Tessalon Perles (Benzonatate) Safety During Breastfeeding
Tessalon Perles (benzonatate) should be avoided during breastfeeding due to insufficient safety data and the availability of safer alternatives for cough suppression.
Safety Assessment
The 2020 guidelines from the Association of Anaesthetists 1 do not specifically mention benzonatate (Tessalon Perles) in their comprehensive review of medications during breastfeeding. This absence of specific guidance is significant, as the guidelines cover numerous medications across multiple drug classes.
When a medication is not explicitly addressed in breastfeeding guidelines, clinical decision-making should prioritize:
- Known safety profile
- Availability of safety data
- Existence of safer alternatives
Pharmacological Considerations
Benzonatate is a non-narcotic cough suppressant that works by anesthetizing stretch receptors in the lungs. Key concerns include:
- Limited data on transfer into breast milk
- Chemical similarity to tetracaine (an ester local anesthetic)
- Risk of potential toxicity in infants if transferred in significant amounts
- Potential for adverse effects including drowsiness, CNS depression, or allergic reactions
Alternative Options
The Association of Anaesthetists guidelines 1 provide information on several safer alternatives for breastfeeding mothers:
- Paracetamol (Acetaminophen): "The amount of paracetamol that an infant would ingest via breast milk is significantly less than the pediatric therapeutic dose" 1
- NSAIDs (for associated pain/inflammation):
Monitoring Recommendations
If Tessalon Perles must be used (when benefits clearly outweigh risks):
- Use the lowest effective dose for the shortest duration
- Monitor the infant for:
- Unusual drowsiness
- Poor feeding
- Respiratory depression
- Decreased alertness
Clinical Decision Algorithm
First-line approach: Non-pharmacological cough management
- Adequate hydration
- Humidification
- Honey (if infant >1 year old)
If medication needed: Choose safer alternatives with established safety profiles
- Acetaminophen for associated discomfort
- Short-term use of dextromethorphan (which has more safety data in breastfeeding)
Consider Tessalon Perles only if:
- Other options have failed
- Cough is severe enough to impact maternal health
- Benefits clearly outweigh potential risks
Important Caveats
- The American Academy of Pediatrics emphasizes that "only a small proportion of medications are contraindicated in breastfeeding mothers" 2, but safety data should guide decisions
- When specific data is lacking, caution is warranted, especially with medications that affect the central nervous system
- The LactMed database (maintained by the National Library of Medicine) should be consulted for the most current information on specific medications
Remember that the safety of the breastfeeding infant is paramount, and when uncertainty exists about a medication's safety profile, safer alternatives should be prioritized.