Yes

Analgesic, Narcotic

Relief of moderate to severe pain; preoperative analgesia, postoperative and surgical anesthesia, and obstetrical analgesia during labor and delivery

B/D (if used for prolonged periods or in high doses at term)

Hypersensitivity to nalbuphine or any component, including sulfites

Use with caution in patients with recent myocardial infarction, biliary tract surgery, or sulfite sensitivity; may produce respiratory depression; use with caution in women delivering premature infants; use with caution in patients with a history of drug dependence, head trauma or increased intracranial pressure, decreased hepatic or renal function, or pregnancy; tolerance or drug dependence may result from extended use

>10%:

Central nervous system: Drowsiness, CNS depression, narcotic withdrawal

Miscellaneous: Histamine release

1% to 10%:

Cardiovascular: Hypotension, flushing

Central nervous system: Dizziness, headache

Dermatologic: Urticaria, rash

Gastrointestinal: Nausea, vomiting, anorexia, xerostomia

Local: Pain at injection site

Neuromuscular & skeletal: Weakness

Respiratory: Pulmonary edema

<1%: Hypertension, tachycardia, mental depression, hallucinations, confusion, paradoxical CNS stimulation, nervousness, restlessness, nightmares, insomnia GI irritation, biliary spasm, decreased urination, toxic megacolon, ureteral spasm, blurred vision, shortness of breath, respiratory depression

Symptoms of overdose include CNS depression, respiratory depression, miosis, hypotension, bradycardia

Treatment of an overdose includes support of the patient's airway, establishment of an I.V. line and administration of naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat administration as necessary up to a total of 10 mg.

Increased toxicity: Barbiturate anesthetics may increase CNS depression

Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression

Peak effect: I.M.: 30 minutes; I.V.: 1-3 minutes

Metabolism: In the liver

Half-life: 3.5-5 hours

Elimination: Metabolites excreted primarily in feces (via bile) and in urine (~7%)

I.M., I.V., S.C.:

Adults: 10 mg/70 kg every 3-6 hours; maximum single dose: 20 mg; maximum daily dose: 160 mg

Dosing adjustment/comments in hepatic impairment: Use with caution and reduce dose

Alcohol: Additive CNS effects, avoid or limit alcohol; watch for sedation

Administer I.M., S.C., or I.V.

Relief of pain, respiratory and mental status, blood pressure

Drowsiness is common; may cause dizziness; may rarely cause restlessness, nervousness, confusion, depression, or hallucinations

Concurrent use with psychotropic may produce additive sedation

No information available to require special precautions

Anticholinergic side effects can cause a reduction of saliva production or secretion contributes to discomfort and dental disease (ie, caries, oral candidiasis and periodontal disease)

If self-administered, use exactly as directed (do not increase dose or frequency); may cause physical and/or psychological dependence. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). May cause hypotension, dizziness, drowsiness, impaired coordination, or blurred vision (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); loss of appetite, nausea, or vomiting (frequent mouth care, small frequent meals, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help - if constipation remains an unresolved problem, consult prescriber about use of stool softeners). Report chest pain, slow or rapid heartbeat, acute dizziness or persistent headache; changes in mental status; swelling of extremities or unusual weight gain; changes in urinary elimination or pain on urination; acute headache; back or flank pain or muscle spasms; blurred vision; skin rash; or shortness of breath. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. If you are breast-feeding, take medication immediately after breast-feeding or 3-4 hours prior to next feeding.

Observe patient for excessive sedation, respiratory depression, implement safety measures, assist with ambulation; observe for narcotic withdrawal

Injection, as hydrochloride: 10 mg/mL (1 mL, 10 mL); 20 mg/mL (1 mL, 10 mL)

"Drugs for Pain," Med Lett Drugs Ther, 1998, 40(1033):79-84.

Errick JK and Heel RC, "Nalbuphine: A Preliminary Review of Its Pharmacological Properties and Therapeutic Efficacy," Drugs, 1983, 26(3):191-211.

Jaillon P, Gardin ME, Lecocq B, et al, "Pharmacokinetics of Nalbuphine in Infants, Young Healthy Volunteers, and Elderly Patients," Clin Pharmacol Ther, 1989, 46(2):226-33.

Leikin JB, Ehrenpreis ED, Barkin RL, et al, "Nalbuphine vs Meperidine in Sickle Cell Anemia," DICP, 1990, 24(7-8):781-2.

Yoo YC, Chung HS, Kim IS, et al, "Determination of Nalbuphine in Drug Abusers' Urine," J Anal Toxicol, 1995, 19(2):120-3.