Version May 2024
Dosage guidance:
Dosing: The maximum dose is based on the formoterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher budesonide dose per inhalation must be prescribed.
Asthma:
Asthma, intermittent symptom relief or acute exacerbations (mild to moderate):
Note: Based on asthma severity, this regimen can be used as a reliever only or as part of a maintenance/controller PLUS reliever regimen (MART therapy). Patients with worsening symptoms despite initial care should seek immediate medical attention. A valved holding chamber (spacer) is recommended for use with a metered-dose inhaler (Ref).
Metered-dose inhaler (off-label use):
Budesonide 80 mcg/formoterol 4.5 mcg or budesonide 160 mcg/formoterol 4.5 mcg: Oral Inhalation: 1 to 2 inhalations every 4 hours as needed. For persistent symptoms, may administer up to 2 inhalations every 20 minutes for 3 doses; the need for more frequent dosing suggests an incomplete response and may require further medical attention (Ref). Maximum dose: 12 inhalations/day (including maintenance therapy) (Ref); some experts limit to no more than 6 inhalations per hour for management of home exacerbations (Ref).
Dry powder inhaler [Canadian products]:
Mild persistent asthma, inhaler used as reliever therapy only: Symbicort 200 Turbuhaler (budesonide 200 mcg/formoterol 6 mcg): Oral inhalation: Initial: 1 to 2 inhalations, as needed, every 4 hours. For persistent symptoms, may administer up to 2 inhalations every 20 minutes for 3 doses; the need for more frequent dosing suggests an incomplete response and may require further medical attention. Maximum dose (based on delivered dose): 12 inhalations/day (including maintenance therapy) (Ref); some experts limit to no more than 6 inhalations per hour for management of home exacerbations (Ref).
Moderate to severe asthma, reliever therapy (as part of a combined maintenance/reliever protocol using the same inhaler): Symbicort 100 Turbuhaler or Symbicort 200 Turbuhaler (budesonide 100 mcg/formoterol 6 mcg or 200 mcg/formoterol 6 mcg): Oral inhalation: Initial: 1 to 2 inhalations as needed every 4 hours. For persistent symptoms, may administer up to 2 inhalations every 20 minutes for 3 doses; the need for more frequent dosing suggests an incomplete response and may require further medical attention. Maximum dose (based on delivered dose): 12 inhalations/day (including maintenance therapy) (Ref); some experts limit to no more than 6 inhalations per hour for management of home exacerbations (Ref).
Asthma, maintenance/controller: Note: May be used as maintenance/controller only or as part of a maintenance/controller PLUS reliever regimen (MART therapy). A valved holding chamber (spacer) is recommended for use with a metered-dose inhaler (Ref). Product selection: Individualize daily budesonide dose based on severity of symptoms, typically as follows: low doses for mild persistent asthma; low to medium doses for moderate persistent asthma; and medium to high doses for severe persistent asthma. Select a product with a favorable dosage per actuation to improve convenience and adherence (Ref). Safety: The recommended dosage range and maximum dose for each inhaler is based on the formoterol component; do NOT adjust the number of inhalations to change the corticosteroid dose; use an alternative inhaler (Ref).
|
Low dose |
Medium dose |
High dose | |
|---|---|---|---|
|
Budesonide |
200 to 400 mcg/day |
>400 to 800 mcg/day |
Use noncombination budesonide inhaler. |
Usual dosage ranges, mild to moderate:
Metered-dose inhaler:
Budesonide 80 mcg/formoterol 4.5 mcg: Oral inhalation: 2 inhalations twice daily; maximum dose: 12 inhalations/day (including reliever therapy) (Ref).
Budesonide 160 mcg/formoterol 4.5 mcg: Oral inhalation: 2 inhalations twice daily; maximum dose: 12 inhalations/day (including reliever therapy) (Ref).
Dry powder inhaler (Canadian products):
Symbicort 100 or 200 Turbuhaler: Budesonide 100 mcg/formoterol 6 mcg or 200 mcg/formoterol 6 mcg: Oral inhalation: 1 to 2 inhalations twice daily or 2 inhalations once daily; maximum dose: 12 inhalations/day (including reliever therapy).
