Flixotide

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Flixotide on Prescriptsy

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Flixotide is a prescription-only inhaled corticosteroid (ICS) used as regular maintenance treatment for asthma.

It contains fluticasone propionate, one of the most potent and widely prescribed inhaled corticosteroids available in the United Kingdom.

Flixotide is manufactured by GlaxoSmithKline and is available as a metered-dose inhaler (MDI, also known as an Evohaler), Accuhaler (dry powder inhaler), and nebules for specialist use.

It is used daily to reduce inflammation in the airways, prevent asthma symptoms, and reduce the risk of asthma attacks.

Asthma is a chronic inflammatory condition of the airways that affects approximately 5.4 million people in the United Kingdom, including 1.1 million children.

It is characterised by reversible airway obstruction, bronchial hyperresponsiveness, and underlying inflammation.

Common symptoms include wheezing, breathlessness, chest tightness, and coughing, which are often worse at night or in the early morning and are triggered by exercise, allergens, cold air, or respiratory infections.

Without regular preventer treatment, airway inflammation persists, leading to progressive structural changes in the airway walls known as airway remodelling.

This page provides a comprehensive clinical overview of Flixotide, including its mechanism of action, dosing, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Flixotide

• Flixotide is a preventer inhaler and must be used every day, even when you feel well.
• It does not relieve acute asthma symptoms. Always carry a separate reliever inhaler (such as salbutamol).
• Rinse your mouth with water and spit after each dose to reduce the risk of oral thrush and hoarseness.
• Do not stop Flixotide suddenly without medical advice, particularly after prolonged or high-dose use.
• Flixotide is a prescription-only medicine (POM) in the UK.

Understanding asthma and the role of inhaled corticosteroids

Asthma involves chronic inflammation of the bronchial airways, driven primarily by eosinophils, mast cells, T-helper lymphocytes, and their inflammatory mediators.

When the airways are inflamed, their inner lining swells, excess mucus is produced, and the surrounding smooth muscle contracts, causing the characteristic narrowing that produces symptoms.

Even when a person with asthma feels well, underlying inflammation is usually present.

Without treatment, this low-grade inflammation can cause structural changes (thickening of the airway walls, subepithelial fibrosis, smooth muscle hypertrophy) that lead to fixed airflow obstruction over time.

Inhaled corticosteroids are the cornerstone of asthma management.

The British Thoracic Society and Scottish Intercollegiate Guidelines Network (BTS/SIGN) guidelines and the NICE guideline NG80 recommend ICS therapy for all patients who require a reliever inhaler more than twice a week, who wake at night due to asthma symptoms, or who have had an asthma exacerbation in the preceding two years.

ICS therapy suppresses airway inflammation, reduces bronchial hyperresponsiveness, improves lung function, and significantly reduces the risk of severe asthma attacks and asthma-related hospital admissions.

How Flixotide works: mechanism of action

Fluticasone propionate, the active substance in Flixotide, is a synthetic trifluorinated glucocorticoid.

It crosses the cell membrane and binds to the glucocorticoid receptor in the cytoplasm of airway epithelial cells, inflammatory cells, and smooth muscle cells.

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

It upregulates the expression of anti-inflammatory proteins (including lipocortin-1, which inhibits phospholipase A2 and thereby reduces the production of prostaglandins and leukotrienes) and suppresses the transcription of pro-inflammatory genes encoding cytokines (such as interleukins 1, 3, 4, 5, 6, 8, and 13), chemokines, adhesion molecules, and inflammatory enzymes (including cyclooxygenase-2 and inducible nitric oxide synthase).

Fluticasone propionate has the highest relative glucocorticoid receptor binding affinity of the commonly used ICS (approximately 1800 relative to dexamethasone at 100), which explains its high potency on a microgram-per-microgram basis.

Despite this potency, its systemic exposure is very low.

When delivered via MDI, approximately 10 to 30% of the dose reaches the lungs (more with a spacer), while the remainder is deposited in the oropharynx and swallowed.

The swallowed fraction undergoes near-complete first-pass hepatic metabolism by CYP3A4, resulting in oral bioavailability of less than 1%.

The absorbed fraction from the lungs is also metabolised efficiently, giving fluticasone propionate a favourable therapeutic index (high local anti-inflammatory effect with minimal systemic adverse effects at recommended doses).

Clinical evidence supporting Flixotide

Fluticasone propionate has been extensively studied in randomised controlled trials involving tens of thousands of patients.

The START trial demonstrated that early introduction of low-dose inhaled budesonide (a comparator ICS) in patients with recent-onset mild asthma significantly reduced the risk of severe exacerbations, supporting the principle that early ICS use prevents disease progression.

Head-to-head comparisons have shown that fluticasone propionate provides equivalent or superior asthma control at approximately half the microgram dose of beclometasone dipropionate and budesonide, owing to its higher receptor binding affinity and potency.

