Interacción de Budesonida y formoterol con Fluticasona y salmeterol
Budesonida y formoterol con Fluticasona y salmeterol: ambas etiquetas de prescripción advierten sobre esta combinación con el lenguaje más contundente, como una contraindicación, una advertencia en recuadro o la indicación de evitarla.
No combinar sin la orientación de un prescriptor. El lenguaje de la etiqueta que aparece a continuación es el más contundente que usa la FDA.
Qué dicen las etiquetas de la FDA
De la etiqueta de Fluticasona y salmeterol (Fluticasone Propionate and Salmeterol) · vigente desde 2025-08-21
Avoid Excessive Use of Fluticasone Propionate/Salmeterol and Avoid Use with Other Long-Acting Beta 2 -Agonists Fluticasone Propionate/Salmeterol MDPI should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result.
In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of Fluticasone Propionate/Salmeterol MDPI with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids.
Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol to budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol to mometasone furoate.
Patients using Fluticasone Propionate/Salmeterol MDPI should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting.
De la etiqueta de Budesonida y formoterol (Budesonide and Formoterol Fumarate Dihydrate) · vigente desde 2026-04-24
Serious Asthma-Related Events – Hospitalizations, Intubations and Death Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART) ].
…intubation (endotracheal) 1 2 Asthma-related hospitalization (≥24-hour stay) 115 105 ICS = Inhaled Corticosteroid, LABA = Long-acting Beta2-adrenergic Agonist The pediatric safety trial included 6208 pediatric patients 4 to 11 years of age who received ICS/LABA (fluticasone propionate /salmeterol inhalation powder) or ICS (fluticasone propionate inhalation powder).
Salmeterol Multicenter Asthma Research Trial (SMART) A 28-week, placebo-controlled U.S. trial that compared the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; relative…
Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose.
In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of budesonide and formoterol fumarate dihydrate with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids.
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