Symbicort Forte Turbuhaler: Budesonide 400 mcg/formoterol 12 mcg: Oral inhalation: 1 inhalation once or twice daily; during periods of worsening symptoms, may temporarily increase to 2 inhalations twice daily; maximum dose: 4 inhalations/day.
Titration: For patients whose symptoms are not adequately controlled after 2 to 4 weeks of therapy, may increase controller therapy in a step-wise fashion. For patients whose symptoms are well controlled for 3 to 6 months on a stable regimen, may reduce controller therapy in a step-wise fashion (Ref).
Chronic obstructive pulmonary disease, maintenance: Note: Use of long-acting beta agonist and inhaled corticosteroid is not encouraged. In patients with persistent exacerbations on dual long-acting bronchodilator therapy or elevated eosinophil count (Group E), consider triple therapy (inhaled corticosteroid, long-acting beta agonist, and long-acting muscarinic antagonist). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Budesonide 160 mcg/formoterol 4.5 mcg (Breyna, Symbicort): Metered-dose inhaler: Oral inhalation: 2 inhalations twice daily.
Budesonide 160 mcg/formoterol 4.8 mcg (Symbicort Aerospheres): Metered-dose inhaler: Oral inhalation: 2 inhalations twice daily.
Budesonide 200 mcg/formoterol 6 mcg (Symbicort 200 Turbuhaler [Canadian product]): Dry powder inhaler: Oral inhalation: 2 inhalations twice daily.
Budesonide 400 mcg/formoterol 12 mcg (Symbicort Forte Turbuhaler [Canadian product]): Dry powder inhaler: Oral inhalation: 1 inhalation twice daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
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.
Refer to adult dosing.
(For additional information see "Budesonide and formoterol: Pediatric drug information")
Asthma, maintenance treatment:
Breyna, Symbicort: Metered-dose inhaler: Note: Do not administer more than 2 inhalations twice daily for maintenance treatment. The maximum maintenance dose is based on the formoterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher budesonide dose per inhalation must be prescribed. If asthma symptoms occur in the period between doses, consider an inhaled, short-acting beta-2 agonist for immediate relief.
Children 5 to <12 years (limited data available for <6 years): Budesonide 80 mcg/formoterol 4.5 mcg: Oral inhalation: 2 inhalations twice daily (Ref).
Children ≥12 years and Adolescents: Note: Initial dose prescribed should be based upon asthma severity and risk of exacerbation:
Budesonide 80 mcg/formoterol 4.5 mcg: 2 inhalations twice daily. If adequate response is not seen after 1 to 2 weeks, consider the higher dose combination.
Budesonide 160 mcg/formoterol 4.5 mcg: 2 inhalations twice daily.
Symbicort 100 Turbuhaler, Symbicort 200 Turbuhaler [Canadian products]: Children ≥12 years and Adolescents: Dry powder inhaler: Oral inhalation:
Maintenance therapy:
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; may increase to 4 inhalations twice daily as temporary treatment in periods of worsening asthma; maximum daily dose: 8 inhalations/day.
Symbicort Maintenance and Reliever Therapy (Symbicort SMART) [Canadian product]:
Maintenance: 1 to 2 inhalations twice daily or 2 inhalations once daily.
Reliever therapy: 1 additional inhalation as needed, may repeat if no relief for up to 6 inhalations total; maximum daily dose: 8 inhalations/day.
Asthma, acute exacerbation: Note: Based on asthma severity, this regimen is for use when patient is on budesonide/formoterol as maintenance to allow for a single inhaler for both maintenance PLUS reliever; the benefit seems to be greatest with very early signs of exacerbation (Ref). GINA guideline and study dosing is based on the dry powder inhaler product (Turbuhaler); dry powder inhaler not available in US. Limited data available:
Children 4 to 11 years: Budesonide 80 mcg/formoterol 4.5 mcg: Dry powder inhaler: Oral inhalation:
Maintenance: 1 inhalation once daily at bedtime (Ref).
