Numerous reports of intentional or accidental overdose of propoxyphene preparations, alone or in combination with other CNS depressants (e.g., alcohol); death may occur within 1 hour of overdose.
Many of the deaths have occurred in patients with a history of emotional disturbances or suicidal ideation or attempts and/or with concomitant use of CNS depressants (e.g., sedatives, tranquilizers, skeletal muscle relaxants, antidepressants, alcohol).
Do not use in patients who are suicidal or have a history of suicidal ideation.
Interactions with CYP3A4 Inhibitors
Concomitant use of potent CYP3A4 inhibitors (e.g., amiodarone, aprepitant, clarithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, troleandomycin, verapamil) may increase plasma concentrations of propoxyphene.
Monitor patients receiving any CYP3A4 inhibitor concomitantly with propoxyphene carefully for an extended period of time and adjust dosage if needed.
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