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Initially, at the beginning of inhaled corticosteroid therapy, for therapy during periods of severe asthma or when scaling down or withdrawing oral corticosteroids the dosage should be: Children aged 6 years and older: 100-800 micrograms per day, divided into 2-4 inhalations. With daily doses up to 400 micrograms the full dose may be given in one administration.
Adults: The normal dose range is 200-800 micrograms per day, divided into 2-4 inhalations. In more severe cases daily doses of up to 1600 micrograms may be needed. With daily doses up to 400 micrograms the full dose may be given in one administration.
The maintenance dose should be the lowest possible.
Following a single dose an effect may be expected after a few hours. The full therapeutic effect is only achieved after a few weeks of treatment. Treatment with Budesonide (BUDECORT TURBUHALER) is prophylactic therapy with no demonstrated effect on acute disorders.
Clinical trials indicate that a larger amount of budesonide is deposited in the lungs when administered with Budesonide (BUDECORT TURBUHALER), compared with Budesonide (Budecort pMDI). If a patient in a stable phase is transferred from Budesonide (BUDECORT pMDI) to Budesonide (BUDECORT TURBUHALER) a reduction in dose may therefore be appropriate.
In patients in whom an increased therapeutic effect is desired, in general an increase of the Budesonide (BUDECORT TURBUHALER) dose is to be recommended in preference to combination treatment with oral corticosteroids because of the lower risk of systemic side effects.
Patients dependent on oral steroids: When transfer from oral steroids is initiated the patient must be in a relatively stable condition. A high dose of Budesonide (BUDECORT) is given in combination with the previously used oral steroid dose for 10 days. After that, the oral dose should be gradually reduced by e.g. 2.5 mg prednisolone or equivalent per month to the lowest possible level. The oral steroid can often be discontinued entirely.
There is no experience of treatment of patients with impaired hepatic or renal function. Since budesonide is predominantly eliminated through hepatic metabolism, increased exposure may be expected in patients with severe cirrhosis of the liver.
Instructions for correct use of Turbuhaler: Turbuhaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient: To carefully read the instructions for use: "How to use Budesonide (BUDECORT TURBUHALER)".
To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
Never to breath out through the mouthpiece.
To rinse the mouth out with water after inhaling the prescribed dose to minimise the risk of oropharyngeal thrush.
It is possible that the patient will not taste or perceive any medicine when Budesonide (BUDECORT TURBUHALER) is used; this is because such a small amount of substance is dispensed.
Respules: Bronchial asthma: Maintenance treatment for bronchial asthma: The dosage of Budesonide (BUDECORT RESPULES) Nebulizing Suspension is individual, and should be titrated to the lowest effective maintenance dose once control of asthma is achieved.
Administration can be once or twice daily. Once daily administration can be used for daily doses of 250 mcg-1000 mcg.
Recommended initial dose: Adults/Elderly: 1000 mcg-2000 mcg total daily dose.
Children 6 months or older: 250 mcg-500 mcg total daily dose. In patients depending on oral glucocorticosteroids, a higher starting dose, e.g., 1000 mcg total daily dose may be considered.
Maintenance doses: Adults/Elderly: 500-4000 mcg total daily dose. In very severe cases the dose may be further increased.
Children 6 months or older: 250-2000 mcg total daily dose.
Once daily dosing may be considered both in adult and in paediatric patients, who require a maintenance dose of 250 mcg to 1000 mcg budesonide per day. Once daily administration can be initiated both in noncorticosteroid treated patients and in patients well-controlled by inhaled glucocorticosteroids. The dose can be administered either in the morning or in the evening. If deterioration of asthma occurs, the dose should be increased and divided over the day as necessary.
Onset of effect in maintenance treatment: Improvement in asthma control following maintenance treatment with inhaled Budesonide (BUDECORT RESPULES) Nebulizing Suspension can occur within 3 days of initiation of treatment, although maximum benefit may not be achieved for 2-4 weeks.