The GOAL (Gaining Optimal Asthma Control) study showed that the addition of salmeterol to fluticasone propionate achieved guideline-defined well-controlled asthma in a significantly greater proportion of patients than increasing the dose of fluticasone alone, establishing the evidence base for the step-up to ICS/LABA combination therapy (such as Seretide).

Flixotide remains an appropriate choice for patients whose asthma is well controlled on an ICS alone and who do not require a LABA.

UK prescribing guidance for Flixotide

BTS/SIGN guideline (2019, updated regularly) and NICE NG80 recommend a stepwise approach to asthma management. At Step 1, short-acting beta-2 agonist (SABA) reliever therapy is used alone.

At Step 2, a regular low-dose ICS is added. At Step 3, options include adding a LABA, increasing the ICS dose, or adding a leukotriene receptor antagonist.

Higher steps involve higher-dose ICS, additional controllers, and specialist referral.

Flixotide is listed in the British National Formulary (BNF) as a suitable ICS at Steps 2 and 3. The BNF categorises ICS doses as low, medium, and high.

For fluticasone propionate via MDI, low dose is 100 to 250 micrograms per day, medium is 250 to 500 micrograms per day, and high is 500 to 1000 micrograms per day (adults).

Prescribers are advised to start at an appropriate dose for the severity of asthma and to step down the dose once asthma has been well controlled for at least three months.

NICE NG80 emphasises the importance of checking inhaler technique and adherence before escalating therapy. Poor inhaler technique is one of the most common reasons for apparent treatment failure.

Regular asthma reviews (at least annually) should include assessment of symptom control using a validated tool such as the Asthma Control Test (ACT), review of inhaler technique, assessment of trigger avoidance, and review of the written personalised asthma action plan.

Flixotide compared with other inhaled corticosteroids

Several ICS preparations are available in the UK, including beclometasone dipropionate (Clenil Modulite, Qvar), budesonide (Pulmicort), fluticasone propionate (Flixotide), fluticasone furoate (Relvar Ellipta, in combination with vilanterol), mometasone furoate (Asmanex Twisthaler), and ciclesonide (Alvesco).

Each has different pharmacokinetic properties, delivery devices, and cost profiles.

Fluticasone propionate is approximately twice as potent as beclometasone dipropionate (CFC-free formulation) and budesonide on a microgram basis.

This means that 100 micrograms of fluticasone provides approximately equivalent anti-inflammatory activity to 200 micrograms of beclometasone or budesonide.

When switching between ICS products, dose equivalence tables in the BNF should be consulted to avoid under- or over-dosing.

Beclometasone dipropionate is the most commonly prescribed ICS in UK primary care and is generally the first choice due to its extensive evidence base and low cost.

Flixotide may be preferred when a more potent ICS is needed or when a particular inhaler device (Accuhaler) better suits the patient.

Dosage and administration

Flixotide is available in several strengths and formulations. The Evohaler (MDI) comes in 50, 125, and 250 micrograms per actuation.

The Accuhaler (dry powder inhaler) comes in 50, 100, 250, and 500 micrograms per blister.

Nebules are available at 250 micrograms per mL and 1000 micrograms per mL for specialist use.

For adults with mild asthma, the usual starting dose is 100 to 250 micrograms twice daily. For moderate asthma, 250 to 500 micrograms twice daily is typical.

For severe asthma, doses of 500 to 1000 micrograms twice daily may be required. These doses apply to both the MDI and Accuhaler formulations.

The maximum recommended dose is 1000 micrograms twice daily.

For children aged 4 to 15 years, the usual dose is 50 to 100 micrograms twice daily, with a maximum of 200 micrograms twice daily.

Children should use a spacer with the MDI to improve drug delivery and reduce oral deposition.

Children under 4 years may use Flixotide nebules (0.5 to 1 mg twice daily) under specialist paediatric respiratory supervision.

The inhaler should be used at the same times each day (morning and evening) for consistent coverage.

After each inhalation, rinse the mouth thoroughly with water and spit it out. This simple step substantially reduces the risk of oral candidiasis and dysphonia.

The MDI should be primed (test-fired) before first use or if it has not been used for a week or more.

Side effects of Flixotide

Common local side effects

Oral thrush (oropharyngeal candidiasis) is the most characteristic side effect of ICS therapy.

It affects up to 1 in 10 users and is more likely at higher doses and in patients who do not rinse their mouth after inhalation.

Symptoms include white patches on the tongue and inner cheeks, soreness, and an unpleasant taste. Treatment involves an oral antifungal such as miconazole gel or nystatin suspension.

Using a spacer device and mouth rinsing are effective preventive measures.

Dysphonia (hoarseness) affects up to 1 in 10 users and is caused by local corticosteroid-induced myopathy of the laryngeal adductor muscles.

It is dose-dependent and reversible on dose reduction or discontinuation. Throat irritation, cough on inhalation, and pharyngitis are also commonly reported.

