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and Drug Administration (FDA) in the United States in June 2010.[10] Zenhale's marketing application was voluntarily withdrawn from the EU due to the manufacturer's inability to provide additional information in the necessary timeframe.[11]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