Levosalbutamol Safety in 6-Month-Old Infants
Levosalbutamol is safe to use in 6-month-old infants when administered via nebulization, with FDA approval and clinical trial data supporting its use in children as young as 2 years, though it should be used with caution in infants under 2 years due to limited data. 1
Clinical Context and Indication
The safety and appropriateness of levosalbutamol in a 6-month-old depends critically on the underlying diagnosis:
For Bronchiolitis (Most Common at 6 Months)
Bronchodilators including levosalbutamol are NOT recommended for routine use in bronchiolitis, as the American Academy of Pediatrics issued a strong recommendation against their use based on overall ineffectiveness and lack of benefit on meaningful clinical outcomes. 2
The 2014 AAP bronchiolitis guideline specifically removed the option of a "trial of bronchodilators" that existed in prior versions, given stronger evidence demonstrating no benefit and no validated method to identify responders. 2
Studies using pulmonary function tests show no effect of albuterol (and by extension levosalbutamol) among infants hospitalized with bronchiolitis, and one critical care study showed only small decreases in inspiratory resistance accompanied by clinically significant tachycardia. 2
The only exception is rescue treatment of rapidly deteriorating patients, where clinical judgment may override the guideline recommendation. 2
For Asthma or Reactive Airway Disease
If the 6-month-old has confirmed reactive airway disease or asthma (not bronchiolitis), levosalbutamol can be used safely via nebulization. 1
The recommended dose is 0.31 mg/3 mL every 4-6 hours as needed for children under 5 years, though this should be used with caution in infants under 2 years due to limited data. 1
For acute exacerbations, the dose can be administered every 20 minutes for 3 doses, then every 1-4 hours as needed. 1
Dosing and Administration
Nebulized Levosalbutamol (If Indicated)
Dose: 0.31 mg/3 mL every 4-6 hours as needed for routine bronchospasm in children under 5 years. 1
Levosalbutamol is administered at half the dose of racemic albuterol (which would be 0.63 mg for this age group). 1, 3
Always dilute to a minimum of 3 mL and use oxygen as the preferred gas source at 6-8 L/min flow rate. 3
Safety Monitoring
Monitor for common beta-agonist side effects including tachycardia, skeletal muscle tremor, hypokalemia, headache, and hyperglycemia. 1
Levosalbutamol causes less tachycardia and fewer cardiac side effects compared to racemic salbutamol, making it theoretically safer in young infants when bronchodilator therapy is truly indicated. 4, 5
A 1991 study in infants with median age 6 months (range 1-21 months) demonstrated that nebulized salbutamol was safe, with only a small increase in heart rate (159 vs 151 bpm) after two treatments. 6
Critical Clinical Pearls
The most common pitfall is using bronchodilators for viral bronchiolitis in infants, where they provide no benefit and expose the child to unnecessary side effects and costs. 2
Oral levosalbutamol syrup should never be used in a 6-month-old, as inhaled formulations provide superior bronchodilation with fewer systemic adverse effects. 7
A 2008 study specifically showed that oral salbutamol provided no symptomatic relief in mild bronchiolitis and caused tremors in some infants. 8
Increasing use or lack of expected effect indicates the need for medical re-evaluation, as this suggests either incorrect diagnosis (bronchiolitis rather than asthma) or inadequate disease control. 1
Evidence Quality and Regulatory Status
FDA approval for nebulized albuterol extends to children ≥1 year of age, with studies demonstrating safety in infants under 2 years. 7
Levosalbutamol specifically has FDA approval and safety data for children as young as 2 years via nebulization, but lacks FDA-approved labeling for children under 6 years. 1
A 2005 multicenter randomized trial in children aged 2-5 years demonstrated that levosalbutamol 0.31 mg was generally well-tolerated and led to significant bronchodilation compared with placebo. 9