Fluticasone-Salmeterol

Combination product

Pronunciation: floo-TIK-a-soen and sal-ME-ter-ol

Combination of Fluticasone and Salmeterol.

Each component keeps its own pharmacology page; the combination itself adds no new mechanism.

Fluticasone-Salmeterol mascot — mnemonic cartoon — Visual mnemonic: Fluticasone-Salmeterol mascot
**Flo’s ventilated Flute case + Salamander meter Servant**

Components (2)

Fluticasone ballicule — decagon mechanism diagram — Fluticasone

Salmeterol ballicule — decagon mechanism diagram — Salmeterol

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
Asthma	Adults & adolescents >=12 y	1 inhalation BID (~12 h apart) of 100/50, 250/50, or 500/50 mcg — strength by asthma severity/prior ICS dose	1 inhalation BID	500/50 mcg 1 inhalation BID
Asthma	Children 4-11 y not controlled on ICS	100/50 mcg 1 inhalation BID (~12 h apart)	1 inhalation BID	100/50 mcg 1 inhalation BID
COPD, maintenance	Adults	250/50 mcg 1 inhalation BID (~12 h apart)	1 inhalation BID	250/50 mcg 1 inhalation BID

Titration Asthma: if inadequate response after 2 weeks on a strength, may replace with next higher strength

Renal Undefined

Hepatic No formal PK studies in hepatic impairment; both components are predominantly cleared by hepatic metabolism and may accumulate in plasma - closely monitor patients with hepatic disease

Maximum benefit may take >=1 week; onset within 30 min possible

Instructions

Oral inhalation only; rinse mouth with water without swallowing after each dose
Do not exceed 1 inhalation BID of prescribed strength; do not use additional LABA
Use inhaled SABA for symptoms between doses

Available strengths

inhaler 100/50, 250/50, 500/50 mcg (Diskus)

Contraindications

Primary treatment of status asthmaticus or acute asthma/COPD episodes requiring intensive measures
Severe hypersensitivity to milk proteins

Cautions

LABA monotherapy increases serious asthma-related events; never add another LABA
Do not initiate in acutely deteriorating asthma/COPD; not for acute symptoms
Oropharyngeal candidiasis — rinse mouth after use
Increased pneumonia risk in COPD
Immunosuppression: worsening infections; severe chickenpox/measles risk
Adrenal suppression; taper systemic corticosteroids slowly on transfer
Paradoxical bronchospasm — discontinue if it occurs
Caution with cardiovascular or CNS disorders (beta-adrenergic stimulation)
Bone mineral density decrease; monitor growth in pediatric patients
Glaucoma/cataracts with long-term ICS
Eosinophilic conditions, hypokalemia, hyperglycemia; caution in convulsive disorders, thyrotoxicosis, diabetes, ketoacidosis

Adverse reactions

Asthma (>=3%): upper respiratory tract infection/inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headache, nausea/vomiting
COPD (>=3%): pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headache, musculoskeletal pain

Pregnancy Insufficient human data; animal teratogenicity at maternal-toxic/supratherapeutic exposures; poorly controlled asthma itself raises perinatal risk

Lactation No human milk data; plasma levels after inhaled dosing are low so milk levels likely low; weigh breastfeeding benefit vs need

Cost

Fluticasone-Salmeterol

Strength		#/mo	CostPlus
100/50 mcg	inhaler	per unit	not offered
250/50 mcg	inhaler	per unit	not offered
500/50 mcg	inhaler	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Fluticasone-Salmeterol is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Part D rank #109.

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