What are the considerations for using Tessalon Perles (Benzonatate) in pediatric patients?

Tessalon Perles (Benzonatate) Should Not Be Used in Pediatric Patients

Benzonatate is contraindicated in children under 10 years of age and should be avoided in all pediatric populations due to the high risk of fatal overdose, rapid onset of life-threatening toxicity, and lack of established safety data.

Critical Safety Concerns

Fatal Toxicity Risk in Children

• Benzonatate has caused fatal outcomes in infants and children following accidental ingestion, with death occurring rapidly—within 1 hour of ingestion in documented cases 1, 2
• The medication poses extreme danger because the liquid-filled capsules ("perles") can be mistaken for candy by children, and if chewed or punctured, release concentrated drug that causes immediate oropharyngeal anesthesia followed by systemic toxicity 1, 2
• A single case report documented an infant death after choking on Tessalon perles, with the child found with the capsules 1

Rapid Progression to Life-Threatening Events

• Overdose can cause cardiac arrest, seizures, and permanent neurological damage including blindness, with limited treatment options available 2
• A 17-year-old who ingested at least 10 capsules (2000 mg total) developed cardiac arrest within 1-2 hours and subsequently developed permanent blindness despite aggressive supportive care including hypothermia protocol 2
• The structurally similar local anesthetic properties to tetracaine and procaine contribute to rapid cardiovascular collapse and CNS toxicity 2

Age-Specific Contraindications

Children Under 10 Years

• Absolute contraindication: Benzonatate should never be prescribed to children under 10 years of age due to the extreme risk of fatal toxicity 3
• The risk of accidental ingestion is particularly high in this age group, as the capsules resemble candy and children may not understand the danger of chewing them 2, 3

Adolescents (10-18 Years)

• While not absolutely contraindicated in older children and adolescents, benzonatate should be avoided due to:
  • Risk of intentional overdose in suicide attempts, as demonstrated by the case of the 17-year-old 2
  • Lack of pediatric safety and efficacy data 3
  • Availability of safer alternative cough suppressants

Clinical Management Considerations

If Overdose Occurs

• Immediate emergency management is required with focus on airway protection, cardiac monitoring, and seizure prophylaxis 2
• Gastric lavage may be performed if presentation is early, though efficacy is limited given rapid absorption 2
• Magnesium may be administered as prophylaxis against recurrent dysrhythmias 2
• Supportive care is the mainstay of treatment, as there is no specific antidote 2

Prescribing Practices to Prevent Harm

• Rational prescribing requires avoiding benzonatate entirely in pediatric populations and selecting alternative antitussive agents with better safety profiles 2, 3
• Parents and caregivers must receive explicit training on proper storage of all medications to prevent accidental pediatric ingestion 3
• Clinicians should be vigilant in withholding unnecessary drugs, including cough suppressants for viral infections where symptomatic treatment may not be indicated 3

Common Pitfalls to Avoid

• Never prescribe benzonatate to children under 10 years of age under any circumstances 3
• Do not assume that capsule formulation provides adequate safety—children can and do chew or puncture the capsules 1, 2
• Do not underestimate the rapidity of toxicity—fatal outcomes can occur within 1 hour of ingestion 1, 2
• Avoid prescribing to households with young children even for adult use, given the high risk of accidental pediatric exposure 2, 3