Budesonide with formoterol inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalation formulations of budesonide and formoterol fumarate dihydrate.
Drugs List
Therapeutic Indications
Uses
Asthma: Maintenance
Asthma: Maintenance and reliever therapy
Chronic obstructive pulmonary disease (FEV1<70% predicted normal)
Dosage
Duoresp Spiromax is available in two different strengths representing the delivered dose per actuation: Budesonide 160micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation, which is equivalent to a metered dose of budesonide 200micrograms and formoterol fumarate dihydrate 6micrograms. Budesonide 320micrograms and formoterol fumarate dihydrate 9micrograms per actuation, which is equivalent to a metered dose of budesonide 400micrograms and formoterol fumarate dihydrate 12micrograms.
Fobumix Easyhaler is available in three different strengths representing the delivered dose per actuation:
Budesonide 80micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation, which is equivalent to a metered dose of budesonide 100micrograms and formoterol fumarate dihydrate 6micrograms.
Budesonide 160micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation, which is equivalent to a metered dose of budesonide 200micrograms and formoterol fumarate dihydrate 6micrograms. Budesonide 320micrograms and formoterol fumarate dihydrate 9micrograms per actuation, which is equivalent to a metered dose of budesonide 400micrograms and formoterol fumarate dihydrate 12micrograms.
Symbicort Budesonide 200micrograms and formoterol fumarate dihydrate 6micrograms, which is equivalent to a delivered dose of budesonide 160micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation.
Budesonide 100micrograms and formoterol fumarate dihydrate 3micrograms, which is equivalent to a delivered dose of budesonide 80micrograms and formoterol fumarate dihydrate 2.25micrograms per actuation.
Symbicort Turbohaler is available in three different strengths representing the metered dose per actuation: Budesonide 100micrograms and formoterol fumarate dihydrate 6micrograms, which is equivalent to a delivered dose of budesonide 80micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation. Budesonide 200micrograms and formoterol fumarate dihydrate 6micrograms, which is equivalent to a delivered dose of budesonide 160micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation. Budesonide 320micrograms and formoterol fumarate dihydrate 9micrograms, which is equivalent to a delivered dose of budesonide 400micrograms and formoterol fumarate dihydrate 12micrograms per actuation.
WockAIR is available in two different strengths representing the delivered dose per actuation: Budesonide 160micrograms and formoterol fumarate dihydrate 4.5micrograms per actuation, which is equivalent to a metered dose of budesonide 194.7micrograms and formoterol fumarate dihydrate 6.1micrograms. Budesonide 320micrograms and formoterol fumarate dihydrate 9micrograms per actuation, which is equivalent to a metered dose of budesonide 346.3micrograms and formoterol fumarate dihydrate 10.8micrograms.
Adults
Asthma
There are two treatment approaches:
Routine maintenance therapy: The combination inhaler is used for regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.
Maintenance and reliever therapy: The combination inhaler is used for regular maintenance treatment and when needed in response to symptoms.
DuoResp Spiromax and WockAIR
Routine Maintenance therapy:
160micrograms/4.5micrograms: 1 to 2 inhalations twice a day (up to a maximum of 4 inhalations twice daily).
320micrograms/9micrograms: 1 inhalation twice a day (up to a maximum of 2 inhalations twice daily).
Maintenance and reliever therapy:
160micrograms/4.5micrograms: 2 inhalations once daily or 1 inhalation twice daily.
Take 1 additional inhalation as needed as reliever.
If the symptoms persist after a few minutes then another inhalation should be taken (up to a maximum of 6 inhalations for any single episode).
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
Fobumix Easyhaler
Routine Maintenance therapy:
80micrograms/4.5micrograms and 160micrograms/4.5micrograms inhalers: 1 to 2 inhalations twice a day (up to a maximum of 4 inhalations twice daily).
320micrograms/9micrograms: 1 inhalation twice a day (up to a maximum of 2 inhalations twice daily).
Maintenance and reliever therapy:
80micrograms/4.5micrograms and 160micrograms/4.5micrograms inhalers: 2 inhalations once daily or 1 inhalation twice a day.
Take 1 additional inhalation as needed as reliever.
If the symptoms persist after a few minutes then another inhalation should be taken (up to a maximum of 6 inhalations for any single episode).
No more than 8 inhalations are usually needed, however 12 inhalations may be used for a limited period. If more than 8 inhalations are used in a day, medical advice and reassessment of maintenance dose is strongly recommended.
