arformoterol [Inhaled]

Adult Dosing

Maintenance therapy in COPD

15 mcg (2 ml) bid by nebulization
Max: 30 mcg/day

Pediatric Dosing

Safety and effectiveness in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Long term maintenance therapy of bronchoconstriction in COPD

Contraindications ⬆ ⬇

Hypersensitivity to any of the components of the product
Asthma patients without use of a long-term asthma control medication
Acutely deteriorating COPD
Pediatric patients
Concurrent use of other long-acting beta-2 agonists

Black Box Warnings ⬆ ⬇

Long acting beta2-adrenergics may increase the risk of asthma related deaths. Data from large placebo-controlled US study showed an increase in asthma-related deaths in patients receiving salmeterol along with usual asthma therapy. These findings may apply to arformoterol. Arformoterol is contraindicated in patients with asthma without use of a long-term control medication

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: No dose adjustments

Hepatic Dose Adjustment

Hepatic impairment: No dose adjustments, use with caution

Warnings/Precautions ⬆ ⬇

Increased risk of asthma related death [US Black Box Warning]
Indicated in the long term maintenance treatment for bronchoconstriction in COPD, not in the treatment of acute episodes. Should not be initiated in acutely deteriorating COPD.
Avoid treatment in patients with acutely deteriorating COPD; to treat acute symptoms of COPD, use of inhaled, short-acting beta2-agonist is recommended
Instruct patients who have been taking inhaled, short-acting beta2-agonists on a regular basis to discontinue and use those drugs only for symptomatic relief of acute symptoms
Can produce life-threatening paradoxical bronchospasm
Hypersensitivity reactions like anaphylactic reactions, angioedema, bronchospasm, rash, and urticaria may occur
Clinically significant changes in SBP and/or DBP pulse rate and electrocardiograms have occurred
It may produce significant hypokalemia in some patients
Long-term administration at the recommended dose may produce clinically significant changes in blood glucose and/or serum potassium
Fatalities may occur in association with excessive use of inhaled sympathomimetic drugs

Use cautiously in

Hypersensitivity to milk proteins
Cardiovascular disorders
Coronary insufficiency
Cardiac arrhythmias
Hypertension
Diabetes
Convulsive disorders
Thyrotoxicosis
Thyroid disorder
Hypokalemia

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown; no published data exists on the use of arformoterol during breastfeeding. However, use of inhaled bronchodilators is considered acceptable due to low bioavailability and maternal serum levels. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 29 September 2010). Manufacturer advises caution.

Adverse Reactions ⬆ ⬇

Note: Increased risk of asthma related deaths [US Black Box Warning]
RESP: Asthma related deaths, asthma exacerbation/deterioration, paradoxical bronchospasm, bronchitis, dyspnea, pulmonary/chest congestion
EENT: Sinusitis
CNS: Headache, asthenia, nervousness, weakness, tremor, dizziness, insomnia
CV: Chest pain, angina, hypertension or hypotension, tachycardia, arrhythmias, peripheral edema, palpitation, heart block, QT prolongation
GI: Vomiting, diarrhea, nausea, dry mouth
METABOLIC: Hyperkalemia, hypokalemia, hyperglycemia, metabolic acidosis
HEMA: Leukocytosis
MUSC: Pain, back pain, leg cramps, muscle cramps
MISC: Hypersensitivity reactions including anaphylaxis, angioedema, flu-syndrome, fatigue, malaise

Clinical Pharmacology ⬆ ⬇

Long acting beta-2 agonist; stimulates intracellular adenyl cyclase, resulting in increased intracellular cyclic AMP levels causing relaxation of bronchial smooth muscle
Some systemic absorption following inhalation
Metabolized by liver by CYP2D6 and CYP2C19
63 % excreted in urine (1% unchanged) and 11% excreted in feces
Half-life: 26 hrs

Brands and Availability ⬆ ⬇