Evigrade

Fluticasone propionate

AEMPS

Inhaled corticosteroids (ICS)

ATC code: R03BA05

Brand names: Advair

Updated · Methodology

Indications

A

Asthma

First line

Asthma controller per 2024. Regular twice-daily dosing. Mild-to-moderate asthma: 100–250 mcg twice daily; severe asthma: up to 500 mcg twice daily. Most patients are optimally treated with a fixed-dose combination with LABA (fluticasone/salmeterol, fluticasone/vilanterol). Children over 4 years: 50–200 mcg twice daily.

ICD-10: J45 · ICD-11: CA23

B

Chronic obstructive pulmonary disease

Individual decision

Per 2024, ICS in COPD is reserved for subgroups with frequent exacerbations or eosinophilia. The TORCH trial with fluticasone/salmeterol showed reduced exacerbations and potentially reduced mortality but raised pneumonia risk. In patients without ICS indications, dual bronchodilation is preferred.

ICS in COPD only with frequent exacerbations or blood eosinophils ≥ 300/μL.

ICD-10: J44 · ICD-11: CA22

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Immune support and respiratory infection care

Not recommended

Fluticasone propionate is an inhaled or nasal corticosteroid. It is prescribed for asthma (inhaled) and allergic rhinitis or nasal polyps (nasal) ( 2024, 2024). In Russia and the CIS, fluticasone propionate is nebulized to children and adults for acute respiratory infections, bronchitis, and laryngitis outside an asthma indication. No clinical studies of nebulization use for colds exist; this practice is dangerous – the drug causes oropharyngeal candidiasis, hoarseness, and with systemic absorption in children HPA axis suppression. If fluticasone propionate was prescribed via nebulizer for a cold, consider seeking a second opinion.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

High-affinity glucocorticoid receptor agonist with pronounced anti-inflammatory activity in the airways. Local potency is 1.5–2 fold higher than budesonide at equivalent doses. Systemic bioavailability after inhalation is below 1 %. Twice-daily dosing. Available as pMDI, DPI, and in fixed combinations with salmeterol (Seretide) and vilanterol (Relvar).

Safety

Contraindications

  • Hypersensitivity
  • Active pulmonary tuberculosis
  • Systemic fungal infections

Serious adverse effects

  • Adrenal suppression at high doses
  • Pneumonia in COPD (ICS class effect)
  • Reduced bone mineral density with long-term use

Common adverse effects

  • Oral candidiasis
  • Dysphonia
  • Throat irritation
  • Post-inhalation cough

Uncommon adverse effects

  • Paradoxical bronchospasm
  • Perioral dermatitis

Pregnancy: can you take Fluticasone propionate?

AEMPS summary of product characteristics (section 4.6): there are no adequate and well-controlled studies of fluticasone propionate in pregnant women. In pregnancy, it should be considered only if the expected benefit for the mother outweighs any potential risk to the fetus. A retrospective observational cohort study found no increased risk of major congenital malformations after first-trimester exposure to fluticasone propionate compared with other inhaled corticosteroids. Animal reproductive studies showed only effects typical of glucocorticoids, at systemic exposures above those seen with the recommended inhaled dose.

Breastfeeding: can you take Fluticasone propionate?

Compatible with breastfeeding.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Use regularly twice daily regardless of symptoms. Rinse the mouth with water and spit after inhalation. Onset is 1–2 weeks, assess at 4–6 weeks. With optimal control for 3 months, recommends step-down to the minimum effective dose.

Device compatibility

Inhaler type matters. Inhaled corticosteroids are delivered via metered-dose inhaler (pMDI), dry powder inhaler (DPI), or jet (compressor) nebulizer. Ultrasonic nebulizers must not be used — ultrasound disrupts the corticosteroid suspension and fails to aerosolize the drug correctly (Boucher RM, Kreuter J. Ann Allergy 1968; manufacturer SmPCs of ICS suspensions). For patients who cannot coordinate inhalation with actuation (children under 5, elderly, severe exacerbations), use a spacer with face mask or a jet nebulizer. With pMDI, a spacer increases lower-airway deposition by 60–80 % and reduces oral candidiasis and dysphonia. After ICS inhalation, rinse the mouth with water and spit — this prevents oral candidiasis.
Label mentions14 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • «Se espera que el tratamiento concomitante con inhibidores de CYP3A, incluyendo medicamentos que contienen cobicistat, aumente el riesgo de reacciones adversas sistémicas. Se debe evitar esa…»

    AEMPS, section 4.5 · Open on CIMA

  • Majorinhibidores del CYP3A4class named in the label
    «Se espera que el tratamiento concomitante con inhibidores de CYP3A, incluyendo medicamentos que contienen cobicistat, aumente el riesgo de reacciones adversas sistémicas. Se debe evitar esa…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • «DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 )»

    FDA, section 7 · Open on DailyMed

  • «En un estudio sobre la interacción del fármaco llevado a cabo en sujetos sanos, se ha demostrado que ritonavir (potente inhibidor del citocromo P450 3A4) puede aumentar de manera considerable las…»

    AEMPS, section 4.5 · Open on CIMA

  • «DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. ( 7.1 )»

    FDA, section 7 · Open on DailyMed

  • «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • ModerateCYP3A4 inhibitorsclass named in the label
    «Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole…»

    FDA, section 7 · Open on DailyMed

  • ModerateKetoconazole
    «En varios estudios realizados se ha demostrado que otros inhibidores del citocromo P450 3A4 producen incrementos insignificantes (eritromicina) y menores (ketoconazol) de la exposición sistémica al…»

    AEMPS, section 4.5 · Open on CIMA

  • «En varios estudios realizados se ha demostrado que otros inhibidores del citocromo P450 3A4 producen incrementos insignificantes (eritromicina) y menores (ketoconazol) de la exposición sistémica al…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Established and Other Potentially Significant Drug Interactions: Atazanavir with ritonavir ↑ fluticasone With concomitant use of fluticasone propionate and atazanavir with ritonavir systemic…»

    FDA, section 7 · Open on DailyMed

  • «Esteroides: Pulverizador nasal acuoso de fluticasona propionato»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Fluticasone propionate used for?

Fluticasone propionate is evaluated for the following indications with varying evidence strength: Asthma (evidence tier A), Chronic obstructive pulmonary disease (evidence tier B), Immune support and respiratory infection care (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Fluticasone propionate?

Common side effects of Fluticasone propionate (≥ 1 in 100): Oral candidiasis, Dysphonia, Throat irritation, Post-inhalation cough. See the Safety section for uncommon and serious reactions.

Is Fluticasone propionate safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are no adequate and well-controlled studies of fluticasone propionate in pregnant women. In pregnancy, it should be considered only if the expected benefit for the mother outweighs any potential risk to the fetus. A retrospective observational cohort study found no increased risk of major congenital malformations after first-trimester exposure to fluticasone propionate compared with other inhaled corticosteroids. Animal reproductive studies showed only effects typical of glucocorticoids, at systemic exposures above those seen with the recommended inhaled dose.

Is Fluticasone propionate compatible with breastfeeding?

Compatible with breastfeeding.

Who should not take Fluticasone propionate?

Fluticasone propionate is contraindicated in: Hypersensitivity; Active pulmonary tuberculosis; Systemic fungal infections. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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