Symbicort and Symbicort Turbohaler
Routine Maintenance therapy:
100micrograms/6micrograms and 200micrograms/6micrograms inhalers: 1 to 2 inhalations twice a day (up to a maximum of 4 inhalations twice daily).
100micrograms/3micrograms: 2 to 4 inhalations twice a day (up to a maximum of 8 inhalations twice daily).
400micrograms/12micrograms inhaler: 1 inhalation twice daily (up to a maximum of 2 inhalations twice daily).
Maintenance and reliever therapy:
100micrograms/6micrograms and 200micrograms/6micrograms inhalers: 2 inhalations once daily or 1 inhalation twice a day.
Take 1 additional inhalation as needed as reliever.
If the symptoms persist after a few minutes then another inhalation should be taken (up to a maximum of 6 inhalations for any single episode).
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
100micrograms/3micrograms: 4 inhalations per day, give as 2 inhalations in the morning, and 2 inhalations in the evening, or alternatively as 4 inhalations in either the morning or evening
Take 2 additional inhalation as needed as reliever. If symptoms persist after a few minutes, an additional 2 inhalations should be taken (up to a maximum of 12 inhalations for any single episode).
A total daily dose of more than 16 inhalations is not normally needed; however, a total daily dose of up to 24 inhalations could be used for a limited period. Patients using more than 16 inhalations daily should be strongly recommended to seek medical advice.
COPD
DuoResp Spiromax and WockAIR (COPD with FEV1 less than 70% of predicted normal):
160micrograms/4.5micrograms inhaler: 2 inhalations twice daily.
320micrograms/9micrograms inhaler: 1 inhalation twice daily.
Fobumix Easyhaler (COPD with FEV1 less than 70% of predicted normal):
80micrograms/4.5micrograms inhaler: Not licensed for this indication.
160micrograms/4.5micrograms: 2 inhalations twice daily.
320micrograms/9micrograms: 1 inhalation twice daily.
Symbicort (COPD with FEV1 less than 70% of predicted normal):
200micrograms/6micrograms inhaler: 2 inhalations twice daily.
Symbicort Turbohaler (COPD with FEV1 less than 70% of predicted normal):
100micrograms/6micrograms inhaler: Not licensed for this indication.
200micrograms/6micrograms inhaler: 2 inhalations twice daily.
400micrograms/12micrograms inhaler: 1 inhalation twice daily.
Children
Asthma
Symbicort Turbohaler
Maintenance therapy for adolescents aged 12 to 18 years:
100micrograms/6micrograms and 200/6micrograms inhalers: 1 to 2 inhalations twice a day.
400micrograms/12micrograms inhaler: 1 inhalation twice daily.
Maintenance therapy for children aged 6 to 12 years:
100micrograms/6micrograms inhaler: 2 inhalations twice daily.
Symbicort
Maintenance therapy for children aged 12 to 18 years:
100micrograms/3micrograms inhaler: 2 to 4 inhalations twice daily.
Symbicort Turbohaler
Maintenance and reliever therapy aged 12 to 18 years:
100micrograms/6micrograms and 200micrograms/6micrograms inhalers: 2 inhalations once daily or 1 inhalation twice daily.
Take 1 additional inhalation as needed as reliever.
If the symptoms persist after a few minutes then another inhalation should be taken (up to 6 inhalations for any single episode).
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
WockAIR
Routine Maintenance therapy for children aged 12 to 18 years:
160micrograms/4.5micrograms: 1 to 2 inhalations twice a day.
320micrograms/9micrograms: 1 inhalation twice a day.
Additional Dosage Information
In usual practice when control of asthma symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include the use of budesonide with formoterol dry powder inhaler given once daily.
