Budesonide (Inhaled)

STRENGTH- AND DEVICE-SPECIFIC: figures are from the SPC for Budelin Novolizer 200 micrograms per actuation inhalation powder; a 400 micrograms strength is available for the 400 microgram doses. If a patient is switched from an alternative inhalation device the dose should be reviewed and adjusted individually, considering the active substance, dose regimen and method of delivery. Adjust the dose until control is achieved, then titrate to the lowest dose maintaining effective control of asthma. If asthma control deteriorates (persistent respiratory symptoms, increased bronchodilator use), the inhaled steroid dose should be increased; patients on the once-daily regimen should be advised to double their dose, i.e. give the once-daily dose twice daily, and seek medical advice as soon as possible. A short-acting inhaled beta-2-agonist must be available at all times for relief of acute symptoms - budesonide is NOT indicated for acute dyspnoea or status asthmaticus. Transfer from oral steroids: start when the patient is in a relatively stable phase, give a high dose of inhaled budesonide combined with the previously used oral steroid dose for about 10 days, then reduce the oral steroid dose gradually (for example by 2.5 milligrams prednisolone or the equivalent each month) to the lowest possible level. Intended for long-term therapy; improvement may appear in 24 hours but 1-2 weeks of additional treatment may be needed for maximum benefit. Inhale before meals and rinse the mouth with water or brush the teeth after each inhalation to reduce oral candidiasis and hoarseness. PAEDIATRIC (from the same SPC, fixed microgram doses - no per-kg dose is stated): children 6-12 years initial recommended dose 200 micrograms twice daily or 200-400 micrograms once daily, maximum recommended 400 micrograms twice daily, posology limits 200-800 micrograms daily; once-daily dosing up to 400 micrograms may be used in children 6-12 years with mild to moderate asthma already controlled on twice-daily inhaled glucocorticosteroids. Not recommended below 6 years of age due to insufficient data on safety and efficacy. Children should only use this product under the supervision of an adult; growth should be monitored. Verify paediatric dosing against a children's formulary. Hepatic: in severe hepatic dysfunction elimination may be reduced and systemic availability increased - check HPA axis function at regular intervals. NOTE ON SOURCES: the openFDA record in this bundle is a US over-the-counter budesonide NASAL SPRAY (different route and indication) and was NOT used for this inhaled dose.