Budesma

Management of bronchial asthma. Seasonal allergic & allergic/non-allergic perennial rhinitis. Treatment & prevention of nasal polyps after polypectomy.

Individualized dose. Once daily dose: Adult (including elderly) & childn >12 yr 200-400 mcg in patient w/ mild to moderate asthma who have not previously received inhaled glucocorticoids. Up to 800 mcg may be used in patient w/ mild to moderate asthma already controlled on inhaled steroids (eg, budesonide or beclomethasone dipropionate), administered bid. Childn ≤12 yr 200-400 mcg in childn w/ mild to moderate asthma who have not previously received inhaled glucocorticosteroids, or who are already controlled on inhaled steroids (eg, budesonide or beclomethasone dipropionate), administered bid. Divided doses (bid): Adult (including elderly) & childn >12 yr 200-1,600 mcg daily in divided doses when starting treatment, during periods of severe asthma & while reducing/discontinuing oral glucocorticoids. In less severe cases & childn >12 yr, 200-800 mcg daily in divided doses may be used. Can be increased up to 1,600 mcg in divided doses during periods of severe asthma. Childn ≤12 yr 200-800 mcg daily in divided doses, can be increased up to 800 mcg during periods of severe asthma.

Hypersensitivity to budesonide or other steroids. As primary treatment of status asthmaticus or other acute episodes/exacerbations of asthma or in patients w/ moderate to severe bronchiectasis. Not recommended for use in concomitant untreated active or quiescent pulmonary TB & untreated fungal, bacterial or systemic viral infections.

Risk of adrenal insufficiency when patients are transferred from systemic corticosteroids to inhalation therapy, especially when exposed to trauma, surgery or infections, particularly gastroenteritis. Instruct patients who have been w/drawn from systemic corticosteroids to immediately resume systemic steroids in dosages that were previously effective during periods of stress or severe asthmatic attack. Transfer from systemic steroid therapy to budesonide may unmask allergic conditions previously suppressed by systemic steroid therapy eg, rhinitis, conjunctivitis, & eczema. Caution in patients already on alternate-day prednisone regimens for any disease. Slowly discontinue use if symptoms of systemic effects eg, mental disturbances, increased bruising, wt gain, cushingoid features, acneiform lesions & cataracts occur. Development of pharyngeal & laryngeal candidiasis. Not to be regarded as a bronchodilator & not indicated for rapid relief of bronchospasm. Should not be stopped abruptly; gradually taper off (as w/ other steroids). Replacement of systemic steroid w/ budesonide has to be gradual & carefully supervised since systemic symptoms (eg, joint &/or muscle pain, lassitude, depression) may occur upon w/drawal. Pulmonary infiltrates w/ eosinophils may occur during therapy. May mask some signs of infections & new infections may appear. Avoid exposure to illnesses eg, chickenpox & measles in childn & adults who have not had these diseases. Periodically assess hypothalamic-pituitary-adrenal (HPA) function & hematological status during long-term therapy. Enhanced effect on patients w/ hypothyroidism & cirrhosis. Caution when using aspirin in conjunction w/ corticosteroids in hypoprothrombinemia. Pregnancy & lactation. Infants of mothers treated w/ corticosteroids during pregnancy should be carefully monitored for hypoadrenalism. Prolonged HPA axis suppression may eventually lead to systemic effects including growth retardation in childn & adolescents.

Ocular complications, reduced bone density, suppression of HPA axis responsiveness to stress & inhibition of growth velocity in childn; glaucoma exacerbation; dose-dependent bone loss. Paradoxical bronchospasm; adrenal suppression; growth of Candida albicans in mouth & throat, hoarseness, dry mouth or throat irritation; allergic rhinitis & eczema. Headache, light-headedness, dryness & irritation of nose & throat, & unpleasant taste & smell. Rarely, immediate & delayed hypersensitivity reactions eg, urticaria, angioedema, rash & bronchospasm; pruritus, erythema & edema of eyes, face, lips & throat.

Concomitant use w/ aspirin.

Antiasthmatic & COPD Preparations

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

Rx