Dosing and uses of Brovana, Erdotin (arformoterol)
Adult dosage forms and strengths
nebulizer solution
- 15mcg/2mL
Chronic Obstructive Pulmonary Disease
15 mcg inhaled via nebulization twice daily (AM & PM)
Not to exceed 30 mcg/day
Renal Impairment
Dose adjustment not necessary
Hepatic Impairment
Use caution; systemic drug exposure prolonged; dose adjustment not necessary
Pediatric dosage forms and strengths
Saftety and efficacy not established
Brovana, Erdotin (arformoterol) adverse (side) effects
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%)
Warnings
Black box warnings
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
Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue LABA) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid
Do not use LABAs if asthma is adequately controlled on low or medium dose inhaled corticosteroids
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients; for pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be considered to ensure adherence with both drugs
Safety and efficacy of arformoterol in patients with asthma not established
Contraindications
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
Cautions
May cause paradoxical bronchospasm
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)
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Brovana, Erdotin (arformoterol)
Mechanism of action
Long-acting beta2-agonist, R,R-enantiomer of racemic formoterol; relaxes bronchial smooth muscle by acting selectively on beta2-receptors
Pharmacokinetics
Excretion: Urine (67%); feces (22%)
Onset: 7-20 min
Half-life: 26hr
Peak plasma time: 0.5-3hr
Peak Plasma: 4.3 pg/mL
AUC: 34.5 pg.hr/mL
Protein Bound: 52-65%
Metabolism: uridine diphosphoglucuronosyltransferases (glucuronidation), CYP2D6, CYP2C19 (O-demethylation)
Renal Clearance: 8.9 L/hr
