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LAMA + LABA inhaler Pregnancy: §4.6: 'There are no data from the use of Ultibro Breezhaler in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures. Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Therefore, Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.' Breast-feeding: it is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk, though excretion was shown in the milk of lactating rats — 'The use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.' Fertility: reproduction and other animal studies do not indicate a concern in either males or females.

Glycopyrronium with indacaterol

Brand names: Ultibro Breezhaler, Ulunar Breezhaler

A fixed-dose dual long-acting bronchodilator inhaler combining the long-acting antimuscarinic glycopyrronium with the long-acting beta-2 agonist indacaterol, used as maintenance therapy for COPD. It is not a reliever and has no role in acute breathlessness.

Adult dose

Dose: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD): inhale the contents of ONE capsule once daily, using the Ultibro Breezhaler inhaler. Administer at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day; patients should be instructed not to take more than one dose in a day. Sourced from Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder (hard capsules); Ulunar Breezhaler, the parallel brand also named on this page, is not separately covered by this source. NOT for asthma and NOT for acute bronchospasm.
Route: Inhalation use only. §4.2, verbatim: 'The capsules must not be swallowed. The capsules must be administered only using the Ultibro Breezhaler inhaler. The inhaler provided with each new prescription should be used. Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.'
Frequency: Once daily, at the same time of the day each day.
Max: One capsule — one dose — in any 24 hours. §4.2, verbatim: 'Patients should be instructed not to take more than one dose in a day.'
LICENSED INDICATION (§4.1, verbatim and complete): 'Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).' PRODUCT SWAP SINCE THE PREVIOUS REVIEW: this page was previously held because the bundle carried 'Enerzair Breezhaler' — the TRIPLE combination with mometasone furoate, licensed for asthma. The bundle now carries the DUAL indacaterol/glycopyrronium product this page describes, so the regimen above is the right one. NOT FOR ASTHMA (§4.4, verbatim): 'Ultibro Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication. 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.' NOT FOR ACUTE USE (§4.4): 'Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.' NO DOUBLING UP (§4.4): 'Ultibro Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ultibro Breezhaler belong.' SPECIAL POPULATIONS (§4.2, verbatim): elderly — 'can be used at the recommended dose in elderly patients (75 years of age and older)'; mild to moderate renal impairment — recommended dose; severe renal impairment or end-stage renal disease requiring dialysis — 'used only if the expected benefit outweighs the potential risk', with close monitoring for adverse reactions; mild and moderate hepatic impairment — recommended dose; severe hepatic impairment — no data available, observe caution. So no numeric dose adjustment is stated for any special population. CAUTIONS (§4.4): narrow-angle glaucoma and urinary retention — no data, use with caution and tell patients the signs of acute narrow-angle glaucoma and to stop if they develop; cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension) — use with caution; convulsive disorders, thyrotoxicosis, and patients unusually responsive to beta2-adrenergic agonists — use with caution. EXCIPIENT (§4.4): 'This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.' ⚠ THE openFDA PROVIDER IN THIS BUNDLE IS THE WRONG PRODUCT and was not used: it is 'Qbrexza' (Journey Medical Corporation), a glycopyrronium-tosylate single-use cloth whose §2 reads 'For topical use only. Qbrexza is for topical use in the underarm area only' — a topical treatment for axillary hyperhidrosis containing only one of the two components and given by a different route. Nothing from it appears in this draft. Some sections of the product information we used were incomplete — check the full SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3, verbatim and complete: 'Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.'
  • §4.4 warning (not a §4.3 contraindication): should not be used for the treatment of asthma, due to the absence of data in this indication — long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for asthma
  • §4.4 warning: not indicated for the treatment of acute episodes of bronchospasm
  • §4.4 warning: should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists
  • §4.4 warning: contains lactose — patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product

Side effects

  • Most common adverse reactions related to the medicinal product (at least 3% of patients and greater than placebo): cough, nasopharyngitis and headache
  • Infections — very common: upper respiratory tract infection. Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis
  • Respiratory — common: cough, oropharyngeal pain including throat irritation. Uncommon: paradoxical bronchospasm, dysphonia, epistaxis
  • Nervous system — common: dizziness, headache. Rare: paraesthesia
  • Cardiac — uncommon: ischaemic heart disease, atrial fibrillation, tachycardia, palpitations
  • Immune system — common: hypersensitivity. Uncommon: angioedema
  • Metabolism — common: hyperglycaemia and diabetes mellitus
  • Eye — uncommon: glaucoma
  • Psychiatric — uncommon: insomnia
  • Gastrointestinal: dyspepsia, dental caries, gastroenteritis, dry mouth
  • 'The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination.'
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Paradoxical bronchospasm 'can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.' (§4.4)
  • Immediate hypersensitivity — if signs of allergic reaction occur, in particular angioedema (difficulty breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, discontinue immediately and institute alternative therapy (§4.4)
  • Inform patients of the signs and symptoms of acute narrow-angle glaucoma and to stop using the inhaler if any develop (§4.4)
  • Beta2-adrenergic agonists may produce clinically significant increases in pulse rate and blood pressure and ECG changes — 'In case such effects occur with this medicinal product, treatment may need to be discontinued.' (§4.4)
  • Severe renal impairment (eGFR below 30 ml/min/1.73 m2) including end-stage renal disease requiring dialysis: 'These patients should be monitored closely for potential adverse reactions.' (§4.4)
  • Check inhaler technique — patients who do not experience improvement in breathing should be asked whether they are swallowing rather than inhaling the capsule (§4.2)

Clinical monograph

How it works

Glycopyrronium blocks airway muscarinic receptors to reduce cholinergic bronchoconstriction, while indacaterol stimulates beta-2 receptors to relax bronchial smooth muscle, giving complementary sustained bronchodilation.

Prescribing in practice

  • Maintenance only — it must not be used to relieve acute bronchospasm and patients must retain a separate short-acting reliever inhaler.
  • Avoid in unstable cardiovascular disease; the beta-2 agonist component can cause tachycardia and the antimuscarinic warrants caution in narrow-angle glaucoma and significant bladder outflow obstruction.
  • Confirm inhaler technique and that the patient can use the specific device before relying on it, as deposition determines efficacy.

Monitoring

Monitor symptom control, exacerbation frequency and inhaler technique, watching for antimuscarinic effects such as dry mouth or urinary retention and beta-agonist effects such as palpitations or tremor.

Counselling the patient

  • This is a regular preventer, not a rescue inhaler — keep using your blue reliever for sudden symptoms.
  • Report new palpitations, eye pain or difficulty passing urine.

Evidence & guidelines

NICE and GOLD support dual LABA/LAMA bronchodilation for COPD with persistent breathlessness or exacerbations despite single bronchodilator therapy.

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).

Related

Curated clinical cross-links plus same-class fallbacks.

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