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Aclidinium Bromide/Formoterol Fumarate Inhalation Powder
In April 2019, the FDA approved a new inhaler: aclidinium bromide/ formoterol fumarate inhalation powder 400mcg/12 mcg.
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Mechanism of Action
Aclidinium bromide is a long-acting, inhaled muscarinic antagonis (LAMA), while formoterol fumarate acts as a long-acting beta-2 agonist (LABA). As aclidinium is an anticholinergic agent, this active ingredient will work on the bronchial smooth muscles in the lungs, resulting in bronchodilation. The following ingredient will selectively block acetylcholine action at muscarinic type-3 receptors through competitive and reversible inhibition. Whereas formoterol is LABA that works to relax bronchial smooth muscles by selectively binding beta-2 receptors.
Administered via dry powder inhalation, patients receive 400 mcg of aclidinium and 12 mcg of formoterol per inhalation. For dosing instructions, adults are indicated to take two inhalations twice a day, one inhalation in the morning and the second inhalation in the evening. The maximum daily dose is 800 mcg of aclidinium and 24 mcg of formoterol per day, or two inhalations. Each inhaler delivers 30 to 60 actuations. The inhaler provides a reassuring dual feedback in two ways: via an audible click and colorcontrolled window that changes color upon inhalation. By Jessica Bailey
The dual feedback may help to improve inhalation administrations. Aclidinium bromide/formoterol fumarate is not for the treatment of asthma and is not a rescue medicine or for the treatment of sudden breathing problems.
Efficacy and Adverse Effects
Aclidinium bromide/formoterol fumarate’s safety and efficacy was evaluated in three dosing ranging trials of 24- week duration, and a long-term safety trial of 28 weeks. The dose of aclidinium is supported by a seven-day, randomized, double-blind, active and placebo-controlled, crossover trial
which evaluated doses of 400, 200 and 100 mcg of aclidinium bromide. Within the trial, doses were administered to patients twice daily and once daily in 79 subjects with COPD. The primary outcome was a change from baseline in FEV1 AUC0- 12 from placebo after seven days, in which the 400 mcg dose showed 208 milliliter improvement. The dose of formoterol is supported by a randomized, double-blind, placebo and open-label controlled crossover trial. The three doses of formoterol fumarate evaluated where 24, 12, and 6 mcg doses were evaluated. The following doses were administered daily in 132 subjects with COPD. The primary outcome was a change from baseline in FEV1 AUC0-12 from placebo after seven days, in which the 12 mcg dose showed a 117 milliliter improvement.
Patient Counseling
Aclidinium bromide/formoterol fumarate does not need to be primed before first inhalation. Before inhalation, patients should gently squeeze the arrows and pull outwards to remove the cap. Patients should be instructed to hold the mouth piece towards them and with the orange button facing upwards. The inhaler should not be tilted, nor should patients tilt their head downwards upon inhalation. Instead patients should bring the mouthpiece up towards their mouth. The orange button should be pressed all the way down and released, but not held down. The inhaler can be checked if it is ready for inhalation by looking at control window, in which case the color should change from red to green. If so, the green control window confirms the inhaler is ready for inhalation. Patients should make sure to breathe out completely to their side. On the next breath in, patients must place their lips around the mouth piece and take a strong, quick, deep inhalation. A click sound will be heard during inhalations when the inhaler is used correctly. Patients should hold their breathe for a maximum of 10 seconds, or for as long as comfortable, and then breathe out slowly. Patients should be instructed the control window will have turned from green back to red, indicating confirmation of administration of a full dose.
Warnings, Precautions and Contraindications
Aclidinium bromide/formoterol fumarate may cause hypersensitivity reactions, upper respiratory tract infection, back pain, bronchospasm as well as central nervous system effects including headache, dizziness and blurred vision. Patients with hypersensitivity to aclidinium, formoterol, or any component of dry powder formulation should avoid use of aclidinium bromide/formoterol fumarate. Dosage form may contain lactose, therefore patients with a severe milk protein allergy should not take aclidinium bromide/ formoterol fumarate because this is a contraindication.It is unknown if aclidinium or formoterol are present in breast milk and patients whom are breastfeeding should speak with their health care provider.
References 1. Center Watch: The Trusted Source for Clinical Trial Information. Duaklir pressair (Aclidinium Bromide and Formoterol Fumarate). https://www.centerwatch.com/druginformation/fda-approved-drugs/drug/100377/duaklirpressair-aclidinium-bromide-and-formoterol-fumarate-. Accessed on 12, February 2020. 2. Circassia Pharmaceuticals Inc.: duaklir pressair. Morrisville, NC. https://www.duaklir.com/. Accessed on 12, February 2020. 3. Lexi-Drugs: duaklir pressair. Wolters Kluwer Health Inc. Riverwoods, IL. http://online.lexi.com.proxy.pba.edu/lco/ action/doc/retrieve/docid/patch_f/5803420?cesid=10XLeuFd Vc7&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dduaklir %2520pressair%2520%26t%3Dname%26va%3Dduaklir%2520p ressair%2520. Accessed on 12, February 2020.
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