Concise Prescribing Info
Patients w/ bronchial asthma who require maintenance treatment w/ glucocorticosteroids for control of underlying airway inflammations.
Dosage/Direction for Use
Individualized dosage. Adult Initially 200-1,600 mcg daily divided in 2-4 doses. Less severe cases: 200-800 mcg daily; more severe cases: 800-1,600 mcg daily. Dose can be given once daily if maintenance dose is ≤400 mcg. Childn ≥7 yr Initially 200-800 mcg daily divided in 2-4 doses, 5-7 yr Initially 200-400 mcg daily divided in 2-4 doses.
Hypersensitivity. Active pulmonary TB.
Special Precautions
If patient presents symptoms eg, blurred vision or other visual disturbances, consider referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases (eg, central serous chorioretinopathy). Patients w/ lung TB & fungal or viral infections. Consider antiviral therapy if chicken pox develops. Patient should adhere to the regular asthma medication when viral upper resp infection is present. Consider short-course oral corticosteroid therapy in patients known to deteriorate rapidly when they have viral resp infection. Rinse mouth w/ water after each inhalation. Avoid concomitant treatment w/ ketoconazole & itraconazole or other potent CYP3A4 inhibitors. Patients transferred from oral glucocorticosteroids. Patients who have required high-dose emergency glucocorticosteroid or prolonged treatment may exhibit signs & symptoms of adrenal insufficiency when exposed to severe stress. Systemic steroid treatment replaced by budesonide may reveal allergies (eg, rhinitis & eczema). Not for rapid relief of bronchospasm. Not suitable as sole therapy for the treatment of status asthmaticus or other acute exacerbations of asthma where intensive measures are required. Seek medical attention if short-acting bronchodilator is ineffective or more inhalations than usual is needed. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. May give +ve result at anti-doping test for sportsmen. Decreased liver function. Pregnancy. Childn on immunosuppressants. Regular growth monitoring is recommended in childn & adolescents receiving long-term treatment.
Adverse Reactions
Candida infection in the oropharynx, throat irritation, coughing, hoarseness.
Drug Interactions
Increased plasma conc by ketoconazole. Marked increase in plasma levels by other potent CYP3A4 inhibitors (ie, itraconazole).
ATC Classification
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
Frenolyn powd for inhalation 200 mcg/dose
100 dose x 1's
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