At what minimum age is Tessalon (benzonatate) indicated for use in children?

Minimum Age for Tessalon (Benzonatate) Use

Tessalon (benzonatate) should not be used in children under 10 years of age due to lack of established safety and efficacy, with documented fatal overdoses occurring in this age group. 1

FDA-Approved Age Indication

• The FDA drug label explicitly states that "safety and effectiveness in children below the age of 10 have not been established." 1
• The label further warns that "accidental ingestion resulting in death has been reported in children below age 10" and emphasizes to "keep out of reach of children." 1
• The minimum approved age for benzonatate use is 10 years old. 1

Critical Safety Concerns in Young Children

Mortality Risk

• Fatal overdoses have been documented in children as young as 2 years old, with death occurring within 15-20 minutes of ingestion in some cases. 2, 3
• Between 1969-2010, five fatalities from accidental benzonatate ingestion occurred in children 2 years of age and younger. 3
• Signs of overdose include seizures, cardiac arrest, coma, brain edema, apnea, and respiratory arrest—often developing within 15 minutes of ingestion. 3, 4

Exposure Patterns

• From 2010-2018,83% of unintentional benzonatate exposures reported to poison control centers involved children 0-5 years old (2,718 cases). 2
• The majority (77%) of pediatric benzonatate exposure cases were unintentional, highlighting the risk of accidental ingestion. 2

Mechanism of Toxicity

• Benzonatate is chemically related to local anesthetics (procaine, tetracaine) and can cause temporary oral anesthesia if the capsule is broken or chewed. 1
• Release of benzonatate in the mouth produces local anesthesia of oral mucosa and can lead to choking. 1
• The drug has sodium channel-blocking properties similar to tetracaine, explaining its rapid and severe toxicity profile. 4

Clinical Guidance

Prescribing Considerations

• Do not prescribe benzonatate for any child under 10 years of age, regardless of weight or clinical indication. 1
• For children 10 years and older, maximum single dose is 200 mg with total daily dosage not exceeding 600 mg. 1
• Counsel patients and caregivers to swallow capsules whole—never break, chew, dissolve, cut, or crush them. 1

Alternative Approaches

• The American College of Chest Physicians recommends against over-the-counter cough suppressants in children due to significant morbidity and mortality risks. 5
• While benzonatate showed effectiveness in 80% of cases with chronic cough in small pediatric case series, this limited evidence does not outweigh the substantial safety concerns in children under 10. 5

Common Pitfalls to Avoid

• Do not assume benzonatate is safe in younger children simply because it is non-narcotic—its toxicity profile is severe and rapid. 3, 4
• Do not extrapolate adult safety data to pediatric populations—children under 10 have documented increased risks of fatal toxicity. 6
• Do not underestimate the risk of accidental ingestion—the gel capsule formulation is particularly attractive to young children and can be easily confused with candy. 2
• Ensure proper storage counseling, as benzonatate prescriptions increased by 52% from 2004-2009, increasing exposure risk. 3