Aroneb

COPD

Chronic Obstructive Pulmonary Disease 15 mcg (1 ampoule) inhaled via nebulization twice daily.

Renal Impairment Dose adjustment not necessary

Hypersensitivity to arformoterol or formoterol, or any ingredients Concurrency with other long-acting beta2-agonists Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid

Long-acting beta2-agonist, R,R-enantiomer of racemic formoterol; relaxes bronchial smooth muscle by acting selectively on beta2-receptors

Long-acting beta2-adrenergic agonists (LABAs), such as arformoterol, may increase the risk of asthma-related deaths; therefore, when treating patients with asthma, this drug should only be used as additional therapy for patients not adequately controlled on other asthma controller medications (eg, low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including LABAs Because of this risk, use of LABAs for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated May cause paradoxical bronchospasm Safety and efficacy in patients with asthma not established; not indicated for asthma Long-acting beta2-agonists may increase risk of asthma-related death Use caution in cardiovascular disorder (arrhythmias, HTN, CAD), hepatic impairment, hypokalemia, thyrotoxicosis, seizure disorders Risk of hypokalemia (usu transient not requiring supplementation) Combined with asthma controller medication (e.g., inhaled corticosteroid) Use only if not adequately controlled by asthma controller medications Use only for shortest duration of time Beta2-agonists may increase serum glucose (use with caution in patients with diabetes)

1-10% Back pain (6%) Chest pain (7%) Diarrhea (6%) Dyspnea (4%) Flu syndrome (3%) Leg cramps (4%) Lung disorder (2%) Pain (8%) Peripheral edema (3%) Rash (4%) Sinusitis (5%)

Pregnancy There are no adequate and well-controlled studies in pregnant women; drug should only be used during pregnancy if expected benefit outweighs potential risk to fetus; women should be advised to contact their physician if they become pregnant while receiving therapy The potential effect of therapy on labor and delivery is unknown; because of potential for beta-agonists interference with uterine contractility, use of inhalation solution during labor should be restricted to whom benefits clearly outweigh risk Animal data In animal reproduction studies with rats and rabbits at exposures approximately 370 and 8,400 times adult exposure at maximum recommended human daily inhalation dose (MRHDID) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth Adverse effects generally occurred at large multiples of the MRHDID when drug was administered by oral route to achieve high systemic exposures; no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the MRHDID Lactation There are no data on presence of arformoterol or its metabolites in human milk, effects on breastfed infant, or on milk production; however, arformoterol was excreted in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition