Nubain Warnings

Drug Dependence: Nubain cannot be substituted for heroin, methadone or other narcotics in physically dependent individuals in fact, it will precipitate abstinence in such patients. Nubain has been shown to have a low abuse potential. Psychological and physical dependence and tolerance may follow the misuse or abuse of nalbuphine, therefore, caution should be observed in prescribing it for emotionally unstable patients or for individuals with a history of narcotic abuse. When Nubain is selected for the control of chronic pain, care should be taken to avoid increases in dosage or the frequency of administration which, in susceptible individuals, might result in physical dependence and tolerance. Abrupt withdrawal after chronic use can precipitate abstinence syndrome.
Use in Ambulatory Patients: Nubain may impair the mental or physical abilities required for the performance of potentially dangerous tasks eg, driving a car or operating machinery. Therefore, Nubain should be administered with caution to ambulatory patients who should be warned to avoid such hazards.
Use in pregnancy: Safe use of Nubain in pregnancy (other than labor) has not been established. It should only be administered to pregnant women (other than in labor) when, in the judgment of the physician, the potential benefits outweigh the possible hazards. Potent analgesics should be used with caution in women delivering premature infants. In full-term labor, 10-15 mg of nalbuphine has provided analgesia equivalent to that of 75-113 mg of meperidine with fewer maternal side effects.
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 1:1.6. Fetal and neonatal adverse effects that have been reported following the administration of nalbuphine to the mother during labor include fetal tachycardia, respiratory depression at birth, apnea and cyanosis. 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 should be used with caution in women during labor and delivery and newborns should be monitored for respiratory depression, apnea, bradycardia and arrhythmias if Nubain 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 preexisting increase in intracranial pressure. Furthermore, potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Therefore, nalbuphine HCl 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 possesses narcotic antagonistic activity, there is evidence that in non-dependent patients, it will not antagonize a narcotic analgesic administered just before, concurrently, or just after an injection of Nubain. Therefore, patients receiving narcotic analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics or other CNS depressants (including alcohol) concomitantly with Nubain may exhibit an additive effect. When such combined therapy is contemplated, the dose of one or both agents should be reduced.