Reviewed by Dr Simon Rowley, Dr Innes Asher, Dorothy Cooper
September 1996
Administration Newborn Drug Protocol Index Newborn Services Home Page

Dose and Administration

  1. Starting dose 0.5 mg (12 hourly) for six weeks until improved and stable.
  2. Usual maintenance dose 0.25 mg 12 hourly.
  3. If no response increase to 0.5 mg 12 hourly.


  1. Infants with severe chronic lung disease with bronchial hyper-reactivity. Consider use via a spacer. Contact Pharmacy or Asthma Nurse re availability of a spacer.

Contraindications and Precautions

  1. Known sensitivity to budesonide.
  2. Caution neonates with fungal and viral infections in the airways.
  3. Caution neonates who are being transferred from oral corticosteroids to budesonide.
  4. Caution, may need to wean dose, not stop suddenly.

Clinical Pharmacology

Budesonide is a potent, nonhalogenated corticosteroid. Budesonide has shown a favourable relation between local anti-inflammatory effect and systemic corticoid side effects over a wide dose range. This is explained by an extensive (90%) first-pass metabolism of budesonide in the liver after systemic absorption ie any drug deposited on the oral buccal mucosa will be rapidly eliminated from the body. Budesonide has shown anti-inflammatory effect and is manifested as decreased bronchial obstruction.

A proportion of the drug may be swallowed. The percentage of the inhaled dose reaching the lung will depend upon the method and delivery of the nebulised budesonide. After a single dose of budesonide, improvement of the lung function is achieved within a few hours. The duration of effect is more than 12 hours. Full effect is not achieved until after a couple of days.

Budesonide is protein-bound 88%.  Vd is 4.3 L/kg and half-life is 2 hours.

Possible Adverse Effects

  1. Posterior subcapsular cataracts.
  2. Mild irritation in the throat.
  3. Candida infection in the oropharynx.
  4. Facial skin irritation.
  5. Bronchoconstriction (rare).
  6. Gastrointestinal (nausea and vomiting).

Special Considerations

  1. Ideally before starting, do short synacthen test.