PULMICORT RESPULES NEBULISING SUSPENSION FOR INHALATION 0.5 mg/ml
4.1 Therapeutic indications
Treatment of bronchial asthma.
PULMICORT may also be used when replacement or reduction in oral steroid therapy is desirable.
PULMICORT RESPULES provide budesonide in a nebulising suspension which is recommended when other modes of steroid therapy are unsuitable.
4.3 Contraindications
Hypersensitivity to budesonide or any other ingredients.
4.2 Posology and method of administration
Bronchial asthma
PULMICORT RESPULES Nebulising Suspension
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 is dependent on flow rate, volume of nebuliser chamber and volume fill. A suitable fill for most nebulisers is 2–4 mL.
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
1–2 mg twice daily.
Children
0.5–1 mg 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
0.5–1 mg twice daily.
Children
0.25–0.5 mg twice daily.
Patient Instructions
It is essential that the patient be instructed that PULMICORT is a preventative agent, which must be taken regularly and is not to be used as sole therapy to relieve an acute asthma attack.
The patient should be instructed in the proper use of the inhaler device considered appropriate for his/her particular needs. A full set of instructions are provided with each pack of PULMICORT.
Patients also receiving bronchodilators by inhalation should be advised to use the bronchodilator before PULMICORT in order to enhance its penetration into the bronchial tree. Several minutes should elapse between the use of the two inhalers.
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 Section 4.4 Special warnings and precautions for use – Oral Corticosteroid usage and Potential systemic effects of inhaled corticosteroids – HPA axis suppression and adrenal insufficiency – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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.
