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ICS + LABA inhaler Pregnancy: SPC 4.6 verbatim - Pregnancy: 'A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate. Animal studies have shown reproductive toxicity after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids. Administration of AirFluSal Forspiro to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.' Breast-feeding: 'It is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk... A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue AirFluSal Forspiro therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.' Fertility: 'There are no data in humans. However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility.'

Fluticasone with salmeterol

Brand names: Seretide, AirFluSal, Sereflo, Sirdupla

This inhaler combines the inhaled corticosteroid fluticasone propionate with the long-acting beta2 agonist salmeterol (e.g. Seretide), used as maintenance therapy for 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: One inhalation of AirFluSal Forspiro 50 micrograms salmeterol / 500 micrograms fluticasone propionate per metered dose, twice daily - the same dose for severe asthma (adults aged 18 years and older) and for COPD (adults)
Route: Inhalation use only, via the Forspiro pre-dispensed dry powder inhaler (60 doses, with a dose counter counting down from 60). SPC 4.2 technique: open the protective cap, move the white lever fully over until it clicks and then close it fully to load a dose; breathe out as much as is comfortable away from the mouthpiece, hold the inhaler level with the cap pointing downwards, close the lips firmly around the mouthpiece and breathe in steadily and deeply through the inhaler, not through the nose; hold the breath for 5-10 seconds or as long as is comfortable; then rinse the mouth with water and spit it out.
Frequency: Twice daily, used regularly every day for optimum benefit, even when asymptomatic
STRENGTH: each metered dose of the sourced product contains salmeterol 50 micrograms with fluticasone propionate 500 micrograms - both components of the fixed combination are quantified by the product name. || SPC 4.2 verbatim, ASTHMA: 'Adults - aged 18 years and older: One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.' SPC 4.2 verbatim, COPD: 'Adults: One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.' || SEVERE ASTHMA ONLY, AND NOT FOR INITIATION (SPC 4.2 verbatim): 'AirFluSal Forspiro is only appropriate for use in the treatment of patients with severe asthma. If an individual patient should require dosages outside the recommended regimen, appropriate doses of beta-2 agonist and/or corticosteroid should be prescribed.' 'It should not be used for the treatment of patients with mild or moderate asthma or for the initiation of treatment for patients with severe asthma unless the requirement for such a high dose of the corticosteroid together with a long-acting beta-2 agonist has been established previously. AirFluSal Forspiro is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time. Patients should commence treatment with a fixed-dose combination containing a lower dose of the corticosteroid component and will then be titrated up in respect of the corticosteroid dose until control of asthma is achieved.' || SINGLE STRENGTH - STEP-DOWN REQUIRES A DIFFERENT PRODUCT (SPC 4.2 verbatim): 'AirFluSal Forspiro is available on the market in the strength of 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate per metered dose only... Therefore, when it is appropriate to titrate down to a lower strength not available for AirFluSal Forspiro, a change to an alternative fixed dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.' 'In patients with asthma, the dose should always be titrated to the lowest dose at which effective control of symptoms is maintained.' Once control of asthma is attained, review treatment and consider stepping down to a lower-corticosteroid fixed-dose combination and ultimately to an inhaled corticosteroid alone. || NO MAXIMUM DOSE IS STATED: the retrieved SPC 4.2 gives one inhalation twice daily as the only recommended regimen and states no ceiling (no 'maximum' wording anywhere in the retrieved text), so maxDose is deliberately left empty; note that 4.4 and 4.8 were truncated at the source-fetch limit, so do not treat the retrieved text as the complete posology. || NOT A RELIEVER (SPC 4.4): must not be used to treat acute asthma symptoms, for which a fast and short-acting bronchodilator is required, and patients should have their reliever inhaler available at all times; patients should not be initiated during an exacerbation or if they have significantly worsening or acutely deteriorating asthma. || CESSATION (SPC 4.4): treatment should not be stopped abruptly in patients with asthma because of the risk of exacerbation - therapy should be down-titrated under physician supervision. || ELDERLY (SPC 4.2): 'There is no need to adjust the dose in elderly patients.'

Dose adjustments

Renal

SPC 4.2 verbatim: 'There is no need to adjust the dose in elderly patients or in those with renal impairment.' No dose adjustment is required in renal impairment.