Reliever therapy: 1 inhalation as needed; may repeat if no relief; maximum daily dose: 8 inhalations/day (including maintenance dose) (Ref).
Children ≥12 years and Adolescents: Budesonide 80 mcg/formoterol 4.5 mcg: Dry powder inhaler: Oral inhalation:
Maintenance: 1 inhalation twice daily or 2 inhalations once daily at bedtime (Ref).
Reliever therapy: 1 inhalation as needed; may repeat if no relief; maximum daily dose: 11 inhalations/day (including maintenance dose) (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported incidences are for adolescents and adults unless specified otherwise. Also see individual agents.
>10%:
Nervous system: Headache (3% to 11%; children: ≥3%)
Respiratory: Nasopharyngitis (7% to 11%), upper respiratory tract infection (including viral upper respiratory tract infection: 4% to 11%; children: ≥3%)
1% to 10%:
Cardiovascular: Hypertension (adults: 2%)
Gastrointestinal: Abdominal distress (7%), diarrhea (adults: 2%), oral candidiasis (1% to 6%), vomiting (3%)
Infection: Influenza (2% to 3%)
Nervous system: Voice disorder (2%)
Neuromuscular & skeletal: Back pain (2% to 3%), muscle spasm (2%)
Respiratory: Cough (adults: 2%), nasal congestion (3%), pharyngitis (children: ≥3%), pharyngolaryngeal pain (6% to 9%), pulmonary infection (adults with COPD: 8%; including bronchitis [2% to 5%], lower respiratory tract infection [viral]), rhinitis (children: ≥3%), sinusitis (4% to 6%)
Postmarketing (any age population):
Cardiovascular: Angina pectoris, atrial arrhythmia (including atrial fibrillation), extrasystoles, hypotension, palpitations, tachycardia, ventricular arrhythmia
Endocrine & metabolic: Hypercorticoidism signs and symptoms, hyperglycemia, hypokalemia
Gastrointestinal: Nausea
Hematologic & oncologic: Bruise
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema, type 1 hypersensitivity reaction, type IV hypersensitivity reaction)
Nervous system: Agitation, behavioral changes, depression, dizziness, nervousness, restlessness, sleep disturbance, tremor
Neuromuscular & skeletal: Linear skeletal growth rate below expectation, muscle cramps
Ophthalmic: Cataract, glaucoma, increased intraocular pressure
Respiratory: Oropharyngeal candidiasis, throat irritation
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 (Breyna, Symbicort).
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to inhaled lactose.
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. Adult 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: The use of long-acting beta-2 agonists (LABAs) as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART 2006; Walters 2007); additional data from other clinical trials suggests risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma-related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (aged 4 to 11 years) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017).
• 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, antiseizure medications, 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; tuberculosis (TB) infection (latent TB) or disease (active TB) 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.
Disease-related concerns:
• Asthma: Appropriate use: For acute asthma exacerbations, budesonide/formoterol is preferred as a reliever; however, short-acting beta-2 agonists (SABAs) may be used. In patients presenting to primary care or acute care facility, SABAs are recommended for the acute management of exacerbations (GINA 2023).
• 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. Beta-2 agonists may also increase risk of arrhythmias and 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; beta-2 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; beta-2 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.
Special populations:
• Pediatric: LABAs when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone. 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.
Other warnings/precautions:
• 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.
Symbicort Aerosphere: FDA approved April 2023; anticipated availability is unknown.
