General dosing considerations: In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. The improvement in asthma control following inhaled administration can occur within 2 to 8 days of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks.
The maximum dose in children is 1 mg/day.
Budesonide can be administered once daily either in the morning or in the evening. Gently shake the inhalation suspension using a circular motion before use.
The safety and efficacy of budesonide inhalation suspension when administered in excess of recommended doses have not been established. In children 6 months to 8 years of age should not be administered the excess of the recommended dose.
If deterioration in asthma occurs, the frequency of daily dosing and / or the total dose of budesonide may need to be increased.
Improvement in asthma control following inhaled administration can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.
Concomitant therapy with oral corticosteroids: For patients who are maintained on chronic oral corticosteroids, the usual maintenance dose should be used concurrently with the initial budesonide therapy. After approximately 1 week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after 1 or 2 weeks, depending on the response of the patient. Generally, these decrements should not exceed 25% of the prednisone dose or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal (eg, joint or muscular pain, lassitude, depression) despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with budesonide but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily, and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.
Admixture compatibility: The effects of mixing Aeronide 200 mcg with other nebulizable medications have not been adequately assessed. Administer separately in the nebulizer.
Elderly: No dosage adjustment is necessary for elderly patients.
Hepatic function impairment: Exercise caution when administering to patients with hepatic impairment.
Patients not receiving systemic (oral) corticosteroids: Patients who require maintenance therapy of asthma may benefit from treatment with Aeronide 200 mcg at the doses recommended. For patients who do not respond adequately to the starting dose, consideration should be given to administering the total daily dose as a divided dose if a once-daily dosing schedule was followed. If necessary, higher doses, up to the maximum recommended doses, may provide additional asthma control.
Asthma: Children 1-8 years of age: Recommended Dosages in Children 1-8 years of age: See Table 1.
Dosage adjustment: If once-daily treatment does not provide adequate control of asthma symptoms, the total daily dose should be increased or administered as a divided dose.
Symptomatic children not responding to nonsteroidal therapy (e.g., bronchodilator, mast-cell stabilizer): A starting dose of 200 mcg once daily may also be considered.
Children 7 years of age and above: Recommended dose is 200 to 800 mcg daily in divided into 2 to 4 administrations.
In children with mild to moderate asthma who have not previously received inhaled glucocorticosteroids, or who are already controlled on inhaled steroids (e.g. budesonide or beclomethasone dipropionate): 200 to 400 mcg daily may be used in divided into 2 administrations.
During periods of severe asthma, the daily dose can be increased up to 800 mcg.
Adults and children over 12 years of age: Recommended dose is 200 to 1600 mcg daily divided into 2 to 4 administrations.
In less severe cases 200 to 800 mcg daily (200 to 400 mcg may be used in patients with mild to moderate asthma who have not previously received inhaled glucocorticosteroids and up to 800 mcg may be used by patients with mild to moderate asthma already controlled on inhaled steroids e.g. budesonide or beclomethasone dipropionate, administered twice daily.)
In more severe cases 800 to 1600 mcg daily. Administration twice daily (morning and evening) is usually sufficient. In severe asthma and during exacerbations some patients may benefit from dividing the daily dose into 3 to 4 administrations per day. In mild asthmatics requiring up to 400 mcg daily for symptom control, the dose could be given once daily in the morning or in the evening.
The maintenance dose should be individualised and should be the lowest dose which leaves the patient symptom-free. Recommended doses are 100 to 400 mcg/daily. This may be given as a twice daily dose, or as a once daily dose given in the morning or the evening.