Adult Dosing
Moderate to severe pain
- 70 kgs: 10 mg IM/IV/SC q3-6 hrs if needed
- Nontolerant individuals: Max-20 mg/dose; Max-160 mg/day
Supplement to balanced anesthesia
- Initial dose: 0.3-3 mg/kg IV over a period of 10 to 15 min
- Maintenance dose: 0.25-0.5 mg/kg IV as required
Notes:- Adjust dose according to the severity of the pain, physical status of the patient, and concomitant medications, which the patient may be receiving
- In patients chronically receiving morphine, codeine, or other opioids, 25% of the usual dose is given initially and observed for withdrawal symptoms
- If such untoward symptoms occur, discontinue nalbuphine and institute appropriate treatment
- Nalbuphine doses may be increased progressively until the desired level of analgesia is obtained if withdrawal symptoms do not occur
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Only persons specifically trained in the use of IV anesthetics and management of respiratory effects of potent opioids should administer this drug as a supplement to general anesthesia. Keep naloxone hydrochloride injection, resuscitative and intubation equipment, and oxygen readily available
- Closely supervise emotionally unstable patients or individuals with a history of opioid abuse when prolonged nalbuphine therapy is contemplated
- Nalbuphine may impair the mental or physical abilities necessary for performing potentially hazardous tasks like driving or operating machinery. Patients should be warned to avoid such tasks
- Severe fetal bradycardia has occurred when nalbuphine is administered during labor. Use of this drug during pregnancy may cause similar adverse effects. Appropriate measures such as fetal monitoring, to detect and manage any potential adverse effect to the fetus, should be employed if used during pregnancy
- Fetal and neonatal adverse effects including severe and prolonged fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia have occurred following administration of nalbuphine to the mother during labor. Permanent neurological damage attributed to fetal bradycardia has also been reported. Monitor newborns for respiratory depression, apnea, bradycardia and arrhythmias if used during labor and delivery
- Nalbuphine should be administered during pregnancy, labor, and delivery only if clearly indicated and the benefits outweigh the risks
- Maintain patients under observation until recovered from nalbuphine effects that would affect performing dangerous tasks after emergency procedures
- Higher incidence of bradycardia has been reported in patients on nalbuphine injections who did not receive atropine pre-operatively
- Presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure may exaggerate the possible respiratory depressant effects and the potential of potent analgesics to elevate cerebrospinal fluid pressure
- Effects of potent analgesics may obscure the clinical course of patients with head injuries. Use only in circumstances where it is utmost essential and administer with extreme caution
- Patients receiving CNS depressants including alcohol concomitantly with nalbuphine may exhibit an additive effect; reduce the dose of one or both agents when such combined therapy is contemplated
- Do not abruptly discontinue the therapy; reduce the dose slowly or it may cause withdrawal symptoms
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Pulmonary impairment
- Myocardial infarction
- Biliary tract surgery or disease
- Elderly patients
- Hypersensitivity to sulfites
Supplemental Patient Information
- Advise patients to avoid performing potentially dangerous tasks such as driving a car or operating machinery because nalbuphine may impair the mental or physical abilities
- Caution patients that the use of nalbuphine with other opioids and its abrupt discontinuation after prolonged usage may cause signs and symptoms of withdrawal
Pregnancy Category:B
Breastfeeding: It is poorly excreted into breastmilk. Due to poor oral absorption, it is unlikely to adversely affect the breastfed infant. No special precautions are required. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 January 2011). Manufacturer advises caution.
