Indications for: SEREVENT DISKUS

As an adjunct to inhaled corticosteroid (ICS) for the treatment of asthma and in the prevention of bronchospasm in reversible obstructive airway disease (including nocturnal asthma). Prevention of exercise-induced bronchospasm (EIB). Maintenance treatment of COPD-associated bronchospasm in adults.

Limitations of Use:

Not for relief of acute bronchospasm.

Adults and Children:

Allow approx. 12hrs between doses. Asthma: ≥4yrs: 1 inh twice daily with concomitant ICS. EIB: ≥4yrs: 1 inh at least 30mins before exercise; do not use additional doses for 12hrs after administration or if already using twice daily dosing. COPD: 1 inh twice daily. Max 1 inh twice daily.

SEREVENT DISKUS Contraindications:

Treatment of asthma without concomitant use of ICS. Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. Severe hypersensitivity to milk protein.

Boxed Warning:

Asthma-related death.

SEREVENT DISKUS Warnings/Precautions:

LABA monotherapy (without ICS) may increase risk of asthma-related events (death, hospitalizations, intubations). Do not use for asthma adequately controlled on low- or medium-dose ICS. Use fixed-dose combination product of an ICS and a LABA in children with asthma to ensure adherence. Do not initiate in rapidly or acutely deteriorating asthma or COPD. Salmeterol is not a substitute for steroids. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Hepatic impairment; monitor. Labor & delivery. Pregnancy. Nursing mothers.

SEREVENT DISKUS Classification:

Long-acting beta-2 agonist (LABA).


Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended. Caution during or within 2 weeks of discontinuing MAOIs or tricyclic antidepressants, β-blockers (consider cardioselective), K+-depleting diuretics.

Adverse Reactions:

Headache, influenza, nasal/sinus congestion, pharyngitis, rhinitis, tracheitis/bronchitis, cough, musculoskeletal pain, throat irritation, viral respiratory infection.

How Supplied:

Diskus (60 blisters)—1