Beclometasone extrafine particles with formoterol inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalation formulations of beclometasone dipropionate and formoterol fumarate.
Drugs List
Therapeutic Indications
Uses
Asthma: Maintenance
Asthma: Maintenance and reliever therapy
Chronic obstructive pulmonary disease (FEV1<50% predicted normal)
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.
This fixed combination preparation is not intended for the initial management of asthma. The dosage of the components is individual and should be adjusted to the severity of the disease. This should be considered when treatment with combination products is initiated or the dose adjusted. If an individual patient should require dosages outside the recommended regimen, appropriate doses of beta agonist and/or corticosteroids should be prescribed.
Adults
Asthma
Maintenance therapy
One or two inhalations twice daily of the CFC-Free or dry powder inhalers 100/6micrograms or 200/6micrograms. The maximum daily dose is 4 inhalations.
Reliever therapy
Patients should take one additional inhalation as needed in response to symptoms of the CFC-free inhaler or dry powder inhaler 100/6micrograms. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations.
COPD
Two inhalations twice daily of the CFC-Free or dry powder inhalers 100/6micrograms. The maximum daily dose is 4 inhalations.
Contraindications
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
Adrenal insufficiency
Arterial aneurysm
Arteriosclerosis
Breastfeeding
Cardiac arrhythmias
Congestive cardiac failure
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertrophic obstructive cardiomyopathy
Hypoxia
Idiopathic subvalvular aortic stenosis
Ischaemic heart disease
Lactose intolerance
Myocardial infarction
Occlusive peripheral vascular disorder
Phaeochromocytoma
Pregnancy
Pulmonary tuberculosis
Severe cardiac disorder
Severe hypertension
Tachyarrhythmia
Third degree atrioventricular block
Thyrotoxicosis
Correct electrolyte disorders before treatment
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Therapy should not be initiated during exacerbation of asthma
Ensure patient has a fast acting bronchodilator available
Not all available strengths are licensed for all indications
Not all formulations are licensed for all uses
Some formulations contain lactose
Consider use of a spacer device for suitable patients and formulations
Check patient is using correct inhaler technique
Consider adrenal suppression when transferring from systemic steroid
Consider monitoring ECG in patients at risk of QT prolongation
If visual disturbances occur, perform ophthalmic evaluation
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
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
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
This is a combination beclometasone dipropionate and formoterol fumarate pressurised metered-dose inhaler and has extra-fine particles and is more potent than traditional beclometasone dipropionate inhalers.
Only the CFC-Free or dry powder inhaler 100/6micrograms can be used to relieve an acute asthmatic attack.
Pregnancy and Lactation
Pregnancy
Use beclometasone with formoterol with caution during pregnancy.
The manufacturer states that beclometasone with formoterol should be used during pregnancy if the benefits outweigh the potential risks. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of reproductive toxicity after high systemic exposure.
There is limited data on the use of this treatment with pregnant women.
Lactation
Use beclometasone with formoterol with caution during breastfeeding.
The manufacturer states that beclometasone with formoterol should be used during breastfeeding if the expected benefits outweigh the potential risks.
Beclometasone is expected to be secreted in milk similar to other corticosteroids. It is not known if formoterol is passed into human breast milk.
Side Effects
Adrenal suppression
Aggression
Allergic dermatitis
Angina pectoris
Angioedema
Anxiety
Atrial fibrillation
Behavioural disturbances (children)
Blood pressure changes
Blurred vision
Bronchospasm (paradoxical)
Burning sensation of the lips
Cataracts
Cough
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Depression
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
ECG changes
Erythema
Exacerbation of pre-existing asthma
Facial oedema
Fatigue
Flushing
Gastro-enteritis
Glaucoma
Granulocytopenia
Headache
Hyperaemia
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypertriglyceridaemia
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
Irritability
Muscle spasm
Myalgia
Myocardial ischaemia
Nausea
Nephritis
Ocular oedema
Oedema of the lips
Oesophageal candidiasis
Oropharyngeal candidiasis
Oropharyngeal pain
Otosalpingitis
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
Suppression of growth in children and adolescents
Tachyarrhythmia
Tachycardia
Throat irritation
Thrombocytopenia
Tremor
Urticaria
Vaginal candidiasis
Ventricular extrasystoles
Visual disturbances
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: December 2015
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.
Summary of Product Characteristics: Fostair 100/6 inhalation solution. Chiesi Ltd. Revised March 2018.
Summary of Product Characteristics: Fostair 200/6 inhalation solution. Chiesi Ltd. Revised November 2018.
Summary of Product Characteristics: Fostair NEXThaler 100micrograms/6micrograms inhalation solution. Chiesi Ltd. Revised September 2018.
Summary of Product Characteristics: Fostair NEXThaler 200micrograms/6micrograms inhalation solution. Chiesi Ltd. Revised March 2017.
Summary of Product Characteristics: Luforbec 100/6 micrograms per actuation pressurised inhalation solution. Lupin Healthcare (UK) Ltd. Revised June 2021.
Summary of Product Characteristics: Luforbec 200/6 micrograms per actuation pressurised inhalation solution. Lupin Healthcare (UK) Ltd. Revised July 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 August 2022
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