Budoneb 0,25 mg/ml & 0,5 mg/ml Film-coated tablets.

Budoneb 0,25 mg/ml & 0,5 mg/ml Film-coated tablets.

S3
PDF Leaflet Revision Date: 13 July 2018


Clinical Summary

Quick overview from the medicine insert

Indication

Management of asthma and acute laryngotracheobronchitis in children.

Dosage (summary)

Adults: 0.5-1 mg twice daily; Children: 0.25-1 mg twice daily based on previous therapy.

Onset of Action / Duration

Onset: 10-30 mins, Duration: 2-3 hours

Special Populations

  • Children under 12 months
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Safety in pregnancy and lactation not established.

Key Drug Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole)

Contraindications

  • Hypersensitivity to budesonide
  • Lung tuberculosis
  • Fungal and viral infections

Common side effects

  • Oral thrush
  • Hoarseness
  • Coughing
  • Cataract
  • Skin bruising

Counselling Points

  • Rinse mouth after use
  • Wash face after nebuliser use
  • Monitor for signs of adrenal insufficiency

Serious warnings

  • Not for rapid relief of acute asthma episodes
  • Monitor growth in children
  • Risk of adrenal insufficiency

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Budoneb 0,25 mg/ml & 0,5 mg/ml Film-coated tablets.
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