Formoterol

Long-acting beta2-agonists (LABAs) increase the risk of asthma-related deaths. Formoterol should only be used in asthma patients as adjuvant therapy in patients who are currently receiving but are not adequately controlled on a long-term asthma control medication (ie, an inhaled corticosteroid). Monotherapy with an LABA is contraindicated in the treatment of asthma. In a large, randomized, placebo-controlled US clinical trial (SMART 2006), salmeterol was associated with an increase in asthma-related deaths (when added to usual asthma therapy); risk is considered a class effect among all LABAs. Data are not available to determine if the addition of an inhaled corticosteroid lessens this increased risk of death associated with LABA use; however, current guidelines recommend the use of an inhaled corticosteroid before adding a LABA (GINA 2015; NIH/NHLBI 2007). Assess patients at regular intervals once asthma control is maintained on combination therapy to determine if step-down therapy is appropriate and the LABA can be discontinued (without loss of asthma control), and the patient can be maintained on an inhaled corticosteroid. LABAs are not appropriate in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. In a more recent multicenter, randomized, double-blinded trial, the use of salmeterol and an inhaled corticosteroid (ie, fluticasone) combined in a single inhaler in a large number of children, adolescent, and adult patients with pe

Paradoxical bronchospasm that may be life-threatening and may occur with use of inhaled bronchodilating agents; this reaction should be distinguished from inadequate response. Discontinue immediately if paradoxical bronchospasm occurs and institute alternative therapy.

Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.

Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics. Disease-related concerns:

Appropriate use: - Foradil Aerolizer: Do not use for acute bronchospasm. Short-acting beta2-agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments. Do not initiate in patients with significantly worsening or acutely deteriorating asthma; reports of severe (sometimes fatal) respiratory events have been reported when formoterol has been initiated in this situation. Corticosteroids should not be stopped or reduced when formoterol is initiated. Formoterol is not a substitute for inhaled or systemic corticosteroids and should not be used as monotherapy. During initiation, watch for signs of worsening asthma. - Perforomist: Not FDA approved for the treatment of asthma; safety and efficacy in asthma patients have not been established.

Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension, HF, or aneurysm); beta-agonists may cause elevation in blood pressure and heart rate and result in CNS stimulation/excitation. Beta2-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.

Do not use for acute episodes of chronic obstructive pulmonary disease (COPD). Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Data are not available to determine if LABA use increases the risk of death in patients with COPD.

Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose; the effect is usually transient.

Because LABAs may disguise poorly controlled persistent asthma, frequent or chronic use of LABAs for exercise-induced bronchospasm is discouraged by the NIH Asthma Guidelines (NIH, 2007).

Use with caution in hyperthyroidism; may stimulate thyroid activity.

Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium; the effect is usually transient.

Use with caution in patients with pheochromocytoma; may worsen symptoms.

Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Foradil Aerolizer: [US Boxed Warning]: LABAs may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. In general, a combination product containing a LABA and an inhaled corticosteroid is preferred in patients Dosage form specific issues:

The contents of the capsules are for inhalation only via the Aerolizer device. There have been reports of incorrect administration (swallowing of the capsules).

Powder for oral inhalation contains lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy. Other warnings/precautions:

Patients using inhaled, short-acting beta2-agonists should be instructed to discontinue routine use of these medications prior to beginning treatment; short-acting agents should still be provided to patients; however, use should be reserved for symptomatic relief of acute symptoms. Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of short-acting beta2-agonists may indicate deterioration of asthma or COPD, and medical evaluation must not be delayed.

Tolerance to the bronchodilator effect, measured by FEV1, has been observed in studies.