Symbicort Rapihaler

Symbicort Rapihaler Special Precautions

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Full Prescribing Info
Special Precautions
It is recommended that the dose be tapered when long-term treatment is discontinued and should not be stopped abruptly.
If patient finds the treatment ineffective, or exceed the prescribed dose of Budesonide + Formoterol fumarate dihydrate (SYMBICORT RAPIHALER), 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, eg, a course of oral corticosteroids, or antibiotic treatment if an infection is present.
Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Treatment with Budesonide + Formoterol fumarate dihydrate (SYMBICORT RAPIHALER) should not be used to treat a severe exacerbation.
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: Toxicology: Preclinical Safety data under Actions).
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 RAPIHALER) 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.
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 fumarate dihydrate (SYMBICORT RAPIHALER) is not expected to adversely affect the ability to drive or use machines.
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