Fluticasone/salmeterol

Fluticasone/salmeterol
Fluticasone propionate (top)
and salmeterol (bottom)
Combination of
Fluticasone propionateGlucocorticoid
SalmeterolLong-acting β2 agonist (LABA)
Names
Trade namesAdvair, Seretide, others
Clinical data
Pregnancy
category
  • AU: B3
  • US: C (Risk not ruled out)
    Routes of
    use    		Inhalation
    Defined daily doseNot established[1]
    External links
    AHFS/Drugs.comFDA Professional Drug Information
    US NLMFluticasone/salmeterol
    MedlinePlusa699063
    Legal
    Legal status
    • AU: S4 (Rx-only)
    • CA: ℞-only
    • UK: POM (Prescription only)
    • US: ℞-only
    • In general: ℞ (Prescription only)

    Fluticasone/salmeterol, sold under the brand name Advair among others, is a combination medication containing fluticasone propionate and salmeterol.[2] It is used in the management of asthma and chronic obstructive pulmonary disease (COPD).[2] It is used by inhaling the medication into the lungs.[2]

    Common side effects include thrush, headache, and cough.[3] Serious side effects may include worsening asthma, anaphylaxis, seizures, and heart problems.[3] Safety in pregnancy and breastfeeding is unclear.[4] Fluticasone, a corticosteroid, works by decreasing inflammation while salmeterol, a long-acting beta-adrenoceptor agonist (LABA), works by activating beta-2 adrenergic receptors.[3]

    The combination was approved for medical use in the United States in 2000.[3] A generic version was approved in the United States in 2019.[5] A two month supply in the United Kingdom costs the National Health Service about £35 per month as of 2019.[2] In the United States the wholesale cost of this amount is about 89 USD.[6] In 2019, it was the 80th most commonly prescribed medication in the United States, with more than 9 million prescriptions.[7][8]

    Medical uses

    Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination which decreases inflammation in the lungs. This leads to improvement in breathing. Salmeterol, a LABA, treats constriction of the airways. The combination of both is meant to be used as maintenance therapy and not as a rescue therapy for sudden symptoms.

    Dosage

    The defined daily dose is not defined.[1]

    Side effects

    The common side effects of this combination are those of its individual drugs. For instance, the use of inhaled corticosteroids is associated with oral candidiasis, commonly known as yeast infection or thrush. Rinsing the mouth with water after inhaling the medication decreases the risk of developing this condition.

    While the use of inhaled steroids and LABA are recommended for the resulting improvement in control of symptoms of asthma,[9] concerns have been raised that salmeterol may increase the risk of death due to asthma, and this additional risk is not reduced by the addition of inhaled steroids.[10] Other side effects from this drug combination may include increased blood pressure, change in heart rate, an irregular heartbeat, increased risk of osteoporosis, cataracts, and glaucoma.[11] Studies have demonstrated the safety of inhaled fluticasone propionate in children. A systematic review published in 2013 found no significant adverse effect on the function of the hypothalamic–pituitary–adrenal axis, growth, and bone mineral density in asthmatic children when inhaled fluticasone is used for up to three months.[12]

    Mechanism of action

    Fluticasone/salmeterol contains fluticasone propionate, a synthetic corticosteroid, and salmeterol, a selective long-acting beta-adrenergic receptor agonist. Fluticasone works as a potent anti-inflammatory agent, inhibiting multiple cell types such as mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils all of which contribute to inflammation, a large component in the pathogenesis of asthma. Salmeterol works by stimulating intracellular adenyl cyclase which acts as a catalyst in the production of cyclic AMP. Increased cyclic AMP levels lead to a relaxation of bronchial smooth muscles. Additionally, cyclic AMP inhibits the release of mediators of immediate hypersensitivity.[13]

    Society and culture

    Cost

    A two month supply in the United Kingdom costs the National Health Service about £35 per month as of 2019.[2] In the United States the wholesale cost of this amount is about 89 USD.[6] In 2017, it was the 65th most commonly prescribed medication in the United States, with more than twelve million prescriptions.[14][15]

    • Fluticasone/salmeterol costs (US)
    • Fluticasone/salmeterol prescriptions (US)

    Generics

    On January 30, 2019, the FDA granted Mylan N.V. the first generic approval for Advair Diskus.[16]

    Civil settlements

    In 2012, Advair was part of a larger civil settlement agreement between GlaxoSmithKline (GSK) and the United States, in which GSK agreed to pay $1.043 billion; the United States said that GSK promoted off-label uses of Advair and paid kickbacks to healthcare professionals to sell this drug, among others.[17]

    References

    1. 1 2 "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 5 February 2021. Retrieved 7 September 2020.
    2. 1 2 3 4 5 British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 263–264. ISBN 9780857113382.
    3. 1 2 3 4 "Fluticasone and Salmeterol inhalation - FDA prescribing information, side effects and uses". Drugs.com. Archived from the original on 6 March 2019. Retrieved 4 March 2019.
    4. ↑ "Fluticasone / salmeterol Pregnancy and Breastfeeding Warnings". Drugs.com. Archived from the original on 6 March 2019. Retrieved 3 March 2019.
    5. ↑ Office of the Commissioner. "Press Announcements - FDA approves first generic Advair Diskus". www.fda.gov. Archived from the original on 6 February 2019. Retrieved 1 February 2019.
    6. 1 2 "NADAC as of 2019-02-27". Centers for Medicare and Medicaid Services. Archived from the original on 2019-03-06. Retrieved 3 March 2019.
    7. ↑ "The Top 300 of 2019". ClinCalc. Archived from the original on 12 February 2021. Retrieved 16 October 2021.
    8. ↑ "Fluticasone; Salmeterol - Drug Usage Statistics". ClinCalc. Archived from the original on 19 October 2021. Retrieved 16 October 2021.
    9. ↑ "Guideline 101: British Guideline on the Management of Asthma". British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN). Archived from the original on 2015-04-18.
    10. ↑ Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE (June 2006). "Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths". Ann. Intern. Med. 144 (12): 904–12. doi:10.7326/0003-4819-144-12-200606200-00126. PMID 16754916.
    11. ↑ "US fluticasone propionate/Salmeterol label" (PDF). FDA. April 2016. Archived (PDF) from the original on 2016-11-30. Retrieved 2016-11-30.
    12. ↑ Muley, Prasad; Shah, Monali (2013). "Safety of Inhaled Fluticasone Propionate Therapy for Pediatric Asthma - A Systematic Review". Current Drug Safety. 8 (3): 186–194. PMID 23859431.
    13. ↑ "Advair Diskus 100/50" (PDF). Food and Drug Administration. Archived (PDF) from the original on 23 January 2021. Retrieved 30 October 2019.
    14. ↑ "The Top 300 of 2020". ClinCalc. Archived from the original on 12 February 2021. Retrieved 11 April 2020.
    15. ↑ "Fluticasone Propionate; Salmeterol Xinafoate - Drug Usage Statistics". ClinCalc. Archived from the original on 11 April 2020. Retrieved 11 April 2020.
    16. ↑ "FDA approves first generic Advair Diskus". U.S. Food and Drug Administration. Archived from the original on 2019-02-06. Retrieved 2019-01-31.
    17. ↑ "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data". Department of Justice: Office of Public Affairs. July 2, 2012. Archived from the original on December 19, 2014. Retrieved December 16, 2014.
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