Nalbuphine Hcl (nalbuphine HCl)

Opiate analgesics should be given at the lowest effective dosage and for the shortest duration of therapy consistent with the treatment goals of the patient. Dosage of nalbuphine hydrochloride should be adjusted according to the severity of pain, physical status of the patient, and other drugs that the patient is receiving. If concomitant therapy with other CNS depressants is required, the lowest effective dosages and shortest possible duration of concomitant therapy should be used. (See Cautions: Precautions and Contraindications and Drug Interactions: Benzodiazepines and Other CNS Depressants.) Care should be taken to avoid increases in dose or frequency of administration which in susceptible individuals might result in physical dependence.

For analgesia, the usual parenteral dose of nalbuphine hydrochloride is 10 mg in an adult weighing 70 kg (about 0.14 mg/kg) who is not dependent on opiate agonists. This dose may be repeated every 3-6 hours as necessary. In patients who are not tolerant to opiate agonists, the maximum single dose is 20 mg and the maximum total daily dose is 160 mg.

In patients who have been chronically receiving morphine, meperidine, codeine, or other opiate agonists with a similar duration of action, 25% of the usual dose of nalbuphine hydrochloride is given initially. The patient is observed for withdrawal symptoms (i.e., abdominal cramps, nausea, vomiting, lacrimation, rhinorrhea, anxiety, restlessness, increased temperature, piloerection). If these symptoms are troublesome, morphine may be given IV slowly in small increments until withdrawal symptoms are relieved. However, since withdrawal symptoms induced by the opiate antagonist effect of nalbuphine are self-limited, waiting until the abstinence syndrome abates is probably preferred. If withdrawal symptoms do not occur, nalbuphine doses may be increased progressively until the desired level of analgesia is obtained.

For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opiate analgesia (generally 3 days or less and rarely more than 7 days).

When nalbuphine hydrochloride is used as a supplement to balanced anesthesia, doses larger than those recommended for analgesia are required. For induction, doses of the drug range from 0.3-3 mg/kg given IV over a period of 10-15 minutes. For maintenance, doses of 0.25-0.5 mg/kg may be given IV as necessary.

For further information on the management of opiate analgesic therapy, see Dosage and Administration: Dosage, in the Opiate Agonists General Statement 28:08.08.

Nalbuphine hydrochloride is administered by subcutaneous, IM, or IV injection. As with other parenteral products, nalbuphine hydrochloride injection should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Safe use of nalbuphine during pregnancy (except during labor and delivery) has not been established. Although animal reproduction studies have not revealed teratogenic or embryotoxic effects, nalbuphine should not be administered to pregnant women unless the possible benefits outweigh the potential risks. When nalbuphine is administered during labor and delivery, fetal bradycardia, respiratory depression, apnea, and cyanosis may occur in the neonate. These adverse effects may resolve in some cases following maternal administration of naloxone during labor. However, fetal bradycardia may be severe and prolonged and permanent neurological damage associated with fetal bradycardia has been reported. In addition, a sinusoidal fetal heart rate pattern has been associated with maternal use of nalbuphine. The drug should be used with caution in women during labor and delivery, especially in those delivering premature infants; neonates should be monitored for respiratory depression, apnea, bradycardia, and cardiac arrhythmias.

No enhanced messaging available.

No enhanced messaging available.