Glycopyrronium and formoterol inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalation formulation of glycopyrronium and formoterol.
Drugs List
Therapeutic Indications
Uses
Chronic obstructive pulmonary disease
Maintenance treatment of symptomatic relief of chronic obstructive pulmonary disease in adults.
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
Benign prostatic hyperplasia
Diabetes mellitus
Electrolyte imbalance
End stage renal disease
History of torsade de pointes
Hypoxia
Ischaemic heart disease
Narrow angle glaucoma
Severe cardiac failure
Severe cardiovascular disorder
Severe hepatic impairment
Severe renal impairment
Tachyarrhythmia
Thyrotoxicosis
Urinary retention
Correct electrolyte disorders before treatment
Not suitable for acute treatment of bronchospasm
Advise ability to drive/operate machinery may be affected by side effects
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients with hepatic impairment for adverse effects
Monitor serum electrolytes
Discontinue if paradoxical bronchospasm occurs
Glycopyrronium and formoterol 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
Glycopyrronium and formoterol is contraindicated during pregnancy.
The manufacturer advises caution if glycopyrronium and formoterol is used during pregnancy, and states that glycopyrronium and formoterol 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 glycopyrronium and formoterol during pregnancy. Potential risks are unknown.
Glycopyrronium has been shown to cross the human placenta.
It is unknown if formoterol crosses the human placenta.
Lactation
Glycopyrronium and formoterol is contraindicated during breastfeeding.
The manufacturer advises caution if glycopyrronium and formoterol is used during breastfeeding, and states that a decision must be made whether to discontinue glycopyrronium and formoterol, 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.
Side Effects
Agitation
Anxiety
Atrial fibrillation
Cardiac arrhythmias
Chest pain
Dizziness
Dry mouth
Extrasystoles
Headache
Hyperglycaemia
Hypersensitivity reactions
Insomnia
Muscle spasm
Nausea
Palpitations
Pruritus
Rash
Restlessness
Supraventricular arrhythmias
Tachycardia
Tremor
Urinary retention
Urinary tract infections
Further Information
Last Full Review Date: March 2021
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 March 2021.
Summary of Product Characteristics: Bevespi Aerosphere 7.2micrograms/5micrograms pressurised inhalation suspension. AztraZeneca UK Limited. Revised September 2020.
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 2018.
Last accessed: 17 March 2021.
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