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Pronunciation |
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(NAL
byoo
feen) |
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U.S. Brand
Names |
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Nubain® |
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Generic
Available |
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Yes |
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Synonyms |
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Nalbuphine Hydrochloride |
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Pharmacological Index |
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Analgesic, Narcotic |
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Use |
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Relief of moderate to severe pain; preoperative analgesia, postoperative and
surgical anesthesia, and obstetrical analgesia during labor and
delivery |
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Pregnancy Risk
Factor |
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B/D (if used for prolonged periods or in high doses at
term) |
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Contraindications |
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Hypersensitivity to nalbuphine or any component, including
sulfites |
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Warnings/Precautions |
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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 |
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Adverse
Reactions |
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>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
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Overdosage/Toxicology |
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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. |
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Drug
Interactions |
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Increased toxicity: Barbiturate anesthetics may increase CNS
depression |
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Mechanism of
Action |
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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 |
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Pharmacodynamics/Kinetics |
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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%) |
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Usual Dosage |
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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 |
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Dietary
Considerations |
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Alcohol: Additive CNS effects, avoid or limit alcohol; watch for
sedation |
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Administration |
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Administer I.M., S.C., or I.V. |
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Monitoring
Parameters |
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Relief of pain, respiratory and mental status, blood
pressure |
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Mental Health: Effects
on Mental Status |
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Drowsiness is common; may cause dizziness; may rarely cause restlessness,
nervousness, confusion, depression, or hallucinations |
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Mental Health:
Effects on Psychiatric
Treatment |
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Concurrent use with psychotropic may produce additive
sedation |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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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) |
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Patient
Information |
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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. |
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Nursing
Implications |
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Observe patient for excessive sedation, respiratory depression, implement
safety measures, assist with ambulation; observe for narcotic
withdrawal |
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Dosage Forms |
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Injection, as hydrochloride: 10 mg/mL (1 mL, 10 mL); 20 mg/mL (1 mL, 10
mL) |
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References |
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"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. |
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