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Bronchial Asthma: PULMICORT RESPULES should be administered from a suitable nebuliser. The dose delivered to the patient varies between 40-60% of the nominal dose depending on the nebulising equipment used. The nebulisation time and the dose delivered are dependent on flow rate, volume of nebuliser chamber and volume fill. A suitable fill for most nebulisers is 2-4mL.
Some sedimentation may occur during storage of PULMICORT RESPULES. If this does not readily resuspend completely upon shaking, the RESPULE should be discarded.
Dosage initially, or during periods of severe asthma, or while reducing oral corticosteroids: Adults: 1-2mg twice daily.
Children: 0.5-1mg twice daily.
Maintenance: The maintenance dose should be individualised and should be the lowest dose, which keeps the patient symptom-free. Recommended doses are: Adults: 0.5-1mg twice daily.
Children: 0.25-0.5mg twice daily.
Clinical Management: Patients - not oral corticosteroid dependent: Treatment with the recommended doses of PULMICORT usually gives a therapeutic effect within 10 days.
In patients with excessive mucus secretion in the bronchi, an initial short course (about 2 weeks) of an oral corticosteroid, commencing with a high dose and gradually reducing, should be given in addition to PULMICORT. Treatment should be continued for at least one month before determining the maximal response to a given dose of PULMICORT.
Patients - oral corticosteroid dependent: Transfer of patients dependent on oral corticosteroids to PULMICORT requires special care because of slow normalisation of the disturbed hypothalamic-pituitary-adrenal function caused by extended treatment with oral corticosteroids (see PRECAUTIONS - Oral Corticosteroid usage and Potential systemic effects of inhaled corticosteroids - HPA axis suppression and adrenal insufficiency).
When PULMICORT treatment is initiated, the patient's asthma should be in a relatively stable phase. A high dose of PULMICORT should then be given in combination with the previously used oral corticosteroid dose for about 2 weeks. The dose of oral corticosteroid should then be reduced gradually (for example 1mg prednisolone or equivalent every four days, however, the exact rate of reduction will depend on individual clinical response) to the lowest possible level. The dose of PULMICORT should not be changed while the patient remains on oral corticosteroids.
In many cases, it may be possible to completely replace the oral corticosteroid with inhaled PULMICORT. In other patients, a low oral steroid maintenance dose may be necessary. Some patients may experience uneasiness during the withdrawal of oral corticosteroids due to the decreased systemic corticosteroid effect. The physician may need to actively support the patient and to stress the reason for the PULMICORT treatment.
The length of time needed for the body to regain sufficient natural corticosteroid production is often extended and may be as long as 12 months. Transferred patients should carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress, such as severe infection, trauma or surgery. During such times it may be necessary to give additional oral corticosteroids.
During transfer from oral therapy to PULMICORT, a lower systemic steroid action is experienced. Earlier allergic symptoms may recur (eg. rhinitis, eczema, conjunctivitis) or patients may suffer from tiredness, headache, muscle and joint pain, lassitude and depression or occasionally nausea and vomiting. In these cases, further medical support may be required.
Croup: In infants and children with croup, the usual dose is 2mg of nebulised budesonide. This dose is given as a single administration, or as two 1mg doses separated by 30 minutes. Dosing can be repeated every 12 hours up to 36 hours or until clinical improvement.
Exacerbations of COPD: Patients should be treated with daily doses of 4 to 8 mg of PULMICORT RESPULES, divided into two to four administrations, until clinical improvement is achieved, but for no longer than 10 days.
The use of nebulised budesonide has not been evaluated in clinical trials in patients with an exacerbation of COPD with respiratory failure requiring invasive mechanical ventilation or admission to intensive care unit.
Time to effect in exacerbations of COPD: Following inhaled administration of PULMICORT RESPULES for the treatment of exacerbations of COPD the time to symptom improvement is comparable to administration of systemic corticosteroids.
