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Pharmacologic class: Beta2-adrenergic receptor agonist (long-acting)
Therapeutic class: Bronchodilator
Pregnancy risk category C
FDA Box Warning
• Drug may increase risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from long-acting beta2-adrenergic agonists. Because of this risk, use of salmeterol xinafoate for the treatment of asthma without a concomitant long-term asthma control medication such as an inhaled corticosteroid is contraindicated. When treating asthmatic patients, use only as additional therapy for those not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants treatment with two maintenance therapies (including salmeterol). Once asthma control is achieved and maintained, assess patient at regular intervals and step down therapy (for example, discontinue salmeterol xinafoate), if possible, without loss of asthma control and maintain patient on a long-term asthma-control medication such as an inhaled corticosteroid. Don't use salmeterol for patients whose asthma is adequately controlled on low-or medium-dose inhaled corticosteroids
• Available data from controlled clinical trials suggest that long-acting beta2-adrenergic agonists increase risk of asthma-related hospitalization in children and adolescents. For children and adolescents with asthma who require addition of a long-acting beta2-adrenergic agonist to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and a long-acting beta2-adrenergic agonist should ordinarily be used to ensure adherence with both drugs. In cases in which use of a separate long-term asthma-control medication (for example, inhaled corticosteroid) and a long-acting beta2-adrenergic agonist is clinically indicated, take appropriate steps to ensure adherence with both treatment components. If adherence can't be assured, a fixed-dose combination product containing both an inhaled corticosteroid and a long-acting beta2-adrenergic agonist is recommended.
Stimulates intracellular adenylate cyclase, an enzyme that catalyzes conversion of adenosine triphosphate to cyclic-3', 5'-adenosine monophosphate (cAMP). Increased cAMP levels relax bronchial smooth muscle and inhibit release of mediators of immediate hypersensitivity (especially from mast cells).
Powder for inhalation using Diskus delivery system: 50 mcg/blister (60 blisters)
Indications and dosages
➣ Maintenance treatment of asthma; prevention of bronchospasm in patients with reversible obstructive airway disease; maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD)
Adults and children older than age 4: 50 mcg (one inhalation) b.i.d. approximately 12 hours apart
➣ Prevention of exercise-induced bronchospasm
Adults and children older than age 4: 50 mcg (one inhalation) 30 to 60 minutes before exercise. Withhold additional doses for at least 12 hours.
• Cystic fibrosis
• High-altitude pulmonary edema
• Atopic asthma
• Hypersensitivity to drug or its components
• Acute asthma attack
Use cautiously in:
• cardiovascular disease, diabetes mellitus, hyperthyroidism
• concurrent use of MAO inhibitors or tricyclic antidepressants (extreme caution required)
• pregnant or breastfeeding patients
• children younger than age 4.
• To use Serevent Diskus, activate device and hold in horizontal position.
• Make sure patient doesn't exhale into device.
• Preferably, give doses 12 hours apart in morning and evening.
CNS: headache, nervousness, dizziness, tremor
CV: palpitations, hypertension, tachycardia, arrhythmias
GI: nausea, diarrhea, abdominal pain
Metabolic: hyperglycemia, hypokalemia
Musculoskeletal: muscle cramps and soreness
Respiratory: paradoxical bronchospasm
Skin: urticaria, angioedema, rash
Other: hypersensitivity reaction
Drug-drug. Beta-adrenergic blockers: decreased salmeterol efficacy, increased risk of severe bronchospasm in patients with asthma or COPD
Diuretics (except potassium-sparing): increased risk of hypokalemia and ECG changes
MAO inhibitors, tricyclic antidepressants: potentiation of salmeterol's cardiovascular actions
Drug-diagnostic tests. Glucose: increased level
Potassium: decreased level
Drug-food. Caffeine-containing foods and beverages: increased stimulant effect
Urine-acidifying foods: increased drug blood level
Drug-herbs. Caffeine-containing herbs (such as cola nut, yerba maté), ephedra (ma huang): increased stimulant effect
• Assess pulmonary status and vital signs.
☞ Stay alert for signs and symptoms of hypersensitivity reaction, particularly rash, urticaria, angioedema, and paradoxical bronchospasm.
• Remind patient that drug isn't a rescue bronchodilator and won't give immediate relief in emergency.
• Teach patient proper technique for using inhaler or Diskus. Instruct him not to exhale into device or use a spacer with Diskus.
• Advise patient to keep Diskus dry. Tell him not to rinse, wash, or take it apart.
• Instruct patient to take regular doses 12 hours apart. Tell him to take doses for exercise-induced bronchospasm 30 to 60 minutes before exercising.
• Advise patient to take drug exactly as prescribed and not to exceed one inhalation twice daily.
• Tell patient to consult prescriber if he needs more inhalations than usual.
• Caution patient not to stop taking drug without consulting prescriber.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.