Budesonide + formoterol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: Inhalation Asthma Each actuation delivers budesonide 80 mcg or 160 mcg and formoterol 4.5 mcg: 2 inhalations bid. Each actuation delivers budesonide 320 mcg and formoterol 9 mcg: Maintenance therapy: 1 inhalation bid, up to 2 inhalations bid if needed. COPD Each actuation delivers budesonide 160 mcg and formoterol 4.5 mcg: 2 inhalations bid. Each actuation delivers budesonide 320 mcg and formoterol 9 mcg: 1 inhalation bid.
Contraindications
As primary treatment of status asthmaticus, acute episodes of asthma or COPD requiring intensive measures, and potentially worsening or rapidly deteriorating asthma or COPD.
Special Precautions
Patient 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. Patient Counselling Rinse mouth thoroughly every after inhalation. Monitoring Parameters 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.
Adverse Reactions
Oral candidiasis, headache, tremor, palpitations, coughing, hoarseness, mild throat irritation, nasopharyngitis, angina pectoris, tachycardia, atrial and ventricular tachyarrhythmia, AF, extrasystoles, hypercorticism, cataract, glaucoma, increased intraocular pressure, nausea, angioedema, bronchospasm, urticaria, exanthema, pruritus, anaphylactic reaction, hyperglycaemia, hypokalaemia, muscle cramps, dizziness, behaviour and sleep disturbances, nervousness, agitation, depression, restlessness, dysphonia, skin bruising, hypotension/HTN; reduced growth (childn).
Drug Interactions
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).
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
R03AC13 - formoterol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
D07AC09 - budesonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Disclaimer: This information is independently developed by CIMS based on budesonide + formoterol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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