Budesma Patient Counseling Information

Special Instructions for patients for use: Budesonide aerosol for inhalation is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
It is important to note the following: Carefully read the patient information leaflet, which is packed with the formulation.
Breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
Never to breathe out through the mouthpiece.
To rinse the mouth out with water and spit it out, or to brush the teeth (also cleansing dentures) after inhaling the prescribed dose, to minimize the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using the formulation due to the small amount of drug dispensed.
Note: The effect of Budesonide depends on its regular use and on the proper technique of inhalation. Hence, the patient should be made aware of the prophylactic nature of therapy with inhaled Budesonide, and that Budesonide should be taken regularly, even when the patient is asymptomatic. The patient must also be instructed, in the correct method to use the Budesonide Inhaler to ensure that the drug reaches the target areas within the lungs.
In the presence of excessive mucus secretion, the drug may fail to reach the bronchioles. Therefore, if an obvious response is not obtained after 10 days, attempts should be made to control the secretion of mucus and other inflammatory changes in the lung with expectorants and/or with a short course of systemic corticosteroid therapy. Continuation of treatment with inhaled Budesonide usually maintains the improvement achieved, the oral steroid being gradually withdrawn.
Patients Receiving Systemic Steroids: In prednisone-dependent asthmatic patients, budesonide 1 milligram per day (given 4 times daily) by pressurized aerosol delivered through a large volume spacer was equivalent to prednisone 35 milligrams per day in anti-asthmatic effect. The systemic effect of this dose of budesonide on cortisol level was equivalent to 7.6 milligrams of prednisone. The systemic effect of 15 milligrams of prednisone was equivalent to budesonide 2 milligrams/day. Potency ratios between the two drugs vary widely between patients; doses need to be titrated individually.
In non-prednisone-dependent asthmatic patients, budesonide 1 milligram per day (given four times daily) by pressurized aerosol delivered through a large volume spacer was equivalent to prednisone 58 milligrams per day in anti-asthmatic effect and to 8.7 milligrams prednisone in systemic effect on cortisol level. The systemic effect of 15 milligrams of prednisone was equivalent to budesonide 1.7 milligrams/day. Potency ratios between the two drugs vary widely between patients; doses need to be titrated individually.
The transfer of steroid-dependent patients to Budesonide and their subsequent management needs special care mainly because recovery from impaired adrenocortical function, caused by prolonged systemic therapy, is slow. Patients' bronchial asthma should be stable before being given Budesonide in addition to the usual maintenance dose of systemic steroid. After about a week, gradual withdrawal of the systemic steroid is started by reducing the daily dose by 1 mg of prednisone, or its equivalent of other corticosteroid, at not less than weekly intervals, if the patient is under close observation. In children, the usual rate of withdrawal is 1 mg of the daily dose of prednisone every 8 days when under close supervision. If continuous supervision is not feasible, the withdrawal of the systemic steroid should be slower, approximately 1 mg of the daily dose of prednisone (or equivalent) every 10 and every 20 days in adults and in children, respectively. A slow rate of withdrawal cannot be over emphasized.
If withdrawal symptoms appear, the previous dose of the systemic drug should be resumed for a week before any further decrease is attempted. Patients who have been treated with systemic steroids for long periods of time or at a high dose may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously.
Some patients may feel unwell during the withdrawal phase experiencing symptoms such as joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. Such patients should be encouraged to persevere with Budesonide but should be watched carefully for objective signs of adrenal insufficiency such as hypotension and weight loss. If evidence of adrenal insufficiency occurs, the systemic steroid dosage should be boosted temporarily and thereafter further withdrawal should be continued more slowly.
Transferred patients whose adrenocortical function is impaired should carry a warning card indicating that they need supplementary treatment with systemic steroids during periods of stress, e.g., surgery, chest infection or severe asthma attack. Consideration should be given to supplying such patients with oral steroids to use in an emergency. The dose of inhaled Budesonide should be increased at this time and then reduced to the maintenance level after the systemic steroid has been discontinued.
Exacerbations of bronchial asthma which occur during the course of treatment with Budesonide should be treated with a short course of systemic steroid which is gradually tapered as these symptoms subside. Under stressful conditions or when the patient has a severe exacerbation of bronchial asthma, after complete withdrawal of the systemic steroid, use of the latter must be resumed in order to avoid relative adrenocortical insufficiency.
There are some patients who cannot completely discontinue the oral corticosteroid. In these cases, a minimum maintenance dosage should be given in addition to inhaled Budesonide.