Adult: As metered-dose aerosol or dry powd inhaler delivering budesonide 80 mcg or 160 mcg and formoterol 4.5 mcg/actuation: 2 inhalations bid. As metered-dose dry powd inhaler delivering budesonide 320 mcg and formoterol 9 mcg/actuation: Maintenance therapy: 1 inhalation bid, increase if necessary, up to 2 inhalations bid. Child: ≥ 12 yr: Same as adult dose.
Adult: As metered-dose aerosol or dry powd inhaler delivering budesonide 160 mcg and formoterol 4.5 mcg/actuation: 2 inhalations bid. As metered-dose dry powd inhaler delivering budesonide 320 mcg and formoterol 9 mcg/actuation: 1 inhalation bid.
As primary treatment of status asthmaticus, acute episodes of asthma or COPD requiring intensive measures, and potentially worsening or rapidly deteriorating asthma or COPD.
Patients w/ asthma that is adequately controlled on low- or medium-dose inhaled corticosteroids; bacterial (e.g. active or quiescent pulmonary TB), fungal, parasitic, and viral (e.g. chickenpox, measles, ocular herpes simplex) infection, hypokalaemia, thyrotoxicosis, cataract/glaucoma, phaeochromocytoma, DM, CV disorders (e.g. arrhythmia, heart failure, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm), osteoporosis, seizures. Hepatic impairment. Pregnancy and lactation.
Perform FEV1, peak flow meter and/or other pulmonary function tests. Monitor signs of asthma or COPD deterioration, growth in paediatric patients, and symptom relief.
Increased plasma concentration of budesonide when used w/ CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, HIV protease inhibitors). Decreased effect of formoterol if concomitantly used w/ β-adrenergic blockers. May prolong QTc-interval and increase the risk of ventricular arrhythmias when used w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAOIs, and TCAs. May precipitate hypertensive reactions w/ furazolidone, procarbazine and MAOIs. May increase risk of arrhythmias w/ anaesthesia (w/ halogenated hydrocarbons) and digitalis (if patient has hypokalaemia).
Description: Budesonide is a corticosteroid that exhibits potent glucocorticoid and weak mineralocorticoid activities. It controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes/fibroblasts, and reverses capillary permeability and cellular lysosomal stabilisation to control inflammation. Formoterol is a long-acting selective β2 adrenoceptor agonist. It relaxes bronchial smooth muscles by stimulation of adenyl cyclase, thereby increasing cyclic-3’-5’-adenosine monophosphate (cAMP) levels. Onset: Asthma: 15 min. Pharmacokinetics: Absorption: Rapidly absorbed. Budesonide: Time to peak plasma concentration: 30 min. Bioavailability: Approx 49%. Formoterol: Time to peak plasma concentration: W/in 10 min. Bioavailability: Approx 61%. Distribution: Budesonide: Volume of distribution: 3 L/kg. Plasma protein binding: Approx 90%. Formoterol: Volume of distribution: approx 4 L/kg. Plasma protein binding: Approx 50%. Metabolism: Budesonide: Undergoes extensive first-pass metabolism in the liver by CYP3A4 enyme to major metabolites 6-β-hydroxybudesonide and 16-α-hydroxyprednisolone. Formoterol: Metabolised via glucuronidation and O-demethylation to active O-demethylated and deformylated metabolites. Excretion: Budesonide: Via urine (mainly as conjugated form). Terminal elimination half-life: 2-4 hr. Formoterol: Via urine (8-13% as unchanged drug). Terminal elimination half-life: 17 hr.
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