Budesonide and FormoterolPronunciation
(byoo DES oh nide & for MOH te rol)
- Budesonide and Eformoterol
- Eformoterol and Budesonide
- Formoterol and Budesonide
- Formoterol Fumarate Dihydrate and Budesonide
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol for oral inhalation:
Symbicort 80/4.5: Budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (6.9 g); budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.2 g)
Symbicort 160/4.5: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (6 g); budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.2 g)
Brand Names: U.S.
- Beta2 Agonist
- Beta2-Adrenergic Agonist, Long-Acting
- Corticosteroid, Inhalant (Oral)
Formoterol: Relaxes bronchial smooth muscle by selective action on beta2 receptors with little effect on heart rate; formoterol has a long-acting effect.
Budesonide: A corticosteroid which controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes/fibroblasts, and reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation.
Onset of Action
Asthma: 15 minutes; maximum benefit: May take ≥2 weeks
Use: Labeled Indications
Asthma: Treatment of asthma in patients ≥6 years.
Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD); including chronic bronchitis and emphysema.
Limitations of use: Budesonide/formoterol is not indicated for the relief of acute bronchospasm.
Hypersensitivity to budesonide, formoterol, or any component of the formulation; primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
Documentation of allergenic cross-reactivity for corticosteroids and/or sympathomimetics are limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity can not be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to inhaled lactose.
Note: If asthma or COPD symptoms occur in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Starting dose is based on asthma severity.
Budesonide 80 mcg/formoterol 4.5 mcg or budesonide 160 mcg/formoterol 4.5 mcg: Metered-dose inhaler: 2 inhalations twice daily; if response is inadequate, may increase to higher dose combination after 1 to 2 weeks (maximum: budesonide 160 mcg/formoterol 4.5 mcg: 2 inhalations twice daily).
Symbicort 100 Turbuhaler, Symbicort 200 Turbuhaler [Canadian products]: Dry powder inhaler:
Initial: 1 to 2 inhalations twice daily until symptom control, then titrate to lowest effective dosage to maintain control
Maintenance: 1 to 2 inhalations once or twice daily (maximum: 8 inhalations/day as temporary treatment in periods of worsening asthma)
Symbicort Maintenance and Reliever Therapy (Symbicort SMART) [Canadian product]: Dry powder inhaler:
Maintenance: Symbicort 100 Turbuhaler or Symbicort 200 Turbuhaler: 1 to 2 inhalations twice daily or 2 inhalations once daily
Reliever therapy: Symbicort 100 Turbuhaler or Symbicort 200 Turbuhaler: 1 additional inhalation as needed, may repeat if no relief for up to 6 inhalations total (maximum: 8 inhalations/day)
Budesonide 160 mcg/formoterol 4.5 mcg: Metered dose inhaler: 2 inhalations twice daily (maximum: 2 inhalations twice daily)
Symbicort 200 Turbuhaler [Canadian product]: Dry powder inhaler: 2 inhalations twice daily (maximum: 2 inhalations twice daily)
Refer to adult dosing.
Note: If asthma symptoms occur in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Children 6 to 11 years: Budesonide 80 mcg/formoterol 4.5 mcg: Metered dose inhaler: 2 inhalations twice daily (maximum: 2 inhalations twice daily). Note: The guidelines recommend use in children 5 to 11 years (NAEPP 2007).
Children ≥12 years and Adolescents: Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution and monitor closely; may lead to accumulation of budesonide and formoterol.
Metered-dose inhaler: For oral inhalation only administered every morning and evening, approximately 12 hours apart. Prior to first use, inhaler must be primed by releasing 2 test sprays into the air; shake well for 5 seconds before each spray. Inhaler must be reprimed if not used for >7 days or if it has been dropped. Shake well for 5 seconds before each use. Discard inhaler after the labeled number of inhalations have been used or within 3 months after removal from foil pouch. Rinse mouth with water (spit out without swallowing) after each use. Do not wash inhaler with water; clean mouthpiece using a dry wipe every 7 days.
