Mometasone/formoterol
Mometasone furoate and formoterol.svg
Combination of
Mometasone furoateCorticosteroid
Formoterol fumarateLong-acting β2 adrenoreceptor agonist (LABA)
Clinical data
Trade namesZenhale, Dulera, others
AHFS/Drugs.comProfessional Drug Facts
License data
Routes of
administration
Inhalation (MDI)
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG
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Mometasone/formoterol, sold under the brand name Dulera among others, is a fixed-dose combination medication used in the long-term treatment of asthma.[1] It contains mometasone a steroid and formoterol a long-acting beta agonist.[1] It is only recommended in those for whom an inhaled steroid is not sufficient.[1] It is used by inhalation.[1] It should not be used for sudden worsening of asthma.[1]

Common side effect include headache and sinusitis.[1] More serious side effects may include thrush, immunosuppression, allergic reactions, and cataracts.[1] Use is not recommended in those less than twelve years of age.[1] It has not been studied during pregnancy or breastfeeding.[1] Mometasone works by decreasing inflammation while formoterol works by relaxing smooth muscle in the airways.[1]

The combination was approved for medical use in the United States in 2010.[1] No generic version is available as of 2019. In 2017, it was the 243rd most commonly prescribed medication in the United States, with more than one million prescriptions.[2][3] It is on the World Health Organization's List of Essential Medicines.[4]

Medical use

It is used in the long-term treatment of asthma.[1]

It is not for the treatment of acute bronchospasm.[5] To relieve acute symptoms, a rapid-onset short-duration inhaled bronchodilator (such as salbutamol) should be available.[6]

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.[6] 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.[7]

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.[8]

Society and culture

Legal status

Zenhale was approved in Canada in early 2011.[9] Dulera was approved by the Food and Drug Administration (FDA) in the United States in June 2010.[10] Zenhale's marketing application was voluntarily withdrawn from the EU due to the manufacturer's inability to provide additional information in the necessary timeframe.[11]

Formulation

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.

References

  1. ^ a b c d e f g h i j k l "Dulera- mometasone furoate and formoterol fumarate dihydrate aerosol". DailyMed. 12 August 2019. Retrieved 29 April 2020.
  2. ^ "The Top 300 of 2020". ClinCalc. Retrieved 11 April 2020.
  3. ^ "Formoterol Fumarate; Mometasone Furoate - Drug Usage Statistics". ClinCalc. Retrieved 11 April 2020.
  4. ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  5. ^ Waknine Y. "FDA Approves Mometasone-Formoterol Combo for Asthma". Medscape Today FDA Approvals. Medscape. Retrieved August 16, 2011.
  6. ^ a b "Zenhale product monograph" (PDF). Merck Canada. Retrieved August 16, 2011.
  7. ^ Donohue JF. "Asthma Medications: Black Box Warnings -- Where Do We Go From Here?". Medscape. Retrieved August 16, 2011.
  8. ^ "Zenhale Patient Information" (PDF). Zenhale Product Monograph. Merck & Co. Retrieved August 16, 2011.
  9. ^ "British Columbia Drug and Poison Information Center". BC DPIC.
  10. ^ "Merck's Dulera Inhalation Aerosol for asthma receives FDA approval". News-Medical.net.
  11. ^ "Withdrawal of the marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate) Questions and Answers" (PDF). European Medicines Agency (EMA).