Benzonatate Age and Dosing Guidelines
Benzonatate is FDA-approved for use in adults and children over 10 years of age, with a standard dose of one 100 mg or 200 mg capsule three times daily as needed for cough, up to a maximum of 600 mg daily in three divided doses. 1
Minimum Age Requirement
- The approved minimum age for benzonatate use is greater than 10 years old 1
- Benzonatate is contraindicated in children under 10 years of age due to significant risk of fatal overdose from accidental ingestion 2, 3
- The FDA issued a Drug Safety Communication specifically warning about the increased risk of death in children younger than 10 years following accidental benzonatate ingestion 4
Standard Dosing Regimen for Patients ≥10 Years
- The usual dose is one 100 mg or 200 mg capsule three times daily as needed for cough 1
- Maximum daily dose: 600 mg in three divided doses if necessary to control cough 1
- Capsules must be swallowed whole and never broken, chewed, dissolved, cut, or crushed 1
Critical Safety Warnings
Risk of Rapid-Onset Toxicity
- Signs and symptoms of overdose can occur within 15 minutes of ingestion and include seizures, cardiac arrest, coma, brain edema or anoxic encephalopathy, apnea, tachycardia, and respiratory arrest 2
- Benzonatate has sodium channel-blocking properties and local anesthetic effects similar to tetracaine, making overdose particularly dangerous 4
- Fatal outcomes have been documented, with 20 of 31 overdose cases in the FDA database resulting in death, including five fatalities in children 2 years and younger 2
Pediatric Exposure Patterns
- From 2010-2018,77% of benzonatate exposures in children were unintentional, with 83% occurring in children 0-5 years old 3
- Rising patterns of intentional benzonatate ingestion have been observed in adolescents 10-16 years old, including cases of misuse or abuse 3
- Despite the 10-year age restriction, unintentional pediatric exposures continue to occur, emphasizing the need for strict storage precautions 3, 5
Clinical Pitfalls to Avoid
- Never prescribe benzonatate for children under 10 years of age under any circumstances 1, 2
- Counsel all patients and caregivers that capsules must never be chewed or dissolved, as this releases the medication immediately and can cause rapid-onset local anesthesia of the oral mucosa, followed by systemic toxicity 1, 4
- Emphasize safe storage out of reach of young children, as even a single capsule can be fatal in a young child 2
- Educate patients to seek immediate medical care if overdose is suspected, given the rapid onset of life-threatening symptoms 2
Management Considerations
- Intentional exposures in adolescents and adults warrant significant therapeutic interventions and have higher incidence of serious toxicity including seizures, dysrhythmias, and cardiovascular collapse 5
- Treatment is primarily supportive, with potential need for antiepileptics, antidysrhythmics, vasopressors, sodium bicarbonate, or intravenous lipid therapy in severe cases 5
- Unintentional exposures in adults rarely result in clinically significant adverse effects and may be candidates for home management with close monitoring 5