Nalbun 1: Each ml injectable solution contains Nalbuphine Hydrochloride INN 10 mg.
Nalbun 2: Each 2 ml injectable solution contains Nalbuphine Hydrochloride INN 20 mg.
Nalbun DS: Each ml injectable solution contains Nalbuphine Hydrochloride INN 20 mg.
Nalbuphine Hydrochloride is a synthetic opioid analgesic, which binds with mu, kappa and delta receptor. Its analgesic potency is equivalent to Morphine on a milligram basis and 10 times more than that of Pentazocine but has lower side effects and less abuse potential than Morphine. The onset of action of Nalbuphine occurs within 2 to 3 minutes after intravenous administration and in less than 15 minutes following intramuscular injection. The plasma half-life of Nalbuphine is 5 hours and the duration of analgesic activity is 3 to 6 hours.
Relief of moderate to severe pain associated with myocardial infarction (MI)
As a supplement of balanced anesthesia
Pre-operative and post-operative analgesia
Obstetrical analgesia during labor and delivery
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.
In balanced anesthesia: by intravenous or intramuscular injection 0.1-0.2 mg/kg.
Obstetrical analgesia during labor and delivery: by intravenous injection 0.3-1 mg/kg over 10-15 minutes with maintenance dose of 0.25-0.5 mg/kg in single intravenous administration as required.
Intra-operative 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.
Generally Nalbuphine is well tolerated. However few side-effects like sedation, sweating, nausea, vomiting, dizziness, vertigo, dry mouth, headache, respiratory depression, dyspnea and asthma may be seen.
Caution should be taken in the following conditions: impaired respiration, impaired renal or hepatic function, billiary tract surgery, myocardial infarction and hypotension.
Nalbuphine is pregnancy category B. The placental transfer of Nalbuphine is high and rapid. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Less than 1% of the administered dose is excreted in milk. However cautions should be exercised when Nalbuphine is administered to a nursing mother.
The immediate intravenous administration of an opiate antagonist such as Naloxone or Nalmefene is a specific antidote. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated. Sleepiness and mild dysphoria may occur due to overdose.
Nalbun 1 : Each box contains 5 ampoules of 1 ml.
Nalbun 2 : Each box contains 5 ampoules of 2 ml.