Symbicort 6.9 g canisters contain 60 actuations, and the 10.2 g canisters contain 120 actuations.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, Inhalation:
Breyna: Budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.3 g); Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.3 g)
Symbicort: Budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (6.9 g, 10.2 g); Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (6 g, 10.2 g)
Generic: Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.2 g); Budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg per actuation (10.2 g)
Yes
Aerosol (Breyna Inhalation)
80-4.5 mcg/ACT (per gram): $37.81
160-4.5 mcg/ACT (per gram): $43.22
Aerosol (Budesonide-Formoterol Fumarate Inhalation)
80-4.5 mcg/ACT (per gram): $34.56
160-4.5 mcg/ACT (per gram): $39.51
Aerosol (Symbicort Inhalation)
80-4.5 mcg/ACT (per gram): $24.07
160-4.5 mcg/ACT (per gram): $31.84
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol Powder Breath Activated, Inhalation:
Symbicort 100 Turbuhaler: Budesonide 100 mcg and formoterol fumarate 6 mcg per inhalation (1 ea) [contains lactose]
Symbicort 200 Turbuhaler: Budesonide 200 mcg and formoterol fumarate 6 mcg per inhalation (1 ea) [contains lactose]
Symbicort Forte Turbuhaler: Budesonide 400 mcg and formoterol fumarate 12 mcg per inhalation (1 ea) [contains lactose]
Metered-dose inhaler:
Symbicort Aerospheres: For oral inhalation only, administered every morning and evening, approximately 12 hours apart. Prior to first use, inhaler must be primed by releasing 4 tests sprays into the air; shake well before each spray. Inhaler must be reprimed with 2 sprays if not used for >7 days, it has been dropped, or after weekly cleaning. Shake well 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. Clean inhaler once weekly; remove canister from actuator; do not clean or allow canister to get wet. With the cap removed hold the actuator under warm tap water for ~30 seconds; turn actuator upside down and run warm tap water through for about another 30 seconds. Shake actuator well and ensure medicine build-up has been completely washed away; repeat rinsing with water if medicine build-up still remains. Allow actuator to dry (eg, overnight); do not put canister into a wet actuator.
Breyna, Symbicort: 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.
Oral inhalation: Rinse mouth with water after use and spit to reduce risk of oral candidiasis.
Metered-dose inhaler: Prior to first use, inhaler must be primed by releasing 2 test sprays into the air (away from the face); shake well for 5 seconds before each spray. Inhaler must be reprimed if inhaler has not been used for >7 days or has been dropped. Shake well for 5 seconds before each use. Discard after labeled number of inhalations has been used or within 3 months after foil wrap has been removed; do not use immerse in water or use "float test" to determine number of inhalations left.
Dry powder inhaler: Symbicort Turbuhaler [Canadian product]: To prepare inhaler prior to use, remove cover and hold the inhaler in upright position and turn the red grip as far as it will go in one direction and then turn it as far as it will go in the other direction. Prior to first use, this procedure should be done twice; with subsequent dosing, perform this procedure once even when not used regularly. Clicking sound means inhaler is loaded with dose and ready for use. Place mouthpiece between teeth and close lips over mouthpiece. Inhale deeply and forcefully. Do not exhale through inhaler. If the Turbuhaler is dropped, shaken, or breathed into after it is loaded, the dose will be lost and a new dose will need to be loaded. When the "0" on the red background has reached the middle of the window, the inhaler should be discarded. Do not wash inhaler with water; clean mouthpiece using a dry wipe every 7 days.
Asthma: Treatment of asthma in patients ≥6 years of age.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce COPD exacerbations.
Budesonide 160 mcg/formoterol 4.5 mcg and budesonide 160 mcg/formoterol 4.8 mcg are the only strengths indicated for treatment of COPD.
Asthma, reliever for acute exacerbations
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: 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. Risk C: Monitor therapy
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: Avoid combination
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. Risk C: Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination
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. Risk C: Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Cocaine (Topical): 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. Risk D: Consider therapy modification
Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Oral Inhalation). Management: Consider alternatives to this combination when possible. If combined, monitor for increased corticosteroid adverse effects during coadministration of inhaled budesonide and strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination
Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: 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. Risk X: Avoid combination
Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Nirmatrelvir and Ritonavir: May increase the serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor therapy
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy
Adverse events were observed in animal reproduction studies using this combination. Refer to individual monographs.
Budesonide is present in breast milk; excretion of formoterol is not known.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Refer to individual monographs.
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
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.
See individual agents.
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