Beclometasone extrafine particle and formoterol and glycopyrronium
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Extrafine particle inhalation formulation of beclometasone dipropionate and formoterol fumarate and glycopyrronium bromide.
Chronic obstructive pulmonary disease
The particle size distribution of the beclometasone component of this preparation results in a more potent effect than conventional (i.e. not extrafine) formulations. A 100microgram dose of beclometasone extrafine is approximately equivalent to a 250microgram dose of conventional beclometasone. This should be taken into account when transferring patients from conventional formulations of beclometasone.
When selecting the starting strength consider the patient's condition severity, previous therapy including the dose of inhaled corticosteroid, and risk of future exacerbations.
Two inhalations twice daily.
Both combinations of beclometasone, formoterol and glycopyrronium inhalation solution with the strengths 172mcg/5mcg/9mcg and 87mcg/5mcg/9mcg recommends the same daily dose.
Additional Dosage Information
Doses should be titrated to the lowest dose for effective control of symptoms.
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
Benign prostatic hyperplasia
Congestive cardiac failure
History of torsade de pointes
Hypertrophic obstructive cardiomyopathy
Idiopathic subvalvular aortic stenosis
Ischaemic heart disease
Narrow angle glaucoma
Occlusive peripheral vascular disorder
Renal impairment - glomerular filtration rate below 30ml/minute/1.73m sq
Severe cardiac disorder
Severe hepatic impairment
Third degree atrioventricular block
Correct electrolyte disorders before treatment
Not suitable for acute treatment of bronchospasm
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Ensure patient has a fast acting bronchodilator available
Not all presentations are licensed for all indications
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs/symptoms of pneumonia in patients at risk
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
High doses may cause adrenal suppression/bone metabolism changes
May cause hypokalaemia
Patient should seek medical advice if signs of pulmonary infection develop
Prolonged treatment may lead to dental caries
Systemic effects possible with any inhaled corticosteroid
Discontinue at least 12 hours before the start of anaesthesia
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Discontinue if symptoms of acute angle closure glaucoma occur
Discontinue treatment if skin rash or other allergic reaction occurs
Use lowest dose at which effective control of asthma is maintained
Advise patient to rinse mouth with water after each dose
Advise patient to seek medical advice if treatment is ineffective
Consider issuing Steroid Treatment/Steroid Emergency Card
High dose:Advise patient to avoid chickenpox,measles etc; see Dr if exposed
Use regularly to maintain freedom from symptoms
Pregnancy and Lactation
Use the combination of beclometasone and formoterol and glycopyrronium with caution during pregnancy.
The manufacturer notes that as glucocorticoid drugs are known to cause effects in early gestation and beta2-sympathomimetic drugs have tocolytic effects, this medication should only be used if the benefit to the patient outweighs any risk to the foetus. The manufacturer also notes that babies born to mothers on this medication should be observed for adrenal suppression.
The combination of beclometasone and formoterol and glycopyrronium is contraindicated during breastfeeding.
The manufacturer notes that as glycopyrronium may suppress lactation, a decision should be made whether to cease breastfeeding or stop taking the medication.
Blood pressure changes
Burning sensation of the lips
Decrease in bone mineral density
Exacerbation of pre-existing asthma
Increase in blood levels of free fatty acids
Increase in blood levels of insulin
Increase in blood levels of ketones
Increased platelet count
Lower respiratory tract infection
Oedema of the lips
Prolongation of QT interval
Raised C-reactive protein
Reduction in serum cortisol levels
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2017
Summary of Product Characteristics: Trimbow 87micrograms/5micrograms/9micrograms pressurised inhalation, solution. Chiesi Limited. Revised January 2021.
Summary of Product Characteristics: Trimbow pMDI 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution. Chiesi Limited. Revised July 2022.
Summary of Product Characteristics: Trimbow NEXThaler 88micrograms/5micrograms/9micrograms inhalation powder. Chiesi Limited. Revised January 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 July 2022
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.