Hepatic

SPC 4.2 verbatim: 'There are no data available on the use of AirFluSal Forspiro in patients with hepatic impairment.' No numeric hepatic dose adjustment is given.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 - the only contraindication in SPC 4.3
  • Not a contraindication but a licensed-age restriction for this product (SPC 4.2, 4.4, verbatim): 'AirFluSal Forspiro is not recommended for use in either children aged 12 years and younger or in adolescents aged 13 to 17 years. The safety and efficacy of AirFluSal Forspiro in children and adolescents aged less than 18 years of age has not been established. No data are available.' This is specific to the AirFluSal Forspiro 50/500 product sourced here, not a statement about every salmeterol/fluticasone combination - verify any paediatric use against a children's formulary
  • Not a contraindication but a severity restriction (SPC 4.4): AirFluSal Forspiro is for use in patients with severe asthma only; it should not be used in patients with mild or mild to moderate asthma, and should not be used as initial maintenance therapy in patients with moderate persistent asthma
  • Not a contraindication but a use restriction (SPC 4.4): it should not be used to treat acute asthma symptoms, for which a fast and short-acting bronchodilator is required
  • Not a contraindication but an initiation bar (SPC 4.4): 'Patients should not be initiated on AirFluSal Forspiro during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.'
  • SPC 4.5 (interactions with other medicinal products) was not retrieved in this bundle - review the SPC directly before assuming there are no interaction-based restrictions

Side effects

  • SPC 4.8: 'As AirFluSal Forspiro contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.'
  • Very common: headache; nasopharyngitis
  • Common: candidiasis of the mouth and throat; pneumonia (in COPD patients); bronchitis; hypokalaemia; throat irritation; hoarseness/dysphonia; sinusitis; contusions; muscle cramps; arthralgia; myalgia; traumatic fractures
  • Uncommon: cutaneous hypersensitivity reactions; respiratory symptoms (dyspnoea); hyperglycaemia; anxiety; sleep disorders; tremor; cataract; palpitations; tachycardia; atrial fibrillation; angina pectoris
  • Rare: oesophageal candidiasis; angioedema (mainly facial and oropharyngeal oedema); respiratory symptoms (bronchospasm); anaphylactic reactions including anaphylactic shock; Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density; behavioural changes including psychomotor hyperactivity and irritability (predominantly in children); glaucoma; cardiac arrhythmias including supraventricular tachycardia and extrasystoles; paradoxical bronchospasm
  • Not known: depression, aggression (predominantly in children); vision, blurred
  • SPC 4.8: 'The pharmacological side effects of beta-2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.'
  • SPC 4.8 note on the table: headache and nasopharyngitis were reported commonly/very commonly in placebo, and pneumonia, bronchitis, hypokalaemia, sinusitis, contusions and traumatic fractures were reported over 3 years in a COPD study
  • Section 4.8 was truncated at the source-fetch limit - the description of selected adverse reactions is incomplete here

Monitoring

  • SPC 4.2: patients should be regularly reassessed by a doctor so that the strength of the salmeterol/fluticasone propionate inhaler they are receiving remains optimal and is only changed on medical advice; in asthma the dose should always be titrated to the lowest dose at which effective control of symptoms is maintained
  • SPC 4.2: correct use of the Forspiro inhaler should be demonstrated to the patient and checked regularly
  • SPC 4.2, 4.4: rinse the mouth with water and spit it out after each dose - this may help prevent oral candidiasis and hoarseness
  • SPC 4.4: increased requirements for reliever medication (short-acting bronchodilators), or a decreased response to reliever medication, indicate deterioration of asthma control and the patient should be reviewed by a physician; sudden and progressive deterioration in control of asthma is potentially life threatening and requires urgent medical assessment
  • SPC 4.4: patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation
  • SPC 4.4: regular review of patients as treatment is stepped down; once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of inhaled corticosteroid, and the lowest effective dose should be used
  • SPC 4.4: in COPD, patients should be instructed to seek medical attention if symptoms deteriorate, since exacerbations typically require systemic corticosteroids
  • SPC 4.8 (rare, class effects to watch for on long-term high-dose inhaled corticosteroid): adrenal suppression, decreased bone mineral density, cataract and glaucoma, and growth retardation in children and adolescents

Clinical monograph

How it works

Fluticasone propionate provides anti-inflammatory corticosteroid action, while salmeterol gives prolonged bronchodilation by stimulating beta2 adrenoceptors; salmeterol has a slow onset and is unsuitable for acute relief.

Prescribing in practice

  • Salmeterol has a slow onset and must never be used to treat an acute asthma attack, and the long-acting beta2 agonist must always be paired with the inhaled corticosteroid.
  • Inhaled corticosteroid use raises pneumonia risk in COPD and can cause oral candidiasis and dysphonia.
  • Beta2 agonist effects include tremor, palpitations and hypokalaemia, warranting caution in cardiovascular disease.

Monitoring

Review symptom control and inhaler technique, monitor for pneumonia in COPD, oral thrush, and growth in children on long-term therapy.

Counselling the patient

  • Use regularly as a preventer; it will not relieve sudden breathlessness.
  • Rinse the mouth after each dose to reduce thrush and hoarseness.
  • Always carry a fast-acting reliever and seek help if symptoms worsen.

Evidence & guidelines

A long-established inhaled corticosteroid/long-acting beta2 agonist combination supported by large asthma and COPD trials and embedded in UK respiratory guidance.

Reference: BTS/SIGN; NICE NG115; 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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