What is the appropriate pediatric dose of benzonatate (Tessalon) for an 11‑year‑old child?

Benzonatate (Tessalon) is Contraindicated in an 11-Year-Old Child

Benzonatate is FDA-approved only for children over 10 years of age, and an 11-year-old falls just at the threshold where extreme caution is warranted—given the narrow therapeutic window and high risk of life-threatening toxicity, alternative antitussive agents should be strongly considered. 1

FDA-Approved Dosing

• The FDA label specifies that benzonatate is approved for children over 10 years of age at a dose 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 (200 mg three times daily). 1
• For an 11-year-old who technically meets the age criterion, the starting dose would be 100 mg three times daily, with potential escalation to 200 mg three times daily only if cough control is inadequate. 1

Critical Safety Concerns in This Age Group

The 11-year-old patient sits at the very edge of the approved age range, where the risk-benefit ratio remains unfavorable:

• Fatal overdoses have occurred in children as young as 2 years old within 15 minutes of accidental ingestion, with signs including seizures, cardiac arrest, coma, apnea, and respiratory arrest. 2
• A 13-year-old experienced coma, seizures, hypotension, prolonged QT interval, and severe metabolic acidosis after benzonatate overdose. 3
• A 14-year-old developed torsades de pointes and cardiac arrest following benzonatate ingestion, representing the only reported pediatric case with this arrhythmia. 4
• Benzonatate has sodium channel-blocking properties and local anesthetic effects similar to tetracaine, making overdose rapidly lethal. 3

Trends in Pediatric Exposure

• From 2010 to 2018, unintentional benzonatate exposures increased among children 0-5 years old (83% of unintentional exposures), while intentional exposures rose among children 10-16 years old. 5
• Among cases involving misuse or abuse, 61% occurred in children 10-16 years old, highlighting the risk in early adolescence. 5
• The FDA issued a Drug Safety Communication warning that accidental benzonatate ingestion in children younger than 10 years of age carries increased risk of death. 3

Practical Prescribing Algorithm

If benzonatate must be prescribed to an 11-year-old (which I strongly discourage):

1. Start with 100 mg three times daily (not 200 mg). 1
2. Counsel the patient and family that capsules must be swallowed whole—never broken, chewed, dissolved, cut, or crushed—as local anesthetic effects in the mouth can lead to choking and aspiration. 1
3. Emphasize immediate medical attention if signs of overdose appear: seizures, altered mental status, chest pain, palpitations, or difficulty breathing. 2
4. Ensure secure storage away from younger siblings, as even a single 200 mg capsule can be fatal to a toddler. 2
5. Limit the prescription to the smallest quantity necessary (e.g., 9 capsules for 3 days) to minimize overdose risk. 5, 2

Safer Alternatives

• Dextromethorphan-containing prescription antitussives have far higher pediatric utilization and a more favorable safety profile compared to benzonatate. 5
• Non-pharmacologic measures (honey for children over 1 year, humidified air, adequate hydration) should be prioritized before any antitussive medication.

Common Pitfalls to Avoid

• Do not prescribe 200 mg capsules as the initial dose in an 11-year-old; start with 100 mg. 1
• Do not assume the patient will follow instructions to swallow capsules whole—adolescents may chew or dissolve medications. 1
• Do not overlook the risk of intentional overdose in this age group, where self-harm behaviors are emerging. 5
• Do not prescribe benzonatate if there is any concern for impulsivity, suicidal ideation, or access by younger children in the household. 5, 2