What is Dulera (mometasone and formoterol)?

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Last updated: April 10, 2025View editorial policy

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From the Guidelines

Dulera is a prescription medication used to treat asthma in patients 5 years and older, containing mometasone furoate and formoterol fumarate, and is recommended for individuals aged 12 y and older with moderate to severe persistent asthma as a single inhaler used as both daily controller and reliever therapy, as opposed to higher-dose ICS-LABA as daily controller therapy and SABA for quick-relief therapy, according to the expert panel conditional recommendation with high certainty of evidence 1.

Key Points

  • Dulera is a combination of an inhaled corticosteroid (mometasone furoate) and a long-acting beta2-adrenergic agonist (formoterol fumarate)
  • It is used to treat asthma in patients 5 years and older
  • The medication works through a dual mechanism: mometasone reduces inflammation in the airways, while formoterol helps relax and open the airways to improve breathing
  • Dulera is not intended for acute asthma attacks or as a rescue inhaler; patients should continue to use a rescue inhaler like albuterol for sudden symptoms
  • Common side effects may include throat irritation, headache, and oral thrush
  • To prevent thrush, patients should rinse their mouth with water after each use

Recommendations

  • In individuals aged 12 y and older with mild persistent asthma, the expert panel conditionally recommends either daily low-dose ICS and as-needed SABA for quick-relief therapy or as-needed ICS and SABA used concomitantly 1
  • In individuals aged 12 y and older with moderate to severe persistent asthma, the expert panel conditionally recommends ICS-formoterol in a single inhaler used as both daily controller and reliever therapy, as opposed to higher-dose ICS-LABA as daily controller therapy and SABA for quick-relief therapy 1
  • In individuals aged 12 y and older with uncontrolled persistent asthma, the expert panel conditionally recommends adding LAMA to ICS-LABA, as opposed to continuing the same dose of ICS-LABA 1

Important Considerations

  • Dulera should be used regularly as prescribed, even when feeling well, to maintain asthma control
  • Patients should continue to use a rescue inhaler like albuterol for sudden symptoms
  • The expert panel recommends against the use of FENO measurements in isolation to assess asthma control, predict future exacerbations, or assess exacerbation severity, but conditionally recommends the addition of FENO measurement as an adjunct to the evaluation process in individuals aged 5 y and older for whom the diagnosis of asthma is uncertain 1

From the Research

Definition of Dulera

  • Dulera is a combination of two medications: mometasone furoate, an inhaled corticosteroid, and formoterol fumarate dihydrate, a long-acting β2-agonist 2.
  • It is administered via a metered-dose inhaler with a dose counter and is indicated for daily maintenance therapy in patients aged 12 years and older with persistent asthma 2.

Components of Dulera

  • Mometasone furoate is a synthetic steroid that exhibits a strong affinity for the glucocorticoid receptor, has a low bioavailability, and a high plasma protein binding 3.
  • Formoterol fumarate is a full β2-agonist with a rapid onset and 12 hours of duration 3.

Uses of Dulera

  • Dulera is used for the treatment of persistent asthma in patients who are not adequately controlled on inhaled corticosteroids alone 4, 5.
  • It is also used to reduce asthma deteriorations, improve lung function, and improve asthma control and quality of life 2, 5.

Safety and Efficacy of Dulera

  • Clinical safety studies have found that Dulera has a low incidence of local and systemic side effects 2.
  • Randomized, controlled trials have suggested that Dulera reduces asthma deteriorations, improves lung function, and improves asthma control and quality of life 2, 5.
  • A post hoc analysis of a large clinical trial dataset found that maintenance on Dulera is not associated with an increased risk of serious asthma outcomes and significantly reduces the risk of asthma exacerbations compared with step-down to mometasone monotherapy 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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