United States - English - NLM (National Library of Medicine)

hospira, inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride 10 mg in 1 ml - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings ], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): nalbuphine hydrochloride injection should not be used for an extended period of time unless the pain ‎remains severe enough to require an opioid analgesic and for which ‎alternative treatment options continue to be inadequate.‎ nalbuphine hydrochloride injection is contraindicated in patients with: nalbuphine hydrochloride injection contains nalbuphine, a substance which is subject to misuse and abuse, which can lead to the ‎development of substance use disorder, including addiction [see warnings ]. misuse is the intentional use, for therapeutic purposes, of a drug by an ‎individual in a way other than prescribed by a healthcare provider or for ‎whom it was not prescribed.‎ abuse is the intentional, non-therapeutic use of a drug, even once, for its ‎desirable psychological or physiological effects.‎ drug addiction is a cluster of behavioral, cognitive, and physiological ‎phenomena that may include a strong desire to take the drug, difficulties ‎in controlling drug use (e.g., continuing drug use despite harmful ‎consequences, giving a higher priority to drug use than other activities ‎and obligations), and possible tolerance or physical dependence.‎ misuse and abuse of nalbuphine hydrochloride injection ‎increases risk of overdose, which ‎may lead to central nervous system and respiratory depression, ‎hypotension, seizures, and death. the risk is increased with concurrent ‎abuse of nalbuphine hydrochloride injection ‎with alcohol and other cns ‎depressants. abuse of and addiction to opioids in some individuals may ‎not be accompanied by concurrent tolerance and symptoms of physical ‎dependence. in addition, abuse of opioids can occur in the absence of ‎addiction.‎ all patients treated with opioids require careful and frequent reevaluation ‎for signs of misuse, abuse, and addiction, because use of opioid analgesic ‎products carries the risk of addiction even under appropriate medical use. ‎patients at high risk of nalbuphine hydrochloride injection ‎abuse include those with a history ‎of prolonged use of any opioid, including products containing nalbuphine, those with a history ‎of drug or alcohol abuse, or those who use nalbuphine hydrochloride injection ‎in combination ‎with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. nalbuphine hydrochloride injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. abuse of nalbuphine hydrochloride injection poses a risk of overdose and death. the risk is increased with concurrent use of nalbuphine hydrochloride injection with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after ‎repeated administration (i.e., a higher dose of a drug is required to ‎produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response ‎to repeated drug use, manifested by withdrawal signs and symptoms after ‎abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with ‎opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist ‎analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists ‎‎(e.g., buprenorphine). physical dependence may not occur to a clinically ‎significant degree until after several days to weeks of continued use.‎ nalbuphine hydrochloride injection should not be abruptly discontinued in a physically-dependent patient [see dosage and administration ]. if nalbuphine hydrochloride injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically‑dependent on opioids will also be physically‑dependent and may exhibit respiratory difficulties and withdrawal signs [see precautions; pregnancy ].

United States - English - NLM (National Library of Medicine)

general injectables & vaccines, inc - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride 10 mg in 1 ml - nalbuphine hydrochloride injection is indicated for the management of moderate to pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings ), reserve nalbuphine hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products). - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection in contraindicated in patients with: - significant respiratory depression [see warnings ] ) - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscit

United States - English - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride 20 mg in 1 ml - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or su

United States - English - NLM (National Library of Medicine)

medical purchasing solutions, llc - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipmen

United States - English - NLM (National Library of Medicine)

hospira, inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use: because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings ], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): nalbuphine hydrochloride injection should not be used for an extended period of time unless the pain ‎remains severe enough to require an opioid analgesic and for which ‎alternative treatment options continue to be inadequate. nalbuphine hydrochloride injection is contraindicated in patients with: nalbuphine hydrochloride injection contains nalbuphine, a substance which is subject to misuse and abuse, which can lead to the ‎development of substance use disorder, including addiction‎ [see warnings ]. misuse is the intentional use, for therapeutic purposes, of a drug by an ‎individual in a way other than prescribed by a healthcare provider or for ‎whom it was not prescribed.‎ abuse is the intentional, non-therapeutic use of a drug, even once, for its ‎desirable psychological or physiological effects.‎ drug addiction is a cluster of behavioral, cognitive, and physiological ‎phenomena that may include a strong desire to take the drug, difficulties ‎in controlling drug use (e.g., continuing drug use despite harmful ‎consequences, giving a higher priority to drug use than other activities ‎and obligations), and possible tolerance or physical dependence.‎ misuse and abuse of nalbuphine hydrochloride injection ‎increases risk of overdose, which ‎may lead to central nervous system and respiratory depression, ‎hypotension, seizures, and death. the risk is increased with concurrent ‎abuse of nalbuphine hydrochloride injection ‎with alcohol and other cns ‎depressants. abuse of and addiction to opioids in some individuals may ‎not be accompanied by concurrent tolerance and symptoms of physical ‎dependence. in addition, abuse of opioids can occur in the absence of ‎addiction.‎ all patients treated with opioids require careful and frequent reevaluation ‎for signs of misuse, abuse, and addiction, because use of opioid analgesic ‎products carries the risk of addiction even under appropriate medical use. ‎patients at high risk of nalbuphine hydrochloride injection ‎abuse include those with a history ‎of prolonged use of any opioid, including products containing nalbuphine, those with a history ‎of drug or alcohol abuse, or those who use nalbuphine hydrochloride injection ‎in combination ‎with other abused drugs.‎ "drug-seeking" behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. nalbuphine hydrochloride injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. abuse of nalbuphine hydrochloride injection poses a risk of overdose and death. the risk is increased with concurrent use of nalbuphine hydrochloride injection with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after ‎repeated administration (i.e., a higher dose of a drug is required to ‎produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response ‎to repeated drug use, manifested by withdrawal signs and symptoms after ‎abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with ‎opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist ‎analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists ‎‎(e.g., buprenorphine). physical dependence may not occur to a clinically ‎significant degree until after several days to weeks of continued use.‎ nalbuphine hydrochloride injection should not be abruptly discontinued in a physically-dependent patient [see dosage and administration ]. if nalbuphine hydrochloride injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. infants born to mothers physically‑dependent on opioids will also be physically‑dependent and may exhibit respiratory difficulties and withdrawal signs [see precautions; pregnancy ].

United States - English - NLM (National Library of Medicine)

general injectables and vaccines,inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection is contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnin

United States - English - NLM (National Library of Medicine)

general injectables and vaccines, inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection is contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnin

United States - English - NLM (National Library of Medicine)

henry schein, inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of moderate to pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings ), reserve nalbuphine hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products). - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection in contraindicated in patients with: - significant respiratory depression [see warnings ] ) - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscit

United States - English - NLM (National Library of Medicine)

henry schein, inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection is contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnin

United States - English - NLM (National Library of Medicine)

henry schein, inc. - nalbuphine hydrochloride (unii: zu4275277r) (nalbuphine - unii:l2t84iqi2k) - nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia nalbuphine hydrochloride injection is contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnin