Symbicort Turbuhaler Special Precautions

80 mcg/4.5 mcg: It is recommended that the dose is tapered when long-term treatment is discontinued and should not be stopped abruptly.
If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER), medical attention must be sought.
Sudden and progressive deterioration in control of asthma 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, eg, a course of oral corticosteroids, or antibiotic treatment if an infection is present.
Treatment with Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) should not be initiated to treat a severe exacerbation.
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 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.
Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) should be administered with caution in patients with severe cardiovascular disorders (including heart rhythm abnormalities), diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
High doses of beta₂-agonists can lower s-potassium by inducing a redistribution of potassium from the extracellular to the intracellular compartment, via stimulation of Na⁺/K⁺-ATPase in muscle cells. The clinical importance of this effect is uncertain.
Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) contains lactose (<1 mg/inhalation). This amount does not normally cause problems in lactose intolerant people.
160 mcg/4.5 mcg: Dosing advice: It is recommended that the maintenance dose is tapered when long-term treatment is discontinued and the dosing should not be stopped abruptly. Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm the diagnosis of asthma.
Deterioration of disease: If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide/Formoterol fumarate (SYMBICORT TURBUHALER), 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, e.g., 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.
Transfer from oral 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.
Excipients: Budesonide/Formoterol fumarate (SYMBICORT TURBUHALER) contains lactose (<1 mg/inhalation). This amount does not normally cause problems in lactose intolerant people.
Caution with special diseases: Budesonide/Formoterol fumarate (SYMBICORT TURBUHALER) should be administered with caution in patients with severe cardiovascular disorders (including heart rhythm abnormalities), diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
High doses of β₂ agonists can lower serum potassium by inducing a redistribution of potassium from the extracellular to the intracellular compartment, via stimulation of Na⁺/K⁺- ATPase in muscle cells. The clinical importance of this effect is uncertain.
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.
320 mcg/9 mcg: It is recommended that the dose is tapered when long-term treatment is discontinued and should not be stopped abruptly.
If patients find the treatment ineffective, or exceed the prescribed dose of Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER), medical attention must be sought. Increasing use of rapid acting bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy. In asthma, consideration should be given to the need for increased therapy with Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) or the addition of inhaled corticosteroids and/or long acting beta₂-agonists or a course of oral corticosteroids. In COPD, consideration should be given to the need for adding a course of oral corticosteroids, and/or antibiotic treatment if an infection is present.
Patients should be advised to have their rapid-acting bronchodilator available at all times.
Treatment with Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) should not be initiated to treat a severe exacerbation.
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.
Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) should be administered with caution in patients with severe cardiovascular disorders (including heart rhythm abnormalities), diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
High doses of beta₂-agonists can lower s-potassium by inducing a redistribution of potassium from the extracellular to the intracellular compartment, via stimulation of Na⁺/K⁺-ATPase in muscle cells. The clinical importance of this effect is uncertain.
Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) contains lactose (<1 mg/inhalation). This amount does not normally cause problems in lactose intolerant people.
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.
Effects on ability to drive and use machines: Budesonide/Formoterol (SYMBICORT TURBUHALER) is not expected to adversely affect the ability to drive or use machines.
Use in Children: Physicians should closely follow the growth of children and adolescents taking long-term corticosteroids by any route, and weigh the benefits of the corticosteroid therapy against the possible risk of growth suppression (see Pharmacology: Pharmacodynamics under Actions).