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ICS/LABA Combination Pregnancy: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative or feto/neonatal toxicity related to Seretide. Animal studies have shown reproductive toxicity after administration of beta-2 adrenoreceptor agonists and glucocorticosteroids. Administration to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus, and the lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used. Breastfeeding: it is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk; a risk to breastfed newborns/infants cannot be excluded, so a decision must be made whether to discontinue breastfeeding or the medicine.

Fluticasone-Salmeterol

Brand names: Seretide, AirFluSal

A fixed-dose combination inhaler of an inhaled corticosteroid (fluticasone) and a long-acting beta-2 agonist (salmeterol) used for maintenance treatment of asthma and COPD.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: ASTHMA — adults and adolescents 12 years and older: one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily, OR one inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily, OR one inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily. 'The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.' Where a short-term trial is considered as initial maintenance therapy in moderate persistent asthma for whom rapid control is essential, 'the recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily'. COPD — adults: one inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily. SCOPE OF THIS DOSE: these are the ACCUHALER (dry-powder inhaler) strengths only, as quoted from the Seretide Accuhaler SPC. Pressurised metered-dose inhaler (Evohaler) strengths and their per-actuation regimens were NOT sourced and are different — do not apply these figures to a pMDI.
Route: Inhalation use, via the Seretide Accuhaler dry-powder device — 'The device is opened and primed by sliding the lever. The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled and the device closed.'
Frequency: Twice daily. In asthma, as an alternative, 'patients requiring a long-acting beta-2 agonist could be titrated to Seretide given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control' — given at night where there is a history of nocturnal symptoms, and in the morning where symptoms are mainly daytime.
Max: 500 micrograms fluticasone propionate (with 50 micrograms salmeterol) per inhalation twice daily — the highest strength in the adult Accuhaler posology quoted, and also the licensed COPD dose. In children the SPC states 'the maximum licensed dose of fluticasone propionate delivered by Seretide Accuhaler in children is 100 microgram twice daily'.
SOURCE: UK SPC via the eMC, product 'Seretide 100 Accuhaler' (eMC product 5504), section 4.2 — quoted in full and NOT truncated. Note that although the fetched SPC is the 100 strength, its own posology section lists the 100, 250 and 500 fluticasone propionate strengths verbatim, and all three are quoted above from that text. Patients 'should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease'; if a patient requires dosages outside the recommended regimen, appropriate doses of beta-2 agonist and/or corticosteroid should be prescribed separately. 'Seretide 50 microgram/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-combination can be used in patients with severe asthma.' Seretide is not intended for the initial management of mild asthma, and must not be used to treat acute asthma symptoms — a fast- and short-acting bronchodilator is required for those and patients should have their reliever inhaler available at all times. Patients should not be initiated on Seretide during an exacerbation or if asthma is significantly worsening or acutely deteriorating. SPECIAL GROUPS (quoted): 'There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Seretide in patients with hepatic impairment.' TRUNCATION: sections 4.4 (warnings) and 4.8 (adverse reactions) in this bundle end at the source-fetch limit, so the warnings and side-effect lists below are partial; the posology used for the dose above is complete. VERBATIM adult quote: 'Adults and adolescents 12 years and older: - One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. or - One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. or - One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.'

Paediatric dose

Dose: Children 4 years and older (asthma): one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. This is the label's own paediatric figure and is NOT weight-based — it must not be scaled by body weight.
Route: Inhalation use via the Accuhaler dry-powder device
Frequency: Twice daily
Max: The maximum licensed dose of fluticasone propionate delivered by Seretide Accuhaler in children is 100 micrograms twice daily.
'There are no data available for use of Seretide in children aged under 4 years.' Growth retardation in children and adolescents is listed as a rare endocrine adverse reaction, and behavioural changes including psychomotor hyperactivity and irritability are reported predominantly in children. Verify any paediatric use against a children's formulary.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances (salmeterol, fluticasone propionate) or to any of the excipients listed in section 6.1

Side effects

  • Candidiasis of the mouth and throat (common); oesophageal candidiasis (rare)
  • Pneumonia in COPD patients (common); bronchitis (common); nasopharyngitis (very common); sinusitis (common)
  • Throat irritation and hoarseness/dysphonia (common)
  • Headache (very common); tremor (uncommon)
  • Hypokalaemia (common); hyperglycaemia (uncommon)
  • Hypersensitivity reactions — cutaneous reactions (uncommon), angioedema mainly facial and oropharyngeal (rare), dyspnoea (uncommon), bronchospasm (rare), anaphylactic reactions including anaphylactic shock (rare)
  • Endocrine (rare): Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density
  • Anxiety and sleep disorders (uncommon); behavioural changes including psychomotor hyperactivity and irritability, predominantly in children (rare); depression and aggression, predominantly in children (not known)
  • Cataract (uncommon), glaucoma (rare), blurred vision (not known)
  • Palpitations and tachycardia (uncommon); cardiac arrhythmias including supraventricular tachycardia and extrasystoles (rare); atrial fibrillation and angina pectoris (uncommon)
  • Paradoxical bronchospasm with an immediate increase in wheezing and shortness of breath after dosing (rare)
  • Contusions (common); muscle cramps, traumatic fractures, arthralgia and myalgia (common)
  • NOTE: section 4.8 in this bundle ends at the source-fetch limit — this list is partial

Monitoring

  • Patients should be regularly reassessed by a doctor so that the strength received remains optimal, and the dose changed only on medical advice
  • Increased requirement for reliever medication, or a decreased response to it, indicates deterioration of control — the patient should be reviewed by a physician
  • Sudden and progressive deterioration in asthma control is potentially life-threatening and requires urgent medical assessment
  • Once symptoms are controlled, consider gradually reducing the dose; regular review of patients as treatment is stepped down is important, using the lowest effective dose
  • NOTE: section 4.4 in this bundle ends at the source-fetch limit — further monitoring requirements may exist beyond the retrieved text

Clinical monograph

How it works

Fluticasone suppresses airway inflammation via glucocorticoid receptor activation, while salmeterol produces sustained bronchodilation through beta-2 adrenoceptor stimulation and airway smooth muscle relaxation.

Prescribing in practice

  • A long-acting beta-2 agonist must never be used without a concomitant inhaled corticosteroid in asthma, which this combination ensures; it is for maintenance and not for relief of acute symptoms.
  • Rinse the mouth after use to reduce oral candidiasis and hoarseness.
  • In COPD, weigh the recognised increased risk of pneumonia associated with inhaled corticosteroid use.

Monitoring

Monitor symptom control, exacerbation frequency, inhaler technique and, in children, growth on long-term therapy.

Counselling the patient

  • Use it regularly as a preventer and keep a separate fast-acting reliever for sudden symptoms.
  • Rinse your mouth and spit out after each dose.
  • Report a persistent cough, fever or worsening breathlessness.

Evidence & guidelines

Combination ICS/LABA inhalers are recommended in asthma and COPD guidance for patients inadequately controlled on inhaled corticosteroid alone.

Reference: GINA Guidelines 2024; NICE NG80; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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