Not For Use in Patients at Risk of Suicide or Addiction
- Do not prescribe propoxyphene for patients who are suicidal or addiction-prone.
- The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics.
Avoid with CNS Pharmacotherapy, Alcohol
- Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.
- Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs.
- Patients should be advised of the additive depressant effects of these combinations.
- Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.
- Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths.
- Fatalities within the first hour of overdosage are not uncommon. In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes).
- Propoxyphene should not be taken in doses higher than those recommended by the physician.
- Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs.
- Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs. Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Propoxyphene products in excessive doses or in drug interations with CNS depressants (including alcohol) are major cause of drug related deaths.
- Instruct patient about not exceeding recommended doses and of drug interactions with CNS depressants (including alcohol).
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information