Dulera Daily Dosing Recommendations
Dulera (mometasone/formoterol) is dosed at either 2 inhalations of 100/5 mcg twice daily (total daily dose: 400 mcg mometasone/20 mcg formoterol) or 2 inhalations of 200/5 mcg twice daily (total daily dose: 800 mcg mometasone/20 mcg formoterol), depending on asthma severity, with the maximum daily dose being 800 mcg mometasone/20 mcg formoterol. 1
Standard Dosing by Severity
Moderate Persistent Asthma (Step 3)
- Dulera 100/5 mcg: 2 inhalations twice daily (morning and evening) 1
- Total daily dose: 400 mcg mometasone/20 mcg formoterol 1
- This lower dose is appropriate for patients stepping up from medium-dose inhaled corticosteroids alone 1
Severe Persistent Asthma (Step 4)
- Dulera 200/5 mcg: 2 inhalations twice daily (morning and evening) 1
- Total daily dose: 800 mcg mometasone/20 mcg formoterol 1
- This higher dose is indicated for patients previously on high-dose inhaled corticosteroids who remain uncontrolled 1
Age Restrictions and Safety Considerations
Pediatric Limitations
- Dulera is NOT approved for children under 12 years of age 2, 3
- The Expert Panel Report 3 guidelines explicitly state that formoterol via metered-dose inhaler lacks safety and efficacy data for children 0-11 years 2, 3
- Children under 4 years cannot generate sufficient inspiratory flow for adequate medication delivery 3
Safety Warnings for All Ages
- Never use as monotherapy: Formoterol must always be combined with an inhaled corticosteroid due to FDA warnings about increased risk of severe exacerbations and deaths with long-acting beta-agonists alone 3, 4
- Dulera should only be used for maintenance therapy, not for acute symptom relief 5
- Patients should have a separate short-acting beta-agonist (albuterol) for rescue use 5
Important Dosing Principles
Administration Timing
- Administer twice daily, approximately 12 hours apart (morning and evening) 1, 6
- Consistent timing optimizes both the anti-inflammatory effect of mometasone and the bronchodilator effect of formoterol 6
Maximum Dose Limits
- Do not exceed 2 inhalations of the 200/5 mcg strength twice daily (800 mcg mometasone/20 mcg formoterol total daily) 1
- Higher doses do not provide additional benefit and increase risk of systemic corticosteroid effects 1
Spacer Device Considerations
- Using a spacer with Dulera reduces systemic exposure to both mometasone (by 28%) and formoterol (by 38%) compared to without a spacer 7
- While this may reduce potential systemic side effects, it also reduces drug delivery, so spacer use should be considered based on individual patient factors 7
Clinical Pearls
Onset of Action
- Formoterol provides rapid bronchodilation within 5 minutes, making Dulera effective for both maintenance and relatively quick symptom improvement 1
- However, full asthma control typically requires 1-2 weeks of consistent twice-daily use 1, 6
Drug Interactions
- Avoid potent CYP3A4 inhibitors (ritonavir, ketoconazole) as they can increase systemic mometasone concentrations and cause Cushing syndrome or adrenal insufficiency 8
Common Pitfall to Avoid
- Do not confuse Dulera with SMART regimens: Unlike budesonide/formoterol, which can be used as both maintenance and reliever therapy (SMART), Dulera is approved only for scheduled maintenance dosing, not as-needed use 4
- SMART regimens allow up to 12 total inhalations daily, but this approach has only been validated with budesonide/formoterol, not mometasone/formoterol 4