Salmeterol is a beta2-adrenergic agonist indicated for treatment of asthma in patients aged 4 years and older with an ICS., among other approved uses. It is available as inhalation powder for oral use. MedsAcross supplies Salmeterol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
SEREVENT DISKUS 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.
Source: US FDA prescribing information
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. The pharmacologic effects of beta 2 -adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP).
Source: US FDA prescribing information
SEREVENT DISKUS 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.
Source: US FDA prescribing information
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. • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to salmeterol or any of the excipients.
Source: US FDA prescribing information
Boxed warning (asthma-related death): Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. • 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.
Source: US FDA prescribing information
LABA, including salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death. Data from a large 28-week placebo-controlled U.S. trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: US FDA prescribing information
• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of cardiovascular effects. • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.
Source: US FDA prescribing information
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). Store in a dry place away from direct heat or sunlight. SEREVENT DISKUS should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Salmeterol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Serevent Diskus 50 mcg inhalation powderInhalation, oral | GlaxoSmithKline | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 4 February 1994 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Salmeterol in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Salmeterol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Salmeterol, including Serevent Diskus.
Yes. The US FDA first approved Salmeterol on 4 February 1994, according to Drugs@FDA.
No listed presentation of Salmeterol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Salmeterol is classified under ATC code R03AC12 (Salmeterol).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.