BLACK BOX WARNING
- asthma-related death when used without inhaled corticosteroid in asthma
salmeterol
Brand: Serevent
⚠ BBW Prototype Drug
Drug Class: bronchodilator
Drug Family: bronchodilator
Subclass: long-acting beta-2 agonist (LABA)
Organ Systems: respiratory
Mechanism of Action
Selective beta-2 agonist with long lipophilic side chain anchoring to airway smooth muscle membrane; prolonged bronchodilation lasting 12 hours.
beta-2 adrenergic receptor
Indications
- asthma maintenance (with ICS only — never monotherapy)
- COPD maintenance
Contraindications
- status asthmaticus
- asthma as monotherapy (BBW)
Adverse Effects
Common
- tachycardia
- palpitations
- tremor
- hypokalemia
Serious
- paradoxical bronchospasm
- severe cardiovascular events
Pharmacokinetics (ADME)
| Absorption | inhaled |
| Distribution | local pulmonary |
| Metabolism | hepatic CYP3A4 |
| Excretion | fecal |
| Half-life | 5-6 hours (inhaled-acting) |
| Onset | 10-20 min |
| Peak | 3-4 hours |
| Duration | 12 hours |
| Protein Binding | 94-98% plasma |
| Vd | local |
Drug Interactions
| Drug / Agent | Mechanism | Severity |
|---|---|---|
| beta-blockers | antagonize bronchodilation | major |
| strong CYP3A4 inhibitors | may increase salmeterol plasma levels — CV risk | moderate |
Nursing Considerations
- MUST always be combined with ICS in asthma (NEVER as monotherapy)
- Not a rescue inhaler — fixed twice-daily schedule regardless of symptoms
- SMART trial: salmeterol alone in asthma caused more asthma-related deaths vs placebo
- 12-hour duration: dose BID at regular intervals
Clinical Pearls
- SMART trial: increased asthma deaths with salmeterol monotherapy — class-wide BBW for all LABAs
- Safe in COPD as monotherapy (different pathophysiology — TORCH, SUMMIT trials)
Safety Profile
Pregnancy use-with-caution
Lactation use-with-caution
Renal Adjustment Not required
Hepatic Adjustment Not required
TDM Not required
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.