Vero-Butorphanol (Vero-Butorphanol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceButorphanolButorphanol
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    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:
    In 1 ml of solution contains:
    active substance: Butorphanol tartrate in terms of dry matter 2 mg; Excipients: citric acid, sodium citrate for injection, sodium chloride, water for injection.
    Description:Transparent colorless liquid.
    Pharmacotherapeutic group:An analgesic opioid: an opioid receptor agonist is an antagonist
    ATX: & nbsp

    N.02.A.F.01   Butorphanol

    Pharmacodynamics:
    Opioid analgesic for parenteral administration from the group of mixed agonist-antagonists opioid receptors (stimulates kappa and sigma receptors, blocks mu receptors). By the expression of analgesic action is similar to morphine.After intravenous administration, the effect comes immediately, the maximum effect - in a few minutes; after intramuscular injection, the effect occurs after 10-15 minutes, the maximum activity is 30-60 minutes, the duration of the action is 3-4 hours. To a lesser extent than morphine, depresses breathing, has a lower narcogenic potential, less often than other opioids causes constipation. It has antitussive and sedative effect, stimulates the vomiting center, causes pupils to narrow, increases systemic arterial pressure, pulmonary artery pressure, the end diastolic volume of the left ventricle, and the overall peripheral resistance of the vessels.
    The onset of the effect after intramuscular injection is 10-30 minutes, intravenous injection is 2-3 minutes, the time to reach the maximum effect after intramuscular injection is 30-60 minutes, intravenous injection is 30 minutes, the duration of the effect in the absence of tolerance with intramuscular injection is 3-4 hours, intravenous - 2-4 hours.
    Pharmacokinetics:Absorption from the site of intramuscular injection is high. Time to reach the maximum concentration in the plasma - 20-40 minutes, the maximum concentration in the plasma - 2,2 ng / ml; connection with plasma proteins - 80%.Penetrates through blood-brain and placental barriers, excreted in breast milk (concentration in the breast milk of the mother, after intramuscular injection of 2 mg 4 times a day - 4 μg / l). Metabolised in the liver. The half-life in young patients is 4.7 hours, in the elderly - 6.6 hours, in patients with renal insufficiency -10.5 hours. It is excreted by the kidneys, mainly in the form of metabolites - 70-80% (5% unchanged); through the intestine - 15%.
    Indications:Pain syndrome of different genesis of medium and strong intensity, when it is advisable to use opioid analgesic (including postoperative pain syndrome, migraine); premedication before general anesthesia; as a component of general anesthesia; anesthesia during childbirth.
    Contraindications:Hypersensitivity, pregnancy (except for anesthesia of childbirth), lactation.
    Carefully:
    Drug addiction, craniocerebral trauma, intracranial hypertension, respiratory failure, hepatic and / or renal failure, chronic heart failure, acute myocardial infarction, hypertension, children under 18 years of age (efficacy and safety not established), elderly years).
    Dosing and Administration:
    Intravenous, intramuscular.
    Dosage regimen is individual, depending on the indications and the clinical situation. With pain syndrome - 1 mg intravenously (with severe pain syndrome - up to 2 mg) or 2 mg intramuscularly (with severe pain syndrome - up to 4 mg) every 3-4 hours (or as needed). In elderly patients and patients with hepatic renal insufficiency, the dose is reduced by 2 times, and the interval between injections increases to 6 hours. For premedication, 2 mg intramuscularly administered 60-90 minutes before surgery or 2 mg intravenously immediately before surgery.
    In the general anesthesia - 2 mg before induction, then the anesthesia is maintained by repeated intravenous injections of 0.5-1 mg. The total dose required for anesthesia is 4-12.5 mg.
    During labor, 1-2 mg intramuscularly or intravenously to women with a gestation period of at least 37 weeks (in the absence of signs of intrauterine pathology in the fetus) and no more than once in 4 hours, the last injection should be made no later than 4 hours before estimated time of delivery.
    Side effects:

    From the nervous system and sensory organs: drowsiness, dizziness, anxiety, confusion,euphoria, dysphoria, insomnia, nervousness, anxiety, paresthesia, ringing in the ears, diplopia, nightmares or unusual dreams, tremors, convulsions.

    From the side of cardiovascular activity: decrease or increase of blood pressure, palpitations.

    From the respiratory system: apnea, shallow breathing

    From the digestive system: nausea, vomiting, anorexia, constipation, dryness of the oral mucosa, pain in the epigastric region.

    From the urinary system: decreased diuresis.

    From the skin: itching, rash, hives.

    Other: asthenia, headache, lethargy, sensation of fever, excessive sweating, drug dependence, withdrawal syndrome.

    Overdose:
    Symptoms: respiratory depression, cardiovascular failure, depression of consciousness (up to coma).
    Treatment: maintenance of sufficient pulmonary ventilation, systemic hemodynamics, body temperature. Patients should be under continuous supervision; if necessary, the use of a specific opioid antagonist - naloxone.
    Interaction:
    Strengthens the effect of medicines,oppressing the central nervous system (CNS) (barbiturates, anxiolytics, antipsychotic drugs, H1-histamine receptor blockers, ethanol, other opioids). Pharmaceutically incompatible with diazepam, barbiturates.
    Medicines with anticholinergic activity increase the risk of constipation up to intestinal obstruction, as well as the risk of urinary retention and CNS depression. Simultaneous use with loperamide can increase the risk of severe constipation.
    Strengthens the hypotensive effect of drugs that reduce blood pressure (including ganglion blockers, diuretics).
    Buprenorphine (including the previous therapy) reduces the effect of other opioid analgesics; against the background of the use of low doses of agonists mu-or kappa-opioid receptors can enhance respiratory depression. Reduces the effect of metoclopramide.
    Continuous monitoring is necessary in case of simultaneous use with monoamine oxidase (MAO) inhibitors because of possible overexcitation or inhibition with the emergence of hyper- or hypotensive crises (first, to assess the interaction effect, the dose should be reduced to 1/4 of the recommended one).
    Naloxone reduces the effect of opioid analgesics, as well as the respiratory depression and central nervous system caused by them; can accelerate the appearance of symptoms of "withdrawal syndrome" against the background of drug dependence.
    Naltrexone reduces the effect; accelerates the appearance of the symptoms of "withdrawal syndrome" against the background of drug dependence (symptoms can appear only 5 minutes after drug administration, continue for 48 hours, are characterized by persistence and difficulty of their elimination).
    Special instructions:
    In patients with drug dependence before the start of treatment should take measures aimed at complete removal of the drug from the body.
    Effect on the ability to drive transp. cf. and fur:During treatment, do not engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, should not be consumed ethanol.
    Form release / dosage:
    Solution for intravenous and intramuscular administration 2 mg / ml.
    Packaging:
    1 ml in the ampoule. 5 or 10 ampoules in a box or a pack of cardboard. For 5 or 10 ampoules in a contour cell package. For 1 contour cell pack of 10 ampoules, or 2 contourcell packs of 5 ampoules per pack of cardboard.
    In the box or bundle, insert the instructions for use and the opener for opening ampoules, or the ampoule scaler. When using ampoules with incisions or a fracture ring, a scarifier ampoule or a knife for opening ampoules is not inserted.
    Storage conditions:List A. In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000118/09
    Date of registration:14.01.2009 / 12.10.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.01.2017
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