Salmeterol

This product contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to this combination product.

• Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA).ICD-10: J45.909

• Fluticasone Propionate/Salmeterol MDPI is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions ( 5.10 ) and Description ( 11 )] .contraindicated

For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) 1 inhalation of Fluticasone Propionate/Salmeterol 55 mcg/14 mcg, 113 mcg/14 mcg, or 232 mcg/14 mcg twice daily. ( 2.2 ) Do not use with a spacer or volume holding chamber. ( 2.2 ) 2.1 Administration Instructions Fluticasone Propionate/Salmeterol MDPI is for oral inhalation and does not require priming. Do not use Fluticasone Propionate/Salmeterol MDPI with a spacer or volume holding chamber. Do not use more than two times every 24 hours. More frequent administration or a greater number of daily inhalations (more than one inhalation twice daily) is not recommended as some patients are more likely to experience adverse reactions with higher salmeterol dosages. Avoid the concomitant use of other long acting beta 2 -adrenergic agonist (LABAs) [see Warnings and Precautions ( 5.3 , 5.11 )]. If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. 2.2 Recommended Dosage Administer 1 inhalation of Fluticasone Propionate/Salmeterol MDPI twice daily by oral inhalation (approximately 12 hours apart at the same time every day). Rinse the mouth with water without swallowing after each inhalation. Dosage Selection The recommended starting dosage for Fluticasone Propionate/Salmeterol MDPI is based on asthma severity and current inhaled corticosteroid use and strength.

LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Do not use in combination with an additional medicine containing LABA because of risk of overdose. ( 5.3 ) Localized infections: 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. ( 5.4 ) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.5 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Fluticasone Propionate/Salmeterol. ( 5.6 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone Propionate/Salmeterol slowly. ( 5.7 ) Paradoxical bronchospasm: Discontinue Fluticasone Propionate/Salmeterol and institute alternative therapy if paradoxical bronchospasm occurs.

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] Oropharyngeal candidiasis [see Warnings and Precautions ( 5.4 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.5 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.11 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.12 )] Growth effects in pediatrics [see Warnings and Precautions ( 5.13 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (greater than or equal to 3%): nasopharyngitis, oral candidiasis, headache, cough and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Asthma Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Hepatic impairment: Monitor for systemic corticosteroid effects. ( 8.6 ) 8.1 Pregnancy Risk Summary There are no randomized clinical studies of fluticasone propionate/salmeterol MDPI or individual monoproducts, fluticasone propionate and salmeterol, in pregnant women. There are clinical considerations with the use of Fluticasone Propionate/Salmeterol MDPI in pregnant women [see Clinical Considerations] . Animal reproduction studies are available with the combination of fluticasone propionate and salmeterol as well as individual components. In animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (MRHDID) on a mcg/m 2 basis [see Data] . However, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the MRHDID on a mcg/m 2 basis [see Data] . Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

Metabolism

Absorption Fluticasone Propionate: Fluticasone Propionate/Salmeterol MDPI acts locally in the lung; therefore, plasma levels may not predict therapeutic effect. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate was negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver.

This product contains both fluticasone propionate and salmeterol; therefore, the risks associated with overdosage for the individual components described below apply to Fluticasone Propionate/Salmeterol MDPI. Treatment of overdosage consists of discontinuation of Fluticasone Propionate/Salmeterol MDPI together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta‑receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage. Fluticasone propionate Chronic overdosage of fluticasone propionate may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.7 )] .

• Sep 19, 1997NDANDA020692Glaxosmithkline
• Aug 24, 2000NDANDA021077Glaxo Grp Ltd
• Jun 8, 2006NDANDA021254Glaxo Grp Ltd
• Jan 27, 2017NDANDA208799Teva Pharm
• Jan 30, 2019ANDAANDA208891Mylan
• Dec 17, 2020ANDAANDA203433Hikma
• Dec 13, 2021ANDAANDA213948Teva Pharms Usa
• Jan 12, 2026ANDAANDA214464Respirent Pharms

1. 1Dyspnoea17,15416%
2. 2Drug Ineffective11,21210%
3. 3Asthma10,81310%
4. 4Cough7,8227.3%
5. 5Pneumonia7,2606.8%
6. 6Wheezing5,4995.1%
7. 7Fatigue5,3615.0%
8. 8Malaise5,3425.0%
9. 9Headache4,9234.6%
10. 10Pain4,5234.2%
11. 11Product Quality Issue4,5014.2%
12. 12Off Label Use4,4854.2%
13. 13Nausea4,0573.8%
14. 14Product Dose Omission Issue3,7813.5%
15. 15Chronic Obstructive Pulmonary Disease3,4893.2%

