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Bronchodilator

Budesonide / Formoterol

Brand names: Symbicort, DuoResp Spiromax, Fobumix

This is a fixed-dose inhaler of the inhaled corticosteroid budesonide with the long-acting beta-2 agonist formoterol, used for maintenance asthma and COPD treatment and, in asthma, as combined maintenance and reliever therapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: All doses are inhalations of DuoResp Spiromax 160/4.5 micrograms. ASTHMA - B. maintenance and reliever therapy (MART), adults and adolescents 12 years and older: maintenance 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening; for some patients a maintenance dose of 2 inhalations twice daily may be appropriate; plus 1 additional inhalation as needed in response to symptoms, and if symptoms persist after a few minutes an additional inhalation. ASTHMA - A. maintenance therapy (with a separate rapid-acting reliever inhaler), adults 18 years and older: 1-2 inhalations twice daily. ASTHMA - C. reliever therapy in mild asthma, adults and adolescents 12 years and older: 1 inhalation as needed in response to symptoms, and if symptoms persist after a few minutes an additional inhalation. COPD, adults 18 years and older: 2 inhalations twice daily.
Route: Inhalation use only, via the Spiromax breath-actuated inspiratory-flow-driven dry powder inhaler (open, breathe, close). Do not shake the inhaler before use; breathe in forcefully and deeply through the mouthpiece and hold the breath for 10 seconds or as long as comfortable.
Frequency: Asthma MART: a daily maintenance dose (2 inhalations per day, or 2 inhalations twice daily in some patients) plus as-needed inhalations. Asthma maintenance therapy: twice daily, with titration to once daily possible once control is achieved. COPD: twice daily.
Max: Asthma maintenance and reliever therapy (MART) and reliever therapy, SPC 4.2 verbatim: 'Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.' Absolute ceiling therefore 12 inhalations of DuoResp Spiromax 160/4.5 in a day (limited period only), and 6 inhalations on any single occasion. For asthma maintenance therapy the separate ceiling is 4 inhalations twice daily - SPC 4.2: 'Some patients may require up to a maximum of 4 inhalations twice daily.' Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice and be reassessed.
STRENGTH: each inhalation of the sourced product delivers budesonide 160 micrograms with formoterol fumarate dihydrate 4.5 micrograms - both components of the fixed combination are quantified by the product name. || SPC 4.2 verbatim, MART: 'Patients take a daily maintenance dose of DuoResp Spiromax and in addition take DuoResp Spiromax as needed in response to symptoms. Patients should be advised to always have DuoResp Spiromax available for rescue use.' MART 'should especially be considered for patients with: inadequate asthma control and in frequent need of a reliever inhaler; asthma exacerbations in the past requiring medical intervention.' 'Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of DuoResp Spiromax as-needed inhalations.' || SPC 4.2 verbatim, maintenance therapy: 'Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.' 'Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.' || TITRATION: 'The dose should be titrated to the lowest dose at which effective control of symptoms is maintained'; when it is appropriate to titrate down to a lower strength than is available for DuoResp Spiromax, change to an alternative fixed-dose combination containing a lower dose of inhaled corticosteroid. 'It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly' (SPC 4.4). || The reliever inhalations 'are not intended for regular prophylactic use, e.g. before exercise'; prophylactic use before exercise has not been studied (SPC 4.4). 'In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used.' || 'Patients should not be initiated on DuoResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma' (SPC 4.4). || Advise patients to rinse the mouth with water after inhaling. Elderly (>=65 years): 'There are no special dosing requirements for elderly patients.' A written personal asthma action plan is recommended for all patients with asthma.

Paediatric dose

Route: Inhalation use only, via the Spiromax dry powder inhaler
Frequency: Twice daily for maintenance therapy; MART maintenance plus as-needed inhalations for adolescents 12 years and older
Max: Adolescents 12 years and older on maintenance and reliever therapy or reliever therapy, SPC 4.2 verbatim: 'Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.'
NOT A PER-KG OR PER-M2 DRUG - dosing is by age band and inhalation count, so dosePerKg is deliberately null and concentration is not applicable to a dry powder inhaler. AGE BANDS (SPC 4.2, verbatim): maintenance therapy - 'Adolescents (12 years to 17 years): 1-2 inhalations twice daily'; maintenance and reliever therapy and reliever therapy - 'Adults and adolescents (12 years and older)' as for adults (MART maintenance 2 inhalations per day, or 2 inhalations twice daily in some patients, plus 1 additional inhalation as needed). UNDER 12 YEARS - NOT RECOMMENDED, all three approaches: 'DuoResp Spiromax maintenance therapy is not recommended for children', 'DuoResp Spiromax maintenance and reliever therapy is not recommended for children', 'DuoResp Spiromax reliever therapy is not recommended for children' (children under 12 years), and SPC 4.2: 'The safety and efficacy of DuoResp Spiromax in paediatric patients below 12 years of age have not been established. No data are available. This medicinal product is not recommended for use in children under the age of 12 years.' Verify any paediatric use against a children's formulary.