Delivery of dose: Instruct patient to place mouthpiece gently between teeth, closing lips around inhaler. Instruct patient to inhale deeply, press the top counter, and hold breath for up to 10 seconds or as long as they comfortably can. Remove mouthpiece from mouth prior to exhalation. Patient should not breathe out through the mouthpiece. Wait ≥30 seconds prior to the second inhalation dose.
Dry powder inhaler: Symbicort Turbuhaler [Canadian product]:
To “load” inhaler: Turn red grip on inhaler as far as it will move in one direction, then turn in opposite direction as far as it will go (inhaler is “loaded” with a dose, indicated by a “click”). Prior to first use, this procedure should be done twice, it does not need to be repeated with subsequent uses even when not used regularly.
Delivery of dose: Instruct patient to place mouthpiece gently between teeth, closing lips around inhaler. Instruct patient to inhale deeply and hold breath for as long as they comfortably can. Remove mouthpiece prior to exhalation. Patient should not breathe out through the mouthpiece. Dose is lost if patient drops, shakes, or exhales into inhaler after a dose has been loaded. After use of the inhaler, patient should rinse mouth/oropharynx with water and spit out rinse solution. Do not wash inhaler with water; clean mouthpiece using a dry wipe every 7 days.
Symbicort 80/4.5, Symbicort 160/4.5: Store at 20°C to 25°C (68°F to 77°F) with mouthpiece down; temperatures above 49°C (120°F) may cause bursting. Contents under pressure; do not puncture, incinerate, or store near heat or open flame. Discard inhaler after the labeled number of inhalations have been used (the dose counter will read “0”) or within 3 months after removal from foil pouch.
Symbicort Turbuhaler [Canadian product]: Store at room temperature of 15°C to 30°C (59°F to 77°F).
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy
Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy
Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Formoterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Formoterol. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy
Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Oral Inhalation). Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Inhalational Anesthetics: May enhance the arrhythmogenic effect of Formoterol. Monitor therapy
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Long-Acting Beta2-Agonists: May enhance the adverse/toxic effect of other Long-Acting Beta2-Agonists. Avoid combination
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination
MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification
Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Telaprevir: May increase the serum concentration of Budesonide (Oral Inhalation). Management: Concomitant use of these agents is not recommended, unless the risk for excessive systemic corticosteroid effects is outweighed by the potential benefits. If combined, monitor patients closely for signs and symptoms of corticosteroid excess/toxicity. Consider therapy modification
Theophylline Derivatives: May enhance the adverse/toxic effect of Formoterol. Theophylline Derivatives may enhance the hypokalemic effect of Formoterol. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
Note: Percentage of adverse events may be dose related; causation not established. Also see individual agents.
Central nervous system: Headache (7% to 11%)
Respiratory: Nasopharyngitis (7% to 11%), upper respiratory tract infection (4% to 11%)
1% to 10%:
Central nervous system: Dizziness (<3%)
Gastrointestinal: Abdominal distress (1% to 7%), oral candidiasis (1% to 6%), vomiting (1% to 3%)
Infection: Influenza (2% to 3%)
Neuromuscular & skeletal: Back pain (2% to 3%)
Respiratory: Pharyngolaryngeal pain (6% to 9%), lower respiratory tract infection (3% to 8%), sinusitis (4% to 6%), bronchitis (5%), nasal congestion (3%)
<1% (Limited to important or life-threatening): Agitation, anaphylaxis, angina pectoris, angioedema, anxiety, atrial arrhythmia, behavioral changes, bronchospasm, bruise, cataract, cough, decreased linear skeletal growth rate (pediatric patients), depression, dermatitis, extrasystoles, glaucoma, hypercorticoidism signs and symptoms, hyperglycemia, hypersensitivity reaction, hypertension, hypokalemia, hypotension, immunosuppression, increased intraocular pressure, insomnia, muscle cramps, nausea, nervousness, palpitations, pruritus, restlessness, skin rash, tachycardia, throat irritation, tremor, urticaria, ventricular arrhythmia, voice disorder
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Do not use this product to transfer patients from oral corticosteroid therapy.
