Tessalon Perles (Benzonatate) for Cough
Tessalon Perles (benzonatate) is FDA-approved for cough suppression in patients aged 10 years and older at a dose of 100-200 mg three times daily (maximum 600 mg/day), but should be reserved for opioid-resistant or difficult-to-control cough rather than first-line therapy, with treatment limited to short-term use and mandatory reassessment if cough persists beyond 3 weeks. 1, 2
FDA-Approved Dosing and Administration
- Approved age: Adults and children over 10 years of age only 1
- Standard dose: 100-200 mg capsule three times daily as needed 1
- Maximum dose: 600 mg daily in three divided doses 1
- Critical administration requirement: Capsules must be swallowed whole—never broken, chewed, dissolved, cut, or crushed 1
Position in Treatment Algorithm
Benzonatate is not a first-line agent for acute cough. The appropriate treatment hierarchy is:
- First-line for acute cough: Simple home remedies (honey and lemon), dextromethorphan at therapeutic doses (60 mg for maximum effect), or voluntary cough suppression 3, 4
- Second-line: Ipratropium bromide for post-infectious cough 3
- Later-line therapy: Benzonatate is positioned as a local anesthetic option specifically for opioid-resistant cough that does not respond to peripheral antitussives 2
Duration of Treatment and Reassessment
Critical timing thresholds:
- Reassess at 3 weeks: If cough persists beyond 3 weeks despite benzonatate, discontinue and investigate underlying causes rather than continuing antitussive therapy 2, 4
- Beyond 8 weeks: Cough is now chronic and requires full diagnostic workup for asthma, GERD, post-nasal drip, or other treatable causes 4
- Benzonatate should provide short-term symptomatic relief only—it is not appropriate for prolonged use without identifying and treating the underlying condition 2
Critical Safety Warnings
Life-Threatening Risks in Children
- Accidental ingestion in children under 10 has resulted in death 1
- Signs of overdose appear within 15-20 minutes; death has occurred within 1 hour 1
- Overdose symptoms include restlessness, tremors, convulsions, coma, and cardiac arrest 1, 5, 6
- Keep out of reach of children at all times 1
Administration Hazards
- If capsule is chewed or dissolved in mouth: Produces temporary local anesthesia of oral mucosa, which can cause choking 1
- If numbness or tingling of tongue, mouth, throat, or face occurs, refrain from eating or drinking until numbness resolves 1
- Seek immediate medical attention if symptoms worsen or persist 1
Adult Overdose Risk
- Overdose resulting in death may occur in adults 1, 6
- Never exceed single dose of 200 mg or total daily dose of 600 mg 1
- Cardiac arrest has been reported in adults after ingestion of less than 30 capsules (6000 mg) 6
- Residual neurological damage (including blindness) has been documented in overdose survivors 5
Special Populations
- Pregnancy Category C: Use only if clearly needed; fetal harm potential unknown 1
- Nursing mothers: Unknown if excreted in breast milk; use with caution 1
- Children under 10: Safety and effectiveness not established; contraindicated 1
Clinical Context for Use
Benzonatate is most appropriate for:
- Opioid-resistant chronic cough in advanced cancer patients when other treatments fail 2, 7, 8
- Difficult-to-control cough as part of multimodal therapy alongside nebulized lidocaine/bupivacaine 2
- Patients requiring a peripherally-acting (non-opioid) antitussive with proven efficacy 7, 8
Common Pitfalls to Avoid
- Do not prescribe as first-line for acute viral cough or bronchitis 2, 3
- Do not continue beyond 3 weeks without reassessing for underlying pathology 2, 4
- Do not prescribe for children under 10 under any circumstances 1
- Do not assume it is "innocuous"—it carries significant overdose risk despite being non-opioid 5, 6
- Never instruct patients to take missed doses together—if a dose is missed, skip it and resume normal schedule 1