Budesonide

NO ADULT CEILING IS STATED. SPC 4.2, verbatim: 'Adults (including the elderly): Usually 1 - 2 mg twice daily. In very severe cases the dosage may be further increased.' Because the SPC explicitly permits further increase in very severe cases and gives no adult maximum, maxDose is left empty rather than inferred. The only numeric ceiling in the section is paediatric (2 mg per day under 12 years) and is recorded under paedDose. || DOSE TITRATION (SPC 4.2, verbatim): 'The dosage of Budesonide 0.5 mg nebuliser suspension should be adjusted to the need of the individual. The dose should be reduced to the minimum needed to maintain good asthma control.' 'The maintenance dose should be individualised and be the lowest dose which keeps the patient symptom-free.' || DOSE/VOLUME TABLE at 0.25 mg/ml (SPC 4.2): 0.25 mg = 1 ml; 0.5 mg = 2 ml; 0.75 mg = 3 ml; 1.0 mg = 4 ml; 1.5 mg = 6 ml; 2.0 mg = 8 ml. || TRANSFER FROM ORAL STEROID (SPC 4.2): start when the patient is in a relatively stable phase; give a high dose of the nebuliser suspension in combination with the previously used oral steroid dose for about 10 days, then reduce the oral steroid gradually (for example by 2.5 mg prednisolone or equivalent each month) to the lowest possible level. 'Where an increased therapeutic effect is desired, especially in those patients without major mucus secretion in the airways, an increased dose ... is recommended, rather than combined treatment with oral corticosteroids, because of the lower risk of systemic effects.' || MIXING (SPC 4.2): can be mixed with 0.9% saline and with nebuliser solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide; the admixture should be used within 30 minutes. || PATIENT ADVICE (SPC 4.2): rinse the mouth out with water after inhaling to minimise oropharyngeal candidiasis, and wash the facial skin with water after using a face mask to prevent facial skin irritation. || A therapeutic effect is usually reached within 10 days (SPC 4.4).

NOT A PER-KG DRUG - the SPC doses this by age band, not by weight, so dosePerKg is deliberately null. BRONCHIAL ASTHMA (SPC 4.2, verbatim): initiation of therapy - 'Children 12 years and older: Dosage as for adults' (i.e. usually 1-2 mg twice daily); 'Children 3 months to 12 years: 0.5 - 1 mg twice daily'. Maintenance - children 12 years and older 0.5-1 mg twice daily; 'Children 3 months to 12 years: 0.25 - 0.5 mg twice daily'. || CROUP (a separate indication, SPC 4.2, verbatim): 'In infants and children with croup, the usual dose is 2 mg of nebulised budesonide. This dose is given as a single administration, or as two 1 mg doses separated by 30 minutes. Dosing can be repeated every 12 hour for a maximum of 36 hours or until clinical improvement.' || Volume to draw at 0.25 mg/ml: 0.25 mg = 1 ml, 0.5 mg = 2 ml, 0.75 mg = 3 ml, 1.0 mg = 4 ml, 1.5 mg = 6 ml, 2.0 mg = 8 ml. || Growth must be monitored in children (SPC 4.8: 'Due to the risk of growth retardation in the paediatric population, growth should be monitored as described in section 4.4'). No dose below 3 months of age is given in this bundle. Verify any paediatric dose against a children's formulary.