"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
NUBAIN (nalbuphine hydrochloride) should be administered as a supplement to general anesthesia only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
Naloxone, resuscitative and intubation equipment and oxygen should be readily available.
Caution should be observed in prescribing NUBAIN (nalbuphine hydrochloride) for emotionally unstable patients, or for individuals with a history of opioid abuse. Such patients should be closely supervised when long-term therapy is contemplated (see Drug Abuse And Dependence).
Use in Ambulatory Patients
NUBAIN (nalbuphine hydrochloride) may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Therefore, NUBAIN (nalbuphine hydrochloride) should be administered with caution to ambulatory patients who should be warned to avoid such hazards.
Use in Emergency Procedures
Maintain patient under observation until recovered from NUBAIN (nalbuphine hydrochloride) effects that would affect driving or other potentially dangerous tasks.
Use in Pregnancy (Other Than Labor)
Severe fetal bradycardia has been reported when NUBAIN (nalbuphine hydrochloride) is administered during labor. Naloxone may reverse these effects. Although there are no reports of fetal bradycardia earlier in pregnancy, it is possible that this may occur. This drug should be used in pregnancy only if clearly needed, if the potential benefit outweighs the risk to the fetus, and if appropriate measures such as fetal monitoring are taken to detect and manage any potential adverse effect on the fetus.
Use During Labor and Delivery
The placental transfer of nalbuphine is high, rapid, and variable with a maternal to fetal ratio ranging from 1:0.37 to 1:6. Fetal and neonatal adverse effects that have been reported following the administration of nalbuphine to the mother during labor include fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia. Some of these events have been life-threatening. Maternal administration of naloxone during labor has normalized these effects in some cases. Severe and prolonged fetal bradycardia has been reported. Permanent neurological damage attributed to fetal bradycardia has occurred. A sinusoidal fetal heart rate pattern associated with the use of nalbuphine has also been reported. NUBAIN (nalbuphine hydrochloride) should be used during labor and delivery only if clearly indicated and only if the potential benefit outweighs the risk to the infant. Newborns should be monitored for respiratory depression, apnea, bradycardia and arrhythmias if NUBAIN (nalbuphine hydrochloride) has been used.
Head Injury and Increased Intracranial Pressure
The possible respiratory depressant effects and the potential of potent analgesics to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre- existing increase in intracranial pressure. Furthermore, potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Therefore, NUBAIN (nalbuphine hydrochloride) should be used in these circumstances only when essential, and then should be administered with extreme caution.
Interaction with Other Central Nervous System Depressants
Although NUBAIN (nalbuphine hydrochloride) possesses opioid antagonist activity, there is evidence that in nondependent patients it will not antagonize an opioid analgesic administered just before, concurrently, or just after an injection of NUBAIN (nalbuphine hydrochloride) . Therefore, patients receiving an opioid analgesic, general anesthetics, phenothiazines, or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with NUBAIN (nalbuphine hydrochloride) may exhibit an additive effect. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
At the usual adult dose of 10 mg/70 kg, NUBAIN (nalbuphine hydrochloride) causes some respiratory depression approximately equal to that produced by equal doses of morphine. However, in contrast to morphine, respiratory depression is not appreciably increased with higher doses of NUBAIN (nalbuphine hydrochloride) . Respiratory depression induced by NUBAIN (nalbuphine hydrochloride) can be reversed by NARCAN® (naloxone hydrochloride) when indicated. NUBAIN (nalbuphine hydrochloride) should be administered with caution at low doses to patients with impaired respiration (e.g., from other medication, uremia, bronchial asthma, severe infection, cyanosis, or respiratory obstructions).
Impaired Renal or Hepatic Function:
Because NUBAIN (nalbuphine hydrochloride) is metabolized in the liver and excreted by the kidneys, NUBAIN (nalbuphine hydrochloride) should be used with caution in patients with renal or liver dysfunction and administered in reduced amounts.
As with all potent analgesics, NUBAIN (nalbuphine hydrochloride) should be used with caution in patients with myocardial infarction who have nausea or vomiting.
Biliary Tract Surgery:
As with all opioid analgesics, NUBAIN (nalbuphine hydrochloride) should be used with caution in patients about to undergo surgery of the biliary tract since it may cause spasm of the sphincter of Oddi.
During evaluation of NUBAIN (nalbuphine hydrochloride) in anesthesia, a higher incidence of bradycardia has been reported in patients who did not receive atropine pre-operatively.
NUBAIN (nalbuphine hydrochloride) may interfere with enzymatic methods for the detection of opioids depending on the specificity/sensitivity of the test. Consult the test manufacturer for specific details.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term carcinogenicity studies were performed in rats (24 months) and mice (19 months) by oral administration at doses up to 200 mg/kg (1180 mg/m2) and 200 mg/kg (600 mg/m2) per day, respectively. There was no evidence of an increase in tumors in either species related to NUBAIN (nalbuphine hydrochloride) administration. The maximum recommend human dose (MRHD) in a day is 160 mg subcutaneously, intramuscularly or intravenously, or approximately 100 mg/m2/day for a 60 kg subject.
NUBAIN (nalbuphine hydrochloride) did not have mutagenic activity in the AMES test with four bacterial strains, in the Chinese Hamster Ovary HGPRT assays or in the Sister Chromatids Exchange Assay. However, NUBAIN (nalbuphine hydrochloride) induced an increased frequency of mutation in the mouse lymphoma assay. Clastogenic activity was not observed in the mouse micronucleus test of the cytogenicity bone marrow assay in rats.
Impairment of Fertility
A reproduction study was performed in male and female rats at subcutaneous doses up to 56 mg/kg/day or 330 mg/m2/day. NUBAIN (nalbuphine hydrochloride) did not affect either male or female fertility rats.
Usage in Pregnancy
Teratogenic Effects: Pregnancy Category B
Reproduction studies have been performed in rats by subcutaneous administration of nalbuphine up to 100 mg/kg/day, or 590 mg/m2/day which is approximately 6 times the MRHD, and in rabbits by intravenous administration of nalbuphine up to 32 mg/kg/day, or 378 mg/m2/day which is approximately 4 times the MRHD. The results did not reveal evidence of developmental toxicity, including teratogenicity, or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Neonatal body weight and survival rates were reduced at birth and during lactation when nalbuphine was subcutaneously administered to female and male rats prior to mating and throughout gestation and lactation or to pregnant rats during the last third of gestation and throughout lactation at doses approximately 4 times the maximum recommended human dose.
Use During Labor and Delivery
Limited data suggest that NUBAIN (nalbuphine hydrochloride) is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when NUBAIN (nalbuphine hydrochloride) is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 18 years have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/4/2008
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