Is Tessalon (benzonatate) safe for a 13-year-old patient to use?

Tessalon (Benzonatate) Safety in 13-Year-Olds

Tessalon (benzonatate) can be used in a 13-year-old, as the FDA has established safety and effectiveness for children 10 years of age and older, but it requires strict adherence to dosing limits and careful patient education due to the risk of life-threatening toxicity in overdose. 1

FDA-Approved Age Range

• Safety and effectiveness in children below the age of 10 have not been established by the FDA, but benzonatate is approved for use in children 10 years and older 1
• A 13-year-old falls within the approved age range for benzonatate use 1

Critical Safety Requirements

Dosing Limits

• Maximum single dose: 200 mg 1
• Maximum total daily dose: 600 mg 1
• Never exceed these limits, as overdosage resulting in death may occur in both children and adults 1

Administration Instructions

• Capsules must be swallowed whole—never broken, chewed, dissolved, cut, or crushed 1
• Release of benzonatate in the mouth produces temporary local anesthesia of oral mucosa and can cause choking 1
• If numbness or tingling of the tongue, mouth, throat, or face occurs, the patient must refrain from eating or drinking until numbness resolves 1

Storage and Access

• Keep benzonatate out of reach of younger siblings or children in the household 1
• Accidental ingestion in children below age 10 has resulted in death, with signs of overdose appearing within 15-20 minutes and death reported within one hour 1

Evidence of Toxicity Risk in Adolescents

While benzonatate is FDA-approved for ages 10 and up, serious toxicity has been documented in teenagers:

• A 14-year-old who ingested 14 capsules (2,800 mg) developed torsades de pointes and cardiac arrest but recovered fully 2
• A 13-year-old who overdosed presented with coma, seizures, hypotension, prolonged QT interval, and severe metabolic acidosis 3
• A 17-year-old who ingested at least 10 capsules experienced cardiac arrest and developed permanent blindness 4

Overdose Manifestations

• Signs and symptoms appear rapidly (within 15-20 minutes) and may include restlessness, tremors, convulsions, coma, and cardiac arrest 1
• Severe hypersensitivity reactions including bronchospasm, laryngospasm, and cardiovascular collapse have been reported 1
• Psychiatric effects including bizarre behavior, mental confusion, and visual hallucinations can occur, particularly when combined with other medications 1

Clinical Context: Consider Alternatives First

• Over-the-counter cough suppressants should not be used in children, as they may cause significant morbidity and mortality according to the American College of Chest Physicians 5
• For chronic cough in children, benzonatate has shown effectiveness in 80% of cases with malignant pulmonary involvement in small case series, though evidence is limited 5
• Benzonatate may be effective for cough unresponsive to opioids in select cases 5

Monitoring and Follow-Up

• If accidental overdose occurs, seek medical attention immediately—do not wait for symptoms to develop 1
• If a dose is missed, skip it and take the next scheduled dose; never double-dose 1
• Educate the patient and family about the narrow therapeutic window and potentially fatal consequences of overdose 6, 7