• Asthma-related deaths: [US Boxed Warning]: Long-acting beta2-agonists (LABAs), such as formoterol, increase the risk of asthma-related deaths; budesonide/formoterol should only be used in patients not adequately controlled on other long-term asthma control medication (ie, inhaled corticosteroid) or whose disease severity requires initiation of 2 maintenance therapies. In a large, randomized, placebo-controlled US clinical trial (SMART, 2006), salmeterol was associated with an increase in asthma-related deaths (when added to usual asthma therapy); risk is considered a class effect among all LABAs. Data are not available to determine if the addition of an inhaled corticosteroid lessens this increased risk of death associated with LABA use; however, current guidelines recommend the use of an inhaled corticosteroid before adding a LABA (GINA 2015; NIH/NHLBI 2007). Assess patients at regular intervals once asthma control is maintained on combination therapy to determine if step-down therapy is appropriate (without loss of asthma control), and the patient can be maintained on an inhaled corticosteroid only. LABAs are not appropriate in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. In a more recent multicenter, randomized, double-blinded trial, the use of salmeterol and an inhaled corticosteroid (ie, fluticasone) combined in a single inhaler in a large number of children, adolescent, and adult patients with persistent asthma (non-life threatening and stable) did not increase the risk of serious asthma-related events compared with fluticasone alone; in addition, patients receiving fluticasone/salmeterol had fewer severe asthma exacerbations compared with patients receiving fluticasone alone (Peters 2016; Stempel 2016a; Stempel 2016b ).
• Bone density: Long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density. Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); high doses and/or long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.
• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use if possible in patients with ocular herpes; active or quiescent tuberculosis infections of the respiratory tract; or untreated viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin or pooled intravenous immunoglobulin may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. If exposure to measles, prophylaxis with pooled intramuscular immunoglobulin may be indicated.
• Lower respiratory infections: Pneumonia and other lower respiratory tract infections have been reported in patients with COPD following the use of inhaled corticosteroids; monitor COPD patients closely since pneumonia symptoms may overlap symptoms of exacerbations.
• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while either continuing or interrupting (if necessary) budesonide/formoterol therapy.
• Serious effects/fatalities: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.
• Asthma: Appropriate use: Do not use for acute bronchospasm. Short-acting beta2-agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments. Do not initiate in patients with significantly worsening or acutely deteriorating asthma.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, or hypertension); beta agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2- agonists may also increase risk of arrhythmias and electrocardiogram (ECG) changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.
• COPD: Appropriate use: Do not use for acute episodes of COPD. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Data are not available to determine if LABA use increases the risk of death in patients with COPD.
• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Hepatic impairment: Use with caution in patients with hepatic impairment; may lead to accumulation of budesonide and formoterol; monitor closely.
• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium (transient).
• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.
• Seizure disorders: Use with caution in patients with seizure disorders; beta agonists may result in CNS stimulation/excitation.
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroidism.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult Drug Interactions for more detailed information.
• Pediatric: [US Boxed Warning]: LABAs may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.
• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose; consider reducing the daily prednisone dose by 2.5 mg on a weekly basis beginning after at least 1 week of inhalation therapy. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal.
FEV1, peak flow meter and/or other pulmonary function tests; monitor growth in pediatric patients, symptom relief, monitor for increased use if short-acting beta2-adrenergic agonists (may be a sign of asthma or COPD deterioration); HPA axis suppression; bone mineral density; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium
Adverse events were observed in animal reproduction studies using this combination. Refer to individual agents.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience pharyngitis, throat pain, back pain, abdominal pain, or rhinitis. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), angina, tachycardia, anxiety, mouth sores, bone pain, dizziness, passing out, seizures, severe headache, tremors, severe nausea, vomiting, severe loss of strength and energy, insomnia, burning or numbness feeling, flu-like signs, sinusitis, vision changes, eye pain, severe eye irritation, thrush, or signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about budesonide/formoterol
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- En Español
- 108 Reviews – Add your own review/rating
- Drug class: bronchodilator combinations
- Budesonide and Formoterol
- Budesonide and formoterol inhalation
- Budesonide and formoterol Inhalation (Advanced Reading)
Other brands: Symbicort