Please see below the links for UK core Symbicort® product information for asthma, with details on pharmacodynamics, indications for Symbicort Turbuhaler®, Symbicort dose, asthma contraindications and warnings/precautions to be taken in to account when prescribing or using Symbicort. Information for pregnant females, Symbicort interactions with other drugs and potential side effects are also provided.
SEE YOUR LOCAL COUNTRY SYMBICORT PRODUCT INFORMATION, AS PRESCRIBING INFORMATION MAY VARY FROM COUNTRY TO COUNTRY.
- Download Full Product Prescribing Information for Symbicort Turbuhaler (budesonide/formoterol) 80/4.5 µg/inhalation
- Download Full Product Prescribing Information for Symbicort Turbuhaler (budesonide/formoterol) 160/4.5 µg/inhalation
- Download Full Product Prescribing Information for Symbicort Turbuhaler (budesonide/formoterol) 320/9 µg/inhalation
Abbreviated Core Data Sheet
Symbicort Turbuhaler (budesonide and formoterol). Inhalation powder 80/4.5 mcg/inhalation, 160/4.5 mcg/inhalation and 320/9 mcg/inhalation (delivered dose).
SEE YOUR LOCAL COUNTRY SYMBICORT PRODUCT INFORMATION, AS PRESCRIBING INFORMATION MAY VARY FROM COUNTRY TO COUNTRY.
Pharmacodynamic Properties
Symbicort Turbuhaler is an inhaled combination medicinal product. It contains budesonide and formoterol, which show additive effects in terms of reduction of asthma and COPD exacerbations. Budesonide is a glucocorticosteroid with high local anti-inflammatory effect. Formoterol is a selective beta2-adrenergic agonist that induces relaxation of bronchial smooth muscle. The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation and has a duration of 12 hours after a single dose.
Indications
Asthma
Regular treatment of asthma, where use of a combination therapy (inhaled corticosteroid and long acting ß2-agonist) is appropriate.
Dosage
Dosage is individual and adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose, which could include Symbicort Turbuhaler given once daily.
Asthma
For Symbicort there are two alternative therapies:
Symbicort maintenance and reliever therapy:
Symbicort is taken as both regular maintenance treatment, and also as needed in response to symptoms. The as needed inhalations provide both rapid relief and improved asthma control. Patients should be advised to have Symbicort available for rescue use at all times. A separate inhaler for rescue use is not necessary.
80/4.5 and 160/4.5 µg/inhalation:
Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate (for 160/4.5 µg/inhalation only). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
Children (4 years and older): The usual maintenance dose is 1 inhalation once daily. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 4 inhalations should be taken on any single occasion.
A reassessment of asthma therapy should be considered in patients using an increasing number of Symbicort inhalations for symptom relief without achieving improved asthma control within 2 weeks. A total daily dose of more than 8 inhalations for adults and adolescents and 4 inhalations for children is not normally needed, however a total daily dose of up to 12 inhalations for adults and adolescents and 8 inhalations for children could be used temporarily.
Symbicort maintenance therapy:
Symbicort taken as regular maintenance treatment, with a separate rapid-acting bronchodilator as rescue. Patients should be advised to have their separate rapid-acting bronchodilator available for rescue at all times.
Adults (18 years and older):
80/4.5 and 160/4.5 µg/inhalation: Usual dose is 1– 2 inhalations twice daily. Maximum dose is 4 inhalations twice daily.
320/9 µg/inhalation: Usual dose is 1 inhalation twice daily. Maximum dose is 2 inhalations twice daily.
Adolescents (12-17 years):
80/4.5 and 160/4.5 µg/inhalation: 1–2 inhalations twice daily.
320/9 mcg/inhalation: 1 inhalation twice daily.
Children (6-11 years):
80/4.5 µg/inhalation: 2 inhalations twice daily.
Symbicort 320/9 µg/inhalation should be used as Symbicort maintenance therapy only. Lower strengths are available for the Symbicort maintenance and reliever therapy regimen.
Contraindications
Hypersensitivity to budesonide, formoterol or inhaled lactose.
Warnings and precautions
The patient should seek medical advice if a previously effective dosage regimen no longer gives the same relief. There are no data available on the use of Symbicort Turbuhaler in the treatment of an acute asthma attack. Particular care is needed for patients who have transferred from systemic to inhaled glucocorticosteroids. High doses of, or long-term treatment with glucocorticosteroids may lead to signs or symptoms of hypercorticism, suppression of HPA function and/or suppression of growth in children and adolescents.
The growth of children and adolescents taking glucocorticosteroids in long-term treatment by any route should be closely followed. Symbicort Turbuhaler should be administered with caution in patients with severe cardiovascular disorders, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Pregnancy and Lactation
Symbicort Turbuhaler should only be used after special consideration, especially during the first three months and shortly before delivery. As with other drugs administered during pregnancy, the benefits for the mother should be weighed against the risks to the foetus. It is not known whether budesonide or formoterol passes into human milk.
Interactions
Beta-adrenergic blockers (including eye drops) can weaken or inhibit the effect of Symbicort Turbuhaler. The metabolism of budesonide is primarily mediated by CYP3A4, a subfamily of cytochrome P450. Inhibitors of this enzyme, e.g. ketoconazole, may therefore increase systemic exposure to budesonide. This is of limited clinical importance for short term (1-2 weeks) treatment with ketoconazole, but should be taken into consideration during long-term treatment with ketoconazole.
Undesirable Effects:
Common: Palpitations, candida infection in the oropharynx, headache, tremor, mild irritation in the throat, coughing, hoarseness. Uncommon: Tachycardia, nausea, muscle cramps, dizziness, agitation, restlessness, nervousness, sleep disturbances. Rare: Cardiac arrythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles. Immediate and delayed hypersensitivity reactions, e.g. dermatitis, exanthema, urticaria, pruritus and angioedema. Bronchospasm and skin bruising. Very rare: Angina pectoris, signs and symptoms of systemic glucocorticosteroid effects, e.g. hypofunction of the adrenal gland. Hyperglycaemia, depression and behavioural disturbances.
Legal category:
On medical prescription
Further information is available on request from AstraZeneca or local AstraZeneca subsidiaries.
Symbicort and Turbuhaler are trademarks owned by the AstraZeneca Group.
Neither the Symbicort SMART® posology nor the dry powder formulation, Turbuhaler®, are currently approved in the US.
Using Symbicort SMART®
Which inhaler should I prescribe with Symbicort SMART®?
Symbicort 320/9 µg/inhalation is not approved for use as Symbicort SMART. The two strengths of Symbicort approved for Symbicort SMART are 160/4.5 µg/inhalation and 80/4.5 µg/inhalation. Clinical trials have shown both formulations to be effective and safe [1-7]. Read more about Symbicort safety and efficacy. Symbicort 160/4.5 µg/inhalation is the preferred option for adult patients and can be given as a maintenance dose of two inhalations/day with extra inhalations as needed. For some patients, a higher maintenance dose of two inhalations twice daily may be appropriate.
Is there a minimum and maximum daily dose recommended with Symbicort SMART®?
Yes. Patients using Symbicort SMART should take their maintenance medication daily, even when asymptomatic. The minimum maintenance dose should be two inhalations/day with additional inhalations as needed if symptoms occur. Patients do not normally need to use more than a total of eight inhalations in one day; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than eight inhalations/day should seek medical advice and their maintenance therapy should be reconsidered.
The above is based on the EU SmPc. Labels vary across different countries in the world. Please see national prescribing information for further information regarding dosing instructions.
What should I tell my patients to do if their asthma deteriorates when using Symbicort SMART®?
Similar to what any asthma patients should do, if treatment is ineffective or the patient exceeds the highest recommended dose of treatment, medical attention must be sought and the patient should undergo urgent medical assessment.
A Symbicort SMART treatment plan provided with supporting materials includes guidance to your patients on how they can assess their asthma control, and when they need to seek medical assistance.
How to use Symbicort SMART
Can I allow patients using Symbicort SMART® to also use a separate SABA for symptom relief?
No, it is not recommended as the full benefits of the Symbicort SMART management approach, i.e. treating the underlying inflammation as symptoms occur, would not be maximised.
Can I prescribe Symbicort SMART® to patients with exercise-induced asthma?
Yes. Both monocomponents in Symbicort, when taken as maintenance medication, reduce exercise-induced symptoms [8,9]. However, the benefit of additional doses of Symbicort before exercise has not been studied. Symbicort should only be used as reliever therapy in response to asthma symptoms, including exercise-related symptoms, and is not intended for regular prophylactic use before exercise. For such use, a separate rapid-acting bronchodilator should be considered.
References
- O'Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005;171:129-136.
- Scicchitano R, Aalbers R, Ukena D, et al. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004;20:1403-1418.
- Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007;61:725-736.
- Bousquet J, Boulet LP, Peters MJ, et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007;101:2437-2446.
- Rabe KF, Atienza T, Magyar P, et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet 2006;368:744-753.
- Rabe KF, Pizzichini E, Stallberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest 2006;129:246-256.
- Vogelmeier C, D'Urzo A, Pauwels R, et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005;26:819-828.
- Hermansen MN, Nielsen KG, Buchvald F, et al. Acute relief of exercise-induced bronchoconstriction by inhaled formoterol in children with persistent asthma. Chest 2006;129:1203-1209.
- Vidal C, Fernandez-Ovide E, Pineiro J, et al. Comparison of montelukast versus budesonide in the treatment of exercise-induced bronchoconstriction. Ann Allergy Asthma Immunol 2001;86:655-658.
