Loading…
SYMBICORT TURBOHALER is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Asthma Symbicort Turbohaler is indicated in adults, and adolescents aged 12 - 17 years, for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and “as needed”…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
For inhalation use. Posology Asthma Symbicort is not intended for the initial management of asthma. The dosage of the components of Symbicort is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted.
If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Recommended doses:
Adults (18 years and older): 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily. Adolescents (12-17 years): 1 inhalation twice daily. Patients should be regularly reassessed by their prescriber/health care provider, so that the dosage of Symbicort remains optimal.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When long- term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Symbicort given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Children (6 years and older):
A lower strength (100 micrograms/6 micrograms/inhalation) is available for children 6 - 11 years.
Children under 6 years:
As only limited data are available, Symbicort is not recommended for children younger than 6 years. Symbicort 400/12 should be used as Symbicort maintenance therapy only. Lower strengths are available for the Symbicort maintenance and reliever therapy regimen (200 micrograms/6 micrograms/inhalation and 100 micrograms/6 micrograms/inhalation).
Since Symbicort contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
The most common drug related adverse reactions are pharmacologically predictable side effects of β2 agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. Adverse reactions, which have been associated with budesonide or formoterol, are given below, listed by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 to <1/1000) and very rare (<1/10 000). g. g. atrial fibrillation, supraventricular tachycardia, extrasystoles Cardiac disorders Very rare Angina pectoris.
Prolongation of QTc- interval Vascular disorders Very rare Variations in blood pressure Common Mild irritation in the throat, coughing, dysphonia including hoarseness Respiratory, thoracic and mediastinal disorders Rare Bronchospasm Gastrointestinal disorders Uncommon Nausea Skin and subcutaneous tissue disorders Uncommon Bruises Musculoskeletal and connective tissue disorders Uncommon Muscle cramps Candida infection in the oropharynx is due to drug deposition.
Advising the patient to rinse the mouth out with water after each maintenance dose will minimise the risk. Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.
If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. As with other inhalation therapy, paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.
Dosing advice Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Symbicort. Regular review of patients as treatment is stepped down is important. 2). Patients should be advised to have rescue inhaler available at all times.
Patients should be reminded to take their Symbicort maintenance dose as prescribed, even when asymptomatic. 8), the patient should be instructed to rinse their mouth out with water after inhaling the maintenance dose. It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
Deterioration of disease Serious asthma-related adverse events and exacerbations may occur during treatment with Symbicort. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Symbicort.
2). Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and the patient should undergo urgent medical assessment.
g. a course of oral corticosteroids, or antibiotic treatment if an infection is present. Patients should not be initiated on Symbicort during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Transfer from oral therapy If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to Symbicort therapy.
The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time.
1 (lactose, which contains small amounts of milk proteins).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
COPD Recommended doses:
Adults: 1 inhalation twice daily.
General information Special patient groups:
There are no special dosing requirements for elderly patients. There are no data available for use of Symbicort in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
Method of administration Instructions for correct use of Symbicort Turbohaler:
The inhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note:
It is important to instruct the patient • to carefully read the instructions for use in the patient information leaflet which is packed together with each Symbicort Turbohaler inhaler. • to breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
• never to breathe out through the mouthpiece. • to replace the cover of the Symbicort Turbohaler Inhaler after use. • to rinse their mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using Symbicort Turbohaler inhaler due to the small amount of drug dispensed.
Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. 4). Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur.
Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity. Treatment with β2 agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In such circumstances HPA axis function should be monitored regularly. During transfer from oral therapy to Symbicort, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Excipients Symbicort Turbohaler contains lactose monohydrate (<1 mg/inhalation). This amount does not normally cause problems in lactose intolerant people. The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.
5). If this is not possible, the time interval between administration of the interacting drugs should be as long as possible. Caution with special diseases Symbicort should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Caution should be observed when treating patients with prolongation of the QTc-interval. Formoterol itself may induce prolongation of the QTc- interval. Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
g. xanthine derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β2 adrenoceptor agonist. Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia is increased.
It is recommended that serum potassium levels are monitored during these circumstances. As for all β2 adrenoceptor agonists, additional blood glucose controls should be considered in diabetic patients. The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Systemic effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
8). Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have coexisting risk factors for osteoporosis. Long-term studies with inhaled budesonide […]