Nalbuphine Hydrochloride is indicated for the relief of moderate to severe pain. It is also used in the management of pain associated with myocardial infarction. Additionally, Nalbuphine can be used as an adjunct to balanced anesthesia, for preoperative and postoperative pain relief, and for pain management during labor and delivery.

Nalbuphine Hydrochloride is a synthetic opioid analgesic with potency comparable to morphine on a milligram basis. It acts on multiple opioid receptors, including mu, kappa, and delta receptors, with primary activity as a kappa receptor agonist and partial antagonist at mu receptors. Its analgesic effect begins within 2–3 minutes after intravenous administration and within 15 minutes following subcutaneous or intramuscular injection. The plasma half-life of nalbuphine is approximately 5 hours, and its analgesic effect typically lasts between 3 to 6 hours.

The usual recommended adult dose is 10 mg for a 70 kg individual, administered 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.

Moderate to severe pain: by intravenous or intramuscular injection 10–20 mg for 70 kg patient, adjusted as required; child up to 0.3 mg/kg repeated once or twice as necessary.

Preoperative anesthesia: by intravenous or intramuscular injection 0.1–0.2 mg/kg.

Obstetrical analgesia during labor & delivery: by intravenous injection 0.3–1 mg/kg over 10–15 minutes with maintenance doses of 0.25–0.5 mg/kg in single intravenous administration as required.

Intraoperative analgesia: by intravenous injection 0.25–0.5 mg/kg at 30 minutes intervals.

Myocardial infarction: By slow intravenous injection 10–20 mg, repeated after 30 minutes if necessary. Larger dose is required when used as supplement of anesthesia than that required for analgesia.

Children from 18 months to 15 years old: usually 0.2 mg/kg body weight, given preferably by intravenous or intramuscular injection. Maintenance doses may be given at intervals of 4 to 6 hours or the dose must be determined by the physician.

No significant hazardous interactions have been identified with Nalbuphine. However, similar to other opioids, additive effects may occur when used with narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedatives, hypnotics, or other central nervous system depressants, including alcohol.

Nalbuphine Hydrochloride is contraindicated in patients with known hypersensitivity to nalbuphine or any of its components.

Nalbuphine is generally well tolerated. However, some patients may experience side effects such as sedation, sweating, nausea, vomiting, dizziness, vertigo, dry mouth, headache, respiratory depression, shortness of breath, or asthma.

Pregnancy Category B. Nalbuphine crosses the placenta rapidly. There are no adequate and well-controlled studies in pregnant women, so it should be used only if clearly necessary. Nalbuphine is excreted in breast milk in very small amounts (less than 1% of the dose), which is considered clinically insignificant. However, caution is advised when administering it to nursing mothers.

Nalbuphine should be used with caution in patients with impaired respiration, renal or hepatic dysfunction, those undergoing biliary tract surgery, patients with myocardial infarction, and those with hypotension.

Overdose may lead to drowsiness and mild respiratory depression. Immediate treatment includes intravenous administration of opioid antagonists such as naloxone or nalmefene. Oxygen therapy, intravenous fluids, vasopressors, and other supportive measures should be provided as needed.

Opioid analgesic

Store below 30°C, protect from light, and keep out of reach of children.