Nalbuphine Hydrochloride
Therapeutic Group: Analgesic, Anti Inflammatory/Opioid analgesics
Therapeutic Group: Analgesic, Anti Inflammatory/Opioid analgesics
Indications:
Nalbuphine 1: Each ml injectable solution contains Nalbuphine Hydrochloride INN 10 mg.
Nalbuphine 2: Each 2 ml injectable solution contains Nalbuphine Hydrochloride INN 20 mg.
Nalbuphine 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 receptors. 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.
Dosage & Administration:
The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, 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, the physical status of the patient, and other medications which the patient may be
receiving.
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, biliary 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 on 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, caution should be exercised when Nalbuphine is administered to a nursing mother.
Overdose:
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.
Storage:
Keep it in a cool and dry place, protected from light and moisture.
- 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
Nalbuphine 1: Each ml injectable solution contains Nalbuphine Hydrochloride INN 10 mg.
Nalbuphine 2: Each 2 ml injectable solution contains Nalbuphine Hydrochloride INN 20 mg.
Nalbuphine 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 receptors. 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.
Dosage & Administration:
The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, 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, the 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. A larger dose is required when used as a 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, biliary 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 on 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, caution should be exercised when Nalbuphine is administered to a nursing mother.
Overdose:
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.
Keep it in a cool and dry place, protected from light and moisture.