|Formoterol fumarate||Long-acting β2 adrenoreceptor agonist (LABA)|
|Trade names||Zenhale, Dulera, others|
|Defined daily dose||not established|
|AHFS/Drugs.com||FDA Professional Drug Information|
Mometasone/formoterol, sold under the brand name Dulera among others, is a combination medication used in the long-term treatment of asthma. It contains mometasone a steroid and formoterol a long-acting beta agonist. It is only recommended in those in who an inhaled steroid is not sufficient. It is used by inhalation. It should not be used for sudden worsening of asthma.
Common side effect include headache and sinusitis. More serious side effects may include thrush, immunosuppression, allergic reactions, and cataracts. Use is not recommended in those less than 12 years of age. It has not been studied during pregnancy or breastfeeding. Mometasone works by decreasing inflammation well formoterol works by relaxing smooth muscle in the airways.
The combination was approved for medical use in the United States in 2010. No generic version is available as of 2019. In the United States the wholesale cost of a puffer is about US$202 as of 2019. In 2017, it was the 243rd most commonly prescribed medication in the United States, with more than one million prescriptions. It is not approved for use in Europe.
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. 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.
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.
Society and culture
In the United States the wholesale cost of a puffer is about US$202 as of 2019. In 2017, it was the 243rd most commonly prescribed medication in the United States, with more than one million prescriptions.
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:
- Inhaled low-dose corticosteroids: 50/5 two inhalations twice daily to a maximum of 200/20 micrograms daily
- Inhaled medium-dose corticosteroids: 100/5 two inhalations twice daily to a maximum of 400/20 micrograms daily
- Inhaled high-dose corticosteroids: 200/5 two inhalations twice daily to a maximum of 800/20 micrograms daily
Zenhale was approved in Canada in early 2011. Dulera was approved by the Food and Drug Administration (FDA) in the United States in June 2010. Zenhale's marketing application was voluntarily withdrawn from the EU due to the manufacturer's inability to provide additional information in the necessary timeframe.
- "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 1 July 2021. Retrieved 9 September 2020.
- "Dulera- mometasone furoate and formoterol fumarate dihydrate aerosol". DailyMed. 12 August 2019. Archived from the original on 7 December 2019. Retrieved 29 April 2020.
- "Dulera Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 1 October 2020. Retrieved 19 April 2019.
- "NADAC as of 2019-02-27". Centers for Medicare and Medicaid Services. Archived from the original on 2019-03-06. Retrieved 3 March 2019.
- "The Top 300 of 2020". ClinCalc. Archived from the original on 12 February 2021. Retrieved 11 April 2020.
- "Formoterol Fumarate; Mometasone Furoate - Drug Usage Statistics". ClinCalc. Archived from the original on 8 July 2020. Retrieved 11 April 2020.
- "Withdrawal of the marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate) Questions and Answers" (PDF). European Medicines Agency. Archived (PDF) from the original on 2020-10-01. Retrieved 2011-08-17.
- Waknine, Yael. "FDA Approves Mometasone-Formoterol Combo for Asthma". Medscape Today FDA Approvals. Medscape. Archived from the original on April 19, 2019. Retrieved August 16, 2011.
- "Zenhale product monograph" (PDF). Merck Canada. Archived from the original (PDF) on August 21, 2019. Retrieved August 16, 2011.
- Donohue MD, Dr. James F. "Asthma Medications: Black Box Warnings -- Where Do We Go From Here?". Medscape. Archived from the original on June 20, 2015. Retrieved August 16, 2011.
- "Zenhale Patient Information" (PDF). Zenhale Product Monograph. Merck & Co. Archived from the original (PDF) on August 21, 2019. Retrieved August 16, 2011.
- "British Columbia Drug and Poison Information Center". BC DPIC. Archived from the original on 2012-03-30. Retrieved 2011-08-17.
- "Merck's DULERA Inhalation Aerosol for asthma receives FDA approval". News-Medical.net. Archived from the original on 2010-09-19. Retrieved 2011-08-17.