LABA/LAMA/ICS triple inhaler Pregnancy: §4.6: no or limited data in pregnant women; data on inhaled budesonide in more than 2,500 exposed pregnancies indicate no increased teratogenic risk; very small amounts of glycopyrronium cross the placenta. 'Administration of this medicinal product to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.' Breast-feeding: inhaled budesonide is excreted in breast milk but was not detected in nursing infant blood (estimated infant plasma concentration <0.17% of maternal); excretion of glycopyrronium and formoterol in human milk is unknown — administer only if the expected benefit to the mother is greater than any possible risk to the child.

Formoterol with glycopyrronium and budesonide

Brand names: Trimbow

This pressurised metered-dose inhaler combines the long-acting beta2 agonist formoterol, the long-acting muscarinic antagonist glycopyrronium and the inhaled corticosteroid budesonide (Trixeo) as twice-daily triple maintenance therapy for COPD.

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: Two inhalations (two inhalations in the morning and two inhalations in the evening) of formoterol fumarate dihydrate 5 micrograms / glycopyrronium 7.2 micrograms / budesonide 160 micrograms per actuation

Route: Inhalation — pressurised metered dose inhaler (Trixeo Aerosphere); may be used with a spacer, including the Aerochamber Plus Flow-Vu, for patients who cannot co-ordinate actuation with inhalation — source product: Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension

Frequency: Twice daily (morning and evening)

Max: §4.2 verbatim: 'The recommended and maximum dose is two inhalations twice daily' — the recommended dose IS the maximum dose

SOURCE: eMC UK SPC, productName 'Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension' (https://www.medicines.org.uk/emc/product/12028/smpc), §4.2. MISSED DOSE (verbatim): 'If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.' ELDERLY: 'No dose adjustments are required in elderly patients.' HEPATIC IMPAIRMENT: can be used at the recommended dose in mild to moderate hepatic impairment, and in severe hepatic impairment only if the expected benefit outweighs the potential risk. PAEDIATRIC: no per-kg dose is stated, hence paedDose is null. §4.2 verbatim: 'There is no relevant use of this medicinal product in children and adolescents (under 18 years of age) for the indication of COPD.' ADMINISTRATION: prime by shaking and actuating into the air four times before first use, or twice if unused for more than seven days, after weekly washing, or if dropped; do not use if the drying agent has leaked out of its packet inside the foil pouch; allow the inhaler to reach room temperature before use; rinse mouth with water after inhaling (do not swallow) to minimise oropharyngeal thrush. NOT FOR ACUTE USE (§4.4): not indicated for treatment of acute episodes of bronchospasm, i.e. not a rescue therapy; treatment should not be stopped abruptly. SECTIONS NOT RETRIEVED: §4.5 (interactions) was not included in the fetched bundle, so no interaction list is given here — clinician to review the SPC. §4.4 and §4.8 were truncated at the fetch limit.

Dose adjustments

Renal

§4.2: 'This medicinal product can be used at the recommended dose in patients with mild to moderate renal impairment. It can also be used at the recommended dose in patients with severe renal impairment or end-stage renal disease requiring dialysis, only if the expected benefit outweighs the potential risk.' No dose reduction is specified.

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 any of the excipients listed in section 6.1 (§4.3)
Not indicated for the treatment of acute episodes of bronchospasm (not a rescue therapy) (§4.4)
Use with caution in clinically significant uncontrolled and severe cardiovascular disease — unstable ischaemic heart disease, acute myocardial infarction, cardiomyopathy, cardiac arrhythmias, severe heart failure — and in known or suspected QTc prolongation (QTc > 450 ms males, > 470 ms females) (§4.4)

Side effects

Pneumonia (4.6%), headache (2.7%) and urinary tract infection (2.7%) — the most commonly reported reactions; oral candidiasis (common)
Hyperglycaemia, anxiety, insomnia, palpitations, nausea, muscle spasms (common); dysphonia and cough (common)
Dizziness, tremor, angina pectoris, tachycardia and cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles) (uncommon)
Dry mouth, bruising, urinary retention, throat irritation, bronchospasm, chest pain (uncommon)
Paradoxical bronchospasm — may be life-threatening; discontinue immediately, assess the patient and institute alternative therapy (§4.4). Systemic corticosteroid effects at high doses over prolonged periods: Cushing's syndrome, adrenal suppression, decreased bone mineral density, cataract, glaucoma; blurred vision and other visual disturbance warrant ophthalmology referral

Clinical monograph

How it works

Formoterol stimulates beta2 adrenoceptors and glycopyrronium blocks muscarinic receptors to provide complementary bronchodilation, while budesonide reduces airway inflammation through glucocorticoid receptor activation.

Prescribing in practice

It is a regular maintenance inhaler only and must never be used to relieve acute breathlessness, which requires a separate short-acting reliever.
The inhaled corticosteroid increases pneumonia risk in COPD, and the antimuscarinic component requires caution in closed-angle glaucoma and bladder outflow obstruction.
Avoid concurrent use of other long-acting bronchodilators or inhaled corticosteroids to prevent duplication and additive effects, and counsel on correct priming and use of the pressurised device.

Monitoring

Monitor symptom control, inhaler technique and adherence, with attention to pneumonia in COPD, oral candidiasis and antimuscarinic adverse effects.

Counselling the patient

Use regularly twice a day; it is not for sudden symptoms.
Rinse the mouth after inhaling to reduce thrush and hoarseness.
Report fever, worsening breathlessness, eye pain or urinary difficulty.

Evidence & guidelines

Fixed triple therapy in a single inhaler is supported by COPD trials showing reduced exacerbations and mortality benefit versus dual therapy and is reflected in NICE COPD guidance.

Reference: NICE NG115; GOLD; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways