Seretide

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Seretide on Prescriptsy

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Seretide is a combination inhaler containing fluticasone propionate (an inhaled corticosteroid, ICS) and salmeterol (a long-acting beta2-agonist, LABA).

It is one of the most widely prescribed maintenance inhalers in the United Kingdom, used for the regular treatment of asthma in adults and children aged 4 and over, and for the symptomatic treatment of COPD in adults with a FEV1 less than 60% predicted and a history of repeated exacerbations.

Seretide addresses both the inflammatory and bronchospastic components of airway disease in a single inhaler, simplifying treatment and ensuring that the LABA is always taken alongside the ICS.

It is a prescription-only medicine (POM) manufactured by GlaxoSmithKline (GSK).

This page provides a detailed clinical guide to Seretide, covering how it works, available strengths, dosage, side effects, important safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Seretide

• Seretide is a preventer inhaler. It must be taken regularly every day, even when you feel well. It does not provide immediate relief of acute symptoms.
• Always carry a separate short-acting reliever inhaler (such as salbutamol) for breakthrough symptoms or asthma attacks.
• Rinse your mouth with water after each inhalation and spit it out to reduce the risk of oral thrush and hoarseness.
• Patients with COPD using Seretide should be alert to symptoms of pneumonia (increased cough, discoloured sputum, fever, breathlessness) and seek prompt medical attention.
• Do not stop Seretide suddenly without medical advice. If step-down is appropriate, your prescriber will reduce the dose gradually.

Understanding combination inhalers in asthma management

Asthma management in the UK follows a stepwise approach as outlined in NICE guideline NG80 and BTS/SIGN guideline SIGN 158.

At step 1, a low-dose ICS preventer and a SABA reliever are prescribed.

If asthma remains uncontrolled despite regular low-dose ICS use with correct inhaler technique and good adherence, a LABA is added as an add-on therapy at step 3.

The addition of a LABA to an ICS is more effective than doubling the ICS dose for most patients with moderate asthma, improving lung function, reducing symptoms, and decreasing reliever use.

Combination inhalers such as Seretide contain both the ICS and the LABA in a single device.

This is the preferred approach because it ensures that the LABA is never taken without the ICS.

LABA monotherapy in asthma is associated with an increased risk of serious adverse events, and a combination inhaler eliminates this risk by design.

Seretide was the first widely available ICS/LABA combination inhaler in the UK and has been a cornerstone of asthma management since its introduction in the late 1990s.

How Seretide works

The two active ingredients in Seretide work through complementary and synergistic mechanisms.

Fluticasone propionate is a synthetic corticosteroid that binds to intracellular glucocorticoid receptors in airway epithelial cells, inflammatory cells, and structural cells.

The activated receptor complex translocates to the cell nucleus, where it modulates gene transcription.

It increases the expression of anti-inflammatory proteins such as lipocortin-1 (which inhibits phospholipase A2 and thus the production of arachidonic acid metabolites) and beta2-receptor mRNA (which upregulates the number of beta2-receptors on airway smooth muscle).

Simultaneously, it reduces the transcription of pro-inflammatory genes encoding cytokines (IL-1, IL-4, IL-5, IL-6, IL-8, TNF-alpha), chemokines, adhesion molecules, and inflammatory enzymes (COX-2, iNOS).

The net effect is suppression of the chronic airway inflammation that underlies asthma, reducing eosinophilic infiltration, mucus hypersecretion, oedema, and airway hyperresponsiveness.

Salmeterol xinafoate is a selective LABA with a unique exosite binding mechanism.

Its long lipophilic side chain anchors in the cell membrane adjacent to the beta2-receptor, allowing repeated receptor stimulation over approximately 12 hours.

Beta2-receptor activation increases intracellular cAMP via adenylyl cyclase, leading to protein kinase A activation and smooth muscle relaxation. This produces sustained bronchodilation, opening the narrowed airways.

Importantly, synergy exists between the two components. Fluticasone upregulates beta2-receptor expression, which may otherwise be downregulated by chronic beta2-agonist use.

Salmeterol, in turn, enhances glucocorticoid receptor nuclear translocation, potentially increasing the anti-inflammatory effect of fluticasone.

This pharmacological synergy means that the combination is more effective than either component alone, providing a scientific rationale for the use of ICS/LABA combination therapy.

Clinical evidence for Seretide

The efficacy of fluticasone/salmeterol combination therapy has been established in numerous large randomised controlled trials.

The GOAL study (Gaining Optimal Asthma controL) demonstrated that the combination of fluticasone and salmeterol achieved total asthma control (no symptoms, no reliever use, no exacerbations, normal lung function) in a significantly higher proportion of patients compared with fluticasone alone.

The study supported the stepwise approach and showed that the ICS/LABA combination was more effective than increasing the ICS dose alone.

In COPD, the TORCH trial (Towards a Revolution in COPD Health) was a landmark study involving over 6,000 patients followed for 3 years.

The fluticasone/salmeterol combination significantly reduced exacerbation rates, improved lung function (FEV1), and improved health-related quality of life compared with placebo.

While the primary endpoint of all-cause mortality narrowly missed statistical significance, the combination showed a 17.5% reduction in mortality risk.

The TORCH trial also identified the increased pneumonia risk associated with ICS use in COPD, a finding that has influenced subsequent prescribing guidance.

The INSPIRE trial compared fluticasone/salmeterol with tiotropium (a LAMA) in moderate to severe COPD and found comparable exacerbation rates but a higher incidence of pneumonia in the fluticasone/salmeterol group.

