What is the recommended dosing regimen of Dulera (fluticasone propionate 100 µg + salmeterol 50 µg) for children and adults?

Dulera Dosing Recommendations

For children aged 5 to less than 12 years, use Dulera 50 mcg/5 mcg (mometasone furoate/formoterol) as 2 inhalations twice daily (morning and evening), and for adults and adolescents 12 years and older, start with Dulera 100 mcg/5 mcg as 2 inhalations twice daily, with the option to increase to Dulera 200 mcg/5 mcg twice daily if asthma control is inadequate after 2 weeks. 1

Age-Specific Dosing

Pediatric Patients (5 to <12 years)

• Dulera 50 mcg/5 mcg: 2 inhalations twice daily
• Maximum daily dose: 200 mcg/20 mcg total
• This is the only approved strength for this age group 1

Adolescents and Adults (≥12 years)

Starting Dose Selection:

• Base initial strength on disease severity, previous asthma therapy (including prior inhaled corticosteroid dose), current symptom control, and exacerbation risk 1

Dulera 100 mcg/5 mcg: 2 inhalations twice daily

• Appropriate for patients with moderate persistent asthma
• If inadequate control after 2 weeks, increase to higher strength 1

Dulera 200 mcg/5 mcg: 2 inhalations twice daily

• For patients requiring higher corticosteroid doses
• Maximum recommended dose: 800 mcg/20 mcg daily (2 inhalations of 200 mcg/5 mcg twice daily) 1

Critical Administration Instructions

Proper Technique:

• Shake well before each inhalation 1
• Prime with 4 test sprays before first use or if not used for >5 days 1
• Rinse mouth with water after each dose (2 puffs) and spit out—do not swallow—to reduce risk of oral thrush 1
• Remove cap from mouthpiece before use; do not remove canister from actuator 1

Important Timing:

• Administer every day at consistent times (morning and evening) 1
• This is maintenance therapy only—not for acute symptom relief 1
• Always have a short-acting beta2-agonist rescue inhaler available 1

Dose Titration Strategy

After achieving asthma stability, titrate to the lowest effective dose to minimize side effects 1. If a previously effective regimen fails to provide adequate control, consider:

1. Increasing to the next strength of Dulera
2. Adding additional inhaled corticosteroid
3. Initiating oral corticosteroids 1

Key Safety Considerations

Not Approved For:

• Children <5 years of age (safety and efficacy not established) 1
• Status asthmaticus or acute asthma episodes requiring intensive measures 1

Common Pitfalls to Avoid:

• Do not use more frequently than twice daily 1
• Do not use other long-acting beta2-agonist (LABA) medications while on Dulera 1
• Do not use the Dulera actuator with other inhaler canisters or vice versa 1

The dosing recommendations align with the broader asthma management guidelines that emphasize combination ICS/LABA therapy for patients not controlled on low-to-medium dose inhaled corticosteroids alone 2. The specific mometasone/formoterol combination in Dulera provides an alternative to fluticasone/salmeterol combinations, with comparable efficacy profiles in maintaining asthma control.