Budesonide, formoterol fumarate and glycopyrronium inhaler
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalation formulation of budesonide, formoterol fumarate and glycopyrronium.
Drugs List
Therapeutic Indications
Uses
Chronic obstructive pulmonary disease
Dosage
Adults
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.
Contraindications
Children under 18 years
Breastfeeding
Long QT syndrome
Pregnancy
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
Cardiomyopathy
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Hypokalaemia
Ischaemic heart disease
Narrow angle glaucoma
Severe cardiac failure
Severe cardiovascular disorder
Severe hepatic impairment
Severe renal impairment
Thyrotoxicosis
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
Pregnancy
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).
Lactation
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
Agitation
Angina pectoris
Angioedema
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Bruising
Candidiasis (mouth or throat)
Cardiac arrhythmias
Cataracts
Chest pain
Cough
Depression
Dizziness
Dry mouth
Dysphonia
Glaucoma
Headache
Hyperglycaemia
Hypersensitivity reactions
Impaired adrenal function
Insomnia
Muscle spasm
Nausea
Nervousness
Palpitations
Pneumonia
Restlessness
Tachycardia
Throat irritation
Tremor
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: www.nice.org.uk 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: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Formoterol Last revised: 31 October 2021
Last accessed: 25 May 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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