Serious and Life-Threatening Risks From Use Of Levorphanol Tartrate Tablets

Addiction, Abuse, and Misuse

• Because the use of levorphanol tartrate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Life-Threatening Respiratory Depression

• Serious, life-threatening, or fatal respiratory depression may occur with use of levorphanol tartrate tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of levorphanol tartrate tablets are essential [see WARNINGS].

Accidental Ingestion

• Accidental ingestion of even one dose of levorphanol tartrate tablets, especially by children, can result in a fatal overdose of levorphanol [see WARNINGS].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants 

• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of levorphanol tartrate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome (NOWS)

• Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):

• Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS].