NUBAIN Nalbuphine Hydrochloride 10mg / mL Solution for Injection 1mL 10's
RXDRUG-DR-X3037-10
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Relief of moderate to severe pain. Pre-operative analgesia, as a supplement to balanced anesthesia, surgical anesthesia, for obstetrical analgesia during labor and for the relief of pain following acute myocardial infarction.
Post-operative somatic and visceral pain.
Post-operative somatic and visceral pain.
Dosage/Direction for Use
Adults: 0.15-0.2 mg/kg. Children: 0.1-0.2 mg/kg up to a total single dose of 10 mg.
Administration: Nubain may be administered SC, IM or IV. The doses may be repeated every 3-6 hrs or as needed. Dosage should be adjusted according to severity of pain and physical status of the patient.
Administration: Nubain may be administered SC, IM or IV. The doses may be repeated every 3-6 hrs or as needed. Dosage should be adjusted according to severity of pain and physical status of the patient.
Overdosage
The administration of single IM doses of 72 mg of Nubain to 8 normal subjects has been reported to have resulted primarily in symptoms of sleepiness and mild dysphoria.
Naloxone HCl is a specific antidote for nalbuphine HCl, but symptomatic and supportive therapy will usually suffice for mild or moderate overdosage. Oxygen, IV fluids, vasopressors and other supportive measures should be employed as indicated.
Naloxone HCl is a specific antidote for nalbuphine HCl, but symptomatic and supportive therapy will usually suffice for mild or moderate overdosage. Oxygen, IV fluids, vasopressors and other supportive measures should be employed as indicated.
Contraindications
Hypersensitivity to nalbuphine HCl.
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.
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.
Special Precautions
Impaired Respiration: Nubain 10 mg causes some respiratory depression approximately equivalent to morphine 10 mg. However, in contrast to morphine, respiratory depression is not appreciably increased with higher doses of Nubain. Respiratory depression induced by Nubain can be reversed by naloxone HCl when indicated. It should be administered with caution at low doses to patients with impaired respiration (eg, from other medication, uremia, bronchial asthma, severe infection, cyanosis or respiratory obstruction).
Impaired Renal or Hepatic Function: Because Nubain is metabolized in the liver and excreted by the kidneys, patients with renal or liver dysfunction may over-react to customary doses. Therefore, in these individuals, Nubain should be used with caution and administered in reduced amounts. However, liver and renal function tests on patients who have received Nubain in single and chronic dosages do not reveal any changes attributable to its administration.
Use in pregnancy & lactation: Caution should be exercised when administered to pregnant and nursing patients. Nalbuphine should only be administered when in the judgment of the physician, the potential benefits outweigh the possible hazards.
Impaired Renal or Hepatic Function: Because Nubain is metabolized in the liver and excreted by the kidneys, patients with renal or liver dysfunction may over-react to customary doses. Therefore, in these individuals, Nubain should be used with caution and administered in reduced amounts. However, liver and renal function tests on patients who have received Nubain in single and chronic dosages do not reveal any changes attributable to its administration.
Use in pregnancy & lactation: Caution should be exercised when administered to pregnant and nursing patients. Nalbuphine should only be administered when in the judgment of the physician, the potential benefits outweigh the possible hazards.
Use In Pregnancy & Lactation
Caution should be exercised when administered to pregnant and nursing patients. Nalbuphine should only be administered when in the judgment of the physician, the potential benefits outweigh the possible 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.
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.
Adverse Reactions
The most commonly occurring reactions are sedation, drowsiness, sweating, nausea, dry mouth and dizziness. Pain at injection site, headache, vomiting and lightheadedness occurs less frequently. Restlessness, blurred vision, chills, euphoria and impaired respiration have been infrequent.
Nubain produces few if any psychotomimetic side effects eg, visual hallucinations and dysphoria.
Nubain produces few if any psychotomimetic side effects eg, visual hallucinations and dysphoria.
Drug Interactions
Additive effect w/ narcotic analgesic, general anesth, phenothiazines or other tranquilizers, sedatives, hypnotics or other CNS depressants (including alcohol).
Caution For Usage
Monitoring on the Usage: Prescriptions of Nubain shall be through an ordinary prescription form wherein the name, address, S2 license number and PTR number of the prescribing practitioner shall be stated, as well as the name, address and age of the patient. The pharmacist must keep a record of its sales including the name and address of the prescribing physician in an Additional Dangerous Drugs Record Book registered prior to use.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Nalbuphine HCl is a potent analgesic, 10 mg of which is comparable in analgesic potency to 8-10 mg of morphine sulfate, whether administered IV, SC or IM.
The onset of action occurs within 2-3 min after IV administration of nalbuphine HCl and in <10 min following SC or IM injection.
Clinical experience suggests that in some patients, analgesia may be longer lasting than from comparable doses of morphine, effects having been observed in acute and chronic pain for 3-8 hrs. The half-life (t½) of nalbuphine is 5 hrs.
Nubain has the effect of lowering the cardiac work load and can be used immediately in myocardial infarction (use with caution where emesis is involved). Hemodynamic studies in patients with severe arteriosclerotic heart changes reveal that nalbuphine HCl has circulatory effects similar to those of morphine ie, a minimal decrease in oxygen consumption, cardiac index, left ventricular end diastolic pressure and cardiac work.
Nubain antagonist activity is ¼ as potent as nalorphine and approximately 1/40 that of naloxone.
The onset of action occurs within 2-3 min after IV administration of nalbuphine HCl and in <10 min following SC or IM injection.
Clinical experience suggests that in some patients, analgesia may be longer lasting than from comparable doses of morphine, effects having been observed in acute and chronic pain for 3-8 hrs. The half-life (t½) of nalbuphine is 5 hrs.
Nubain has the effect of lowering the cardiac work load and can be used immediately in myocardial infarction (use with caution where emesis is involved). Hemodynamic studies in patients with severe arteriosclerotic heart changes reveal that nalbuphine HCl has circulatory effects similar to those of morphine ie, a minimal decrease in oxygen consumption, cardiac index, left ventricular end diastolic pressure and cardiac work.
Nubain antagonist activity is ¼ as potent as nalorphine and approximately 1/40 that of naloxone.
MedsGo Class
Features
Brand
Nubain
Full Details
Dosage Strength
10 mg / ml
Drug Ingredients
- Nalbuphine
Drug Packaging
Solution for Injection 1ml x 10's
Generic Name
Nalbuphine Hcl
Dosage Form
Solution for Injection
Registration Number
DR-X3037
Drug Classification
Prescription Drug (RX)
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