salmeterol xinafoate

FDA Drug Profile — SEREVENT DISKUS

Drug Details

Generic Name
salmeterol xinafoate
Brand Names
SEREVENT DISKUS
Application Number
NDA020692
Sponsor
GlaxoSmithKline LLC
NDC Codes
1
Dosage Forms
POWDER, METERED
Routes
ORAL, RESPIRATORY (INHALATION)
Active Ingredients
SALMETEROL XINAFOATE

Indications and Usage

1 INDICATIONS AND USAGE ADVAIR HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. ADVAIR HFA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Limitations of Use ADVAIR HFA is not indicated for the relief of acute bronchospasm. ADVAIR HFA is a combination of fluticasone propionate, an inhaled corticosteroid, and salmeterol, a long-acting beta 2 ‑adrenergic agonist (LABA), indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. ( 1 ) Limitations of use: Not indicated for relief of acute bronchospasm. ( 1 )