Nalbuphine Serb (Nalbuphine Serb)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNalbuphineNalbuphine
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  • Nalbuphine
    solution w / m in / in 
    MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC     Russia
  • Nalbuphine
    solution for injections 
    MOSCOW ENDOCRINE FACTORY, FSUE     Russia
  • Nalbuphine Serb
    solution for injections 
    Serb S.A.     France
  • Nalbuphine hydrochloride
    solution for injections 
    Roushan Pharma Co., Ltd.     India
    • Dosage form: & nbspinjection
    Composition:In 1 ml of the solution is contained as active substance 10 mg of nalbuphine hydrochloride (in terms of 100% of the substance); Excipients: sodium citrate, citric acid monohydrate, sodium chloride, water for injection.
    Description:Colorless or almost colorless transparent liquid.
    Pharmacotherapeutic group:An analgesic opioid: an opioid receptor agonist-antagonist
    ATX: & nbsp

    N.02.A.F.02   Nalbuphine

    Pharmacodynamics:Nalbuphine has the properties of an agonist-antagonist opioid retenters (agonist kappa and antagonist mu-opioid receptors). Activates endogenous antinociceptive system through kappa-opiate receptors, disrupts interneuronal transmission of pain impulses at various levels of the central nervous system. Influencing the higher parts of the brain, changes the emotional color of pain. It inhibits conditioned reflexes, has a sedative effect, causes dysphoria, miosis, excites the vomiting center. To a lesser extent than morphine, depresses the respiratory center and affects the motility of the gastrointestinal tract. Does not affect hemodynamic parameters. The risk of developing addiction and opioid dependence in controlled use is low. It begins to act 2-3 minutes after intravenous injection and 10-15 minutes after intramuscular injection.
    Pharmacokinetics:

    The maximum concentration in the blood plasma after intramuscular injection is observed after 30-60 minutes, the duration of action is 3-6 hours, the half-life is 2.5-3 hours.

    Metabolised in the liver. It is excreted as metabolites, mainly with bile and in small amounts with urine. Penetrates through the placental barrier, excreted in the mother's milk (less than 1% of the administered dose).

    Indications:

    - The expressed painful syndrome of a various origin (the postoperative period, gynecologic interventions, traumas, malignant neoplasms);

    - pain with myocardial infarction (intravenous administration);

    - as an additional tool for general anesthesia.

    Contraindications:Hypersensitivity; marked inhibition of respiration and central nervous system; epileptic syndrome,intracranial hypertension; head trauma, acute alcohol poisoning, alcoholic psychosis; acute surgical diseases of the abdominal cavity (before diagnosis); surgical interventions on the hepatobiliary system (possible spasm of the sphincter of Oddi).
    Carefully:Elderly age, cachexia, hepatic and / or renal insufficiency, respiratory failure (including chronic obstructive pulmonary disease, uremia), premature birth and presumed immaturity of the fetus, lactation period, pregnancy, child and adolescent age (under 18) , drug dependence on morphine-like drugs (morphine, promedol, fentanyl) - the possibility of developing withdrawal syndrome.
    Dosing and Administration:

    Intravenous, intramuscular or subcutaneous. With intravenous administration, the drug is diluted with 10-15 ml of isotonic sodium chloride solution.

    Pain syndrome: 0,15-0,3 mg / kg of body weight. If necessary, you can re-enter every 4-6 hours. The maximum daily dose is 2.4 mg / kg. When suspected of myocardial infarction - 10-20 mg intravenously slowly. If necessary, the dose can be increased to 30 mg.In the absence of a distinct positive dynamics of the pain syndrome, 20 mg of the drug is given again after 30 minutes.

    For premedication - 100-200 mkg / kg, for introductory anesthesia - 0.3-1 mg / kg for 10-15 minutes, to maintain anesthesia - 250-500 mcg / kg every 30 minutes.

    Side effects:

    From the nervous system: lethargy, drowsiness, confusion, dizziness, headache, agitation, euphoria or depression.

    From the cardiovascular system: decrease or increase in blood pressure, tachy- or bradycardia.

    From the digestive system: nausea, vomiting, dry mouth, dyspepsia, spastic pain.

    Allergic reactions: urticaria, swelling of the larynx, itching, sneezing.

    From the respiratory system: decrease in the minute volume of respiration.

    Other: increased sweating, tenderness at the injection site, withdrawal syndrome (spastic abdominal pain, nausea, vomiting, rhinorrhea, lacrimation, weakness, anxiety, fever).

    Overdose:

    Symptoms: hypoventilation of the lungs, change of consciousness (up to coma), pallor of the skin, hypothermia, miosis, lowering of arterial pressure, cardiovascular insufficiency.

    Treatment: with respiratory depression - intravenously naloxone or nalorphine. Maintenance of adequate pulmonary ventilation and indices of central hemodynamics.

    Interaction:Strengthens the oppressive effect on the central nervous system of funds for general anesthesia, hypnotics, antihistamines, anxiolytic, antipsychotic, antidepressant drugs. Ethanol enhances the inhibitory effect on the central nervous system. It should not be combined with other narcotic analgesics because of the danger of weakening analgesia and the possibility of provoking a withdrawal syndrome in patients with drug dependence. In combination with derivatives of phenothiazine and penicillin can enhance nausea and vomiting. It is pharmaceutically compatible with 0.9% sodium chloride solution, 5% dextrose solution and Hartmann solution in glass, polyvinyl chloride, polyethylene containers.
    Special instructions:Do not exceed the dosage because of the possibility of developing physical dependence.
    Effect on the ability to drive transp. cf. and fur:Ambulatory patients during the treatment period should refrain from engaging in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Solution for injection 10 mg / ml (in ampoules of 1 ml and 2 ml).
    Packaging:For 5 ampoules in a contour acheive box along with instructions for use in a cardboard bundle.
    Storage conditions:List A. In the dark place at a temperature of no higher than 25 ° C.
    Shelf life:3 years. Do not use the drug after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000018
    Date of registration:26.02.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Serb S.A.Serb S.A. France
    Manufacturer: & nbsp
    SERB, S.A. France
    Information update date: & nbsp28.05.2018
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