Salmeterol

DEA Class;  Rx

Common Brand Names; Serevent Disku

  • Beta2 Agonists

Orally inhaled long-acting beta-2 agonist (LABA); given twice daily
Used in adult and pediatric patients 4 years and older for add-on asthma maintenance therapy to an asthma controller medication and for exercise-induced bronchospasm (EIB); also used for maintenance treatment of COPD in adults
LABA monotherapy for asthma is contraindicated due to an increased risk for asthma-related death

For asthma maintenance treatment.
For exercise-induced bronchospasm prophylaxis.
For the maintenance treatment of chronic obstructive pulmonary disease (COPD) (e.g., chronic bronchitis or emphysema).
For altitude sickness prophylaxis, specifically prevention of high altitude pulmonary edema.
 

Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to drug or excipients

Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required

Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid

  • Headache (13-17%)
  • Pain (1-12%)
  • Nasal congestion (9%)
  • Hypertension (4%)
  • Edema (1-3%)
  • Dizziness (4%)
  • Sleep disturbance (1-3%)
  • Migraine (1-3%)
  • Contact dermatitis (1-3%)
  • Urticaria (3%)
  • Hyperglycemia (1-3%)
  • Articular rheumatism (1-3%)
  • Paresthesia (1-3%)
  • Muscular stiffness (1-3%)
  • Photodermatitis (1-2%)
  • Bronchitis (7%)
  • Influenza (5%)
  • Rigidity (1-3%)
  • hinitis (5%)
  • Asthma (3%)
  • Conjunctivitis
  • Hyperglycemia
  • Keratitis
  • Oral candidiasis
  • Chest tightness
  • Cataracts
  • Hypokalemia
  • Myositis

Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; therapy can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms; although such effects are uncommon after administration of salmeterol at recommended doses, if they occur, the drug may need to be discontinued

Drug should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result; clinically significant cardiovascular effects and fatalities reported in association with excessive use of inhaled sympathomimetic drugs; patients should not use another medicine containing a LABA (e.g., formoterol fumarate, arformoterol tartrate, indacaterol) for any reason

Use caution in diabetes mellitus and ketoacidosis; clinically significant and dose-related changes in blood glucose and/or serum potassium seen infrequently during clinical trials at recommended doses

Not for acute asthma; for acute asthma exacerbations, use short-acting beta-agonists (eg, albuterol)

Not for acute episodes of COPD

May increase risk of severe, potentially fatal asthma attacks; small but significant increase in asthma-related deaths for patients using salmeterol vs placebo, with greater risk in African-Americans

Available data from published epidemiological studies and case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Beta-agonists may interfere with uterine contractility

There is no information regarding presence of salmeterol in human milk, effects on breastfed child, or on milk production

Adults

100 mcg/day oral inhalation powder.

Geriatric

100 mcg/day oral inhalation powder.

Adolescents

100 mcg/day oral inhalation powder.

Children

4 years or older: 100 mcg/day oral inhalation powder.
Less than 4 years: Safety and efficacy have not been established.

Salmeterol Xinafoate

powder

  • 50mcg/inhalation

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