What are the contraindications for benzonatate (Tessalon Perles)?

Contraindications for Benzonatate (Tessalon Perles)

The only absolute contraindication to benzonatate is hypersensitivity to benzonatate or related compounds (structurally similar local anesthetics like tetracaine and procaine). 1

Absolute Contraindication

• Hypersensitivity to benzonatate or related compounds is the sole FDA-listed absolute contraindication 1

Critical Relative Contraindications and High-Risk Situations

High Aspiration Risk

• Patients with high aspiration risk—including frail individuals with serious illnesses—should avoid benzonatate or use it only with extreme caution because its local anesthetic effect causes oropharyngeal anesthesia that impairs protective airway reflexes, substantially increasing aspiration likelihood 2
• This is particularly concerning in advanced cancer patients and those with swallowing difficulties 2, 3

Pediatric Access Risk

• Children under 10 years of age represent a critical safety concern due to the risk of accidental ingestion, which has resulted in multiple fatalities 4
• Fatal overdoses have occurred in children as young as 2 years old, with signs of toxicity (seizures, cardiac arrest, respiratory arrest) appearing within 15 minutes of ingestion 4
• The medication must be stored completely out of reach of children, as even small amounts can be lethal 4, 5, 6

Pregnancy and Breastfeeding

• Benzonatate should be used with caution in pregnant or breastfeeding women due to limited safety data, constituting a relative contraindication requiring individualized risk-benefit assessment 7, 2

Critical Safety Precautions for All Patients

First-Dose Monitoring

• The first dose must be administered in an inpatient setting to monitor for possible reflex bronchospasm 2, 3
• Patients must abstain from food and drink for at least one hour after administration to prevent aspiration 2, 3

Overdose Risk Profile

• Benzonatate overdose causes rapid-onset, life-threatening toxicity including seizures, cardiac arrest, dysrhythmias, coma, and death—often within 15 minutes of ingestion 4, 5, 6
• Intentional overdoses carry a 22% risk of serious adverse effects and have resulted in fatalities, with most survivors experiencing significant neurologic deficits 6, 8
• There are no specific antidotes; treatment is purely supportive 6, 8

Common Pitfalls to Avoid

• Do not prescribe benzonatate as first-line therapy—it should be reserved for cough resistant to opioid therapy and peripheral antitussives 2, 3
• Do not prescribe without explicit counseling on safe storage away from children, signs of overdose, and the need for immediate emergency care if overdose occurs 4
• Do not allow patients to chew or dissolve the capsules, as this releases the local anesthetic and can cause severe oropharyngeal anesthesia 2