Pronunciation: NAL-byoo-FEEN HIGH-droe-KLOR-ide
Class: Opioid agonist-antagonist analgesic
- Injection 10 mg/mL
- Injection 20 mg/mL
An opiate analgesic with both narcotic agonist and antagonist actions. Analgesic potency is about equal to that of morphine, and antagonist potency is about 1/ 25 that of naloxone. May cause sphincter of Oddi spasm. Does not increase pulmonary artery pressure, systemic vascular resistance, or myocardial work load.
When nalbuphine is taken orally, it is not as effective for pain relief as when given IM, mainly because of first-pass metabolism in GI and liver. T max is 30 min (IM).
Nalbuphine is not bound to plasma proteins. Nalbuphine crosses the placenta.
Metabolized in the liver.
Approximately 7% eliminated in urine unchanged and in feces. Plasma t 1/ 2 is 5 h and t 1/ 2 is 2.4 h.
Onset of IV nalbuphine is 2 to 3 min. Onset of subcutaneous and IM nalbuphine is less than 15 min.
Duration of analgesic activity is 3 to 6 h.
Indications and Usage
Management of moderate to severe pain; preoperative and postoperative analgesia; supplement to balanced anesthesia; obstetrical analgesia during labor and delivery.
Prevention and treatment of intrathecal morphine-induced pruritus after cesarean delivery.
Dosage and AdministrationAdults
Subcutaneous / IM / IV 10 mg per 70 kg q 3 to 6 h as needed. Individualize dosage. In nontolerant patients, do not exceed 20 mg/dose or 160 mg/day.
- For subcutaneous, IM, or IV administration. Not for intradermal or intra-arterial administration.
- Do not administer if particulate matter or discoloration noted.
- Discard any unused medication per institutional policy and procedure.
- Ensure naloxone, oxygen, and resuscitation and intubation equipment are available for use if needed.
Store ampules and vials at controlled room temperature (59° to 86°F). Protect from excessive light. Store ampules and vials in carton until contents have been used.
Drug InteractionsCNS depressants, including barbiturate anesthetics
Increased respiratory and CNS depression.
Laboratory Test Interactions
May interfere with enzymatic methods for detection of opioids, depending on the specificity of test.
Bradycardia, hypertension, hypotension, tachycardia (1% or less).
Sedation (36%); dizziness, vertigo (5%); headache (3%); agitation, confusion, crying, depression, dysphoria, euphoria, faintness, floating feeling, hallucinations, heaviness feeling, hostility, nervousness, numbness, restlessness, seizures, tingling, unreality, unusual dreams (1% or less).
Flushing (1% or less).
Blurred vision (1% or less).
Nausea, vomiting (6%); dry mouth (4%); bitter taste, cramps, dyspepsia (1% or less).
Urinary urgency (1% or less).
Anaphylactic or anaphylactoid and other hypersensitivity reactions (including shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, or laryngeal edema), stridor, bronchospasm, wheezing, edema, rash, pruritus, nausea, vomiting, diaphoresis, weakness, shakiness (1% or less).
Injection site reactions including burning, hot sensations, pain, redness, swelling (postmarketing).
Pulmonary edema (postmarketing).
Sweaty/clammy feeling (9%); speech difficulty, warmth (1% or less).
Category B .
Excreted in breast milk.
Safety and efficacy not established.
Duration of action may be prolonged in patients with renal function impairment; may need to reduce dose.
Duration of action may be prolonged in patients with hepatic function impairment; may need to reduce dose.
Special Risk Patients
Use drug with caution in patients with impaired respiration, head injury, increased intracranial pressure, or MI with nausea or vomiting, and in patients about to undergo biliary tract surgery.
Contains sodium metabisulfite, which may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthma.
Low abuse potential; however, withdrawal symptoms can occur after long-term use. Use drug with caution in patients who are emotionally unstable or have history of narcotic abuse.
Nalbuphine can precipitate withdrawal; small doses of morphine can be given to relieve discomfort. If patient has received morphine, meperidine, codeine, or other opiate of similar duration, give 25% of normal nalbuphine dose first. Observe for signs of withdrawal and increase nalbuphine dose slowly.
Respiratory depression, hypoxemia, sedation.
- Advise patient or caregiver that medication will usually be prepared and administered by a health care provider in a health care setting.
- Caution patient or caregiver that medication may be habit forming and, if used at home, to use exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider. Advise patient or caregiver to notify health care provider if medication does not adequately control pain.
- Advise patient or caregiver that if medication needs to be discontinued after prolonged use that it will usually slowly be withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal.
- Advise patient or caregiver to notify health care provider if any of the following occur: excessive sedation or drowsiness; slow or shallow breathing; low BP; slow heart rate; severe constipation.
- Instruct patient to get up slowly from lying or sitting position and to avoid sudden position changes to prevent postural hypotension.
- Advise patient to report dizziness with position changes to health care provider.
- Caution patient that hot tubs and hot showers or baths may make dizziness worse.
- Caution patient that drug may cause dizziness or drowsiness and to use caution while driving or performing other tasks requiring mental alertness or coordination until tolerance is determined.
- Caution patient to avoid alcohol and other CNS depressant medications while using this medication.
Copyright © 2009 Wolters Kluwer Health.
More Nalbuphine Hydrochloride resources
- Nalbuphine Hydrochloride Monograph (AHFS DI)
- Nalbuphine Prescribing Information (FDA)
- nalbuphine Injection Advanced Consumer (Micromedex) - Includes Dosage Information
- nalbuphine Concise Consumer Information (Cerner Multum)
- nalbuphine MedFacts Consumer Leaflet (Wolters Kluwer)
- Nubain Prescribing Information (FDA)