Should I use Dulera (mometasone/formoterol) together with a budesonide inhaler, and what are the appropriate dosing and age considerations?

Do Not Use Dulera and Budesonide Inhaler Together

You should not use Dulera (mometasone/formoterol) together with a separate budesonide inhaler, as this would result in unnecessary duplication of inhaled corticosteroid (ICS) therapy and increased risk of systemic corticosteroid side effects without additional benefit.

Why This Combination is Inappropriate

Dulera Already Contains an ICS Component

• Dulera is a fixed-dose combination containing mometasone furoate (an ICS) plus formoterol (a long-acting beta2-agonist or LABA) 1
• Adding a separate budesonide inhaler would mean taking two different ICS medications simultaneously, which is not recommended in asthma guidelines 2
• This approach provides no therapeutic advantage and only increases the risk of ICS-related adverse effects including adrenal suppression, growth suppression in children, osteoporosis, and oral candidiasis 2

Guideline-Based Approach to ICS/LABA Therapy

The preferred strategy for moderate-to-severe persistent asthma is to use a single ICS/LABA combination product, not multiple separate ICS inhalers 3:

• For adults and children ≥12 years with moderate persistent asthma, adding a LABA to low-to-medium dose ICS is the preferred treatment (Evidence A) 3
• LABA is the preferred adjunctive therapy to combine with ICS in youths ≥12 years and adults 2
• If asthma control is inadequate on one ICS/LABA combination, the appropriate step is to increase the dose of that same combination product, not add another ICS 1

Proper Dulera Dosing and Age Considerations

For Adults and Adolescents ≥12 Years 1:

• Starting dose: 2 inhalations twice daily of either:
  • Dulera 100 mcg/5 mcg (lower strength), OR
  • Dulera 200 mcg/5 mcg (higher strength)
• Dose selection should be based on disease severity and previous asthma therapy 1
• Maximum dose: 2 inhalations of Dulera 200 mcg/5 mcg twice daily (total daily dose 800 mcg mometasone/20 mcg formoterol) 1
• If inadequate control after 2 weeks on the 100 mcg strength, increase to the 200 mcg strength 1

For Children Ages 5 to <12 Years 1:

• Dose: 2 inhalations of Dulera 50 mcg/5 mcg twice daily
• Maximum daily dose: 200 mcg mometasone/20 mcg formoterol 1

For Children <5 Years:

• Dulera is not approved for children under 5 years of age 1
• Budesonide nebulizer suspension is the only ICS with FDA-approved labeling for children <4 years 2

What to Do If Asthma is Uncontrolled on Current Therapy

If a patient is already on Dulera and asthma remains uncontrolled, the appropriate steps are 1:

1. First: Ensure proper inhaler technique and adherence
2. Second: Increase Dulera dose to the next strength (if not already at maximum)
3. Third: Consider adding adjunctive therapy such as:
   • Leukotriene receptor antagonist (montelukast, zafirlukast) 2
   • Long-acting muscarinic antagonist (LAMA) for patients ≥12 years 4, 5
   • Omalizumab for severe allergic asthma 2
4. Fourth: For severe persistent asthma uncontrolled on high-dose ICS/LABA, consider oral systemic corticosteroids 2

Critical Safety Considerations

Systemic Corticosteroid Effects

• Using two ICS products simultaneously significantly increases systemic corticosteroid exposure 2
• Mometasone, budesonide, and other ICS are metabolized by CYP3A4 enzymes, and potent inhibitors (ritonavir, ketoconazole) can increase systemic concentrations, potentially causing Cushing syndrome and adrenal insufficiency 2
• In high doses, systemic effects include adrenal suppression, osteoporosis, skin thinning, and bruising 2

Growth Suppression in Children

• In low-to-medium doses, suppression of growth velocity has been observed in children, though this effect may be transient 2
• Doubling ICS exposure by using two products would unnecessarily increase this risk

Alternative Approaches for Enhanced Asthma Control

Single Maintenance and Reliever Therapy (SMART)

• For patients ≥12 years with moderate-to-severe asthma, ICS-formoterol used as both maintenance and reliever therapy is strongly recommended over higher-dose ICS-LABA as maintenance with separate SABA for rescue 4
• This approach uses budesonide-formoterol or beclomethasone-formoterol (not mometasone-formoterol/Dulera) as a single inhaler for both daily maintenance and as-needed symptom relief 6, 7
• SMART reduces severe exacerbations while using lower overall ICS doses 6, 8

Anti-Inflammatory Reliever (AIR) Therapy

• Recent evidence supports using budesonide-albuterol as as-needed reliever therapy (with or without maintenance ICS/LABA) to reduce exacerbations 9, 7
• This represents a paradigm shift from using SABA alone for rescue 9

The bottom line: Use Dulera as prescribed as a single controller medication. Do not add a separate budesonide inhaler. If asthma control is inadequate, work with your healthcare provider to adjust the Dulera dose or add appropriate adjunctive therapy—not another ICS product.