Mometasone/formoterol Combination of mometasone corticosteroid formoterol long-acting beta-adrenoceptor agonist Clinical data Trade names Zenhale, Dulera AHFS/Drugs.com http://www.drugs.com/dulera.html Licence data US Daily Med: Pregnancy cat. C(US) Legal status ℞-only (CA) ℞-only (US) Routes Oral Inhalation Identifiers ATC code ? (what is this?)
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. To relieve acute symptoms, a rapid-onset short-duration inhaled bronchodilator (such as salbutamol) should be available to the patient for use.
Zenhale/Dulera consists of two medications supplied in a single inhaler:
- Formoterol, a long-acting beta-adrenoceptor agonist (bronchodilator)
- Mometasone, an inhaled corticosteroid (anti-inflammatory)
The safety and efficacy of this medication in children less than 12 years of age has not been established.
Warnings and Precautions
Long-acting beta-adrenoceptor agonists (LABAs) are subject to a black box 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 and/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.
How Supplied and Dosage
Zenhale/Dulera 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 2 inhalations twice daily to a maximum of 200/20 micrograms daily
- Inhaled medium-dose corticosteroids: 100/5 2 inhalations twice daily to a maximum of 400/20 micrograms daily
- Inhaled high dose corticosteroids: 200/5 2 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.
- ^ a b c Waknine, Yael. "FDA Approves Mometasone-Formoterol Combo for Asthma". Medscape Today FDA Approvals. Medscape. http://www.medscape.com/viewarticle/724189. Retrieved August 16th, 2011.
- ^ a b c d e f "Zenhale product monograph". Merck Canada. http://www.merck.ca/assets/en/pdf/products/ci/Zenhale-CI_E.pdf. Retrieved August 16th, 2011.
- ^ Donohue MD, Dr. James F. "Asthma Medications: Black Box Warnings -- Where Do We Go From Here?". Medscape. http://www.medscape.org/viewarticle/555291. Retrieved August 16th, 2011.
- ^ "Zenhale Patient Information". Zenhale Product Monograph. Merck & Co.. http://www.merck.ca/assets/en/pdf/products/ci/Zenhale-CI_E.pdf. Retrieved August 16th, 2011.
- ^ "British Columbia Drug and Poison Information Center". BC DPIC. http://dpic.org/druglisting/mometasone-formoterol.
- ^ "Merck's DULERA Inhalation Aerosol for asthma receives FDA approval". News-Medical.net. http://www.news-medical.net/news/20100624/Mercks-DULERA-Inhalation-Aerosol-for-asthma-receives-FDA-approval.aspx.
- ^ "Withdrawal of the marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate) Questions and Answers". European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2010/11/WC500099298.pdf.
Drugs for obstructive airway diseases: asthma/COPD (R03) Adrenergics, inhalantsLong acting β2-agonists (LABA)other Glucocorticoids Anticholinergics/
Mast cell stabilizersCromoglicate • Nedocromil Xanthines Eicosanoid inhibitionThromboxane receptor antagonists Combination products #WHO-EM. ‡Withdrawn from market. Clinical trials: †Phase III. §Never to phase III
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