NUBAIN®

Du Pont Pharma, Nalbuphine HCl, Analgesic

 

Supplied: 10 mg: Each mL contains: nalbuphine HCl 10 mg. Nonmedicinal ingredients: citric acid anhydrous, hydrochloric acid, methylparaben, propylparaben, sodium chloride, sodium citrate and sodium metabisulfite. Glass ampuls of 1 mL. Multi-dose vials of 10 mL.

Indications: For the relief of moderate to severe pain.

Contraindications: Hypersensitivity to nalbuphine or its inactive ingredients.

Pharmacology: Nalbuphine is a synthetic narcotic agonist- antagonist analgesic for parenteral use, related chemically to the narcotic oxymorphone, and to the narcotic antagonist naloxone.

Nalbuphine has an analgesic (agonist action) potency equivalent to that of morphine on a mg basis, and an antagonist activity (reversal of major effects of opioid drugs) about 25% of that of nalorphine and 10 times that of pentazocine. The analgesic effect of 10 mg of nalbuphine is about equal to that of 10 mg of morphine sulfate. The onset of action begins within 2 to 3 minutes after i.v. administration, and within 15 minutes following s.c. or i.m. injection. The plasma half-life of nalbuphine is 5 hours and the duration of action has ranged from 3 to 6 hours.

At the usual dose of 10 mg, nalbuphine produces respiratory depression equivalent to that of equianalgesic doses of morphine. At much higher doses, above 30 mg i.v. (which produces a respiratory depressant activity equivalent to 20 mg of morphine i.v.), the respiratory depressant effect of nalbuphine does not appear to increase appreciably. Nalbuphine may precipitate abstinence, when administered to individuals taking narcotics chronically or produce withdrawal symptoms when discontinued abruptly after prolonged use. It is reported to have an abuse potential comparable to that of pentazocine. The mechanism of action of nalbuphine has not yet been established.

Warnings: In patients physically dependent on opiate drugs, nalbuphine should not be given prior to detoxification since withdrawal symptoms are likely to be produced.

 

Other adverse reactions which may occur are:

	CNS: nervousness, crying, depression, restlessness, euphoria, hostility, confusion, faintness, floating, unusual dreams, numbness, feeling of heaviness, and psychotomimetic effects such as hallucinations, feeling of unreality and dysphoria.
	Cardiovascular: hypertension, hypotension, bradycardia, tachycardia.
	Gastrointestinal: cramps, dyspepsia, bitter taste.
	Respiration: depression, dyspnea, asthma.
	Dermatological: itching, burning, urticaria.
	Miscellaneous: speech difficulty, urinary urgency, blurred vision, flushing and warmth.

 

Store at controlled room temperature (15 to 30°C). Protect from excessive light.