Classes
DEA Class; Rx
Common Brand Names; Brovana, Erdotin
- Beta2 Agonists
Description
Inhaled long-acting beta-2 agonist (LABA); given twice daily by nebulization
Used for the maintenance treatment of COPD in adults
Not indicated for the relief of acute bronchospasm or for the treatment of asthma
Indications
Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).
Contraindications
Hypersensitivity to arformoterol or formoterol, or any ingredients
Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid
Adverse Effects
- 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%)
Warnings
Use only if not adequately controlled by asthma controller medications
Use only for shortest duration of time
Immediate hypersensitivity reactions may occur after administration of arformoterol inhalation solution as demonstrated by cases of anaphylactic reaction, urticaria, angioedema, rash and bronchospasm
Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects; the decrease in serum potassium is usually transient, not requiring supplementation
Beta-agonist medications may produce transient hyperglycemia in some patients; clinically significant and dose-related changes in serum potassium and blood glucose were infrequent during clinical trials with long-term administration of arformoterol inhalation Solution at recommended dose
Use caution in patients with coexisting conditions, including convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines; doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis
As with other inhaled beta2-agonists, arformoterol inhalation solution can produce paradoxical bronchospasm that may be life-threatening; if paradoxical bronchospasm occurs, arformoterol inhalation solution should be discontinued immediately and alternative therapy instituted
Pregnancy and Lactation
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
There are no data on presence of arformoterol or its metabolites in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
30 mcg/day via oral inhalation.
30 mcg/day via oral inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Arformoterol tartrate
nebulizer solution
- 15mcg/2mL