ICS + LABA combination inhaler
Pregnancy: During pregnancy, a fixed-dose combination of budesonide and formoterol should only be used when the benefits outweigh the potential risks, and the lowest effective dose of budesonide needed to maintain adequate asthma control should be used. Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk with inhaled budesonide; there are no adequate data on formoterol in pregnant women. Breast-feeding: budesonide is excreted in breast milk but at therapeutic doses no effects on the suckling child are anticipated; it is not known whether formoterol passes into human breast milk — administration to breast-feeding women should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Budesonide with formoterol
Brand names: Symbicort, DuoResp Spiromax, Fobumix
This is a combination inhaler of inhaled budesonide (corticosteroid) with formoterol (long-acting beta-2 agonist), used for maintenance treatment of asthma and COPD and, in asthma, as a single inhaler for both maintenance and relief.
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:Asthma, maintenance therapy (adults 18 years and older): 1-2 inhalations twice daily. COPD (adults 18 years and older): 2 inhalations twice daily. (Source product delivers budesonide 160 micrograms / formoterol fumarate 4.5 micrograms per inhalation)
Frequency: Twice daily (see notes for the maintenance-and-reliever and reliever-only regimens)
Max: Asthma maintenance therapy: some patients may require up to a maximum of 4 inhalations twice daily. Maintenance-and-reliever and reliever therapy: 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
Source: UK SPC (eMC) §4.2 for DuoResp Spiromax 160 micrograms/4.5 micrograms inhalation powder (https://www.medicines.org.uk/emc/product/3323/smpc). The SPC describes THREE treatment approaches in asthma. (A) MAINTENANCE THERAPY (with a separate rapid-acting bronchodilator reliever inhaler available at all times): adults 18 years and older 1-2 inhalations twice daily, some patients up to a maximum of 4 inhalations twice daily; adolescents 12 to 17 years 1-2 inhalations twice daily; when control is achieved on the twice daily regimen, titration to the lowest effective dose could include once-daily dosing. (B) MAINTENANCE AND RELIEVER THERAPY (adults and adolescents 12 years and older): recommended maintenance dose 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; patients take 1 additional inhalation as needed in response to symptoms and, if symptoms persist after a few minutes, an additional inhalation — not more than 6 inhalations on any single occasion. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice and have maintenance therapy reconsidered. (C) RELIEVER THERAPY (mild asthma, adults and adolescents 12 years and older): 1 inhalation as needed in response to symptoms, with an additional inhalation if symptoms persist after a few minutes; not more than 6 inhalations on any single occasion. COPD: 2 inhalations twice daily (adults 18 years and older). GENERAL: the dosage is individual and should be adjusted to disease severity; titrate to the lowest dose at which effective control of symptoms is maintained; all asthma patients should be provided with a written personal asthma action plan; the dose should be tapered rather than stopped abruptly. ELDERLY: no special dosing requirements for patients ≥ 65 years. PAEDIATRIC: maintenance, maintenance-and-reliever and reliever therapy are all 'not recommended for children' under 12 years; safety and efficacy in paediatric patients below 12 years of age have not been established (no data available) — no per-kg paediatric dose is stated, so paedDose is null; verify any under-12 use against a children's formulary. ADMINISTRATION: open, breathe (forcefully and deeply), close; do not shake the inhaler; patients should rinse their mouth with water after inhaling.
Dose adjustments
Renal
There are no data available for use of the fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment; as both are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis
Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — 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 listed in section 6.1
Side effects
Common: candida infections in the oropharynx and pneumonia (in COPD patients)
Common: headache and tremor; uncommon dizziness; very rare taste disturbances
Common: palpitations; uncommon tachycardia; rare cardiac arrhythmias e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles; very rare angina pectoris and QTc-interval prolongation
Common: mild irritation in the throat, coughing, dysphonia including hoarseness; rare bronchospasm; very rare paradoxical bronchospasm
Rare: hypokalaemia and hypersensitivity reactions (exanthema, urticaria, pruritus, dermatitis, angioedema, anaphylactic reaction); uncommon aggression, psychomotor hyperactivity, anxiety, sleep disorders, nausea, bruises, muscle cramps, blurred vision; very rare Cushing's syndrome, adrenal suppression, growth retardation, decrease in bone mineral density, cataract and glaucoma
Clinical monograph
How it works
Budesonide suppresses airway inflammation through glucocorticoid receptors while formoterol provides fast-onset, long-acting bronchodilation via beta-2 adrenoceptors.
Prescribing in practice
Most important: a long-acting beta-2 agonist must never be used alone in asthma, so this fixed inhaler should be the sole LABA source and the corticosteroid component taken reliably.
Where licensed for maintenance-and-reliever therapy, ensure the patient understands using the same inhaler for symptom relief and does not duplicate LABA therapy.
Prescribe by brand and confirm device-specific inhaler technique.
Monitoring
Monitor asthma or COPD control, inhaler technique, oral candidiasis, and childhood growth on long-term use.
Counselling the patient
Rinse the mouth after each dose to reduce oral thrush and hoarseness.
Use it exactly as prescribed, including any maintenance-and-reliever instructions.
Evidence & guidelines
ICS/LABA combinations including budesonide with formoterol are established maintenance and MART therapy in NICE and GINA guidance.
Reference: NICE NG80; BTS/SIGN; GINA; 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.
