Arformoterol Tartrate Inhalation Solution

1. INDICATIONS AND USAGE Arformoterol Tartrate Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1) Important limitations of use: Arformoterol Tartrate Inhalation Solution is not inidcated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2) Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma.

6. ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as Arformoterol Tartrate, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events. Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma [see Warnings and Precautions (5.1)] . Most common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. Arformoterol Tartrate should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Women should be advised to contact their physician if they become pregnant while taking Arformoterol Tartrate.

5. WARNINGS AND PRECAUTIONS LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. (5.1) Do not initiate Arformoterol Tartrate Inhalation Solution in acutely deteriorating patients. (5.2) Do not use for relief of acute symptoms. Concomitant short-acting beta2­ agonists can be used as needed for acute relief. (5.2) Do not exceed the recommended dose. Excessive use of Arformoterol Tartrate Inhalation Solution, or use in conjunction with other medications containing long-acting beta2-agonists, can result in clinically significant cardiovascular effects, and may be fatal. (5.3, 5.5) Life-threatening paradoxical bronchospasm can occur. Discontinue Arformoterol Tartrate Inhalation Solution immediately. 4. CONTRAINDICATIONS Arformoterol Tartrate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. Use of a LABA, including Arformoterol Tartrate Inhalation Solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see Warnings and Precautions (5)] .