Pulmicort Dosage/Direction for Use

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 - 4 mL.
Some sedimentation may occur during storage of PULMICORT RESPULES. If this does not readily resuspend completely upon shaking, the respules should be discarded.
Bronchial Asthma: Dosage initially, or during periods of severe asthma, or while reducing oral corticosteroids: Adults, Children 12 years and older: 1 - 2 mg twice daily.
Children age 3 months - 12 years: 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 age 3 months - 12 years: 0.25 - 0.5 mg twice daily.
Acute Laryngotracheobronchitis (Croup): In infants and children with croup the usual dose is 2 mg of nebulised budesonide given as a single administration of Pulmicort Respules.
Acute Exacerbations of Asthma: Adults: Daily recommended dose is 4 to 8 mg and can be divided into 1 to 4 administrations.
In very severe cases the dose may be further increased. Maximum dose at one occasion should not exceed 4 mg. Treatment with nebulized Pulmicort for acute exacerbations can be continued until clinical improvement, but for no longer than 10 days.
Children (aged 6 months to 17 years): daily recommended dose is 1.5 to 4 mg, doses up to 6 mg can be considered in children 5 years or above. Daily dose can be divided into 1 to 4 administrations. Maximum dose at one occasion should not exceed 3 mg. Treatment with nebulized Pulmicort for acute exacerbations can be continued until clinical improvement, but for no longer than 10 days.
In both adults and children, nebulised budesonide is not a substitute for systemic corticosteroids in life threatening asthma. Treatment for exacerbations may be followed by ICS (Inhaled Corticosteroids) containing therapy in appropriate doses using suitable delivery systems.
Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): Patients should be treated with daily doses of 4 to 8 mg of PULMICORT nebulizer suspension, divided into 2 to 4 administrations, until clinical improvement but for no longer than 10 days.
Onset of effect: Following inhaled administration of Pulmicort Nebulizer Suspension for the treatment of exacerbations of COPD the time to symptom improvement is comparable to administration of systemic corticosteroids.
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.
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 Oral Corticosteroid usage and Potential systemic effects of inhaled corticosteroids - HPA axis suppression and adrenal insufficiency under PRECAUTIONS).
When PULMICORT treatment is initiated, the patient's asthma should be in a relatively stable phase. The dose of oral corticosteroid should then be reduced gradually 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 (e.g. 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.