |
  Nil
  |
  Evidence summary
  |
  Efficacy
  Prevention of invasive fungal infections
  A systematic review of RCTs found oral nystatin to be highly effective in preventing invasive fungal infection in VLBW infants with a relative risk of 0.16 when compared to placebo.1 A Cochrane meta-analysis2 found a statistically significant reduction in the incidence of invasive fungal infection (typical risk ratio 0.20, 95% CI 0.14-0.27) in very preterm VLBW infants when comparing oral/topical non-absorbed antifungal prophylaxis (nystatin or miconazole) with placebo or no drug. Substantial statistical heterogeneity was present though.2 (LOE 1A, GOR A)
  A study from Australian and New Zealand NICUs reported3 that prophylactic oral nystatin is associated with a significantly lower incidence of fungal infection compared with no antifungal prophylaxis.3
  Treatment of mucocutaneous fungal infection
  Boon et al reported a cure rate of 80% after 2 weeks with the dose of 400,000 units/day.4 In a randomised trial5 comparing nystatin suspension with miconazole gel in immunocompetent infants for treatment of oropharyngeal candidiasis, Hoppe reported miconazole gel to be significantly superior with regard to efficacy, rapidity of achieving cure and oropharyngeal yeast eradication. Relapses and side effects were no different between miconazole and nystatin.5 However, miconazole gel is contraindicated in those under 6 months of age due
  to risk of airway obstruction from gel.
  Safety
  Acute generalised exanthematous pustulosis has been described following oral nystatin therapy.6
  |
  References
  |
  Blyth CC, Barzi F, Hale K, Isaacs D. Chemoprophylaxis of neonatal fungal infections in very low birthweight infants: efficacy and safety of fluconazole and nystatin. J Paediatr Child Health 2012;48:846-51
  Austin N, Cleminson J, Darlow BA, McGuire W. Prophylactic oral/topical non-absorbed antifungal agents to prevent invasive fungal infection in very low birth weight infants. Cochrane Database Syst Rev 2015 Oct 24;(10):CD003478
  Howell A, Isaacs D, Halliday R. The Australasian Study Group for Neonatal Infections. Oral nystatin prophylaxis and neonatal fungal infections. Arch Dis Child Fetal Neonatal Ed 2009;94:F429-F433, ,
  Boon JM, Lafeber HN, t'Mannetje AH, et al. Comparison of ketoconazole suspension and nystatin in the treatment of newborns and infants with oral candidosis. Mycoses 1989;32:312-5
  Hoppe JE. Treatment of oropharyngeal candidiasis in immunocompetent infants: a randomized multicenter study of miconazole gel vs. nystatin suspension. The Antifungals Study Group. Pediatr Infect Dis J 1997;16:288-93
  Kuchler A, Hamm H, Weidenthaler-Barth B, Kampgen E, Brocker EB. Acute generalized exanthematous pustulosis following oral nystatin therapy: a report of three cases. Br J Dermatol 1997;137:808-11.
  |
  Original version Date: 05/12/2016
  |
  Author: NMF Consensus Group
  |
  Current Version number: 2.0
  |
  Current Version Date: 24/12/2020
  |
  Risk Rating: Medium
  |
  Due for Review: 24/12/2023
  |
  Approval by: DTC
  |
  Approval Date: TBA
  |
  |
  | |