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LABA/LAMA Dual Bronchodilator — COPD Pregnancy: There are no data from the use of Ultibro Breezhaler in pregnant women. 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; use 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 studies and other data in animals do not indicate a concern regarding fertility in either males or females.

Indacaterol / Glycopyrronium

Brand names: Ultibro Breezhaler

A fixed-dose maintenance inhaler pairing the long-acting beta-2 agonist indacaterol with the long-acting antimuscarinic glycopyrronium for COPD. It provides once-daily dual bronchodilation and is not intended for acute symptom relief.

Adult dose

Dose: COPD maintenance bronchodilation (to relieve symptoms in adult patients with chronic obstructive pulmonary disease): inhale the contents of ONE capsule once daily using the Ultibro Breezhaler inhaler. The SPC expresses the recommended dose in capsules, not in micrograms — no microgram figure for either active appears in any captured section, and nothing in the fetched text maps the two strengths in the product title to the individual actives, so no per-component strength is asserted here. Read the strength off the SPC or the pack before prescribing.
Route: Inhalation use only, via the Ultibro Breezhaler inhaler. The capsules must NOT be swallowed, and must be administered only using the Ultibro Breezhaler inhaler supplied; the inhaler provided with each new prescription should be used. Patients who do not experience improvement in breathing should be asked whether they are swallowing the medicinal product rather than inhaling it.
Frequency: Once daily, administered 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.
Max: One capsule (one dose) in any one day. The SPC states verbatim: 'Patients should be instructed not to take more than one dose in a day.'
INDICATION CONFIRMED BY §4.1 (newly captured), verbatim and in full: 'Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).' That is this page's exact identity — a LABA/LAMA dual bronchodilator for COPD delivered by Breezhaler DPI — and the fetched product is the page's own brand name. A later matcher fix swapped the product to the dual-component Ultibro Breezhaler with the COPD indication — exactly the source that hold asked for. NOT FOR ASTHMA: §4.4 states it 'should not be used for the treatment of asthma due to the absence of data in this indication', and that long-acting beta-2 agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for asthma. NOT FOR ACUTE USE: it is not indicated for the treatment of acute episodes of bronchospasm. NO DOUBLING UP: it should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists. SPECIAL POPULATIONS, §4.2: it can be used at the recommended dose in elderly patients (75 years of age and older), and in mild to moderate renal impairment and mild to moderate hepatic impairment — no dose change is given for any of them. Some sections of the product information we used were incomplete — check the full SPC.

Paediatric dose

Dose: Not applicable — there is no relevant use in the paediatric population (under 18 years) in the indication COPD
Route: N/A — no paediatric use is described in this SPC
Frequency: N/A
Max: Not established
§4.2 Paediatric population, verbatim and in full: 'There is no relevant use of Ultibro Breezhaler in the paediatric population (under 18 years) in the indication COPD. The safety and efficacy of Ultibro Breezhaler in children have not been established. No data are available.' No paediatric figure is published here and the adult regimen has NOT been carried across or scaled.

Dose adjustments

Renal

§4.2: can be used at the recommended dose in patients with mild to moderate renal impairment — no dose change is given. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk. §4.4 adds that a moderate mean increase in total systemic exposure (AUClast) to glycopyrronium of up to 1.4-fold was seen in mild and moderate renal impairment and up to 2.2-fold in severe renal impairment and end-stage renal disease, defines severe renal impairment as an estimated glomerular filtration rate below 30 ml/min/1.73 m², and directs that these patients be monitored closely for potential adverse reactions.

Hepatic

§4.2: can be used at the recommended dose in patients with mild and moderate hepatic impairment — no dose change is given. There are no data available for use in severe hepatic impairment, therefore caution should be observed in these patients.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

Side effects

  • Very common: upper respiratory tract infection
  • Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis
  • Common: hypersensitivity; uncommon: angioedema
  • Common: hyperglycaemia and diabetes mellitus
  • Common: dizziness, headache; rare: paraesthesia; uncommon: insomnia
  • Common: cough, oropharyngeal pain including throat irritation; uncommon: paradoxical bronchospasm, dysphonia, epistaxis
  • Common: dyspepsia, dental caries; uncommon: gastroenteritis, dry mouth
  • Common: bladder obstruction and urinary retention
  • Common: pyrexia, chest pain; uncommon: peripheral oedema, fatigue
  • Uncommon: glaucoma
  • Cardiac disorders — ischaemic heart disease, atrial fibrillation, tachycardia, palpitations (uncommon)
  • Uncommon: pruritus/rash; uncommon: musculoskeletal pain, muscle spasm, myalgia, pain in extremity
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Do not administer concomitantly with other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists
  • Do not use for asthma, and do not use for acute episodes of bronchospasm
  • Discontinue immediately and institute alternative therapy 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 if paradoxical bronchospasm occurs — it can be life-threatening
  • Narrow-angle glaucoma — no data are available, use with caution; inform patients of the signs and symptoms of acute narrow-angle glaucoma and to stop using the inhaler if these develop
  • Urinary retention — no data are available, use with caution
  • Severe renal impairment (eGFR below 30 ml/min/1.73 m²) or end-stage renal disease requiring dialysis — use only if the expected benefit outweighs the potential risk, and monitor closely for adverse reactions
  • Use with caution in cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension); beta-2 agonists may raise pulse rate and blood pressure and may produce ECG changes — treatment may need to be discontinued if clinically significant cardiovascular effects occur
  • Check inhaler technique — patients who do not experience improvement in breathing should be asked whether they are swallowing the capsule rather than inhaling its contents
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

Indacaterol activates beta-2 receptors to relax airway smooth muscle, and glycopyrronium antagonises muscarinic receptors to oppose cholinergic bronchoconstriction, delivering complementary bronchodilation.

Prescribing in practice

  • It is a preventer, not a reliever — patients must keep a separate short-acting inhaler for breakthrough symptoms and never use this for acute attacks.
  • Use with caution in significant cardiovascular disease, arrhythmias, narrow-angle glaucoma and bladder outflow obstruction given the combined beta-agonist and antimuscarinic effects.
  • Check device technique and suitability at initiation and review, as poor technique undermines efficacy.

Monitoring

Review breathlessness, exacerbation rate and inhaler technique, monitoring for tremor or palpitations and for antimuscarinic effects such as dry mouth and urinary difficulty.

Counselling the patient

  • Use this every day to prevent symptoms; keep your reliever inhaler for sudden breathlessness.
  • Report palpitations, eye pain or trouble passing urine.

Evidence & guidelines

Dual LABA/LAMA therapy is recommended by NICE and GOLD for COPD with continued symptoms or exacerbations despite monotherapy.

Reference: FLAME Trial (Wedzicha et al. NEJM 2016); GOLD 2024; NICE NG115; SPC Ultibro Breezhaler; 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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