Nalbutin10 mg/ml

Nalbutin 10 mg/ml Hydrochloride is indicated for the relief of moderate to severe pain. It is used for relief of moderate to severe pain associated with myocardial infarction (MI). Nalbutin 10 mg/ml Hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

Opioid analgesics

Nalbutin 10 mg/ml Hydrochloride is a synthetic potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that Nalbutin 10 mg/ml binds to mu, kappa, and delta receptors, but not to sigma receptors. Nalbutin 10 mg/ml is primarily a kappa agonist/partial mu antagonist analgesic.

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, physical status of the patient, and other medications which the patient may bereceiving.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.

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, physical status of the patient, and other medications which the patient may bereceiving.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 hazardous interactions have been identified with Nalbutin 10 mg/ml; however, interactions described with other opioids may be anticipated. Patient receiving a narcotic analgesic, general anesthesia, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Nalbutin 10 mg/ml may exhibit an additive effect.

Known hypersensitivity to Nalbutin 10 mg/ml Hydrochloride.

Generally Nalbutin 10 mg/ml 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.

Pregnancy category B. The placental transfer of Nalbutin 10 mg/ml is high and rapid. There are no well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Limited data suggest that Nalbutin 10 mg/ml is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when Nalbutin 10 mg/ml is administered to a nursing woman.

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

Sleepiness & mild dyspnea may occur due to 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

Keep it in a cool and dry place, protected from light and moisture.

Opioid analgesics

Nalbutin 10 mg/ml Hydrochloride is a synthetic potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that Nalbutin 10 mg/ml binds to mu, kappa, and delta receptors, but not to sigma receptors. Nalbutin 10 mg/ml is primarily a kappa agonist/partial mu antagonist analgesic.

Pregnancy category B. The placental transfer of Nalbutin 10 mg/ml is high and rapid. There are no well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Limited data suggest that Nalbutin 10 mg/ml is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when Nalbutin 10 mg/ml is administered to a nursing woman.