Uncommon and rare systemic side effects

At standard recommended doses, systemic absorption of fluticasone propionate is minimal, and systemic side effects are rare.

At high doses used over prolonged periods, the following systemic effects may occur.

Adrenal suppression results from the hypothalamic-pituitary-adrenal (HPA) axis being suppressed by exogenous corticosteroid, reducing the body's ability to produce cortisol in response to stress.

This is more likely when high-dose ICS is combined with other corticosteroid sources (nasal sprays, skin creams, oral courses).

Bone mineral density reduction has been observed with long-term high-dose ICS use. Patients at risk of osteoporosis (postmenopausal women, elderly patients) should discuss bone protection with their prescriber.

Growth retardation in children may occur; linear growth should be monitored annually.

Posterior subcapsular cataracts and glaucoma have been reported rarely with long-term high-dose use; eye examinations should be considered for patients on prolonged high doses.

Paradoxical bronchospasm (sudden wheezing and breathlessness immediately after inhalation) is rare but requires immediate discontinuation of the inhaler and use of a reliever inhaler.

Hypersensitivity reactions (rash, urticaria, angioedema) are very rare. Psychiatric effects including sleep disturbances, anxiety, behavioural changes, depression, and psychomotor hyperactivity have been reported rarely, particularly in children.

When to seek urgent help

Call 999 or go to A&E if you develop severe breathing difficulty, swelling of the face, lips, tongue or throat, or signs of an adrenal crisis (severe weakness, nausea, vomiting, collapse) after stopping or reducing high-dose corticosteroids.

Call NHS 111 if you develop persistent oral thrush unresponsive to treatment, worsening asthma symptoms despite regular preventer use, or voice changes that affect your daily life.

Report suspected adverse reactions via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Adrenal suppression and steroid dependency

Patients being transferred from oral corticosteroids to Flixotide require careful supervision.

Oral steroid dose reduction should be gradual (no faster than 1 mg prednisolone per week), and patients should carry a steroid treatment card.

During periods of stress, infection, or surgery, supplementary systemic corticosteroids may be needed.

Symptoms of adrenal insufficiency include fatigue, malaise, nausea, muscle weakness, and hypotension; if suspected, urgent medical assessment with a morning cortisol level and Synacthen test is required.

Drug interactions

Ritonavir and cobicistat are potent CYP3A4 inhibitors that dramatically increase systemic fluticasone exposure. Co-administration has caused iatrogenic Cushing syndrome and secondary adrenal insufficiency. This combination should be avoided.

Other CYP3A4 inhibitors (ketoconazole, itraconazole) increase systemic fluticasone levels and should be used with caution.

Pregnancy and breastfeeding

Asthma should be actively managed during pregnancy, and BTS/SIGN guidelines advise that inhaled corticosteroids should not be discontinued.

Poorly controlled asthma poses a greater risk to mother and baby (pre-eclampsia, low birth weight, preterm delivery) than the medication.

Beclometasone and budesonide have the most pregnancy safety data among ICS; however, fluticasone propionate is considered acceptable if asthma was well controlled on it before pregnancy.

Small amounts of fluticasone may pass into breast milk, but at therapeutic inhaled doses, clinically significant effects on the infant are unlikely.

How to get Flixotide in the UK

Flixotide is a prescription-only medicine available on the NHS.

Your GP, practice nurse with prescribing qualifications, or hospital respiratory specialist can prescribe it following a clinical assessment of your asthma.

This assessment will typically include a detailed symptom history, lung function testing (peak flow or spirometry), and a review of your current asthma management.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) can also prescribe Flixotide after a suitable clinical consultation.

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

Living with asthma: optimising your preventer inhaler

Getting the best from Flixotide requires correct inhaler technique, consistent daily use, and regular asthma reviews.

Studies consistently show that up to 90% of patients make at least one error with their inhaler technique, which reduces drug delivery to the lungs and increases side effects.

Ask your GP, pharmacist, or asthma nurse to check your technique at every opportunity.

Using a spacer device with the MDI is strongly recommended for all patients, as it slows the aerosol speed, allows more time for inhalation, and reduces the proportion of drug deposited in the mouth and throat.

Adherence is another critical factor. Many patients reduce or stop their preventer inhaler when they feel well, not realising that the underlying inflammation returns within days of stopping.

An asthma action plan helps you understand what to do when symptoms change, including when to increase your preventer dose temporarily and when to seek urgent care.

Avoiding known triggers, staying up to date with annual influenza and pneumococcal vaccinations, maintaining a healthy weight, and not smoking all contribute to better asthma control alongside regular Flixotide use.

Sources

• Flixotide Evohaler, Summary of Product Characteristics (EMC)
• Fluticasone propionate, British National Formulary (BNF)
• BTS/SIGN Guideline on the Management of Asthma
• NICE NG80: Asthma: diagnosis, monitoring and chronic asthma management
• Asthma, NHS
• MHRA Yellow Card Scheme