From the Guidelines
Symbicort is approved for use in adults and children aged 6 years and older for asthma management. The medication combines budesonide (an inhaled corticosteroid) and formoterol (a long-acting beta-agonist) to reduce inflammation and relax airway muscles.
Key Points
- For children with asthma aged 6-11, a lower strength formulation is typically prescribed.
- Symbicort should not be used in children under 6 years of age as safety and efficacy have not been established in this age group, as indicated by the lack of clinical trials in children <4 years of age and the fact that most children <4 years of age cannot provide sufficient inspiratory flow for adequate lung delivery 1.
- The dosage varies based on the condition being treated, its severity, and the patient's age, with administration typically being 2 inhalations twice daily.
- Patients should always follow their healthcare provider's specific dosing instructions, as individual needs may vary based on symptom severity and response to treatment.
Age Range Considerations
- According to the guidelines, budesonide/formoterol is currently approved for use in youths 12 years of age and older, with dosing for children 5-12 years of age based on clinical trials using a dry powder inhaler (DPI) with slightly different delivery characteristics 1.
- For chronic obstructive pulmonary disease (COPD), Symbicort is only approved for adults 18 years and older.
Safety and Efficacy
- The potential adverse effects of Symbicort, including tachycardia, skeletal muscle tremor, hypokalemia, and a diminished bronchoprotective effect, should be carefully considered when prescribing this medication 1.
From the FDA Drug Label
The safety and effectiveness of budesonide and formoterol fumarate dihydrate 80/4.5 in asthma patients 6 to less than 12 years of age have been established in studies of up to 12-week duration The safety and effectiveness of budesonide and formoterol fumarate dihydrate in asthma patients less than 6 years of age have not been established. Safety and effectiveness of budesonide and formoterol fumarate dihydrate in asthma patients 12 years of age and older have been established in studies up to 12 months.
The age range for Symbicort is 6 years and older for asthma patients, with established safety and effectiveness in patients 12 years and older. For patients less than 6 years, the safety and effectiveness have not been established 2.
From the Research
Age Range for Symbicort
- The approved age range for the use of Symbicort (budesonide/formoterol inhalation aerosol) in the United States is for patients ≥12 years of age whose asthma cannot be controlled by an inhaled corticosteroid (ICS) alone 3.
- There is no specific information provided in the studies regarding the use of Symbicort in patients under 12 years of age.
- The studies primarily focus on the efficacy and safety of Symbicort in adults and adolescents ≥12 years of age with asthma or chronic obstructive pulmonary disease (COPD) 4, 5, 6, 7.
Key Findings
- Symbicort has been shown to be effective and generally well-tolerated in patients ≥12 years of age with asthma or COPD 3, 6.
- The combination of budesonide and formoterol in Symbicort provides both anti-inflammatory and bronchodilatory effects, making it a valuable treatment option for patients with asthma or COPD 4, 5.
- Comparisons with other ICS/LABA combinations have found Symbicort to be similar or superior in terms of efficacy and safety 5, 7.