Dulera Dosing for Patients Aged 12 Years and Older with Asthma
For patients aged 12 years and older with asthma, Dulera should be administered as 2 inhalations twice daily (morning and evening), with the starting strength being either 100 mcg/5 mcg or 200 mcg/5 mcg based on disease severity and prior inhaled corticosteroid dose. 1
Starting Dose Selection
Choose your starting strength based on the patient's current asthma control and previous therapy:
- Dulera 100 mcg/5 mcg (2 inhalations twice daily): For patients transitioning from low-to-medium dose inhaled corticosteroids
- Dulera 200 mcg/5 mcg (2 inhalations twice daily): For patients on higher dose inhaled corticosteroids or with more severe disease 1
Dose Titration
If inadequate response after 2 weeks on Dulera 100 mcg/5 mcg twice daily, increase to Dulera 200 mcg/5 mcg twice daily. The maximum recommended dosage is 2 inhalations of Dulera 200 mcg/5 mcg twice daily (total daily dose: 800 mcg mometasone/20 mcg formoterol). 1
Administration Instructions
- Shake well before each inhalation
- Administer twice daily at approximately 12-hour intervals (morning and evening)
- Rinse mouth with water after each dose without swallowing to reduce risk of oral candidiasis 1
Priming Requirements
- First use: Release 4 test sprays into the air (away from face), shaking well before each spray
- After 5+ days of non-use: Prime again with 4 test sprays 1
Clinical Context from Guidelines
The NAEPP guidelines support this approach, recommending that for patients aged 12 years and older with moderate-to-severe persistent asthma, the preferred therapy is an inhaled corticosteroid combined with a long-acting beta-agonist (LABA). 2 The combination of mometasone furoate (an inhaled corticosteroid) with formoterol (a LABA) aligns with Step 3-5 therapy recommendations. 2
Efficacy Timeline
Patients may experience symptom relief within 5 minutes of administration, though maximum benefit typically requires 1 week or longer of consistent treatment. 1 Clinical trials demonstrate that both the 200/10 mcg and 400/10 mcg twice-daily regimens provide rapid and sustained bronchodilation with significant improvements in lung function, asthma control, and reduction in asthma deteriorations compared to monotherapy. 3, 4, 5
Safety Considerations
Critical: LABAs should never be used as monotherapy for asthma. 6, 2 The combination product ensures patients receive both the anti-inflammatory corticosteroid and bronchodilator together. Large safety trials, including one specifically evaluating mometasone furoate/formoterol versus mometasone alone in over 11,000 patients, demonstrated no increased risk of serious asthma-related events (hospitalizations, intubations, death) with the combination therapy, while actually reducing asthma exacerbations. 7
Step-Down Considerations
Once asthma stability is achieved for at least 3 months, consider titrating to the lowest effective dose. 1 However, recent evidence suggests that maintaining patients on ICS/LABA combination therapy (rather than stepping down to ICS monotherapy) does not increase serious asthma outcome risk and significantly reduces exacerbation risk. 8
Common Pitfalls to Avoid
- Do not use Dulera for acute symptom relief: Patients need a separate short-acting beta-agonist (e.g., albuterol) for rescue therapy 1
- Do not use the Dulera actuator with other products or vice versa: The canister and actuator are matched 1
- Do not forget to assess response: If a previously effective regimen fails to provide adequate control, reassess and consider stepping up therapy rather than continuing inadequate treatment 1