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 nebulised Budesonide (BUDECORT RESPULES) Nebulizing Suspension for acute exacerbations can be continued until clinical improvement, but for no longer than 10 days.
Children: (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 nebulised Budesonide (BUDECORT RESPULES) Nebulizing Suspension 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.
Onset of effect for acute Exacerbations of Asthma: Following an initial dose, an effect is expected after a few hours.
Patients maintained on oral glucocorticosteroids: Budesonide (BUDECORT RESPULES) Nebulizing Suspension may permit replacement or significant reduction in dosage of oral glucocorticosteroids with maintained or improved asthma control.
Initially, Budesonide (BUDECORT RESPULES) Nebulizing Suspension should be used concurrently with the patient's usual maintenance dose of oral glucocorticosteroid. After approximately one week the oral dose is gradually reduced to the lowest possible level. A slow rate of withdrawal is strongly recommended. In many cases it is possible to completely substitute the oral glucocorticosteroid with Budesonide (BUDECORT RESPULES) Nebulizing Suspension.
During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, eg, joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Budesonide (BUDECORT RESPULES) Nebulizing Suspension 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 be continued more slowly. During periods of stress or during a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.
Exacerbations of COPD: Patients should be treated with daily doses of 4 to 8 mg of Budesonide (BUDECORT RESPULES) Nebulizing Suspension, divided into 2 to 4 administrations, until clinical improvement but for no longer than 10 days.
Onset of effect: Following inhaled administration of Budesonide (BUDECORT RESPULES) Nebulizing Suspension for the treatment of exacerbations of COPD the time to symptom improvement is comparable to administration of systemic corticosteroids.
Croup: In infants and children with croup, the usual dose is 2 mg of nebulized 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 hours up to 36 hours or until clinical improvement.
Onset of effect: Results from clinical trials with Budesonide (BUDECORT RESPULES) Nebulizing Suspension for treatment of croup showed that a clinically significant improvement of 2 points or more in symptoms score was observed between 1 to 2 hours after treatment initiation. A statistically significant symptom improvement versus placebo was observed 2 hours post-treatment.
Dose division and miscibility: Budesonide (BUDECORT RESPULES) Nebulizing Suspension can be mixed with 0.9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium. The admixture should be used within 30 minutes.
Single dose units can be divided, to allow dose adjustment. The single dose unit is marked with a line (Budesonide (BUDECORT RESPULES) Nebulizing Suspension 250 mcg/mL and 500 mcg/mL only). This line indicates the 1 mL volume when the single dose unit is held up-side down. If only 1 mL is to be used, empty the contents until the surface of the liquid reaches the indicator line. Store the opened single dose unit in the envelope, protected from light. Opened single dose units should be used within 12 hours.
Note that if only 1 mL is used the remaining volume is not sterile. (See Table 1.)
Click on icon to see table/diagram/imageInstruction for correct use of Budesonide (BUDECORT RESPULES) Nebulizing Suspension: Budesonide (BUDECORT RESPULES) Nebulizing Suspension should be administered via a jet nebuliser equipped with a mouthpiece or suitable face mask. The nebuliser should be connected to an air compressor with an adequate air flow (5-8 L/min), and the fill volume should be 2-4 mL.
NOTE: It is important to instruct the patient: To carefully read the instructions for use in the patient information leaflet which are packed together with each nebuliser.
That Ultrasonic nebulisers are not suitable for the administration of Budesonide (BUDECORT RESPULES) Nebulizing Suspension and therefore are not recommended.
Budesonide (BUDECORT RESPULES) Nebulizing Suspension can be mixed with 0.9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate and ipratropium. The admixture should be used within 30 minutes.
To rinse the mouth with water after inhaling the prescribed dose to minimise the risk of oropharyngeal thrush.
To wash the facial skin with water after using the face mask to prevent irritation.
To adequately clean and maintain the nebuliser according to the manufacturer's instructions.
