NUBAIN (nalbuphine hydrochloride) is a synthetic narcotic agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used narcotic antagonist, naloxone, and the potent narcotic analgesic, oxymorphone.
NALBUPHINE HYDROCHLORIDE Nalbuphine hydrochloride is (-)-17-(cyclobutylmethyl)-4, 5alpha- epoxymorphinan-3,6alpha,14-triol hydrochloride. NUBAIN is available in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. Both strengths contain 0.94% sodium citrate hydrous, 1.26% citric acid anhydrous, 0.1% sodium metabisulfite, and 0.2% of a 9:1 mixture of methylparaben and propylparaben as preservatives; pH is adjusted, if necessary, with hydrochloric acid. The 10 mg/mL strength contains 0.1% sodium chloride.
NUBAIN is also available in a sulfite and paraben-free formulation in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. One mL of each strength contains 0.94% sodium citrate hydrous, 1.26% citric acid anhydrous; pH is adjusted, if necessary, with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.
NUBAIN is a potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Its onset of action occurs within 2 to 3 minutes Its onset of action occurs within 2 to 3 minutes after intravenous administration, and in less than 15 minutes following subcutaneous or intramuscular injection. The plasma half-life of nalbuphine is 5 hours and in clinical studies the duration of analgesic activity has been reported to range from 3 to 6 hours.The narcotic antagonist activity of NUBAIN is one-fourth as potent as nalorphine and 10 times that of pentazocine.
NUBAIN (nalbuphine hydrochloride) 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.
NUBAIN should not be administered to patients who are hypersensitive to it.