Butorphanol Tartrate

⛔ FDA Black Box Warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE INJECTION Addiction, Abuse, and Misuse Because the use of Butorphanol Tartrate Injection 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 Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration ‎of Butorphanol Tartrate Injection are essential [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 Injection 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 (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 ] .

Contraindications

CONTRAINDICATIONS Butorphanol Tartrate Injection is contraindicated in: • Patients with significant respiratory depression [see WARNINGS ] • Patients with acute of severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] • Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] • Patients with hypersensitivity to butorphanol tartrate or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ]

Pregnancy & Breastfeeding

Pregnancy Reproduction studies in mice, rats, and rabbits during organogenesis did not reveal any teratogenic potential to butorphanol. However, pregnant rats treated subcutaneously with butorphanol at 1 mg/kg (5.9 mg/m 2 ) had a higher frequency of stillbirths than controls. Butorphanol at 30 mg/kg/oral (360 mg/m 2 ) and 60 mg/kg/oral (720 mg/m 2 ) also showed higher incidences of post‑implantation loss in rabbits. There are no adequate and well-controlled studies of Butorphanol Tartrate Injection in pregnant women before 37 weeks of gestation. Butorphanol Tartrate Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the infant. Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS ].