BUTORPHANOL TARTRATE

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE NASAL SPRAY Addiction, Abuse, and Misuse Because the use of butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of butorphanol tartrate nasal spray are essential [see WARNINGS ]. Accidental Exposure Accidental exposure of even one dose of butorphanol tartrate nasal spray, especially in children, can result in a fatal overdose of butorphanol tartrate[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 butorphanol tartrate nasal spray and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS ; Drug Interactions ]. Neonatal Opioid Withdrawal Syndrome If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, 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