• Moderate to severe pain.
• Supplement to balanced anesthesia.
• Pain control during labor.
• Sedation before surgery.

Contraindicated in:

• Hypersensitivity to nalbuphine or bisulfites
• Patients physically dependent on opioids and who have not been detoxified (may precipitate withdrawal).

Use Cautiously in:

• Personal or family history of substance use disorder or mental illness
• Head trauma
• ↑intracranial pressure
• Severe renal impairment
• Severe hepatic impairment
• Severe pulmonary disease
• Hypothyroidism
• Adrenal insufficiency
• Undiagnosed abdominal pain
• Prostatic hyperplasia
• Patients who have recently received opioid agonists
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk. Has been used during labor but may cause respiratory depression in the newborn; prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant. May cause respiratory depression and excessive sedation in infant
• Pedi: Safety and effectiveness not established in children
• Geri: Dose ↓ suggested in older adults.

CV: hypertension, orthostatic hypotension, palpitations.

Derm: ↑sweating, clammy feeling.

EENT: blurred vision, diplopia, miosis (high doses).

Endo: adrenal insufficiency.

GI: dry mouth, nausea, vomiting, constipation, ileus.

GU: urinary urgency.

Neuro: dizziness, headache, sedation, confusion, dysphoria, euphoria, floating feeling, hallucinations, unusual dreams.

Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA).

Misc: allodynia, opioid-induced hyperalgesia, physical dependence, psychological dependence, tolerance.

Drug-Drug:

• Use with extreme caution in patients receiving MAO inhibitors (may result in unpredictable, severe reactions; ↓ initial dose of nalbuphine to 25% of usual dose).
• Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
• May precipitate withdrawal in patients who are physically dependent on opioid agonists.
• Avoid concurrent use with other opioid agonists; may diminish analgesic effect.
• Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, SNRIs, MAO inhibitors, tramadol, trazodone, mirtazapine, 5HT₃ receptor antagonists, linezolid, methylene blue, and triptans, may ↑ risk of serotonin syndrome.

Drug-Natural Products:

• Concomitant use of kava-kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

(Generic available)

• Solution for injection: 10 mg/mL; 20 mg/mL;

Analgesia

• IM, SC, IV (Adults): Usual dose is 10 mg every 3–6 hr (max = 20 mg/dose or 160 mg/day).
• IM, SC, IV (Children): 0.1–0.15 mg/kg every 3–6 hr (max = 20 mg/dose or 160 mg/day).

Supplement to Balanced Anesthesia

• IV (Adults): Initial: 0.3–3 mg/kg over 10–15 min. Maintenance: 0.25–0.5 mg/kg as needed.

• Binds to opiate receptors in the CNS.
• Alters the perception of and response to painful stimuli while producing generalized CNS depression.
• In addition, has partial antagonist properties, which may result in opioid withdrawal in physically dependent patients.

• Decreased pain.

Therapeutic Classification: opioid analgesics

Pharmacologic Classification: opioid agonists analgesics

Absorption: Well absorbed after IM and SUBQ administration. IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Mostly metabolized by the liver and eliminated in the feces via biliary excretion. Minimal amounts excreted unchanged by the kidneys.

Half-life: Children (1–8 yr): 0.9 hr; Adults: 3.5–5 hr.

Nubain

(analgesia)

• Explain purpose and side effects of nalbuphine to patient. Instruct them how and when to ask for pain medication. Do not stop taking drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Medication Guidebefore starting and periodically during therapy in case of changes.
• May cause drowsiness or dizziness. Advise patient to call for assistance when ambulating and to avoid driving or other activities requiring alertness until response to the medication is known.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient to notify health care professional if pain control is not adequate or if severe or persistent side effects occur.
• Emphasize the importance of aggressive prevention of constipation with the use of nalbuphine.
• Caution patient to change positions slowly to minimize orthostatic hypotension.
• Advise patient that frequent mouth rinses, good oral hygiene, and sugarless gum or candy may ↓ dry mouth.
• Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
• Advise patient to avoid concurrent use of alcohol or other CNS depressants with this medication.
• Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, failure to gain weight); usually occur the first days after birth. Monitor infants exposed to nalbuphine through breast milk for excess sedation and respiratory depression. Chronic use may reduce fertility in females and males.

NAL-byoo-feen

NDC Code^*

• 0409- Hospira, Inc.
  • 0409-1463- Nalbuphine Hydrochloride
    • 0409-1463-49- 10 AMPULE in 1 TRAY (0409-1463-49) > 1 mL in 1 AMPULE

• 0409- Hospira, Inc.
  • 0409-1463- Nalbuphine Hydrochloride
    • 0409-1463-01- 10 AMPULE in 1 TRAY (0409-1463-01) > 1 mL in 1 AMPULE

• 0409- Hospira, Inc.
  • 0409-1464- Nalbuphine Hydrochloride
    • 0409-1464-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1464-01) > 10 mL in 1 VIAL, MULTI-DOSE

• 0409- Hospira, Inc.
  • 0409-1465- Nalbuphine Hydrochloride
    • 0409-1465-01- 10 AMPULE in 1 TRAY (0409-1465-01) > 1 mL in 1 AMPULE

• 0409- Hospira, Inc.
  • 0409-1467- Nalbuphine Hydrochloride
    • 0409-1467-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1467-01) > 10 mL in 1 VIAL, MULTI-DOSE

• 52584- General Injectables and Vaccines, Inc
  • 52584-463- Nalbuphine Hydrochloride
    • 52584-463-01- 1 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE

• 63739- McKesson Corporation
  • 63739-466- Nalbuphine Hydrochloride
    • 63739-466-05- 5 POUCH in 1 BOX (63739-466-05) > 1 AMPULE in 1 POUCH (63739-466-21) > 1 mL in 1 AMPULE

• 71872- Medical Purchasing Solutions, LLC
  • 71872-7114- Nalbuphine Hydrochloride
    • 71872-7114-1- 1 VIAL, MULTI-DOSE in 1 BAG (71872-7114-1) > 10 mL in 1 VIAL, MULTI-DOSE