Combination of
Mometasone furoate Corticosteroid
Formoterol Long-acting β2 adrenoreceptor agonist (LABA)
Clinical data
Trade names Zenhale, Dulera
License data
  • US: C (Risk not ruled out)
Routes of
Inhalation (MDI)
ATC code R03AK09 (WHO)
Legal status
Legal status

Mometasone/formoterol is a combination inhaler containing both an inhaled corticosteroid and long-acting bronchodilator. It is indicated for the maintenance treatment of asthma in adults and children 12 years of age and older whose asthma is not well controlled on low- or medium-dose corticosteroids, or whose disease clearly warrants combination therapy. It is not approved for the treatment of acute bronchospasm.[1] To relieve acute symptoms, a rapid-onset short-duration inhaled bronchodilator (such as salbutamol) should be available to the patient for use.[2]

It consists of two medications supplied in a single inhaler:

The safety and efficacy of this medication in children less than 12 years of age has not been established.[2]

It is marketed by Merck & Co. in Canada and Russia as Zenhale[2] and in the United States as Dulera[1] and is supplied as a metered-dose inhaler.[1][2]

Warnings and precautions

Long-acting β adrenoreceptor agonists (LABAs) are subject to a boxed warning against the possibility of an increased risk of asthma-related death.[2] Formoterol belongs to the LABA class of drugs. As there does not exist at the time of the monograph's publication adequate research to determine whether the rate of asthma-related death is increased with formoterol, it is therefore recommended by the FDA that LABAs only be used for patients not adequately controlled on other asthma controlling medications or whose disease severity clearly warrants initiation of dual therapy.[3]

Side effects

The most commonly reported side effects were: oral thrush, nausea, headache, and pain in the pharynx or larynx. More rarely reported side effects (occurring in <1% of patients during the clinical trial) include: tachycardia, palpitations, dry mouth, allergic reaction (bronchospasm, dermatitis, hives), pharyngitis, muscle spasms, tremor, dizziness, insomnia, nervousness, and hypertension. Patients experiencing an allergic reaction or increase in difficulty breathing while using this medication should immediately discontinue its use and contact their physician.[4]

How supplied and dosage

Mometasone/formoterol is available in a pressurized MDI (pMDI) in three strengths (in micrograms of mometasone/micrograms of formoterol): 50/5, 100/5, and 200/5. The following is the manufacturer's recommended dose based on prior asthma therapy:[2]


Zenhale was approved in Canada in early 2011.[5] Dulera was approved by the Food and Drug Administration (FDA) in the United States in June 2010.[6] Zenhale's marketing application was voluntarily withdrawn from the EU due to the manufacturer's inability to provide additional information in the necessary timeframe.[7]


  1. 1 2 3 Waknine, Yael. "FDA Approves Mometasone-Formoterol Combo for Asthma". Medscape Today FDA Approvals. Medscape. Retrieved August 16, 2011.
  2. 1 2 3 4 5 6 "Zenhale product monograph" (PDF). Merck Canada. Retrieved August 16, 2011.
  3. Donohue MD, Dr. James F. "Asthma Medications: Black Box Warnings -- Where Do We Go From Here?". Medscape. Retrieved August 16, 2011.
  4. "Zenhale Patient Information" (PDF). Zenhale Product Monograph. Merck & Co. Retrieved August 16, 2011.
  5. "British Columbia Drug and Poison Information Center". BC DPIC.
  6. "Merck's DULERA Inhalation Aerosol for asthma receives FDA approval".
  7. "Withdrawal of the marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate) Questions and Answers" (PDF). European Medicines Agency.
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