ICS + LABA inhaler Pregnancy: §4.6: limited data in pregnant women; animal studies have shown reproductive toxicity. 'Administration of Flutiform inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus' — if used, the lowest effective dose to maintain asthma control should be used. Use in labour should be restricted to patients in whom benefit outweighs risk, because of potential beta-agonist interference with uterine contractility. Breastfeeding: excretion in human milk unknown, a risk to the suckling child cannot be excluded — decide whether to discontinue breastfeeding or the medicinal product.

Fluticasone with formoterol

Brand names: Flutiform

Used in: Asthma

This inhaler combines the inhaled corticosteroid fluticasone propionate with the rapid-onset long-acting beta2 agonist formoterol (e.g. Flutiform), used as regular maintenance treatment of asthma.

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: Two inhalations (puffs) of the strength containing the fluticasone propionate dosage appropriate to the severity of disease — Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram or 250 microgram/10 microgram per actuation

Route: Inhalation — press-and-breathe pressurised metered dose inhaler (pMDI). A spacer (AeroChamber Plus Flow-Vu is the recommended device) is advised for patients who find it difficult to synchronise actuation with inspiration; re-titration to the lowest effective dose should always follow introduction of a spacer

Frequency: Twice daily, normally taken in the morning and in the evening

Max: Flutiform 250 microgram/10 microgram per actuation — two inhalations twice daily. §4.2: 'This highest strength is for use in adults only; it should not be used in adolescents and children.'

SOURCE: eMC UK SPC, productName 'Flutiform 125 microgram/5 microgram per actuation pressurised inhalation, suspension' (https://www.medicines.org.uk/emc/product/7649/smpc), §4.2 — the posology section retrieved covers all three strengths. STRENGTH BY AGE (verbatim): 50/5 — 'Recommended dose for adults, adolescents and children aged 5 years and above: Flutiform 50 microgram/5 microgram inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening.' 125/5 — 'Recommended dose for adults and adolescents aged 12 years and above: ... two inhalations (puffs) twice daily'; 'This strength should not be used in children under the age of 12 years.' 250/10 — 'Recommended dose for adults: ... two inhalations (puffs) twice daily'; not for adolescents or children. TITRATION: 'As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained.' Once control is achieved with the lowest strength twice daily, consider stepping down to an inhaled corticosteroid alone. STARTING DOSE: 'For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is two inhalations twice daily of Flutiform 125 microgram /5 microgram inhaler.' INDICATION LIMIT: 'There are no data available for use of Flutiform inhaler in patients with COPD. Flutiform inhaler should not be used in patients with COPD.' Also not intended for initial treatment of mild asthma, and Flutiform 50/5 'is not appropriate in adults and adolescents with severe asthma'. PAEDIATRIC: no per-kg dose is stated, hence paedDose is null; children 5 years and above may use the 50/5 strength only; 'Flutiform inhaler in any strength is not recommended for use in children less than 5 years of age'. ELDERLY: 'There is no need to adjust the dose in elderly patients.' ADMINISTRATION: prime with 4 actuations before first use, if unused for 3 days or more, or after freezing/refrigeration; shake immediately before each actuation; rinse mouth/gargle and spit after inhaling to minimise oral candidiasis or dysphonia; do not use after the dose indicator reads 0. SECTIONS NOT RETRIEVED: §4.5 (interactions) was not included in the fetched bundle, so no interaction list is given here — clinician to review the SPC. §4.4 and §4.8 were truncated at the fetch limit.

Dose adjustments

Renal

§4.2: 'There are no data available for use of Flutiform inhaler in patients with hepatic or renal impairment ... These patients should be regularly monitored by a physician to ensure titration to the lowest dose at which effective control of symptoms is maintained.' Increased exposure can be expected in severe hepatic impairment. No numeric adjustment is stated.

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 (§4.3)
Not for acute asthma symptoms — a fast and short-acting bronchodilator is required for these; patients must have reliever medication available at all times (§4.4)
Do not initiate during an exacerbation, or in significantly worsening or acutely deteriorating asthma (§4.4)
Should not be used in patients with COPD — no data available (§4.2)

Side effects

Sleep disorders including insomnia; headache, tremor, dizziness (uncommon)
Palpitations and ventricular extrasystoles (uncommon); angina pectoris, tachycardia, hypertension (rare)
Exacerbation of asthma, dysphonia, throat irritation (uncommon); dyspnoea and cough (rare)
Oral candidiasis, oral fungal infections and sinusitis (rare); dry mouth (uncommon)
Paradoxical bronchospasm (immediate increase in wheezing and shortness of breath after dosing) — treat straight away with a rapid-acting inhaled bronchodilator, discontinue and reassess
Class effects of the fluticasone component: hypersensitivity reactions (urticaria, pruritus, angio-oedema, anaphylaxis) and systemic corticosteroid effects at high doses over prolonged periods — Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract and glaucoma

Clinical monograph

How it works

Fluticasone propionate reduces airway inflammation via glucocorticoid receptor activation, while formoterol produces both rapid-onset and sustained bronchodilation through beta2 adrenoceptor stimulation.

Prescribing in practice

The long-acting beta2 agonist component must only be used together with the inhaled corticosteroid and not as sole asthma therapy, as long-acting beta2 agonist monotherapy increases the risk of severe asthma events.
Local effects include oral candidiasis and hoarseness, mitigated by mouth rinsing after use.
Systemic beta2 agonist effects include tremor, palpitations and hypokalaemia, with caution in cardiac disease and concurrent QT-prolonging drugs.

Monitoring

Monitor asthma control, inhaler technique, and in long-term use growth in children and signs of systemic corticosteroid exposure.

Counselling the patient

Take regularly every day even when feeling well.
Rinse and spit after inhaling to prevent thrush.
Keep a separate reliever inhaler for acute symptoms.

Evidence & guidelines

A recognised inhaled corticosteroid/long-acting beta2 agonist asthma combination supported by trial data and consistent with NICE and BTS/SIGN asthma management.

Reference: BTS/SIGN; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Fluticasone with salmeterol · ICS + LABA inhaler

Pathways