Benzonatate 200 mg Minimum Age Requirement
Benzonatate 200 mg capsules should only be administered to children over 10 years of age, as this is the FDA-approved minimum age for this medication. 1
FDA-Approved Age and Dosing
- The FDA label explicitly states that benzonatate is approved for "Adults and Children over 10 years of age" with usual dosing of one 100 mg or 200 mg capsule three times daily as needed for cough. 1
- The maximum daily dose is 600 mg in three divided doses, meaning up to three 200 mg capsules daily. 1
- Capsules must be swallowed whole and never broken, chewed, dissolved, cut, or crushed, as this can lead to rapid release and life-threatening toxicity. 1
Critical Safety Concerns in Children Under 10 Years
The strict age restriction exists because benzonatate poses severe and potentially fatal risks in younger children:
- Fatal overdoses have occurred in children as young as 2 years old from accidental ingestion, with death occurring within 15 minutes of exposure in some cases. 2
- Between 1969-2010, the FDA identified 31 overdose cases with 20 fatalities, including 5 deaths in children ≤2 years of age from accidental ingestion. 2
- Most unintentional exposures (83%) occur in children 0-5 years old, with serious adverse effects including seizures, cardiac arrest, coma, brain edema, apnea, tachycardia, and respiratory arrest. 2, 3
- The FDA issued a Drug Safety Communication in December 2010 specifically warning about the increased risk of death from accidental benzonatate ingestion in children younger than 10 years. 4
Mechanism of Toxicity
- Benzonatate is structurally similar to local anesthetics (tetracaine, procaine) and has sodium channel-blocking properties. 5, 4
- The medication produces a tetracaine-like metabolite that causes local anesthetic effects on respiratory stretch receptors, making overdose particularly dangerous. 4
- Toxicity manifests rapidly—within 15 minutes in some cases—leaving minimal time for intervention. 2
Clinical Pitfalls to Avoid
- Never prescribe benzonatate to children under 10 years of age, regardless of weight or maturity. 1, 2
- Counsel all caregivers on safe storage practices, as the soft gelcap appearance can be mistaken for candy by young children. 2, 3
- Be aware that intentional overdoses are increasing among adolescents 10-16 years old, including cases of misuse and abuse. 3
- A 14-year-old who ingested 14 capsules (2,800 mg total) developed torsades de pointes and cardiac arrest, though she ultimately recovered fully. 6
- A 13-year-old overdose case resulted in coma, seizures, hypotension, prolonged QT interval, and severe metabolic acidosis. 4
Patient Education Requirements
- Emphasize immediate medical attention if accidental ingestion occurs, as symptoms can progress to cardiac arrest within minutes. 2
- Instruct patients that capsules dissolving in the mouth can cause local anesthesia of the oral mucosa, which may lead to choking hazards. 1
- Store benzonatate in child-resistant containers and out of reach of all children, not just those under 10 years. 2, 3