Benzonatate Dosing for Pediatric Patients
Primary Recommendation
Benzonatate is FDA-approved only for children over 10 years of age at a dose of 100-200 mg three times daily as needed for cough, with a maximum daily dose of 600 mg in three divided doses. 1
Critical Age Restriction
- Benzonatate is contraindicated in children under 10 years of age due to significant risk of fatal overdose from accidental ingestion 1, 2
- The FDA issued a Drug Safety Communication specifically warning against use in children younger than 10 years due to increased risk of death 3
- Fatal outcomes have occurred in children as young as 2 years old, with some deaths occurring within 15 minutes of accidental ingestion 2
Approved Dosing for Children ≥10 Years
- Standard dose: 100 mg or 200 mg capsule three times daily as needed 1
- Maximum dose: 600 mg daily in three divided doses (200 mg three times daily) 1
- Capsules must be swallowed whole and never broken, chewed, dissolved, cut, or crushed 1
Life-Threatening Toxicity Profile
Benzonatate overdose causes rapid-onset, severe toxicity including:
- Seizures, cardiac arrest, and coma occurring within 15 minutes of ingestion 2
- Torsades de pointes and ventricular dysrhythmias 4
- Severe metabolic acidosis, hypotension, and respiratory arrest 2, 3
- Brain edema, anoxic encephalopathy, and apnea 2
Recent Exposure Trends
- Benzonatate prescriptions increased by 52% from 2004-2009, raising exposure risk 2
- Unintentional ingestions are rising in children 0-5 years old (83% of unintentional exposures) 5
- Intentional overdoses are increasing among adolescents 10-16 years old, including cases of misuse and abuse 5
Essential Safety Counseling
Pharmacists and prescribers must counsel caregivers on:
- Storing benzonatate in child-resistant containers out of reach of all children 2
- The critical importance of never allowing children under 10 to access this medication 2
- Immediate emergency care (call 911) if accidental ingestion occurs, as symptoms can develop within minutes 2
- The capsules must never be chewed or opened, as this releases the medication rapidly 1
Clinical Pitfall
The most dangerous aspect of benzonatate is that it appears similar to candy or other medications, making accidental pediatric ingestion common, and the rapid onset of life-threatening toxicity (within 15 minutes) leaves minimal time for intervention 2. Even small ingestions can be fatal in young children 2.