From the Guidelines
Benzonatate is not recommended for pediatric patients under 10 years of age due to safety concerns, and its use in patients 10 years and older should be approached with caution.
Key Considerations
- The medication works as a non-narcotic cough suppressant by anesthetizing stretch receptors in the lungs, thereby reducing the cough reflex 1.
- Benzonatate carries a black box warning as accidental ingestion by children under 10 has resulted in severe adverse effects including convulsions, cardiac arrest, and death 1.
- For pediatric patients 10 years and older, the typical dose is 100-200 mg three times daily, not to exceed 600 mg per day.
- The capsules should never be chewed or dissolved in the mouth, as this can cause local anesthesia of the oral mucosa and potential choking.
- Parents should be instructed to store the medication securely out of children's reach.
Alternatives for Younger Children
- For younger children with cough, safer alternatives like honey (for children over 1 year) or appropriate doses of dextromethorphan should be considered first, under medical supervision 1.
- Treatment duration should typically be limited to 1-2 weeks as persistent cough requires further evaluation.
Important Safety Information
- Benzonatate has been studied in the setting of cancer and improvement in cough related to the cancer, but its use in pediatric patients is not well-established 1.
- Clinicians should exercise caution when prescribing benzonatate to pediatric patients, considering the potential risks and benefits, and carefully monitoring for adverse effects.
From the FDA Drug Label
Pediatric Use: Safety and effectiveness in children below the age of 10 have not been established Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children. Accidental Ingestion and Death in Children Keep BENZONATATE out of reach of children. Accidental ingestion of BENZONATATE resulting in death has been reported in children below age 10
The use of benzonatate in pediatric patients below the age of 10 is not established due to safety and effectiveness concerns, and there is a risk of accidental ingestion resulting in death 2, 2. Benzonatate should be kept out of reach of children.
From the Research
Use of Benzonatate in Pediatric Patients
- There is limited information available on the use of benzonatate in pediatric patients 3, 4, 5, 6, 7.
- None of the provided studies directly address the use of benzonatate in pediatric patients, but one study mentions that benzonatate is potentially inappropriate for use in pediatric patients as part of the "KIDs List" 4.
- Another study evaluated the effect of benzonatate on cough-reflex sensitivity in adults with acute viral cough, but did not include pediatric patients 5.
- The remaining studies compared the effects of honey, dextromethorphan, and other treatments on nocturnal cough and sleep quality in children, but did not mention benzonatate 3, 6, 7.
- Overall, there is a lack of research on the use of benzonatate in pediatric patients, and its safety and efficacy in this population are not well established 4.