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Budesonide, formoterol fumarate and glycopyrronium inhaler


Inhalation formulation of budesonide, formoterol fumarate and glycopyrronium.

Drugs List

  • budesonide 160microgram and formoterol fumarate 5microgram and glycopyrronium 7.2microgram pressurised inhaler
  • TRIXEO AEROSPHERE 160microgram+5microgram+7.2microgram pressurised inhaler
  • Therapeutic Indications


    Chronic obstructive pulmonary disease



    Two inhalations twice daily (two inhalations in the morning, and two inhalations in the evening), using the inhalation device provided.

    Additional Dosage Information

    If a dose is missed, the dose 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 in order to make up a missed dose.


    Children under 18 years
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Major risk factors for decreased bone mineral content
    Tobacco smoking
    Adrenal insufficiency
    Benign prostatic hyperplasia
    Cardiac arrhythmias
    Diabetes mellitus
    Electrolyte imbalance
    History of torsade de pointes
    Ischaemic heart disease
    Narrow angle glaucoma
    Severe cardiac failure
    Severe cardiovascular disorder
    Severe hepatic impairment
    Severe renal impairment
    Urinary retention

    Caution in transfer from oral steroids in adrenal insufficiency
    Systemic corticosteroids may be needed during elective surgery
    Systemic corticosteroids may be needed during periods of stress
    Check patient is using correct inhaler technique
    If visual disturbances occur, perform ophthalmic evaluation
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor patients with hepatic impairment for toxic effects
    Risk of narrow angle glaucoma
    Corticosteroids may cause growth retardation in children under 18 years
    May cause hypokalaemia
    Systemic effects possible with any inhaled corticosteroid
    Do not withdraw this drug suddenly
    Discontinue if paradoxical bronchospasm occurs
    Advise patient to rinse mouth with water after each dose
    Advise patient to seek medical advice if treatment is ineffective
    Ensure patient receives Steroid Treatment/Steroid Emergency Card

    Budesonide, formoterol fumarate and glycopyrronium. should not be used in patients with severe renal impairment or end-stage renal disease requiring dialysis unless the expected benefit outweighs the potential risk.

    Pregnancy and Lactation


    Budesonide, formoterol fumarate and glycopyrronium is contraindicated during pregnancy.

    The manufacturer does not recommend the use of budesonide, formoterol fumarate and glycopyrronium during pregnancy, and states that budesonide, formoterol fumarate and glycopyrronium should only be used during pregnancy if the potential benefits outweigh the potential risks.

    At the time of writing there is limited published information regarding the use of budesonide, formoterol fumarate and glycopyrronium during pregnancy. Potential risks are unknown.

    Glycopyrronium has been shown to cross the human placenta.

    It is unknown if formoterol crosses the human placenta.

    In animal studies, glucocorticosteroids have been shown to induce malformations. This is not thought to be relevant for humans given recommended doses (Briggs, 2015).


    Budesonide, formoterol fumarate and glycopyrronium is contraindicated during breastfeeding.

    The manufacturer does not recommend the use of budesonide, formoterol fumarate and glycopyrronium during breastfeeding, and states that a decision must be made whether to discontinue budesonide, formoterol fumarate and glycopyrronium, or to discontinue breastfeeding.

    The presence of glycopyrronium and formoterol in human breast milk is unknown. Effects on exposed infants are unknown. LactMed (2018) states that the use of inhaled bronchodilators during breastfeeding is acceptable due to the predicted low bioavailability and maternal serum levels.

    Budesonide has been shown to be excreted into breast milk.

    Side Effects

    Angina pectoris
    Behavioural disturbances
    Blurred vision
    Candidiasis (mouth or throat)
    Cardiac arrhythmias
    Chest pain
    Dry mouth
    Hypersensitivity reactions
    Impaired adrenal function
    Muscle spasm
    Throat irritation
    Urinary retention
    Urinary tract infections

    Further Information

    Last Full Review Date: May 2020

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    NICE Evidence Services Available at: Last accessed: 25 May 2021

    Summary of Product Characteristics: Trixeo Aerosphere 5 micrograms.7.2 micrograms/160micrograms pressurised inhalation suspension. AstraZeneca UK Limited. Revised: January 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Formoterol Last revised: 31 October 2021
    Last accessed: 25 May 2021

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.