What are the guidelines for using benzonatate in pediatric patients?

Benzonatate Use in Pediatric Patients

Benzonatate is contraindicated in children under 10 years of age due to high risk of fatal overdose, and should only be used in children 10 years and older with extreme caution and strict parental counseling about accidental ingestion risks. 1

Age-Based Restrictions and FDA Labeling

• Safety and effectiveness in children below age 10 have not been established, and accidental ingestion resulting in death has been specifically reported in this age group 1
• The FDA-approved indication explicitly states use only in "Adults and Children over 10 years of age" 1
• Fatal outcomes have occurred in children as young as 2 years old, with five deaths documented in children ≤2 years from accidental ingestion 2
• Signs and symptoms of overdose can appear within 15-20 minutes of ingestion, with death reported within one hour 1, 2

Dosing for Children ≥10 Years

When benzonatate is used in appropriate-age pediatric patients (≥10 years):

• Standard dose: 100-200 mg three times daily as needed for cough 1
• Maximum daily dose: 600 mg in three divided doses 1
• Capsules must be swallowed whole—never broken, chewed, dissolved, cut, or crushed, as release in the mouth produces dangerous local anesthesia and choking risk 1

Critical Safety Warnings for Pediatric Use

Life-Threatening Toxicity Profile

• Benzonatate overdose causes seizures, cardiac arrest, coma, brain edema, apnea, tachycardia, respiratory arrest, and ventricular dysrhythmias 2, 3
• Documented cases include torsades de pointes and complete cardiac arrest in adolescents 4
• The drug has sodium channel-blocking properties similar to tetracaine and procaine, explaining its rapid and severe toxicity 3
• Metabolic acidosis (pH as low as 6.87) has been documented in overdose cases 5

Accidental Ingestion Risk

• Twelve emergency department visits involved children aged 1-3 years with accidental benzonatate ingestions captured in national surveillance data 2
• The soft gelatin capsule can be easily bitten or chewed by young children, releasing the medication and causing immediate local anesthesia followed by systemic toxicity 1
• Benzonatate prescriptions increased by 52% from 2004-2009, increasing exposure risk 2

Mandatory Patient/Parent Counseling

Healthcare providers must counsel families on:

• Keep benzonatate out of reach of children at all times—this is a boxed emphasis in FDA labeling 1
• If numbness or tingling of tongue, mouth, throat, or face occurs, refrain from eating or drinking until numbness resolves and seek immediate medical attention if symptoms worsen 1
• Seek emergency medical attention immediately if accidental ingestion occurs, as death can occur within one hour 1
• Never take two doses at once if a dose is missed 1

Clinical Outcomes Data

Recent 20-year poison center data provides important context:

• Intentional exposures resulted in serious adverse effects in 22% of cases with 38% requiring hospitalization 6
• Unintentional exposures rarely caused serious toxicity (0.7% serious adverse effects, 2% hospitalization) 6
• Among 77 unintentional pediatric exposures, none experienced serious adverse effects, though 3% were hospitalized for observation 6
• Two deaths occurred during the study period, both from intentional exposures 6

Treatment of Overdose

• No standard treatment guidelines exist for benzonatate toxicity 6
• Supportive care is the mainstay, with potential interventions including antiepileptics for seizures, antidysrhythmics for cardiac complications, vasopressors for hypotension, sodium bicarbonate for sodium channel blockade, and intravenous lipid emulsion therapy 6
• No therapeutic interventions beyond supportive care were consistently employed in documented cases 6

Clinical Decision Algorithm

For children <10 years: Benzonatate is absolutely contraindicated—choose alternative antitussive agents 1

For children ≥10 years:

• Assess ability to swallow capsules whole without chewing
• Evaluate household safety (presence of younger siblings who could access medication)
• Confirm parent/patient understanding of risks and proper administration
• If all criteria met, prescribe minimum effective dose (100 mg TID) with explicit safety counseling 1
• Consider alternative antitussives if any safety concerns exist

Common pitfall: Prescribing benzonatate for households with young children where accidental access is possible, even when the intended patient is ≥10 years old 2