Stadol NS (Nasal)

Butorphanol tartrate has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental exposure to butorphanol, especially in children, can result in fatal overdose of butorphanol. Prolonged use of butorphanol tartrate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. The concomitant use of butorphanol tartrate with all CYP3A4 inhibitors may result in an increase in butorphanol plasma concentrations, which may cause potentially fatal respiratory depression, and discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in butorphanol plasma concentrations; monitor patients receiving butorphanol tartrate and any CYP3A4 inhibitor or inducer..