Nalbun(Nalbuphine)

Therapeutic Group: Analgesic, Anti Inflammatory

Presentation

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.

Description

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.

Indications

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

Dosage & Administration

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.

Side Effects

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.

Precautions

Caution should be taken in the following conditions: impaired respiration, impaired renal or hepatic function, billiary tract surgery, myocardial infarction and hypotension.

Use in Pregnancy & Lactation

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.

Over Dose

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.

Commercial Pack

Nalbun 1 : Each box contains 5 ampoules of 1 ml.
Nalbun 2 : Each box contains 5 ampoules of 2 ml.