"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.
DOSAGE AND ADMINISTRATION
The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, intramuscularly or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be receiving. (See Interaction with Other Central Nervous System Depressants under WARNINGS). In non-tolerant individuals, the recommended single maximum dose is 20 mg, with a maximum total daily dose of 160 mg.
The use of NUBAIN (nalbuphine hydrochloride) as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia. Induction doses of NUBAIN (nalbuphine hydrochloride) range from 0.3 mg/kg to 3 mg/kg intravenously to be administered over a 10 to 15 minute period with maintenance doses of 0.25 to 0.5 mg/kg in single intravenous administrations as required. The use of NUBAIN (nalbuphine hydrochloride) may be followed by respiratory depression which can be reversed with the opioid antagonist NARCAN® (naloxone hydrochloride).
NUBAIN (nalbuphine hydrochloride) is physically incompatible with nafcillin and keterolac.
Patients Dependent on Opioids
Patients who have been taking opioids chronically may experience withdrawal symptoms upon the administration of NUBAIN (nalbuphine hydrochloride) . If unduly troublesome, opioid withdrawal symptoms can be controlled by the slow intravenous administration of small increments of morphine, until relief occurs. If the previous analgesic was morphine, meperidine, codeine, or other opioid with similar duration of activity, one-fourth of the anticipated dose of NUBAIN (nalbuphine hydrochloride) can be administered initially and the patient observed for signs of withdrawal, i.e., abdominal cramps, nausea and vomiting, lacrimation, rhinorrhea, anxiety, restlessness, elevation of temperature or piloerection. If untoward symptoms do not occur, progressively larger doses may be tried at appropriate intervals until the desired level of analgesia is obtained with NUBAIN (nalbuphine hydrochloride) .
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
NUBAIN® (nalbuphine hydrochloride) injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in:
NDC 63481-508-05 (sulfite-free) 10 mg/mL, 10 mL multiple dose vials (box of
NDC 63481-432-10 (sulfite/paraben-free) 10 mg/mL, 1 mL ampuls (box of 10)
NDC 63481-509-05 (sulfite-free) 20 mg/mL, 10 mL multiple dose vials (box of 1)
NDC 63481-433-10 (sulfite/paraben-free) 20 mg/mL, 1 mL ampuls (box of 10)
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.
Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. Manufactured by: Bristol-Myers Squibb Holdings Pharma, Ltd. Manati, Puerto Rico 00674, USA. NUBAIN® (nalbuphine hydrochloride) is a Registered Trademark of Endo Pharmaceuticals Inc. NARCAN® is a Registered Trademark of Endo Pharmaceuticals Inc. /January, 2005. FDA Rev date: 8/23/2005
Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Nubain Information
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