Beclometasone extrafine particle and formoterol and glycopyrronium
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Extrafine particle inhalation formulation of beclometasone dipropionate and formoterol fumarate and glycopyrronium bromide.
Drugs List
Therapeutic Indications
Uses
Asthma: Maintenance
Chronic obstructive pulmonary disease
Dosage
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.
Adults
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.
Contraindications
Children under 18 years
Breastfeeding
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Adrenal insufficiency
Arterial aneurysm
Arteriosclerosis
Benign prostatic hyperplasia
Cardiac arrhythmias
Congestive cardiac failure
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Hypertension
Hypertrophic obstructive cardiomyopathy
Hypoxia
Idiopathic subvalvular aortic stenosis
Ischaemic heart disease
Myocardial infarction
Narrow angle glaucoma
Occlusive peripheral vascular disorder
Phaeochromocytoma
Pregnancy
Pulmonary tuberculosis
Renal impairment - glomerular filtration rate below 30ml/minute/1.73m sq
Severe cardiac disorder
Severe hepatic impairment
Tachyarrhythmia
Third degree atrioventricular block
Thyrotoxicosis
Urinary retention
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
Pregnancy
Use the combination of beclometasone and formoterol and glycopyrronium with caution during pregnancy.
Drug Combination
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.
Lactation
The combination of beclometasone and formoterol and glycopyrronium is contraindicated during breastfeeding.
Drug Combination
The manufacturer notes that as glycopyrronium may suppress lactation, a decision should be made whether to cease breastfeeding or stop taking the medication.
Side Effects
Adrenal suppression
Aggression
Allergic dermatitis
Angina pectoris
Angioedema
Anxiety
Asthenia
Atrial fibrillation
Blood pressure changes
Blurred vision
Bronchospasm (paradoxical)
Burning sensation of the lips
Cataracts
Chest pain
Cough
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Decreased appetite
Dental decay
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Dysuria
Epistaxis
Erythema
Exacerbation of pre-existing asthma
Extravasation
Facial oedema
Fatigue
Flushing
Gastro-enteritis
Glaucoma
Granulocytopenia
Headache
Hyperaemia
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypersomnia
Hypertension
Hypoaesthesia
Hypokalaemia
Increase in blood levels of free fatty acids
Increase in blood levels of insulin
Increase in blood levels of ketones
Increased platelet count
Influenza
Insomnia
Lower respiratory tract infection
Muscle spasm
Myalgia
Nasopharyngitis
Nausea
Nephritis
Nodal rhythm
Ocular oedema
Oedema of the lips
Oesophageal candidiasis
Oropharyngeal candidiasis
Oropharyngeal pain
Otosalpingitis
Painful extremities
Palpitations
Peripheral oedema
Pharyngeal erythema
Pharyngeal oedema
Pharyngitis
Pneumonia
Prolongation of QT interval
Pruritus
Psychomotor hyperactivity
Raised C-reactive protein
Rash
Reduction in serum cortisol levels
Restlessness
Rhinitis
Sinus bradycardia
Sinusitis
Sleep disturbances
Stomatitis
Tachyarrhythmia
Tachycardia
Throat irritation
Thrombocytopenia
Tremor
Urinary retention
Urinary tract infections
Urticaria
Vaginal candidiasis
Ventricular extrasystoles
Overdosage
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 ).
Further Information
Last Full Review Date: August 2017
Reference Sources
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
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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