fluticasone propionate and salmeterol xinafoate
Drug Details
- Generic Name
- fluticasone propionate and salmeterol xinafoate
- Brand Names
- Fluticasone Propionate and Salmeterol HFA, ADVAIR HFA
- Application Number
- NDA021254
- Sponsor
- Prasco Laboratories
- NDC Codes
- 8
- Dosage Forms
- AEROSOL, METERED
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE
Indications and Usage
1 INDICATIONS AND USAGE Fluticasone Propionate and Salmeterol HFA is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. Fluticasone Propionate and Salmeterol 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 Fluticasone Propionate and Salmeterol HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate and Salmeterol 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 )