What is Symbicort (budesonide and formoterol) used for in the diagnosis and management of respiratory diseases, particularly in patients with asthma or chronic obstructive pulmonary disease (COPD)?

Symbicort: Approved Indications

Symbicort (budesonide/formoterol) is FDA-approved for two primary diagnoses: asthma in patients 6 years and older who require combination therapy, and chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. 1

Primary Indications

Asthma (Ages 6 and Older)

Symbicort is indicated for asthma treatment in patients not adequately controlled on inhaled corticosteroids alone, or whose disease severity warrants initiating both an ICS and LABA simultaneously. 1

• The medication addresses both underlying airway inflammation (via budesonide) and bronchoconstriction (via formoterol), treating two fundamental components of asthma pathophysiology 2, 3
• According to the American College of Physicians, budesonide/formoterol serves as the preferred alternative to fluticasone propionate alone, offering superior exacerbation prevention through the SMART protocol for patients ≥12 years at steps 3-4 of asthma management 4
• The National Asthma Education and Prevention Program recommends budesonide/formoterol at Step 3 and higher for asthma management 5

Critical limitation: Symbicort should NOT be used in patients whose asthma is well-controlled on low-to-medium dose inhaled corticosteroids alone. 1 LABAs like formoterol carry an increased risk of asthma-related death when used as monotherapy, and must always be combined with ICS 5, 6

COPD (Chronic Bronchitis and/or Emphysema)

Only the 160/4.5 mcg strength of Symbicort is FDA-approved for COPD. 1 This indication specifically targets:

• Maintenance treatment of airflow obstruction 1
• Reduction of COPD exacerbations 1
• Improvement of symptoms for better breathing 1

The European Respiratory Society guidelines indicate that ICS/LABA combinations like Symbicort are appropriate for severe COPD patients with FEV1 <50% predicted and ≥2 exacerbations per year 4, 5

Dosing by Indication

Asthma Dosing

• Standard regimen: 2 inhalations twice daily (morning and evening, approximately 12 hours apart) 1
• Available strengths: 80/4.5 mcg or 160/4.5 mcg 1
• Maximum dose: 160/4.5 mcg, 2 inhalations twice daily in patients ≥12 years 1

COPD Dosing

• Only 160/4.5 mcg strength: 2 inhalations twice daily 1
• This is the sole strength indicated for COPD treatment 1

Important Clinical Caveats

Symbicort is NOT indicated for relief of acute bronchospasm in either asthma or COPD. 1 Patients must use a short-acting beta2-agonist for acute symptom relief 1

Safety Considerations

• The American Thoracic Society warns that LABA-containing medications should never be used as monotherapy for asthma due to increased risk of severe exacerbations and death 5
• In COPD, ICS-containing regimens increase pneumonia risk by approximately 4% (odds ratios 1.38-1.48) 6
• Patients should rinse mouth with water after each use to minimize oral candidiasis and hoarseness 1

When NOT to Use Symbicort

• Sudden severe symptoms of asthma or COPD requiring emergency treatment 1
• Patients with asthma well-controlled on low-to-medium dose ICS alone 1
• As monotherapy without the corticosteroid component 5
• Allergy to budesonide, formoterol, or any ingredient 1