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Budesonide

Mild, moderate & severe persistent asthma.

Adult including elderly & adolescent 12-17 yr Mild asthma Initially 200-400 mcg daily. May be increased up to 800 mcg daily. Moderate & severe asthma Initially up to 1,600 mcg daily. Mild & moderate or severe asthma Maintenance dose: 100-400 mcg bid. May be increased up to 1,600 mcg in 2 divided doses & subsequently reduced when asthma is stabilised. Mild & moderate asthma w/o previous inhaled corticosteroid Maintenance dose: 200-400 mcg once daily. 800 mcg once daily in patients already controlled on inhaled corticosteroids bid. Childn 6-11 yr Mild asthma Initially 200-400 mcg daily. Mild & moderate or severe asthma Maintenance dose: 100-200 mcg bid. May be increased up to 800 mcg in 2 divided doses, if needed, & subsequently reduced when asthma is stabilised. Mild to moderate asthma Maintenance dose: 200-400 mcg once daily in steroid naive patients or controlled on inhaled corticosteroids bid.

Hypersensitivity to budesonide or lactose.

Discontinue use immediately if paradoxical bronchospasm occurs. Not for acute dyspnoea or status asthmaticus. Risk of adrenal function impairment in patients on high dose or prolonged therapy. Systemic effects (eg, Cushing's syndrome, cushingoid features, adrenal suppression, decreased bone mineral density, cataract, glaucoma, psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Exacerbation of asthma due to acute resp tract bacterial infections. Transfer from oral therapy to inhaled budesonide. W/drawal symptoms. Patients w/ active & quiescent TB; fungal, viral or other airway infections; excessive mucous secretion of resp tract. Avoid abrupt discontinuation & use regularly even when asymptomatic. Consider additional systemic corticosteroid treatment during periods of stress or elective surgery; rapid-acting inhaled bronchodilator if acute episode of dyspnoea occurs; short-term systemic corticosteroids if asthma symptoms are not adequately controlled. Monitor hypothalamic pituitary adrenocortical axis function regularly in patients previously dependent on oral corticosteroids & w/ reduced liver function. Rinse mouth properly or brush teeth after each administration to reduce risk of oral candidiasis. Regularly monitor height of childn receiving prolonged treatment. Consider discontinuation if oral candidiasis occurs. Avoid concomitant use w/ ketoconazole or other potent CYP3A4 inhibitors. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Growth retardation in childn & adolescents.

Oropharyngeal candidiasis; cough & throat irritation, difficulty in swallowing.

Increased systemic exposure of CYP3A4 inhibitors eg, itraconazole, ketoconazole, ritonavir, nelfinavir, ciclosporin, ethinylestradiol, cobicistat & troleandomycin. Increased risk of systemic side effects w/ cobicistat-containing products. Raised plasma conc & enhanced effects w/ oestrogens & contraceptive steroids. False results w/ ACTH stimulation test.

Antiasthmatic & COPD Preparations

R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.

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