Asthma/COPD:

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.

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.

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.

Pharmacologic Class:

Long-acting beta-2 agonist (LABA).

Interactions:

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