Salmeterol

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Salmeterol on Prescriptsy

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Salmeterol is a long-acting beta2-agonist (LABA) bronchodilator used for the regular maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD).

In asthma, salmeterol must always be prescribed alongside an inhaled corticosteroid (ICS) and should never be used as monotherapy.

It provides sustained bronchodilation for approximately 12 hours and is typically taken twice daily.

Salmeterol is available as a dry powder inhaler (Accuhaler) and as a pressurised metered-dose inhaler (pMDI). The best-known UK brand name is Serevent, manufactured by GlaxoSmithKline (GSK).

This page provides a detailed clinical guide to salmeterol, covering its pharmacology, correct use, dosage, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about salmeterol

• Salmeterol must never be used as the sole treatment for asthma. It must always be combined with an inhaled corticosteroid (ICS).
• Salmeterol is not a reliever inhaler. It does not work quickly enough for acute symptom relief. Always carry a separate short-acting beta2-agonist reliever (such as salbutamol).
• If your asthma symptoms are worsening despite using salmeterol and an ICS, see your GP or asthma nurse urgently.
• Do not stop your ICS while continuing salmeterol. If your ICS is discontinued, salmeterol must also be stopped.
• Call 999 in an asthma emergency. Do not rely on salmeterol to treat an acute attack.

Understanding long-acting bronchodilators in asthma and COPD

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

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

If asthma remains uncontrolled despite regular low-dose ICS use and correct inhaler technique, the next step is to add a LABA such as salmeterol.

The LABA provides additional bronchodilation on top of the anti-inflammatory effect of the ICS, improving symptom control, lung function, and quality of life.

If the LABA provides benefit, it is continued alongside the ICS. If it does not help, it should be stopped and alternative add-on therapies considered.

In COPD, long-acting bronchodilators are the cornerstone of pharmacological management.

NICE guideline NG115 recommends a LABA or a long-acting muscarinic antagonist (LAMA) as initial maintenance therapy, depending on the patient's symptoms and exacerbation history.

Salmeterol may be used as a standalone maintenance bronchodilator in COPD, without the requirement for concomitant ICS, as the safety concern regarding LABA monotherapy applies specifically to asthma, not COPD.

How salmeterol works

Salmeterol xinafoate is a selective beta2-adrenoceptor agonist with a distinctive molecular structure.

It has a long lipophilic side chain that inserts into the lipid bilayer of the cell membrane and acts as an anchor, keeping the active head of the molecule in close proximity to the beta2-receptor.

This exosite binding mechanism allows repeated activation of the receptor over an extended period, producing sustained bronchodilation lasting approximately 12 hours.

This is fundamentally different from salbutamol, which is a hydrophilic molecule that diffuses rapidly to and from the receptor, providing quick but short-lived bronchodilation.

When salmeterol activates the beta2-receptor, the downstream signalling cascade involves stimulatory G-protein (Gs) activation, adenylyl cyclase stimulation, and increased intracellular cyclic AMP.

This leads to protein kinase A activation, which phosphorylates proteins involved in smooth muscle contraction, resulting in relaxation of airway smooth muscle.

The onset of bronchodilation with salmeterol is approximately 10 to 20 minutes, which is slower than salbutamol (3 to 5 minutes) but the effect is sustained for approximately 12 hours compared with 4 to 6 hours for salbutamol.

In addition to bronchodilation, salmeterol has anti-inflammatory properties at the cellular level, including inhibition of mast cell mediator release, reduction of eosinophil recruitment, and decreased airway oedema.

However, these anti-inflammatory effects are not sufficient to control asthma inflammation on their own, which is why an ICS must always accompany salmeterol in asthma management.

The LABA safety concern in asthma

In 2006, the FDA issued a black box warning for all LABAs used in asthma, based on the results of the Salmeterol Multicenter Asthma Research Trial (SMART), which showed a small but statistically significant increase in asthma-related deaths among patients randomised to salmeterol compared with placebo.

Importantly, many patients in the SMART trial were not using concomitant ICS.

Subsequent large randomised controlled trials, including the AUSTRI trial (2016) with over 11,000 patients, evaluated salmeterol when added to background ICS therapy.

AUSTRI found no increased risk of serious asthma-related events when salmeterol was used alongside an ICS.

Based on these data, the FDA removed the boxed warning requirement for LABA use in combination with ICS in 2017.

In the UK, the MHRA has consistently advised that LABAs should only be used in asthma alongside an ICS. The BNF and NICE NG80 reinforce this recommendation.

Fixed-dose combination inhalers (such as Seretide, which contains fluticasone propionate and salmeterol) are preferred in many clinical settings because they ensure that patients cannot take the LABA without the ICS.

Clinical evidence for salmeterol

Salmeterol has been studied extensively in both asthma and COPD.

In asthma, the addition of salmeterol to low-dose ICS has been shown to be more effective than doubling the ICS dose in terms of improving lung function, reducing symptoms, and decreasing rescue inhaler use.

