Glycopyrrolate/formoterol

Pronunciation: gly-koh-PIRR-oh-late / for-MOH-ter-ol.

Generic name
glycopyrrolate and formoterol fumarate
Drug class
LAMA/LABA dual bronchodilator combination (long-acting muscarinic antagonist + long-acting beta2-agonist)
Form
Pressurised metered-dose inhaler (inhalation aerosol)
Route
Oral inhalation
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Bevespi Aerosphere (5) · Full directory

What glycopyrrolate and formoterol fumarate is and how it works

Glycopyrrolate/formoterol is a prescription-only combination inhaler containing two long-acting bronchodilators -- an anticholinergic (glycopyrrolate) and a long-acting beta2-agonist (formoterol) -- used for the ongoing maintenance treatment of chronic obstructive pulmonary disease (COPD). It is not a rescue inhaler and is not used for asthma. (1)

Use this inhaler exactly as your prescriber directs, twice daily (morning and evening), even when you feel well. Always keep a separate fast-acting rescue inhaler on hand for sudden breathing symptoms, since this medicine does not work quickly enough to relieve an acute attack.

Mechanism of action: how glycopyrrolate and formoterol fumarate works

Glycopyrrolate is a competitive muscarinic (M3) receptor antagonist that relaxes airway smooth muscle with a rapid onset of action; formoterol fumarate is a potent, selective long-acting beta2-adrenoceptor agonist acting via intracellular adenylyl cyclase stimulation. The combination provides complementary bronchodilation via two distinct mechanisms. (1) (2)

What glycopyrrolate and formoterol fumarate is used for

Maintenance treatment of COPD

Used for the long-term, twice-daily maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, to help keep airways open. Not indicated for the relief of sudden (acute) bronchospasm and not indicated for asthma. (1) (2)

Before taking glycopyrrolate and formoterol fumarate

Do not take / not appropriate for

  • Do not use this inhaler if you have had a serious allergic reaction to glycopyrrolate, formoterol, or any ingredient in the product. (all countries) (1)
  • This medicine is not indicated for asthma; a long-acting beta2-agonist should never be used as the only asthma treatment without an inhaled corticosteroid. (all countries) (1)

Tell your clinician about

  • Any heart problems, including coronary artery disease, irregular heartbeat, or severe heart failure.
  • Narrow-angle glaucoma or any eye pressure problems.
  • Prostate enlargement, bladder-neck obstruction, or difficulty passing urine.
  • Seizure disorders, an overactive thyroid, or diabetes.
  • All other medicines you take, including other inhalers, anticholinergic medicines, diuretics ('water tablets'), beta-blockers, or antidepressants.
(1) (2)

How to take glycopyrrolate and formoterol fumarate

  • Inhale by mouth, twice daily -- once in the morning and once in the evening, at consistent times.
  • Prime the inhaler before first use, and re-prime it if it has not been used for 7 days or more, following the device instructions.
  • This medicine is for regular ongoing maintenance use only -- it is not a rescue inhaler and will not relieve a sudden breathing attack quickly.
  • Always carry a separate fast-acting rescue inhaler for sudden symptoms, as your prescriber directs.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

If you miss a dose, take it as soon as you remember, but do not take an extra dose to make up for it, and do not double your next dose. Contact your prescriber if you are unsure or if you miss doses often.

Overdose

Seek urgent medical attention if you think you have used too much of this inhaler, especially if you notice a fast or irregular heartbeat, chest pain, tremor, or severe headache. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Urinary tract infection.

What to notice: Urinary tract infection.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Cough.

What to notice: Cough.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Joint pain, chest discomfort, or muscle spasms.

What to notice: Joint pain, chest discomfort, or muscle spasms.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache, dry mouth, or dizziness.

What to notice: Headache, dry mouth, or dizziness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Sudden worsening of breathing right after using the inhaler (paradoxical bronchospasm) — emergency

Symptoms: Wheezing or breathing that gets suddenly worse immediately after a dose.

