Nalbuphine Hydrochloride

Indications

Nalbuphine Hydrochloride is used for: Moderate to severe pain, Pain associated with MI, Balanced anaesthesia

Adult Dose

Parenteral Moderate to severe pain Adult: IM/IV/SC: 10-20 mg 3-6 hrly as required. Non-opioid-tolerant patients: Max single dose: 20 mg. Max daily dose: 160 mg. Intravenous Adjunct in balanced anaesthesia Adult: Induction: 0.3-3 mg/kg over 10-15 min. Maintenance: 0.25-0.5 mg/kg as single admin if required. Hepatic impairment: Caution; dose reduction may be necessary; monitor

Child Dose

Pain <1 year: Safety and efficacy not established >1 year: 0.1-0.2 mg/kg IV/IM/SC q3-4hr PRN; individual dose not to exceed 20 mg; not to exceed 160 mg/day

Renal Dose

Renal impairment: Caution; dose reduction may be necessary; monitor

Administration

IV Administration Administer each 10 mg by IV push over 3-5 minutes

Contra Indications

Hypersensitivity. Absolute: Diarrhea associated with toxins, pseudomembranous colitis, respiratory depression (<12 beats/min) Acute asthma, bradycardia, inflammatory bowel disease, respiratory impairment

Precautions

May impair ability to drive or operate machinery. Emotionally unstable patients or patients with history of opiate abuse; closely monitor these patients during long-term therapy. Impaired respiration due to other drugs, uraemia, bronchial asthma, severe infection, cyanosis, respiratory obstruction. MI patients who exhibit nausea and vomiting and in those about to undergo biliary tract surgery. Head injury, intracranial lesions or pre-existing increased intracranial pressure. Renal or hepatic impairment. Elderly and debilitated patients. Pregnancy and lactation. Lactation: Insignificant amount distributed in milk; use with caution

Pregnancy-Lactation

Pregnancy category: B; D if used for prolonged periods or near term

Interactions

Additive CNS depressant effects may occur with other CNS depressants e.g. alcohol, anaesthetics, anxiolytics, hypnotics, TCAs and antipsychotics.

Adverse Effects

Side effects of Nalbuphine Hydrochloride : >10% Sedation (36%) 1-10% Clamminess (9%),Nausea and vomiting (6%),Dizziness (5%),Xerostomia (4%),Headache (3%) <1% Asthma,Bradycardia,Burning,Dyspnea,Hypertension,Hypotension,Itching,Miosis,Pulmonary edema,Respiratory depression,Tachycardia,Urticaria,Vertigo Potentially Fatal: Anaphylactic or anaphylactoid and other serious hypersensitivity reactions e.g. shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, laryngeal oedema.

Mechanism of Action

Nalbuphine is a phenanthrene derivative opioid analgesic with mixed opioid agonist and antagonist activity. It inhibits the ascending pain pathways, altering the perception of and response to pain by binding to opiate receptors in the CNS. It also produces generalised CNS depression.