Dolopar (Acetaminophen and Propoxyphene) Safety in 16-Year-Olds
Dolopar (acetaminophen and propoxyphene combination) should not be given to a 16-year-old due to safety concerns, particularly the serious cardiotoxicity risks associated with propoxyphene. Instead, plain acetaminophen (paracetamol) would be a safer alternative for pain management in this age group.
Safety Concerns with Propoxyphene
- Propoxyphene has been associated with significant cardiotoxicity, seizures, and other serious adverse effects that outweigh its therapeutic benefits 1
- The drug contains nor-propoxyphene, a non-opioid cardiotoxic metabolite that contributes to its toxicity profile 1
- The risk of fatal overdose is substantial, as indicated by warnings in product labeling 1
Appropriate Acetaminophen Use in Adolescents
For a 16-year-old requiring pain relief, plain acetaminophen (without propoxyphene) would be appropriate:
- Adolescents aged 16 are typically dosed as adults for most medications, including acetaminophen 2
- The FDA-approved dosing for acetaminophen in children 12 years and older is the same as adults 3
- The recommended dosage is 2 caplets every 8 hours, not exceeding 6 caplets in 24 hours 3
Contraindications and Precautions for Acetaminophen
When considering plain acetaminophen as an alternative:
- Do not use with any other drugs containing acetaminophen (prescription or nonprescription) 3
- Do not use if the patient has a known allergy to acetaminophen or any inactive ingredients 3
- Treatment duration should not exceed 10 days unless directed by a doctor 3
Evidence on Efficacy and Safety
- While some older studies have examined the combination of propoxyphene and acetaminophen for pain management 4, 5, more recent evidence indicates that propoxyphene offers minimal additional analgesic benefit beyond acetaminophen alone 1
- The risks associated with propoxyphene, particularly its cardiotoxicity, make it an unfavorable choice compared to safer alternatives 1
- There have been documented cases of delayed toxicity with acetaminophen and propoxyphene combinations, further highlighting safety concerns 6
Conclusion for Clinical Practice
When treating pain in a 16-year-old: