Salmeterol

What it is and how it works

Mechanism of Action Salmeterol is a selective LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 -adrenoceptors than albuterol. Although beta 2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -adrenoceptors are the predominant receptors in the heart, there are also beta 2 -adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta 2 -agonists may have cardiac effects.

Indications

is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.3 ) Treatment of Asthma SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with an ICS in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma. LABA, such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death . Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated . Use SEREVENT DISKUS only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on an ICS.

Dosage and administration (summary)

should be administered by the orally inhaled route only. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) is not recommended as some patients are more likely to experience adverse effects. Patients using SEREVENT DISKUS should not use additional LABA for any reason. • For oral inhalation only. • Treatment of asthma in patients aged 4 years and older: 1 inhalation twice daily in addition to concomitant treatment with an ICS. • EIB: 1 inhalation at least 30 minutes before exercise. • Maintenance treatment of bronchospasm associated with COPD: 1 inhalation twice daily.

Contraindications

Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an ICS is contraindicated . The use of SEREVENT DISKUS is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to salmeterol or any of the excipients • Asthma: Without concomitant use of an ICS.

Warnings and precautions

• LABA as monotherapy (without ICS) for asthma increase the risk of asthma-related death and asthma-related hospitalizations. Prescribe for asthma only as concomitant therapy with an inhaled corticosteroid. • Do not initiate in acutely deteriorating asthma or COPD. Do not use to treat acute symptoms. • Not a substitute for corticosteroids. Patients with asthma must take a concomitant ICS. • Do not use in combination with an additional medicine containing a LABA because of risk of overdose. • If paradoxical bronchospasm occurs, discontinue SEREVENT DISKUS and institute alternative therapy.

Pregnancy

Pregnancy Risk Summary The available data from published epidemiological studies and case reports with use of SEREVENT DISKUS in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Beta‑agonists may interfere with uterine contractility.

Storage and supply

is supplied as a disposable teal green plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00). Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) .

Source: Salmeterol Xinafoate (Serevent Diskus) — US FDA prescribing information, 2022-10-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.