It is 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. Important limitations of use: • This Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. • This Inhalation Solution is not indicated to treat asthma.
For oral inhalation only.
• A total daily dose of greater than 30 mcg is not recommended.
• One 15 mcg/2 mL vial every 12 hours.
• For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air compressor.
This Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. • All LABA, including this Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication
Pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder.
Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies of this Inhalation Solution in pregnant women. Arformoterol has been shown to be teratogenic in rats and rabbits. Arformoterol also caused neonatal mortality and developmental delays in rats. Because animal reproduction studies are not always predictive of human response, this Inhalation Solution should be used during pregnancy, only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers In reproductive studies in rats, arformoterol was excreted in the milk. It is not known whether arformoterol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this Inhalation Solution is administered to a nursing woman