Please consult your physician before taking any medication. Formulation and Dosage Form Each vial of injectable solution contains: 10 mg nalbuphine hydrochloride Vehicle c.b.p. 1 ml. Without conservatives. Dosage and administration BUFIGEN The recommended dose for adults is 10 mg per 70 kg body weight intravenous, intramuscular, subcutaneous or epidural. The dose can be repeated every three to six hours as needed. Maximum daily dose: 160 mg. Maximum rate per application: 20 mg. INDICATIONS: Analgesic. BUFIGEN indicated to treat moderate to severe pain, including pain associated with acute myocardial infarction. BUFIGEN also indicated as an adjunct to general or local anesthesia and to provide pre and postoperative analgesia. BUFIGEN can be used during the third stage of labor and diagnostic examination procedures that can be annoying and / or painful. Pharmacokinetics: Nalbuphine is a potent analgesic agonist-antagonist opioids keeping chemically related to naloxone and oxymorphone. It has an equivalent analgesic potential mg per mg of morphine. Apparently produces analgesia by agonist actions in ky antagonistic actions at mu opioid receptors receptors. Mu receptors are widely distributed throughout the CNS, especially in the limbic system, thalamus, striatum, hypothalamus and midbrain and laminae I, II, IV and V of the dorsal horn of the spinal cord. Kappa receptors are located mainly in the spinal cord and cerebral cortex, therefore, these sites are involved in the areas where it acts nalbuphine. After being administered intravenously, its action starts about 2 minutes. When administered subcutaneously or intramuscularly starts its effect within 15 minutes. The duration of analgesic action lasts three to six hours. Nalbuphine binds to plasma proteins by approximately 30%. It is metabolized in the liver, with a plasma half-life of 5 hours. It is mainly excreted in the feces without undergoing changes and 7% through the urine as unchanged nalbuphine, such as conjugated metabolites.
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