Salmeterol / Fluticasone Propionate

What it is and how it works

Mechanism of Action Fluticasone Propionate and Salmeterol Inhalation Powder Fluticasone propionate and salmeterol inhalation powder contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to fluticasone propionate and salmeterol inhalation powder. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical, physiologic, and inflammatory indices. Fluticasone Propionate Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.

Indications

Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important Limitation of Use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) Treatment of Asthma Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inhalation powder 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). Important Limitation of Use Fluticasone propionate and salmeterol inhalation powder is NOT indicated for the relief of acute bronchospasm.

Dosage and administration (summary)

Fluticasone propionate and salmeterol inhalation powder should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of fluticasone propionate and salmeterol inhalation powder is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol.

Contraindications

The use of fluticasone propionate and salmeterol inhalation powder 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 fluticasone propionate, salmeterol, or any of the excipients . • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures.

Warnings and precautions

• LABA monotherapy increases the risk of serious asthma-related events. ( Error! Hyperlink reference not valid. ) • Do not initiate in acutely deteriorating asthma or COPD. Do not use to treat acute symptoms. • Do not use in combination with an additional medicine containing a LABA because of risk of overdose. ( Error! Hyperlink reference not valid. ) • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.

Pregnancy

Pregnancy Risk Summary There are insufficient data on the use of fluticasone propionate and salmeterol inhalation powder or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women.

Storage and supply

Fluticasone Propionate and Salmeterol Inhalation Powder USP 250 mcg/50 mcg is supplied as a disposable gray plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 68788-8453-6). Store at 20° to 25°C (68° to 77°F).

Source: Fluticasone Propionate And Salmeterol (Fluticasone Propionate And Salmeterol) — US FDA prescribing information, 2025-05-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.