Tolerability
In clinical studies, adverse events (regardless of causality) occurring at an incidence of ≥3% and more commonly than with placebo*†
*All treatments were administered as 2 inhalations twice daily.
†The incidence of common adverse events in the table above is based upon three 12-week, double-blind, placebo-controlled US clinical trials in which 401 adult and adolescent patients aged 12 years and older were treated twice daily with 2 inhalations of SYMBICORT 80/4.5 mcg or SYMBICORT 160/4.5 mcg, budesonide HFA metered-dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebos (MDI and DPI).
SYMBICORT has safety data in long-term studies of up to 1 year
In patients‡ taking up to twice the maximum daily dose of SYMBICORT for up to 1 year, long-term studies demonstrated no significant or unexpected patterns of abnormalities
- Chemistry
- Hematology
- Holter monitor
- Hypothalamic pituitary adrenal (HPA)-axis assessments
- Electrocardiogram (ECG)
The maximum daily recommended dose is 640/18 mcg budesonide/formoterol (given as 2 inhalations of SYMBICORT 160/4.5 twice daily) for patients 12 years and older. Do not use more than twice daily or use a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of SYMBICORT as this will result in a daily dose of formoterol in excess of the dose determined to be safe. For all patients, consideration should be given to titrating to the lowest effective strength after adequate asthma stability has been achieved.
SYMBICORT should not be used more often or at higher doses than recommended. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses.
†≥12 years of age with asthma.
SYMBICORT offers a robust cardiac safety profile
2152 patients were evaluated in five 12-week, active- and placebo-controlled studies.
- No patient had a QT or QTc value ≥500 msec during treatment
553 patients taking SYMBICORT had evaluable continuous 24-hour Holter monitoring in 3 placebo-controlled studies involving 1232 patients.
- No important differences in occurrence of ventricular or supraventricular ectopy and no evidence of increased risk for clinically significant dysrhythmia in the group receiving SYMBICORT, compared with placebo
Beta-agonists have been reported to produce electrocardiogram changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown.