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Nubain (Nalbuphine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

NUBAIN is indicated for the relief of moderate to severe pain. NUBAIN can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

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 as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia. Induction doses of NUBAIN 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 may be followed by respiratory depression which can be reversed with the opioid antagonist NARCAN® (naloxone hydrochloride).

NUBAIN 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. 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 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

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 1)
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® is a Registered Trademark of Endo Pharmaceuticals Inc.
NARCAN® is a Registered Trademark of Endo Pharmaceuticals Inc.
 

                                         Copyright © Endo Pharmaceuticals Inc. 2005

Printed in U.S.A.                                                                                             51-022542-01/August, 2005

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