Nebulizer Solution (Preferred in Children)

• Age: 6–11 years

  • 0.31 mg every 8 hours (TDS) initially.

  • May increase to 0.63 mg every 8 hours if needed.

  • Some children with severe symptoms may need 1.25 mg every 8 hours.

• Age: 12 years and older

  • 0.63 mg or 1.25 mg every 8 hours.

⚠️ Note: Safety and efficacy below 6 years have not been established by US FDA.
👉 However, in clinical practice (India & many countries), some paediatricians use it off-label in toddlers (2–5 years) at 0.31 mg per dose every 8 hours, especially if salbutamol causes side effects.

Inhaler (MDI)

• Age: 4 years and older

  • 2 inhalations (45 mcg each) every 4–6 hours as needed.

  • Maximum: 12 inhalations per day.

💊 Syrup (Levosalbutamol Oral)

• In the US, oral syrup is not commonly FDA-approved.

• In India, Levosalbutamol syrup is marketed (usually 1 mg/5 ml).

• Paediatricians here often prescribe 0.05–0.1 mg/kg/dose, 2–3 times daily (off-label compared to FDA).

✅ Key Points

• FDA-approved use: Nebulizer in children ≥6 years; Inhaler in children ≥4 years.

• Toddlers (under 6 years): Use is off-label; paediatricians sometimes use 0.31 mg neb q8h if salbutamol side effects are troublesome.

• Always strictly weight-based and doctor-guided dosing.

👉 In simple words:

• US FDA: Safe and approved from ≥6 years (neb) and ≥4 years (inhaler).

• Toddlers (<6 years): Not FDA-approved, but often used in practice under close supervision.