Inhaled corticosteroid in fixed combination with long-acting β₂-agonistTWO DISTINCT REGIMENS

Budesonide/formoterol

Symbicort Turbuhaler · Bufomix Easyhaler · DuoResp Spiromax

Formoterol is the only long-acting β₂-agonist with onset within a few minutes, and that property is precisely what makes the combination useful both as maintenance and as reliever therapy. The product can therefore be prescribed in two entirely different ways: as a fixed dose morning and evening with a separate SABA as needed, or as maintenance-and-reliever therapy in the same inhaler. The two regimens must never be confused — this is the most common prescribing error with this drug.

BOXED WARNING

With maintenance-and-reliever therapy, the patient should seek care if more than 8 inhalations per day are needed; this signals a developing exacerbation. Symbicort forte 320/9 is not approved as reliever medication. Inhaled corticosteroid must never be discontinued while LABA continues.

Dosing in adults

By indicationuppdaterad 2026-08-22
IndicationRegimenComment
Asthma, fixed maintenance dose160/4,5 μg: 1–2 inhalations × 2, plus separate SABA as neededthe reliever is a different drug in this regimen
Asthma, maintenance and reliever (MART)160/4,5 μg: 2 inhalations/day as maintenance, plus 1 inhalation for symptoms; normally maximum 8 per day, temporarily up to 12, never more than 6 at one timeno separate SABA should be prescribed in parallel
Asthma, high maintenance dose320/9 μg: 1 inhalation × 2, if needed 2 inhalations × 2fixed dosing — combined with separate SABA
COPD320/9 μg: 1 inhalation × 2only if FEV₁ below 70 % and repeated exacerbations
Dose reductionReduce to lowest dose that keeps the patient symptom-free for 3 monthsnever discontinue the steroid component and keep LABA
Renal impairment

No established dose adjustment.

Hepatic impairment

No formal dose adjustment, but budesonide exposure increases in severe hepatic impairment — use the lowest effective dose.

Children

From 6 years: 80/4,5 μg 1–2 inhalations × 2 as fixed maintenance. Maintenance-and-reliever therapy with 160/4,5 μg approved from 12 years.

Pitfall

Always instruct mouth rinsing after inhalation and avoid prescribing to a patient who has not had technique and regimen demonstrated. The classic trap is a patient on MART who still has their old salbutamol prescription — this eliminates the entire point of the regimen and the steroid dose that should follow the symptoms is missing.

Pharmacokinetics

ONSET (formoterol)
1–3 minutes
DURATION (formoterol)
12 hours
t½ BUDESONIDE
2–3 hours
t½ FORMOTEROL
8–10 hours
BIOAVAIL.
approximately 40 % of inhaled dose systemically
METABOLISM
Budesonide via CYP3A4; formoterol via glucuronidation
EXCRETION
Renal (metabolites)
FULL STEROID EFFECT
after 1–2 weeks of regular use

Adverse effects by frequency

≥ 10 %
Hoarseness, throat irritation, headache, tremor, palpitations
1–10 %
Oropharyngeal candidiasis, cough, muscle cramps, sleep disturbance, tachycardia
< 1 %
Adrenal suppression, paradoxical bronchospasm, hypokalaemia, arrhythmia, glaucoma and cataract