Contraindications
Children under 6 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 6 to 18 years
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Adrenal insufficiency
Arterial aneurysm
Breastfeeding
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
History of torsade de pointes
Hypertrophic obstructive cardiomyopathy
Hypokalaemia
Idiopathic subvalvular aortic stenosis
Ischaemic heart disease
Lactose intolerance
Phaeochromocytoma
Pregnancy
Pulmonary tuberculosis
Severe cardiac failure
Severe cardiovascular disorder
Severe hypertension
Tachyarrhythmia
Thyrotoxicosis
Caution in transfer from oral steroids in adrenal insufficiency
Correct electrolyte disorders before treatment
Re-evaluate therapy in active or quiescent pulmonary tuberculosis
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
Advise visual disturbances may affect ability to drive or operate machinery
Ensure patient has a fast acting bronchodilator available
Not all available brands are indicated for all uses
Not all available brands are licensed for all age groups
Some formulations contain lactose
Consider use of a spacer device for suitable patients and formulations
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
If growth in children is slowed, consider referral to a paediatrician
If reliever required frequently consider alternative without corticosteroid
If visual disturbances occur, perform ophthalmic evaluation
Monitor adrenal function in stressed patients e.g.surgery/intensive care
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs/symptoms of pneumonia in patients at risk
Monitor regularly the height of children receiving prolonged treatment
Monitor serum electrolytes
Monitor serum potassium regularly in severe asthmatic or hypoxic patients
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
During transfer from oral steroids allergic conditions may be unmasked
High doses may affect bone metabolism
May reduce serum potassium levels
Patient should seek medical advice if signs of pulmonary infection develop
Systemic effects possible with any inhaled corticosteroid
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Advise patient to rinse mouth with water after each dose
Advise patient to seek medical advice if treatment is ineffective
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Consider issuing Steroid Treatment/Steroid Emergency Card
Patients may not taste/feel any medication when using dry powder inhalers
Use regularly to maintain freedom from symptoms
Pregnancy and Lactation
Pregnancy
Use the combination of budesonide with formoterol with caution during pregnancy.
The manufacturers recommend only using budesonide with formoterol during pregnancy when the benefits outweigh the potential risks. The manufacturers also note that there are no adequate and well controlled studies of budesonide with formoterol in pregnant women. If necessary, the lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
In animal studies, glucocorticosteroids have been shown to induce malformations. This is not thought to be relevant for humans given recommended doses.
Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
Lactation
Use the combination of budesonide with formoterol with caution during breastfeeding.
The manufacturers note that this medication should only be considered if the benefit to the mother exceeds any possible risk to the child.
Budesonide is excreted in breast milk, although no effects on the breastfed child are anticipated at the prescribed doses. It is not known whether formoterol passes into human breast milk.
Side Effects
Adrenal suppression
Aggression
Anaphylactic reaction
Angina
Angioedema
Anxiety
Atrial fibrillation
Behavioural disturbances
Blood pressure changes
Blurred vision
Bronchospasm (paradoxical)
Bruising
Candidiasis (mouth or throat)
Cardiac arrhythmias
Cataracts
Cough
Cushing's syndrome
Decrease in bone mineral density
Depression
Dermatitis
Dizziness
Dysphonia
Exanthema
Extrasystoles
Glaucoma
Headache
Hoarseness
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Increase in blood levels of free fatty acids
Increase in blood levels of glycerol
Increase in blood levels of insulin
Increase in blood levels of ketones
Muscle cramps
Nausea
Palpitations
Pneumonia
Prolongation of QT interval
Pruritus
Psychomotor hyperactivity
Sleep disturbances
Suppression of growth in children and adolescents
Supraventricular tachycardia
Tachycardia
Taste disturbances
Throat discomfort
Tremor
Urticaria
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 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.
Summary of Product Characteristics: DuoResp Spiromax 160micrograms/4.5micrograms inhalation powder. Teva UK Ltd. Revised July 2020.
Summary of Product Characteristics: DuoResp Spiromax 320micrograms/9micrograms inhalation powder. Teva UK Ltd. Revised July 2020.
Summary of Product Characteristics: Fobumix Easyhler 80/4.5 inhalation powder. Orion Corporation. Revised May 2020.
Summary of Product Characteristics: Fobumix Easyhler 160/4.5 inhalation powder. Orion Corporation. Revised May 2020.
Summary of Product Characteristics: Fobumix Easyhler 320/12 inhalation powder. Orion Corporation. Revised May 2020.
Summary of Product Characteristics: Symbicort 100micrograms/3micrograms inhalation suspension. AstraZeneca UK Limited. Revised June 2020.
Summary of Product Characteristics: Symbicort 200micrograms/6micrograms inhalation suspension. AstraZeneca UK Limited. Revised June 2018.
Summary of Product Characteristics: Symbicort Turbohaler 100micrograms/6micrograms inhalation powder. AstraZeneca UK Limited. Revised June 2020.
Summary of Product Characteristics: Symbicort Turbohaler 200micrograms/6micrograms inhalation powder. AstraZeneca UK Limited. Revised August 2019.
Summary of Product Characteristics: Symbicort Turbohaler 400micrograms/12micrograms inhalation powder. AstraZeneca UK Limited. Revised June 2020.
Summary of Product Characteristics: WockAIR 160micrograms/4.5micrograms inhalation powder. Wockhardt UK Ltd. Revised August 2021.
Summary of Product Characteristics: WockAIR 320micrograms/9micrograms inhalation powder. Wockhardt UK Ltd. Revised May 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 November 2021
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