BETHESDA, MD 24 July 2012—FDA on July 23 approved aclidinium bromide oral inhalation powder for long-term maintenance therapy in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Forest Laboratories Inc. will market aclidinium as Tudorza Pressair, a combination of drug and breath-actuated dose-delivery device. The company announced that the new product will be available to wholesalers during the last quarter of this year.
Aclidinium is not intended for the initial treatment of acute episodes of bronchospasm, according to the drug's labeling (PDF).
The recommended dosage of aclidinium is one inhalation twice daily. Each Tudorza Pressair inhaler provides 60 metered doses consisting of 400 µg of aclidinium bromide in a carrier that contains lactose monohydrate. The device should be stored in its sealed pouch at controlled room temperature until first use.
Once opened, the inhaler should be discarded after 45 days, the dose indicator reads 60, or the device locks, whichever comes first.
Instructions, with diagrams, for using the inhaler appear on seven pages in the product's labeling. There are also four pages of patient information.
In clinical trials, the most frequent adverse events reported by those using aclidinium were headache, nasopharyngitis, and cough.
The labeling warns that aclidinium should be used with caution in patients with narrow-angle glaucoma or urinary retention, conditions that can worsen during treatment with the drug. Cautious use is also recommended in patients with a severe allergy to milk proteins. Patients who have had a hypersensitivity reaction to atropine should be monitored for hypersensitivity to aclidinium, because the two drugs have similar structures.
Aclidinium use should be discontinued in patients who have severe bronchospasm after treatment with the drug.
The labeling for aclidinium warns against concomitant use of that drug and other anticholinergic medications.