Salbutamol
Regulatory sources consulted
- ANSM RCP for VENTOLINE 0,5 mg/1 ml
- AEMPS CIMA FT for SALBUAIR 2.5 mg
- PubMed PMID:39761907 ↗
- PubMed PMID:36430683 ↗
- PubMed PMID:36765418 ↗
- PubMed PMID:38994695 ↗
- PubMed PMID:37675792 ↗
- CredibleMeds.org
- AEMPS CIMA · nº registro 73563 ↗
- ANSM BDPM · CIS 69077942 ↗
Approved indications
- Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease (asthma, COPD).
- Prevention of exercise-induced bronchospasm.
- Treatment of acute hyperkalemia. · off-label
Contraindications
Absolute
- Hypersensitivity to salbutamol or any of the excipients.
Clinical warnings
- Major warning · Cardiovascular effects: May cause tachycardia, increased blood pressure, and myocardial ischemia. Use with caution in patients with cardiovascular disease. — ANSM
- Major warning · Hypokalemia: High doses can cause potentially serious hypokalemia, especially with concomitant use of other hypokalemic drugs (diuretics, corticosteroids). — ANSM
- Major warning · Paradoxical bronchospasm: An acute bronchospasm may occur immediately after inhalation, which can be life-threatening. If it occurs, discontinue immediately and use an alternative bronchodilator. — Clinical Practice
- Lactic acidosis: Very rare cases have been reported with high doses (IV or nebulized), mainly in acute asthma exacerbations. — ANSM
Drug interactions
- HighPropranololC07AA05
Mechanism: Pharmacodynamic antagonism. Non-selective beta-blockers antagonize the bronchodilator effect of salbutamol and can induce severe bronchospasm.
Recommendation: Avoid concomitant use. If a beta-blocker is necessary, use a cardioselective one (e.g., metoprolol, atenolol) with extreme caution.
ANSM RCP
- ModerateHydrochlorothiazideC03AA03
Mechanism: Additive hypokalemic effect. Concomitant use with non-potassium-sparing diuretics can increase the risk of hypokalemia and arrhythmias.
Recommendation: Monitor serum potassium levels, especially with high doses or frequent use of salbutamol.
ANSM RCP
- HighHalothaneN01AB01
Mechanism: Increased cardiac reactivity and sensitization of the myocardium to the effects of catecholamines, with risk of serious ventricular arrhythmias.
Recommendation: Salbutamol treatment is discouraged during halothane anesthesia.
ANSM RCP
Adverse events
Common (≥1%)
tremor · headache · tachycardia · palpitations · muscle cramps
Rare but serious
myocardial ischemia · severe hypokalemia · lactic acidosis · severe hypersensitivity reactions (anaphylaxis, angioedema) · cardiac arrhythmias
Pregnancy and lactation
FDA category: C
Pregnancy: Considered safe during pregnancy due to extensive clinical experience. May cause transient fetal tachycardia. Lactation: Excreted in breast milk; an effect on the infant is unlikely at therapeutic inhaled doses.
Recent literature (PubMed)
Revisión sistemática y metaanálisis que evalúa las intervenciones para la hiperpotasemia aguda. Concluye que el salbutamol (inhalado o IV) es eficaz, reduciendo el potasio sérico en 0.7-1.2 mmol/L, apoyando su uso off-label para esta indicación potencialmente mortal.
Revisión exhaustiva sobre el salbutamol en el manejo del asma. Detalla su mecanismo de acción como relajante del músculo liso bronquial y revisa los perfiles farmacocinéticos, eficacia y efectos adversos de sus diferentes formulaciones (oral, IV, inhalada).
Guía de práctica clínica italiana actualizada para el manejo de la bronquiolitis en lactantes. Refuerza que el tratamiento es de soporte y desaconseja el uso de salbutamol, ya que la evidencia no muestra beneficios y sí potenciales daños.
Revisión sobre miopatías relacionadas con RYR1. Menciona que el salbutamol ha sido explorado como una terapia potencial para estas condiciones, pero su eficacia no ha sido probada de manera concluyente.
Artículo de revisión sobre el uso de terapia inhalada, incluyendo salbutamol, para el tratamiento de enfermedades inflamatorias de las vías respiratorias en gatos (asma felina). Relevancia limitada para la práctica clínica humana.