Action: Use your separate fast-acting rescue inhaler immediately and seek urgent medical help. Contact your prescriber promptly to discuss whether this medicine should be continued -- any change to your regular inhaler should be clinician-directed. (1)

Heart-related symptoms — high caution

Symptoms: A noticeably fast or irregular heartbeat, chest pain, or palpitations.

Action: Contact your prescriber promptly, especially if you have existing heart disease -- the beta2-agonist component can affect heart rate and rhythm. (1) (2)

Signs of worsening narrow-angle glaucoma — high caution

Symptoms: Eye pain, blurred vision, seeing halos or coloured rings around lights, or red eyes.

Action: Seek prompt medical or eye-care attention -- these can be signs of an eye-pressure emergency related to the anticholinergic component. (1)

Signs of urinary retention — high caution

Symptoms: Difficulty or inability to pass urine, or a weak urine stream, especially in men with prostate enlargement.

Action: Contact your prescriber promptly if this occurs. (1)

Interactions

  • Other adrenergic (sympathomimetic) medicines may add to cardiovascular effects such as increased heart rate. (1)
  • Xanthine derivatives, steroid medicines, and non-potassium-sparing diuretics ('water tablets') may worsen low potassium levels and heart-rhythm changes. (1)
  • MAO inhibitors and tricyclic antidepressants may increase cardiovascular effects -- use with extreme caution and only under close clinician supervision. (1)
  • Beta-blocker medicines may both reduce the effect of this inhaler and increase the risk of severe bronchospasm. (1)
  • Combining with other anticholinergic-containing medicines is generally avoided due to additive antimuscarinic effects. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

There is limited human data. Animal studies did not show adverse effects from glycopyrrolate at high exposures, while formoterol showed effects only at animal-only doses far above the maximum recommended human dose. Use only if the potential benefit justifies the potential risk -- discuss with your prescriber. (1) (2) (3) (4) (5)

Breastfeeding

There is no data on whether this medicine passes into human breast milk. The benefits of breastfeeding should be weighed against the mother's clinical need for this medicine, in discussion with a prescriber. (1) (2) (3) (4) (5)

Children

Not established for use in children in the source reviewed; this product is indicated for adult COPD. (1) (2) (3) (4) (5)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed, but cardiovascular and anticholinergic effects should be monitored closely in older adults. (1) (2) (3) (4) (5)

Hepatic_impairment

Not specifically described in the sources reviewed for this dossier; discuss with your prescriber if you have liver disease. (1) (2) (3) (4) (5)

Renal_impairment

Not specifically described in the sources reviewed for this dossier; discuss with your prescriber if you have kidney disease. (1) (2) (3) (4) (5)

Monitoring

Before starting

  • Baseline heart rate, blood pressure, and cardiac history review
  • Eye-pressure/glaucoma history
  • Prostate/urinary symptom history where relevant

During treatment

  • Watching for cardiovascular symptoms such as palpitations or chest pain.
  • Watching for eye symptoms suggestive of narrow-angle glaucoma.
  • Watching for urinary retention symptoms.
  • Confirming a separate rescue inhaler remains available and is being used appropriately.
(1)

Storage

Store at controlled room temperature, 20-25°C (68-77°F). Discard the inhaler when the dose indicator reads zero, or 3 months after removal from the foil pouch, whichever comes first. Keep away from heat and open flame -- temperatures above 49°C (120°F) may cause the canister to burst. Do not puncture or throw the canister into a fire.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States

Indication: Maintenance treatment of COPD

Dose summary: 2 inhalations twice daily by oral inhalation (18 mcg glycopyrrolate/9.6 mcg formoterol fumarate per full daily dose, delivered as 9 mcg/4.8 mcg per actuation). Prime before first use and after 7+ days of non-use. Not for acute bronchospasm or asthma.

