Is benzonatate (Tessalon) suitable for a 12-year-old female?

From the Guidelines

Benzonatate should not be given to a 12-year-old female without careful consideration and consultation with a healthcare provider, as the available evidence does not specifically support its use in pediatric populations for cough suppression, and its safety profile in children is not well-established. When considering the use of benzonatate in a pediatric patient, it is essential to weigh the potential benefits against the risks, particularly given the lack of robust evidence supporting its efficacy and safety in children. The provided evidence primarily discusses the use of various antitussive agents, including benzonatate, in the context of cough associated with lung cancer, without specific reference to pediatric populations 1. Given the potential for serious side effects, such as confusion, hallucinations, or allergic reactions, and the risk of accidental ingestion by younger children being fatal, it is crucial to approach the use of benzonatate in children with caution. Key considerations include:

• The FDA approval and typical dosing for children 10 years and older, which is 100-200 mg three times daily, with a maximum daily dose of 600 mg.
• The importance of storing the medication securely to prevent accidental ingestion.
• The need for close supervision and monitoring for potential side effects.
• The recommendation to follow the prescribed dosage and duration and to contact a healthcare provider if the cough persists beyond a week or is accompanied by fever, rash, or persistent headache. Ultimately, the decision to use benzonatate in a 12-year-old female should be made under the guidance of a healthcare provider, taking into account the individual patient's needs and the potential risks and benefits of treatment.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. Pediatric Use: Safety and effectiveness in children below the age of 10 have not been established

Benzonatate can be given to a 12 year old female as she is above 10 years of age, according to the dosage and administration guidelines 2.

• The recommended dose for children over 10 years old is one 100 mg or 200 mg capsule three times a day as needed for cough.
• It is essential to follow the dosage instructions and ensure the child swallows the capsule whole, without breaking, chewing, dissolving, cutting, or crushing it 2.

From the Research

Benzonatate Administration to a 12-Year-Old Female

• The safety and efficacy of benzonatate in pediatric patients, particularly those around the age of 12, is a concern due to the potential for severe adverse effects 3, 4, 5, 6, 7.
• Studies have reported cases of benzonatate overdose in pediatric patients, including a 14-year-old female who experienced torsades de pointes, cardiac arrest, and complete recovery without neurologic deficits 3.
• Another case reported a 13-year-old female who presented with coma, seizures, hypotension, prolonged QT interval, and metabolic acidosis after a benzonatate overdose 4.
• The US Food and Drug Administration (FDA) has issued warnings about the risks of benzonatate overdose, particularly in children younger than 10 years of age, and has added new information to the Warnings and Precautions section of benzonatate's label 4, 7.
• A systematic review of severe benzonatate poisonings reported in the literature and to the National Poison Data System (NPDS) found that most patients were young and female, and that onset of toxicity was rapid, with common symptoms including cardiac arrest, seizures, and dysrhythmias 6.
• The FDA has analyzed data on benzonatate overdoses among adults and children from 1969-2010 and found that signs and symptoms of overdose included seizures, cardiac arrest, coma, and respiratory arrest, and that some patients experienced these symptoms within 15 minutes of ingestion 7.
• While there is limited information on the safety and efficacy of benzonatate in 12-year-old females, the available data suggest that benzonatate can be toxic in pediatric patients, and that careful consideration should be given to its use in this population 3, 4, 5, 6, 7.