The landmark FACET study (with formoterol, a similar LABA) and the OPTIMA study established the benefit of adding a LABA to ICS in patients with moderate asthma not controlled by ICS alone.

These findings inform the stepwise treatment recommendations in current UK guidelines.

In COPD, the TORCH trial (Towards a Revolution in COPD Health) evaluated the combination of salmeterol and fluticasone propionate versus individual components and placebo over 3 years in over 6,000 patients.

The combination significantly reduced exacerbation rates and improved lung function and health status compared with placebo, though it did not reach statistical significance for the primary endpoint of all-cause mortality.

Salmeterol alone also improved lung function and quality of life compared with placebo.

Salmeterol compared with other LABAs

Formoterol (eformoterol) is another LABA used in asthma and COPD.

Unlike salmeterol, formoterol has a rapid onset of action (within 1 to 3 minutes) as well as a long duration (approximately 12 hours).

This makes formoterol suitable for both maintenance and reliever therapy (MART regimens) when combined with budesonide in a single inhaler.

Salmeterol cannot be used as a reliever due to its slower onset.

Indacaterol, olodaterol, and vilanterol are ultra-long-acting beta2-agonists (ultra-LABAs) that provide 24-hour bronchodilation with once-daily dosing. Vilanterol is used in combination with fluticasone furoate in the Relvar Ellipta inhaler.

These newer agents are primarily used in COPD, though vilanterol-containing combinations are also licensed for asthma.

How to use the salmeterol Accuhaler

The Accuhaler is a dry powder inhaler that contains 60 pre-metered doses.

To use it correctly, hold the device in one hand and slide the thumbgrip away from you until you hear a click, which opens the device.

Slide the lever away from you until it clicks, which loads a single dose. Hold the device away from your mouth and breathe out gently.

Do not breathe out through the Accuhaler as moisture from your breath may affect the powder.

Place the mouthpiece between your lips and breathe in steadily and deeply through your mouth.

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

The dose counter on the Accuhaler shows how many doses remain. When the counter reaches 5, the numbers turn red, indicating it is time to obtain a replacement.

Good inhaler technique is essential for effective drug delivery.

Studies have shown that a significant proportion of patients use their inhalers incorrectly, which reduces the amount of drug reaching the lungs.

Your pharmacist or asthma nurse can check your technique and demonstrate the correct method. Asthma and Lung UK provides online instructional videos for all commonly used inhalers.

How to use the salmeterol Evohaler (pMDI)

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

Breathe out gently away from the inhaler. Place the mouthpiece between your lips and form a good seal.

Begin to breathe in slowly and deeply, and as you start to breathe in, press the canister down once to release one puff.

Continue to breathe in slowly and deeply. Remove the inhaler and hold your breath for about 10 seconds. Wait at least 30 seconds before the second puff.

Each dose of salmeterol from the Evohaler requires two puffs.

A spacer device (such as an AeroChamber or Volumatic) may be used to improve drug delivery and is recommended for anyone who finds it difficult to coordinate pressing the canister and breathing in at the same time.

Dosage and administration

For asthma in adults and adolescents: 50 micrograms twice daily, always alongside an ICS. For children aged 4 to 11: 50 micrograms twice daily, alongside an ICS.

For COPD in adults: 50 micrograms twice daily. Take doses at approximately the same times each day, 12 hours apart. The Accuhaler delivers 50 micrograms per blister.

The pMDI delivers 25 micrograms per actuation (two puffs for a 50 microgram dose).

Side effects of salmeterol

Common side effects include headache, tremor (fine shaking of the hands), and palpitations. These are beta2-agonist class effects, usually mild and transient.

Muscle cramps may occur, particularly in the legs. Throat irritation and hoarseness may occur with dry powder inhaler formulations. Tachycardia is uncommon at standard doses.

Hypokalaemia may occur at high doses or in combination with other potassium-depleting medicines.

Paradoxical bronchospasm (immediate worsening of wheeze) is rare; if it occurs, stop salmeterol and seek medical advice. Cardiac arrhythmias are rare but recognised.

Allergic reactions including rash, urticaria, and angioedema are very rare. Call 999 for severe swelling or difficulty breathing. Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Never use salmeterol as monotherapy for asthma. Always use it with an ICS. Do not use it for acute relief. Carry a separate SABA reliever at all times.

Use with caution in thyrotoxicosis, ischaemic heart disease, cardiac arrhythmias, hypertension, and diabetes. Avoid concomitant potent CYP3A4 inhibitors (ketoconazole, ritonavir) unless the benefit clearly outweighs the risk.

Non-selective beta-blockers should be avoided in asthma.

During pregnancy, continue asthma treatment and discuss with your prescriber; poorly controlled asthma carries greater risk than the medicines used to treat it.

Salmeterol is licensed for children aged 4 and over with asthma, always with ICS.

How to get salmeterol in the UK

Salmeterol 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.

Salmeterol is available as the branded product Serevent and as generic alternatives. Your prescriber or pharmacist can advise on which device is most suitable for you.

Prescription prepayment certificates are available from the NHS Business Services Authority for patients who need multiple prescriptions.

Sources

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