These findings have informed the NICE NG115 recommendation that ICS should only be added for COPD patients with asthmatic features or frequent exacerbations despite bronchodilator therapy.

Seretide compared with other combination inhalers

Several ICS/LABA combination inhalers are available in the UK.

Symbicort (budesonide/formoterol) differs from Seretide in that formoterol has a rapid onset, allowing Symbicort to be used in a MART (Maintenance And Reliever Therapy) regimen, where the same inhaler is used for both regular maintenance and as-needed relief.

Seretide cannot be used in MART because salmeterol has a slow onset and is not suitable for acute relief.

Relvar Ellipta (fluticasone furoate/vilanterol) is a once-daily ICS/LABA combination that offers the convenience of single daily dosing.

Fostair (beclometasone/formoterol) is another option that can be used in a MART regimen and delivers an extra-fine particle formulation for improved small airway deposition.

The choice of combination inhaler depends on patient preference, device suitability, cost, and whether a MART approach is desired.

NICE recommends that the least expensive inhaler that is clinically appropriate should be considered, and that the carbon footprint of inhalers should also be taken into account (dry powder inhalers have a lower carbon footprint than pMDIs).

Available strengths and devices

Seretide Accuhaler (dry powder inhaler) is available in three strengths: 100 (fluticasone 100 mcg/salmeterol 50 mcg), 250, and 500. Each contains 60 doses. One inhalation twice daily.

Seretide Evohaler (pMDI) is available in three strengths: 50 (fluticasone 50 mcg/salmeterol 25 mcg), 125, and 250. Each contains 120 actuations. Two puffs twice daily.

A spacer device may be used with the Evohaler to improve drug delivery and reduce oropharyngeal side effects.

How to use the Seretide Accuhaler

Hold the Accuhaler in one hand and slide the thumbgrip away from you until it clicks to open the device.

Slide the lever away from you until it clicks to load a dose. Hold the device away from your mouth and breathe out gently.

Do not breathe into the Accuhaler. Place the mouthpiece between your lips, forming a good seal, and breathe in steadily and deeply through your mouth.

Remove the device and hold your breath for approximately 10 seconds, then breathe out slowly. Close the Accuhaler by sliding the thumbgrip back towards you.

Rinse your mouth with water afterwards and spit the water out to reduce the risk of oral thrush.

The dose counter shows remaining doses; replace the device when it reaches zero.

How to use the Seretide Evohaler

Remove the mouthpiece cap and shake the inhaler thoroughly. Hold the inhaler upright with your thumb at the base and index finger on top of the canister.

Breathe out gently away from the inhaler.

Place the mouthpiece between your lips and begin to breathe in slowly and deeply, pressing the canister down once as you breathe in. Continue breathing in deeply.

Remove the inhaler and hold your breath for about 10 seconds. Wait at least 30 seconds before taking the second puff. Each dose requires two puffs.

Rinse your mouth with water and spit it out afterwards.

A spacer device improves drug delivery and is recommended for patients who find it difficult to coordinate pressing and breathing simultaneously.

Dosage and administration

For asthma in adults and adolescents: one inhalation of the Accuhaler or two puffs of the Evohaler twice daily, approximately 12 hours apart.

The strength should match the patient's ICS requirement. For children aged 4 to 11: lowest strength only (Seretide 100 Accuhaler or Seretide 50 Evohaler), twice daily.

For COPD: Seretide 500 Accuhaler, one inhalation twice daily. Rinse the mouth after each use. Do not exceed the prescribed dose.

Use a separate SABA reliever for breakthrough symptoms.

Side effects of Seretide

Common side effects include oral candidiasis, hoarseness, headache, nasopharyngitis, and upper respiratory tract infection. Tremor and palpitations (from salmeterol) are usually mild. Muscle cramps may occur.

In COPD, pneumonia risk is increased with ICS use; seek medical attention for symptoms of chest infection.

Long-term high-dose ICS may cause systemic effects including adrenal suppression, reduced bone density, skin thinning, cataracts, and glaucoma. Growth should be monitored in children. Paradoxical bronchospasm is rare.

Allergic reactions are very rare; call 999 for severe swelling or anaphylaxis. Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Seretide must not be used for acute relief. Do not stop suddenly. Contraindicated in known hypersensitivity to either component. Avoid potent CYP3A4 inhibitors (ritonavir, ketoconazole).

Avoid non-selective beta-blockers in asthma. Monitor for pneumonia in COPD. Monitor adrenal function if transferring from oral steroids. Monitor blood glucose in diabetes.

Consider bone density assessment for patients at osteoporosis risk on long-term high-dose ICS. Monitor growth in children. Continue during pregnancy; poorly controlled asthma carries greater risk than treatment.

Seek urgent help if symptoms worsen or reliever use increases. Call 999 in emergency.

How to get Seretide in the UK

Seretide is available on NHS prescription from your GP, asthma nurse, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Generic alternatives containing the same combination (fluticasone propionate/salmeterol) may be available and are often less expensive for the NHS, though the prescriber should ensure the device is suitable for the patient.

Prescription prepayment certificates are available from the NHS Business Services Authority for patients who need multiple prescription items each month.

Sources

• Seretide 250 Accuhaler, Summary of Product Characteristics (EMC)
• Fluticasone with salmeterol, British National Formulary (BNF)
• Asthma: diagnosis, monitoring and chronic asthma management, NICE NG80
• Chronic obstructive pulmonary disease in over 16s, NICE NG115
• Fluticasone inhaler, NHS
• MHRA Yellow Card Scheme