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Beclomethasone dipropionate

AEMPS

Inhaled corticosteroids (ICS)

ATC code: R03BA01

Brand names: Qvar, Clenil Modulite

Updated · Methodology

Indications

A

Asthma

First line

Asthma controller per 2024. Starting dose 100–250 mcg twice daily, up to 500 mcg twice daily in severe asthma. Extra-fine HFA formulations (Qvar, Clenil) are considered equivalent to twice the dose of conventional CFC beclomethasone – important when converting and switching brands. Used as monotherapy or combined with formoterol.

Sources

  1. GINA: Global Strategy for Asthma Management and Prevention (2024)
  2. Cochrane Database of Systematic Reviews: Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma (2021)
  3. Cochrane Database of Systematic Reviews: Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children (2013)

ICD-10: J45 · ICD-11: CA23

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

Beclomethasone is an inhaled or nasal corticosteroid. It is prescribed for asthma (inhaled) and allergic rhinitis (nasal). In Russia and the CIS, beclomethasone is regularly nebulized to adults and children for acute respiratory infections outside an asthma indication. No clinical studies of nebulization use for colds exist. The drug causes oropharyngeal candidiasis, hoarseness, and with systemic absorption at high doses adrenal suppression. If beclomethasone was prescribed via nebulizer for a cold, consider seeking a second opinion.

Sources

  1. Cochrane Database of Systematic Reviews: Corticosteroids for the common cold (2015)
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

Prodrug converted to active beclomethasone 17-monopropionate with high glucocorticoid receptor affinity. Suppresses airway inflammation by inhibiting transcription of pro-inflammatory cytokines. Modern extra-fine formulations (Qvar, Clenil Modulite) provide small-airway deposition, important in asthma with distal obstruction. Systemic bioavailability after inhalation 1–2 %.

Safety

Contraindications

  • Hypersensitivity
  • Active pulmonary tuberculosis
  • Systemic fungal infections

Serious adverse effects

  • Adrenal suppression at high doses
  • Slowed growth in children (about 0.5–1 cm in the first year)

Common adverse effects

  • Oral candidiasis
  • Dysphonia
  • Throat irritation

Pregnancy: can you take Beclomethasone dipropionate?

AEMPS summary of product characteristics (section 4.6): there are not enough data on the safety of beclomethasone dipropionate or the propellant norflurane (HFA 134a) in human pregnancy. In animal reproduction studies, the adverse effects typical of potent corticosteroids appear only at high systemic exposure, and direct inhalation keeps systemic exposure minimal. Animal studies of HFA 134a found no clinically relevant effects on reproductive function or embryofetal development. Beclomethasone is used in pregnancy only if the expected benefit for the mother outweighs any possible risk to the fetus.

Breastfeeding: can you take Beclomethasone dipropionate?

Compatible with breastfeeding.

Calculate RIDFull profile on NIH LactMed ↗

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. Effect develops over 1–2 weeks, peaking at 4–6 weeks. Rinse the mouth with water after each inhalation.

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 mentions5 mentions

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

From this drug’s label

  • ModerateCobicistat
    «La beclometasona es menos dependiente del metabolismo por CYP3A que algunos otros corticosteroides y, por lo general, las interacciones son poco probables; no obstante, no puede descartarse la…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinhibidores del CYP3A4class named in the label
    «La beclometasona es menos dependiente del metabolismo por CYP3A que algunos otros corticosteroides y, por lo general, las interacciones son poco probables; no obstante, no puede descartarse la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRitonavir
    «La beclometasona es menos dependiente del metabolismo por CYP3A que algunos otros corticosteroides y, por lo general, las interacciones son poco probables; no obstante, no puede descartarse la…»

    AEMPS, section 4.5 · Open on CIMA

  • Disulfiram
    «Becloforte contiene una pequeña cantidad de etanol. Existe un teórico potencial de interacción en pacientes particularmente sensibles que estén tomando disulfiram o metronidazol.»

    AEMPS, section 4.5 · Open on CIMA

  • Metronidazole
    «Becloforte contiene una pequeña cantidad de etanol. Existe un teórico potencial de interacción en pacientes particularmente sensibles que estén tomando disulfiram o metronidazol.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Beclomethasone dipropionate used for?

Beclomethasone dipropionate is evaluated for the following indications with varying evidence strength: Asthma (evidence tier A), 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 Beclomethasone dipropionate?

Common side effects of Beclomethasone dipropionate (≥ 1 in 100): Oral candidiasis, Dysphonia, Throat irritation. See the Safety section for uncommon and serious reactions.

Is Beclomethasone dipropionate safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are not enough data on the safety of beclomethasone dipropionate or the propellant norflurane (HFA 134a) in human pregnancy. In animal reproduction studies, the adverse effects typical of potent corticosteroids appear only at high systemic exposure, and direct inhalation keeps systemic exposure minimal. Animal studies of HFA 134a found no clinically relevant effects on reproductive function or embryofetal development. Beclomethasone is used in pregnancy only if the expected benefit for the mother outweighs any possible risk to the fetus.

Is Beclomethasone dipropionate compatible with breastfeeding?

Compatible with breastfeeding.

Who should not take Beclomethasone dipropionate?

Beclomethasone dipropionate 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.

Other drugs in this group

Budesonide, Budesonide/formoterol, Fluticasone, Fluticasone propionate, Ipratropium bromide, Roflumilast, Salmeterol + Fluticasone, Formoterol