Class: Inhaled Corticosteroid and Long-Acting α2-Adrenergic Agonist Combination
Dosage Forms. Inhalation Disk: 100/50 (fluticasone 0.1 mg plus salmeterol 0.05 mg/actuation), 250/50 (fluticasone 0.25 mg plus salmeterol 0.05 mg/actuation), 500/50 (fluticasone 0.5 mg plus salmeterol 0.05 mg/actuation); Metered Dose Inhaler: 45/21 (fluticasone 45 mcg plus salmeterol 21 mcg/actuation), 115/30.45 (fluticasone 115 mcg plus salmeterol 21 mcg/actuation), 230/21 (fluticasone 230 mcg plus salmeterol 21 mcg/actuation)
Common FDA Label Indication, Dosing, and Titration.
1. Asthma: 1 disk or 2 MDI puffs q12h, adjust dose to patient response
2. Chronic obstructive pulmonary disease: 1 disk q12h, adjust dose to patient response
Off-Label Uses. None
MOA. Fluticasone is a synthetic trifluorinated corticosteroid with anti-inflammatory effects. It is a human glucocorticoid receptor agonist that inhibits multiple cell types and mediator production or secretion involved in asthma and COPD. Salmeterol is a long-acting α2-adrenergic agonist, stimulates intracellular adenyl cyclase in catalyzing the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP). The increased cyclic AMP levels result in the relaxation of bronchial smooth muscle and inhibition of the release of mediators of instantaneous hypersensitivity from mast cells.
Drug Characteristics: Fluticasone/Salmeterol
Medication Safety Issues: Fluticasone/Salmeterol
Drug Interactions: Fluticasone/Salmeterol
Adverse Reactions: Fluticasone/Salmeterol
Efficacy Monitoring Parameters. Control of asthma or COPD symptoms, as measured by PFTs.
Toxicity Monitoring Parameters. While only small amounts of fluticasone and almost no salmeterol reach systemic circulation, bone mineral density and growth and development in children should be monitored. Routine ophthalmologic examinations should be performed. Monitor for signs and symptoms of adrenal suppression or infection (including oral candidiasis).
Key Patient Counseling Points. Proper administration technique for these inhaled products; rinse mouth with water after each use to prevent oral infections. Monitor for signs of toxicity, especially adrenal insufficiency, oral candidiasis, and worsening pulmonary function.
Clinical Pearls. Long-acting beta2-agonists (LABAs), such as salmeterol, increase the risk of asthma-related deaths; fluticasone and salmeterol should only be used in patients not adequately controlled on a long-term asthma control medication (ie, inhaled corticosteroid) or whose disease severity requires initiation of two maintenance therapies. Once asthma control is achieved and maintained, discontinue fluticasone/salmeterol if possible without loss of asthma control and maintain the patient on a long-term asthma control medication. Medication guide required at dispensing.