Renal context: Not established in the sources reviewed for this dossier. (1)

United Kingdom

Indication: Maintenance bronchodilator treatment to relieve COPD symptoms

Dose summary: 2 inhalations twice daily (morning and evening); each metered dose contains glycopyrronium bromide 10.4 mcg (equivalent to 8.3 mcg glycopyrronium) and formoterol fumarate dihydrate 5.8 mcg ex-valve.

Renal context: Not established in the sources reviewed for this dossier. (2)

Mechanism of action

Hepatic guidance

Not specifically established in the sources reviewed for this dossier.

Overdose note

Overdose is most likely to manifest as exaggerated beta2-agonist effects (tachycardia, tremor, headache, QTc prolongation) and/or anticholinergic effects; manage supportively with cardiac monitoring as clinically indicated. (1) (2)

Frequently asked questions

Can I use this inhaler for sudden shortness of breath or a COPD flare-up?

No. This is a maintenance inhaler taken twice daily on a schedule -- it does not act fast enough to relieve sudden symptoms. Always keep a separate fast-acting rescue inhaler on hand and use it for sudden breathing problems, as your prescriber has directed. (1) (2)

Is glycopyrrolate/formoterol (Bevespi Aerosphere) available in the US, UK, Europe, Canada, and Australia?

Yes, it is approved and available in the United States, United Kingdom, European Union, Canada, and Australia. Its registration status in New Zealand could not be confirmed from public regulator sources at the time of this review. (1) (2) (3) (4) (5)

What should I do if my breathing suddenly gets worse right after using this inhaler?

This can rarely be paradoxical bronchospasm, where the inhaler itself triggers sudden wheezing or tightness instead of relieving it. Use your fast-acting rescue inhaler immediately and contact your prescriber, who may need to stop this medicine and switch you to an alternative. (1)

What is the mechanism of action of glycopyrrolate and formoterol fumarate?

Glycopyrrolate is a competitive muscarinic (M3) receptor antagonist that relaxes airway smooth muscle with a rapid onset of action; formoterol fumarate is a potent, selective long-acting beta2-adrenoceptor agonist acting via intracellular adenylyl cyclase stimulation. The combination provides complementary bronchodilation via two distinct mechanisms. (1) (2)

What is the generic name of Glycopyrrolate/formoterol?

The generic name is glycopyrrolate and formoterol fumarate. (1)

What class of drug is glycopyrrolate and formoterol fumarate?

Glycopyrrolate/formoterol is classed as: LAMA/LABA dual bronchodilator combination (long-acting muscarinic antagonist + long-acting beta2-agonist). (1)

References

  1. BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate) inhalation aerosol -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, AstraZeneca Pharmaceuticals LP · United States · accessed 2026-07-30 · source 1
  2. Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- AstraZeneca UK Limited · United Kingdom · accessed 2026-07-30 · source 2
  3. Bevespi Aerosphere European Public Assessment Report (EPAR) medicine overviewEuropean Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 3
  4. Bevespi Aerosphere (glycopyrronium bromide/formoterol fumarate dihydrate) Product MonographHealth Canada product monograph · Canada · accessed 2026-07-30 · source 4
  5. Bevespi Aerosphere 7.2/5 -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5

Brand names by country

Single-ingredient glycopyrrolate and formoterol fumarate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Bevespi Aerosphere (1)FDA approved currently labeled · 9 mcg/4.8 mcg per actuation (2 inhalations twice daily) · AstraZeneca Pharmaceuticals LP

United Kingdom

  • Bevespi Aerosphere (2)MHRA licensed emc smpc confirmed · 7.2 mcg/5 mcg per actuation · AstraZeneca UK Limited

Canada

  • Bevespi Aerosphere (4)Health Canada approved confirmed · 9 mcg/4.8 mcg per actuation · AstraZeneca Canada Inc.

Australia

  • Bevespi Aerosphere (5)TGA ARTG registered 2018-10-02 confirmed · 7.2 mcg/5 mcg per actuation · AstraZeneca Pty Ltd
View brands in additional countries.

European Union

Bevespi Aerosphere (3)

This page provides general reference information about glycopyrrolate/formoterol and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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