Country: United States
Language: English
Source: NLM (National Library of Medicine)
NALBUPHINE HYDROCHLORIDE (UNII: ZU4275277R) (NALBUPHINE - UNII:L2T84IQI2K)
Henry Schein, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
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
Nalbuphine Hydrochloride Injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.
Abbreviated New Drug Application
NALBUPHINE HYDROCHLORIDE- NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION HENRY SCHEIN, INC. ---------- NALBUPHINE HYDROCHLORIDE Injection Ampul Fliptop Vial Protect from light. Rx only BOXED WARNING WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Nalbuphine Hydrochloride Injection, particularly when used concomitantly with other opioids or central nervous system depressants. Monitor for respiratory depression, especially during initiation of Nalbuphine Hydrochloride Injection or following a dose increase [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 [see WARNINGS, PRECAUTIONS; DRUG INTERACTIONS]. Reserve concomitant prescribing of nalbuphine hydrochloride and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. DESCRIPTION Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL at 25ºC) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4 ∙ HCl. The structural formula is: Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution of Read the complete document