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Symbicort® Information for Prescribers – COPD
This page provides the link to the UK core product information for Symbicort® in COPD, which gives details on pharmacodynamics, Symbicort dosage and indications, COPD contraindications, warnings and precautions, information for pregnant females, Symbicort interactions with other drugs and undesirable effects that may develop when using Symbicort Turbuhaler®.
SEE YOUR LOCAL COUNTRY SYMBICORT PRODUCT INFORMATION, AS PRESCRIBING INFORMATION MAY VARY FROM COUNTRY TO COUNTRY.
Symbicort® UK Prescribing Information
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).
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.
COPD
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of exacerbations, despite regular therapy with long-acting bronchodilators.
Dosage:
Dosage for patients with COPD 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.
Adults (18 years and older):
160/4.5 µg/inhalation: 2 inhalations twice daily.
320/9 µg/inhalation: 1 inhalation twice daily.
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.
The dry powder formulation Turbuhaler® is not currently approved in the US
