Classes
DEA Class; Rx
Common Brand Names; Serevent Disku
- Beta2 Agonists
Description
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
Indications
Contraindications
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
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
100 mcg/day oral inhalation powder.
100 mcg/day oral inhalation powder.
100 mcg/day oral inhalation powder.
4 years or older: 100 mcg/day oral inhalation powder.
Less than 4 years: Safety and efficacy have not been established.
How supplied
Salmeterol Xinafoate
powder
- 50mcg/inhalation