Dose adjustments

Renal

SPC 4.2, verbatim: 'There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.' No numeric renal dose adjustment is given.

Hepatic

SPC 4.2, verbatim: 'There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.' No numeric hepatic dose adjustment is given.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to the excipient - the only contraindication in SPC 4.3, verbatim: 'Hypersensitivity to the active substances or the excipient listed in section 6.1.' (the inhalation powder contains lactose)
  • Not a contraindication but an initiation bar (SPC 4.4): 'Patients should not be initiated on DuoResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.'
  • Not a contraindication but a use restriction (SPC 4.2, 4.4): maintenance therapy, maintenance and reliever therapy and reliever therapy are all 'not recommended for children' under 12 years; safety and efficacy below 12 years have not been established
  • Not a contraindication but a stop rule (SPC 4.4/4.8): paradoxical bronchospasm is a very rare reported reaction; sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and requires urgent medical assessment

Side effects

  • Common (SPC 4.8): candida infections in the oropharynx; pneumonia (in COPD patients); headache, tremor; palpitations; mild irritation in the throat, coughing, dysphonia including hoarseness
  • Uncommon (SPC 4.8): aggression, psychomotor hyperactivity, anxiety, sleep disorders; dizziness; blurred vision; tachycardia; nausea; bruises; muscle cramps
  • Rare (SPC 4.8): immediate and delayed hypersensitivity reactions e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction; hypokalaemia; cardiac arrhythmias e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles; bronchospasm
  • Very rare (SPC 4.8): Cushing's syndrome, adrenal suppression, growth retardation, decrease in bone mineral density; hyperglycaemia; depression, behavioural changes (predominantly in children); taste disturbances; cataract and glaucoma; angina pectoris, prolongation of the QTc interval; variations in blood pressure; paradoxical bronchospasm
  • SPC 4.8: 'The most common adverse reactions are pharmacologically predictable adverse reactions of beta-2 adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.'
  • In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6% respectively, compared with 4% and 3% in the placebo group (SPC 4.8)
  • Candida infection in the oropharynx is due to active substance deposition; advising the patient to rinse the mouth out with water after each dose will minimise the risk (SPC 4.8)
  • Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods (SPC 4.4)

Monitoring

  • Regular reassessment by the prescriber so that the dose remains optimal and is titrated to the lowest dose maintaining effective control of symptoms (SPC 4.2, 4.4)
  • Close monitoring for dose-related adverse reactions in patients who frequently take high numbers of as-needed inhalations (SPC 4.2)
  • Reliever use as a control marker: patients using more than 8 inhalations daily should be reassessed and their maintenance therapy reconsidered; increasing use of a separate rapid-acting bronchodilator indicates worsening disease and warrants reassessment of asthma therapy (SPC 4.2)
  • Regular review as treatment is stepped down; taper rather than stop abruptly (SPC 4.4)
  • Inhaler technique with the Spiromax device, and mouth rinsing with water after inhaling (SPC 4.2, 4.4)
  • Watch for deterioration - seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation; sudden and progressive deterioration in asthma or COPD control requires urgent medical assessment (SPC 4.4)
  • For patients on reliever therapy only, assessment at regular intervals according to local practice to determine whether as-needed treatment remains optimal or whether regular scheduled inhaled corticosteroid maintenance should be initiated (SPC 4.2)

Clinical monograph

How it works

Budesonide reduces airway inflammation via glucocorticoid receptors while formoterol, a rapid-onset long-acting beta-2 agonist, relaxes bronchial smooth muscle.

Prescribing in practice

  • Most important: in asthma a long-acting beta-2 agonist must always be paired with an inhaled corticosteroid, so this combination should replace any separate LABA, and where used as maintenance-and-reliever therapy the single-inhaler regimen must be clearly understood.
  • Do not co-prescribe an additional separate LABA, and ensure patients on a MART regimen do not also use a separate short-acting reliever inappropriately.
  • Prescribe by brand and device because budesonide/formoterol products are not all interchangeable.

Monitoring

Monitor asthma or COPD control, reliever use, inhaler technique, oral candidiasis, and growth in children on long-term inhaled corticosteroid.

Counselling the patient

  • Rinse the mouth after dosing to reduce oral thrush.
  • Follow the prescribed regimen carefully, especially if this inhaler is both preventer and reliever.

Evidence & guidelines

Budesonide/formoterol maintenance and reliever therapy is supported by randomised trials and endorsed in GINA and NICE asthma guidance.

Reference: BTS/SIGN Asthma 2023; NICE NG80 Asthma; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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