"The US Food and Drug Administration (FDA) has approved an extended-release (ER) morphine sulfate C-II (Arymo ER, Egalet Corp) for the management of pain severe enough to require round-the-clock, long-term opioid management for which alte"...
(nalbuphine hydrochloride) Injection
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
Nalbuphine hydrochloride 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 nalbuphine hydrochloride injection, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of nalbuphine hydrochloride injection. Monitor for respiratory depression, especially during initiation of nalbuphine hydrochloride injection or following a dose increase [see WARNINGS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of nalbuphine hydrochloride injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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 [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, DRUG INTERACTIONS].
- Reserve concomitant prescribing of nalbuphine hydrochloride and benzodiazepines or other CNS depress ants for use in patients for whom alternative treatment options are inadequate.
- Limit dos ages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
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 25°C) 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 nalbuphine hydrochloride in water for injection. This product may be administered by subcutaneous, intramuscular or intravenous injection.
Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg; sodium citrate, dihydrate 0.47 mg and citric acid, anhydrous 0.63 mg added as buffers and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment; pH 3.7 (3.0 to 4.5). Contains sodium chloride for tonicity adjustment.
Multiple-dose vials contain 1.8 mg/mL methylparaben and 0.2 mg/mL propylparaben added as preservatives. Single-dose products contain no bacteriostat or antimicrobial agent and unused portions must be discarded.
What are the possible side effects of nalbuphine (Nubain)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- weak or shallow breathing;
- fast or slow heart rate;
- cold, clammy skin;
- confusion, hallucinations, unusual thoughts or behavior;
- severe weakness or drowsiness; or
- feeling like you might pass out.
Less serious side effects are more likely to occur, such as:
- feeling nervous or...
Last reviewed on RxList: 11/1/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Nubain Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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