Recent PubMed references pinned to Salmeterol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Fluticasone- vs Budesonide-Based Dual Therapy for COPD.
  JAMA network open · 2026 · Feldman WB, Ambati VL, Suissa S, et al.
  PMID 41801200DOI 10.1001/jamanetworkopen.2026.0959
• Single vs Dual Lactose-Polyethylene Glycol 3000 Microcarrier Systems for Pulmonary Salmeterol and Fluticasone Targeted Delivery.
  Drug design, development and therapy · 2026 · Akram MW, Zainudin BH, Mohamed Tenang ME, et al.
  PMID 41778147DOI 10.2147/DDDT.S582476
• Pharmacometric-Based Evaluation of Salmeterol and Its Metabolite α-Hydroxysalmeterol in Plasma and Urine: Practical Implications for Doping Control.
  CPT: pharmacometrics & systems pharmacology · 2026 · Thoueille P, Danion A, Hostrup M, et al.
  PMID 41543451DOI 10.1002/psp4.70187
• Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial.
  Thorax · 2026 · Mathioudakis AG, Bate S, Chatzimavridou-Grigoriadou V, et al.
  PMID 41402044DOI 10.1136/thorax-2025-223282
• Mitigating End-Stage Fatigue: Acute Inhaled Salmeterol Preserves Sprint Power in Simulated Cycling.
  Scandinavian journal of medicine & science in sports · 2025 · Merlini M, Staiano W, Angius L, et al.
  PMID 41195895DOI 10.1111/sms.70159
• Relative Bioavailability of Inhaled Fluticasone Propionate and Salmeterol - is Population Pharmacokinetic Modelling a Relevant Alternative to a Non-Compartmental Approach?
  Drug design, development and therapy · 2025 · Rosenborg J, Bäckman P, Bengtsson T, et al.
  PMID 41180600DOI 10.2147/DDDT.S480189
• Is dual bronchodilation a cost-effective alternative to ICS/LABA in COPD? A Colombian healthcare system evaluation.
  Expert review of respiratory medicine · 2026 · Buendía JA, Patiño DG
  PMID 41148107DOI 10.1080/17476348.2025.2582249
• Brain-targeting nanocages treat Alzheimer's disease via regulating microglial polarization and remodeling microenvironment.
  International journal of pharmaceutics · 2025 · Yang H, Zhao X, Liu M, et al.
  PMID 41115645DOI 10.1016/j.ijpharm.2025.126280

The 10 most recently updated of 419 ClinicalTrials.gov registrations naming Salmeterol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
  Recruiting · Phase 2 · Interventional · 1,147 enrolled · Sanofi
  NCT06676319updated 2026-05-27
• Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
  Not yet recruiting · Interventional · 40 enrolled · Juan Carlos Cardet
  NCT07396987updated 2026-05-26
• Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma
  Active not recruiting · Phase 4 · Interventional · 120 enrolled · Regeneron Pharmaceuticals
  NCT06572228updated 2026-05-22
• Functional Respiratory Imaging Study (DARWiIN)
  Completed · Phase 3 · Interventional · 25 enrolled · Chiesi Farmaceutici S.p.A.
  NCT04876677updated 2026-04-09
• A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
  Not yet recruiting · Phase 3 · Interventional · 304 enrolled · Novartis Pharmaceuticals
  NCT05776927updated 2026-02-03
• Advair HFA in Healthy and HAPE Predisposed Subjects
  Recruiting · Phase 1 · Phase 2 · Interventional · 60 enrolled · University of Colorado, Denver
  NCT06040268updated 2025-09-22
• Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation
  Terminated · Phase 3 · Interventional · 35 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT04655508updated 2025-09-16
• ANTES B+ Clinical Trial
  Terminated · Phase 4 · Interventional · 48 enrolled · Fundacio Privada Mon Clinic Barcelona
  NCT06282861updated 2025-08-14
• Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion
  Not yet recruiting · Interventional · 200 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07114107updated 2025-08-11
• Asthma Research in Children and Adolescents
  Active not recruiting · Observational · 525 enrolled · Parc de Salut Mar
  NCT04480242updated 2025-07-31

CPIC-curated drug–gene pairs for Salmeterol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• ADRB2CPIC D (provisional)ClinPGx 2A

Frequently asked questions

How does Salmeterol work?

This product contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to this combination product.

What is Salmeterol used for?

According to FDA labeling, Salmeterol carries indications including: Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Salmeterol?

Salmeterol is classified as Selective beta-2-adrenoreceptor agonists, beta2-Adrenergic Agonist, Adrenergic beta2-Agonists, Monoamine Oxidase Inhibitors, Bronchodilation.

What are the brand names for Salmeterol?

Salmeterol is marketed under brand names including Advair, AirDuo, Serevent, Wixela.

What are the contraindications for Salmeterol?

Salmeterol labeling lists contraindications including: Fluticasone Propionate/Salmeterol MDPI is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions ( 5.10 ) and Description ( 11 )] .. Always consult the full prescribing information and a clinician.