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【BP Name】Budesonide Pressurised Inhalation
【Generic Name】Budesonide Inhalation Aerosol
【Composition】The active ingredient: Budesonide
【Storage】Store below 30°C. Keep in airtight container.
【Package】An inhaler comprising an aluminium canister sealed with a metering valve, actuator and dust cap, 1 canister per box.
【Shelf life】24 months
Qualitative and quantitative composition Each metered actuation contains 200 micrograms of budesonide from the valve and delivers 165 mcg of budesonide from the actuator, and each canister provides 200 deliveries\
Special warnings and precautions It is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required. Patients should be instructed about the correct use of the inhaler. It provides a prophylactic therapy of the asthmatic disease: therefore, it should be administered regularly at the prescribed doses as long as directed by the physician and should not be stopped abruptly. In case of gastrointestinal ulcer, strict medical surveillance is advisable throughout therapy duration.
The transfer of patients treated with oral corticosteroids to the inhaled corticosteroid and their subsequent management requires special care. The patients should be in a reasonably stable state before initiating a high dose of inhaled corticosteroid in addition to their usual maintenance dose of systemic corticosteroid. After about 10 days, withdrawal of the systemic corticosteroid is started by reducing the daily dose gradually to the lowest possible level. It may be possible to completely replace the oral corticosteroid with inhaled corticosteroid. Transferred patients whose adrenocortical function is impaired may need supplementary systemic corticosteroid during periods of stress.
During transfer from oral therapy to inhaled budesonide symptoms may appear that had previously been suppressed by systemic treatment with glucocorticosteroids, with occurrence of rhinitis, eczema, headache, muscular and articular pain, and, rarely, of nausea and vomiting. Specific treatment should be co-administered to treat these conditions.
For detailed information please refer to product leaflet.
SPC for Budesonide Pressurised Inhalation.pdf