Symbicort Special Precautions

Dosing advice: If patients take Symbicort as maintenance therapy, they should be reminded to take Symbicort as prescribed even when asymptomatic.
Patients should be advised to have their rescue inhaler available at all times, either Symbicort (for asthma patients using Symbicort as anti-inflammatory reliever - therapy A or B) or a separate short-acting bronchodilator (for all patients using Symbicort as maintenance therapy only - therapy C).
It is recommended that the maintenance dose be tapered when the treatment is discontinued and the dosing should not be stopped abruptly. Complete withdrawal of inhaled corticosteroid should not be considered unless it is temporarily required to confirm the diagnosis of asthma.
To minimise the risk of oropharyngeal candida infection, the patient should be instructed to rinse the mouth with water after inhaling the maintenance dose.
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 with Symbicort.
If patients find the treatment ineffective, or exceed the current dose of the fixed combination, medical attention must be sought. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and the patient should undergo urgent medical assessment. In this situation consideration should be given to the need for increased therapy with corticosteroids or addition of systemic anti-inflammatory therapy (Rapihaler), such as a course of oral corticosteroids, or antibiotic treatment if an infection is present. For treatment of severe exacerbations, a combination product of inhaled corticosteroid and long-acting β₂ agonist alone is not sufficient.
Rapihaler: Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Paradoxical bronchospasm: As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. Symbicort should then be discontinued; treatment should be re-assessed and alternative therapy instituted if necessary.
Turbuhaler: Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway (see Adverse Reactions).
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. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
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 in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density. No information regarding the effect of Symbicort at higher doses is available.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Rapihaler: More rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
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.
Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high-dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Interaction with other medicinal products: Concomitant treatment with Symbicort and a potent CYP3A4 inhibitor should be weighed against the increased risk of systemic corticosteroid side effects (see Interactions).
Caution with special diseases: Symbicort should be administered with caution in patients with severe cardiovascular disorders (including hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, ischaemic heart disease, heart rhythm abnormalities or severe heart failure), phaeochromocytoma, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
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 agonists. Concomitant treatment of β₂ agonists with drugs which can induce hypokalaemia or potentiate a hypokalaemic effect, e.g., xanthine-derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β₂ 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 adverse effects is increased. It is recommended that serum potassium levels are monitored during these circumstances.
As for all β₂ 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.
COPD population: Clinical studies and meta-analyses indicate that maintenance treatment of COPD with inhaled corticosteroids may lead to an increased risk of pneumonia.
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.
Turbuhaler: There are no clinical study data on Symbicort Turbuhaler available in COPD patients with a pre-bronchodilator FEV₁ >50% predicted normal and with a post-bronchodilator FEV₁ <70% predicted normal (see Pharmacology: Pharmacodynamics under Actions).
Excipients: Turbuhaler: Symbicort Turbuhaler contains lactose (<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.
Effects on ability to drive and use machines: Turbuhaler: Symbicort Turbuhaler has no or negligible influence on the ability to drive and use machines.
Rapihaler: Symbicort Rapihaler is not expected to adversely affect the ability to drive or use machines.
Use in Children: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid. The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed (see Pharmacology: Pharmacodynamics under Actions). In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.
Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height. However, an initial small but transient reduction in growth (approximately 1 cm) has been observed. This generally occurs within the first year of treatment.