Symbicort™ Turbuhaler™ (budesonide and formoterol). Inhalation powder 80/4.5 mcg/inhalation, 160/4.5 mcg/inhalation and 320/9 mcg/inhalation (delivered dose).

Abbreviated Core Data Sheet
See local Prescribing Information for full details, 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 (inhaled corticosteroid and long acting beta₂-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 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 mcg/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 mcg/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 minues, an additional inhalation should be taken. Not more than 4 inhalations should be taken on any single occasion.

A reassesment 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 fo 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 mcg/inhalation: Usual dose is 1– 2 inhalations twice daily. Maximum dose is 4 inhalations twice daily.
320/9 mcg/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 mcg/inhalation: 1-2 inhalations twice daily.
320/9 mcg/inhalation : 1 inhalation twice daily.
Children (6-11 years):
80/4.5 mcg/inhalation: 2 inhalations twice daily.

Symbicort 320/9 mcg/inhalation should be used as Symbicort maintenance therapy only. Lower strengths are available for the Symbicort maintenance and reliever therapy regimen.

COPD
Adults (18 years and older):
160/4.5 mcg/inhalation: 2 inhalations twice daily.
320/9 mcg/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 hypokalemia 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.
© AstraZeneca 2006. Date of preparation: 5 December, 2006.