Information intended for healthcare professionals only.

This formulary decision guide was developed from content provided by Glenmark Pharmaceuticals Europe Ltd in a format developed by Guidelines in Practice.

View prescribing information here

Key points

  • Stalpex is a branded generic inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) alternative to Seretide™ Accuhaler™ available as 50 mcg/500 mcg dose
  • Stalpex provides dosing equivalence to Seretide™ Accuhaler™, at 25% lower acquisition cost1,2
  • Stalpex offers the same handling experience as the existing standard of care, at the highest dose for treatment available.3


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Drug name

Stalpex (salmeterol xinafoate/fluticasone propionate 50 mcg/500 mcg dose inhalation powder, pre-dispensed)


  • Stalpex is an ICS/LABA indicated for use in:4
    • patients ≥12 years with severe asthma where use of a combination product is appropriate
    • patients with chronic obstructive pulmonary disease (COPD), with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.


  • Stalpex is available in one dose strength:4 salmeterol xinafoate/fluticasone propionate 50 mcg/500 mcg (PIP 4098661)
  • For optimum benefit, Stalpex should be used daily, even when asymptomatic4
  • The recommended dose for asthma and COPD is one inhalation twice daily4
  • See Summary of Product Characteristics4 for additional dosage information.


  • Stalpex comes in blisters made from polyamide (OPA)/aluminium/polyvinyl chloride (PVC)/aluminium/polyethylene terephthalate (PET)/paper contained in a molded plastic inhaler equipped with a mouthpiece and dose counter4
  • One inhaler contains 60 inhalations4
  • The operating principles and pharmaceutical dosage form of Stalpex are equivalent to those of Seretide™ Accuhaler™3
  • The handling of the two inhalation devices (Stalpex and reference product) is equivalent.3

Budgetary implications

  • Stalpex could provide acquisition cost savings of 25% compared to the existing standard of care.2,5
Potential cost savings with Stalpex5
Current annual cost to NHS for ICS/LABA prescriptions (50 mcg/500 mcg dose) £30.5 million
Potential annual acquisition cost savings to NHS using Stalpex versus Seretide™ Accuhaler™ £8 million


  • The bioequivalence of Stalpex compared to Seretide™ Accuhaler™ has been confirmed1
  • Equivalence of the two devices was confirmed by a comparative handling study.3

BTS/SIGN recommendations

  • ICS are the recommended preventer drug for adults and children to achieve treatment goals6
  • First choice add-on therapy: LABA in adults; inhaled LABA or leukotriene receptor antagonist (LTRA) in children6
  • Combination inhalers are recommended to improve treatment adherence6
  • Patient preference and local cost are the most important factors to consider when prescribing an inhaler6
  • Generic prescribing of inhalers should be avoided so that patients are not given unfamiliar devices.6


  1. Medicine and Healthcare products Regulatory Agency (MHRA). Public assessment report. Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed (salmeterol xinafoate and fluticasone propionate). UK/H/6498/003/DC. December 2018. Available at 
  2. Monthly Index of Medical Specialities website. MIMS online. (Accessed August 2019).
  3. Glenmark Pharmaceuticals Europe Ltd data on file. Device specifications.
  4. Glenmark Pharmaceuticals Europe Ltd. Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensedsummary of product characteristics
  5. Glenmark Pharmaceuticals Europe Ltd data on file. Stalpex cost comparison.
  6. British Thoracic Society, Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 153. BTS/SIGN, 2016. Available at

Seretide Accuhaler is a registered trademark of GlaxoSmithKline UK.


Date of preparation: August 2019