Dosing & Uses
Dosage Forms & Strengths
powder
- 50mcg/inhalation
Asthma Prevention and Maintenance
1 inhalation (50 mcg) twice daily; not to exceed twice daily administration
COPD Maintenance
1 inhalation (50 mcg) twice daily; not to exceed twice daily administration
Prevention of Exercise-Induced Asthma
1 inhalation 30 minutes before exercise; a second dose not to be administered for another 12 hr; not for use in individuals receiving twice daily therapy of salmeterol
Dosage Forms & Strengths
powder
- 50mcg/inhalation
Asthma Prevention and Maintenance
< 4 years
- Safety and efficacy not established
> 4 years
- 1 inhalation (50 mcg) twice daily; not to exceed twice daily administration
Prevention of Exercise-Induced Asthma
< 4 years
- Safety and efficacy not established
> 4 years
- 1 inhalation (50 mcg) twice daily; not to exceed twice daily administration
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Headache (13-17%)
Pain (1-12%)
1-10%
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%)
Frequency Not Defined
Conjunctivitis
Hyperglycemia
Keratitis
Oral candidiasis
Chest tightness
Cataracts
Hypokalemia
Myositis
Warnings
Black Box Warnings
Long-acting beta2-adrenergic agonists, such as salmeterol, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, this drug should only be used as additional therapy for patients not adequately controlled on other asthma controller medications (eg, low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including this drug.
Because of this risk, use of salmeterol for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated
Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue LABA) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid
When LABA are used in fixed-dose combination with inhaled corticosteroids (ICS), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
Data from a large placebo-controlled US study that compared the safety of salmeterol (inhalation aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients treated for 28 weeks on placebo)
Contraindications
Hypersensitivity to any component
Status asthmaticus or other acute episodes of asthma
Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid
Cautions
Cardiovascular disorder, convulsive disorder, thyrotoxicosis
Not to administer > twice daily dosing
Not for acute asthma; for acute asthma exacerbations, use short-acting beta agonists (eg, albuterol)
Not for acute epidodes of COPD
May increase risk of severe, potentially fatal asthma attacks; small but significant increase in asthma related deaths for pts using salmeterol vs placebo, with greater risk in African-Americans
Risk of hypokalemia, usually transient
Use caution in patients with hypokalemia, hepatic impairment, seizure disorders, and hyperthyroidism
Paradoxical bronchospasm may occur
Beta-2 agonists may increase serum glucose; use caution in patients with diabetes mellitus
Laryngeal spasm, swelling, irritation reported with use
Use Serevent Diskus only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS; do not use Serevent Diskus for patients whose asthma is adequately controlled on low- or medium-dose ICS
Available data from controlled clinical trials suggest that LABA as monotherapy increase risk of asthma-related hospitalization in pediatric and adolescent patients; for pediatric and adolescent patients with asthma who require addition of a LABA to an ICS, a fixed-dose combination product containing both an ICS and a LABA should ordinarily be used to ensure adherence with both drugs; in cases where use of a separate ICS and a LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components; if adherence cannot be assured, a fixed-dose combination product containing both an ICS and a LABA is recommended
Use only if not adequately controlled on asthma controller medications
Use only for shortest duration of time
Coadministration with CYP3A4 inhibitors may increase salmeterol levels and risk toxicity including QT prolongation
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Unknown if excreted in breast milk, salmeterol plasma levels are very low following inhalation; use caution
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Long-acting beta-2 agonist; action on beta-2 receptors relaxes bronchial smooth muscle with little effect on heart rate
50 times more selective than albuterol
Pharmacokinetics
Peak serum time: 20 min
Half-Life: 5.5 hr
Onset: 30-48 min (asthma); 2 hr (COPD)
Duration: 12 hr
Absorption: Minimal (undetectable)
Protein Bound: 96%
Metabolism: Liver
Excretion: Feces (60%); urine (25%)
Images
Patient Handout
Formulary
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