Procaterol Use in Pediatrics and Adults
Procaterol is not recommended for routine use in either pediatric or adult patients in the United States, as it lacks FDA approval and is not included in current NAEPP asthma guidelines, which instead recommend FDA-approved short-acting beta-2 agonists (like albuterol) for as-needed relief and long-acting beta-2 agonists (like salmeterol or formoterol) only in combination with inhaled corticosteroids for persistent asthma.
Current Guideline-Based Recommendations
For Acute Relief (All Ages)
- Preferred therapy: Inhaled short-acting beta-2 agonists (albuterol) as needed for symptom relief 1
- Regular use of short-acting beta-2 agonists provides no additional benefit over as-needed use and should be prescribed on an as-needed basis only 1
For Long-Term Control in Persistent Asthma
Adults and Children ≥5 Years:
- Step 2 (Mild Persistent): Low-dose inhaled corticosteroids are the preferred first-line controller therapy 1
- Step 3 (Moderate Persistent): Add long-acting beta-2 agonists (salmeterol or formoterol) to low-dose inhaled corticosteroids 1
Children <5 Years:
- Low-dose inhaled corticosteroids remain preferred for mild persistent asthma 1
- Long-acting beta-2 agonists have no data in children under 4 years of age and should not be used 1
- For moderate persistent asthma, either increase inhaled corticosteroid dose to medium range OR add long-acting beta-2 agonist (if ≥4 years old) 1
Critical Safety Principle for All Beta-2 Agonists
Long-acting beta-2 agonists should never be used as monotherapy due to increased risk of severe exacerbations and deaths; they must only be used in combination with inhaled corticosteroids 1
Procaterol-Specific Evidence (Limited and Not Guideline-Supported)
While procaterol has been studied internationally, the available research does not support its use over guideline-recommended alternatives:
Pediatric Data
- A single study in 16 children (ages 6-12) showed bronchodilation with doses of 0.5-1.5 mcg/kg orally, but the higher dose increased tremor incidence 2
- This represents insufficient evidence for routine clinical use, particularly given the availability of better-studied alternatives
Adult Data
- Studies showed procaterol 0.05-0.10 mg orally twice daily produced bronchodilation lasting up to 8 hours 3, 4
- Tremor and nervousness were dose-related side effects 3, 4
- One COPD study (not asthma) showed benefit with inhaled procaterol 20 mcg three times daily 5
- Inhaled procaterol 0.01 mg/inhalation showed efficacy in mild-moderate asthma 6
Why Procaterol Is Not Recommended
Lack of regulatory approval: Procaterol has no FDA approval for use in the United States 1
Superior alternatives exist: FDA-approved beta-2 agonists with extensive safety and efficacy data are readily available:
- Short-acting: Albuterol, levalbuterol (approved for children ≥4 years) 1
- Long-acting: Salmeterol (approved ≥4 years), formoterol (approved ≥5 years) 1
Insufficient pediatric data: Only one small study exists in children, far below the evidence threshold required by current FDA pediatric regulations 1, 2
Clinical Algorithm for Beta-2 Agonist Selection
For any acute symptoms: Use albuterol as needed 1
If requiring controller therapy:
If inadequate control on inhaled corticosteroids alone:
Never use long-acting beta-2 agonists without concurrent inhaled corticosteroids 1
Common Pitfalls to Avoid
- Do not use procaterol when FDA-approved alternatives with superior evidence are available 1
- Do not prescribe long-acting beta-2 agonists as monotherapy in any age group 1
- Do not extrapolate adult beta-2 agonist data to children <4 years of age 1
- Do not use regular short-acting beta-2 agonists for long-term control; they should be as-needed only 1