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.
Dosage Details
Inhalation/Respiratory
Asthma
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.

Inhalation/Respiratory
Chronic obstructive pulmonary disease
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.
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
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.
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).
Inhalation/Respiratory: C
Patient Counseling Information
Rinse mouth thoroughly every after inhalation.
MonitoringParameters
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.
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).
Action
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.
Chemical Structure

Chemical Structure Image
Budesonide

Source: National Center for Biotechnology Information. PubChem Database. Budesonide, CID=5281004, https://pubchem.ncbi.nlm.nih.gov/compound/Budesonide (accessed on Jan. 22, 2020)


Chemical Structure Image
Formoterol

Source: National Center for Biotechnology Information. PubChem Database. Arformoterol, CID=3083544, https://pubchem.ncbi.nlm.nih.gov/compound/Arformoterol (accessed on Jan. 21, 2020)

Storage
Store between 20-25°C.
ATC Classification
R03AK07 - formoterol and budesonide ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
References
Anon. Budesonide and Formoterol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/09/2016.

Buckingham R (ed). Budesonide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/09/2016.

Buckingham R (ed). Formoterol Fumarate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/09/2016.

Joint Formulary Committee. Budesonide with Formoterol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/09/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Budesonide. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 15/09/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Formoterol Fumarate. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 15/09/2016.

Symbicort Aerosol (AstraZeneca LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 15/09/2016.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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