LABA Pregnancy: §4.6: 'There are no data from the use of indacaterol in pregnant women available.' Animal studies do not indicate direct or indirect harmful effects on reproductive toxicity at clinically relevant exposures. Like other beta2-adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. 'Onbrez Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.' Breast-feeding: excretion in human milk unknown (excretion shown in animals); a risk to the breast-fed child cannot be excluded — decide whether to discontinue breast-feeding or therapy.

Indacaterol

Brand names: Onbrez Breezhaler

Indacaterol is a long-acting beta-2 agonist bronchodilator administered by inhalation once daily for maintenance treatment of 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: Inhalation of the contents of one 150 microgram capsule once a day. The dose should only be increased on medical advice: one 300 microgram capsule once a day has been shown to provide additional clinical benefit with regard to breathlessness, particularly in patients with severe COPD

Route: Inhalation — for inhalation use only, using the Onbrez Breezhaler inhaler supplied with each new prescription. The capsules must not be swallowed and must only be removed from the blister immediately before use

Frequency: Once daily, at the same time of day each day

Max: §4.2 verbatim: 'The maximum dose is 300 microgram once daily.' §4.4 adds: 'An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose of 300 microgram is not appropriate.'

SOURCE: eMC UK SPC, productName 'Onbrez Breezhaler 150 microgram inhalation powder (hard capsules)' (https://www.medicines.org.uk/emc/product/7794/smpc), §4.2. VERBATIM: 'The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler.' MISSED DOSE: 'If a dose is missed the next dose should be taken at the usual time the next day.' INDICATION LIMIT (§4.4): 'Onbrez Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma. Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.' It is also not indicated for acute episodes of bronchospasm (not a rescue therapy); if COPD deteriorates during treatment, re-evaluate the patient and the treatment regimen. ELDERLY: maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required. HEPATIC IMPAIRMENT: no dose adjustment for mild and moderate impairment; no data in severe hepatic impairment. PAEDIATRIC: no per-kg dose is stated, hence paedDose is null. §4.2 verbatim: 'There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).' ADMINISTRATION CHECK: 'Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.' 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; no openFDA or WHO data were present in the bundle.

Dose adjustments

Renal

§4.2: 'No dose adjustment is required for patients with renal impairment.'

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 substance or to any of the excipients listed in section 6.1 (§4.3)
Should not be used in asthma — indicated for COPD only (§4.4)
Not indicated for the treatment of acute episodes of bronchospasm, i.e. not a rescue therapy (§4.4)
Use with caution in cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders, thyrotoxicosis, patients unusually responsive to beta2-adrenergic agonists, and in known or suspected QT prolongation or treatment with medicinal products affecting the QT interval (§4.4)

Side effects

Nasopharyngitis (14.3%), upper respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle spasms (3.5%) — the most common reactions at the recommended doses, mostly mild or moderate and becoming less frequent with continued treatment
Sinusitis, dizziness, oropharyngeal pain including throat irritation, rhinorrhoea, chest pain and peripheral oedema (common)
Ischaemic heart disease, atrial fibrillation, palpitations and tachycardia (uncommon)
Diabetes mellitus and hyperglycaemia, paraesthesia, myalgia and musculoskeletal pain (uncommon)
Hypersensitivity, pruritus/rash and paradoxical bronchospasm (uncommon) — immediate hypersensitivity reactions and paradoxical bronchospasm may be life-threatening: discontinue immediately and institute alternative therapy (§4.4)

Clinical monograph

How it works

It stimulates beta-2 adrenoceptors on bronchial smooth muscle, raising cyclic AMP to produce sustained, once-daily bronchodilation.

Prescribing in practice

It is licensed for COPD maintenance and is not indicated for asthma, where long-acting beta-2 agonist monotherapy is unsafe; it does not relieve acute bronchospasm.
It can cause tremor, palpitations, cough on inhalation and hypokalaemia.
Use with caution in cardiovascular disorders, arrhythmias and QT prolongation.

Monitoring

Monitor COPD symptom control, inhaler technique and for cardiovascular or potassium-related adverse effects in at-risk patients.

Counselling the patient

Use it once each day at the same time for ongoing control, not for sudden breathlessness.
Keep your separate reliever inhaler available.
A brief cough just after inhaling can occur and is usually harmless.

Evidence & guidelines

Long-acting bronchodilators are recommended in NICE COPD guidance to improve symptoms and reduce exacerbations.

Reference: NICE NG115; 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

Drugs

Pathways