Supran (Suprane)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDesfluraneDesflurane
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  • Supran
    liquid d / inhal. 
    Baxter Healthcare Corporation     Puerto Rico
    • Dosage form: & nbspLiquid for inhalation.
    Pharmacotherapeutic group:Means for inhalation anesthesia.
    ATX: & nbsp

    N.01.A.B   Halogenated hydrocarbons

    Indications:Desflurane is indicated as an inhaler for anesthetic induction and / or maintenance in adults, as well as for maintaining anesthesia in children, if intubation is used, for surgical interventions in inpatient and outpatient settings.
    Contraindications:
    - with contraindications to general anesthesia;

    - patients with a hypersensitivity to halogenated hydrocarbons in the anamnesis;

    - patients with established or suspected genetic predisposition to malignant hyperthermia;

    - patients with a risk of coronary heart disease or in situations where an increase in the heart rate or blood pressure in patients is undesirable - as the only drug for induction anesthesia;

    - when carrying out anesthesia in children, if intubation is not used, since cough, respiratory arrest, apnea, laryngospasm and increased secretion are often present;

    - when conducting anesthesia in children due to the risk of adverse reactions from the respiratory organs;

    - if there is a history of hepatitis caused by a halogenated inhalation anesthetic or if there is an unexplained mean severity or severe impairment of liver function (eg jaundice accompanied by fever and / or eosinophilia) after anesthesia with a halogenated inhalation anesthetic.
    Dosing and Administration:Inhalation. Desflurane It should be administered only by qualified personnel using specially designed evaporators calibrated for desflurane. Equipment to maintain free airway, artificial ventilation, oxygenation and cardiovascular resuscitation should be ready for immediate use. The minimal alveolar concentration (MAQ) of desflurane decreases with increasing age of the patient.

    Table 1 - Minimum alveolar concentration (MAQ) of desflurane in humans, depending on age:

    Age

    100% sour

    60% of di-

    (years)

    clan (02)

    nitrogene

    oxide

    (N, 0) + 40

    % sour

    gender (02)

    2 weeks

    9,2 ± 0.0 %

    -

    10 weeks

    9.4 ± 0.4 %

    -

    9 months

    10.0 ±0,7%

    7,5 ± 0.8 %

    2 of the year

    9,1 ± 0,6 %

    -

    3 of the year

    -

    6.4 ± 0.4 %

    4 of the year

    8,6 ± 0.6 %

    -

    7 years

    8.1 ± 0.6 %

    -

    25 lay down

    7.3 ± 0.0 %

    4.0 ± 0,3 %

    45 years

    6,0 ± 0.3 %

    2,8 ± 0,6 %

    Older 65

    5.17 ± 0.6 %

    1.67 ±0.4

    years

    %

    Premedication

    Premedication should be selected according to the individual needs of the patient, taking into account the stimulation of salivation. The use of M-holinoblokatorov is carried out at the discretion of an anesthesiologist.

    Introduction to general anesthesia

    When using the drug for introductory anesthesia, an initial application of a concentration of 3% is recommended with a subsequent increase of 0.5-1% every 2-3 breaths. Desflurane concentrations of 4-11% usually lead to a surgical stage of general anesthesia in 2-4 minutes. Higher concentrations of the drug - up to 15% - can be applied with the simultaneous introduction of pure oxygen with an initial concentration of at least 30%. During the introduction to general anesthesia in adults, the overall frequency of occurrence of saturation with oxyhemoglobin (SpO2 <90%) was 6%. In the case of an introductory anesthesia with thiopental sodium or propofol, desflurane apply in an initial dose of 0.5-1.0 MAK with the simultaneous introduction of pure oxygen or a mixture of dinitrogen oxide and oxygen.

    Desflurane, like other inhaled anesthetics, can increase the pressure of cerebrospinal fluid, or intracranial pressure in patients with voluminous neoplasms.Such patients should be administered no more than 0.8 MAF of desflurane in combination with induction with barbiturates and hyperventilation (hypocapnia) in the period before cranial decompression. It is necessary to give due attention to the maintenance of cerebral perfusion pressure. SUPRAN should not be used as the only drug for induction anesthesia in patients at risk of coronary heart disease or in situations where an increase in heart rate or blood pressure in patients is undesirable. In such cases desflurane It is recommended to be used simultaneously with other anesthetics, preferably intravenously injected with narcotic analgesics and sedatives. In order to avoid myocardial ischemia in patients with coronary heart disease, it is important to maintain normal hemodynamics.

    SUPRAN is not recommended for the introduction of anesthesia in children due to the frequent occurrence of coughing, delayed breathing, apnea, laryngospasm and increased secretion.

    Maintaining general anesthesia

    Maintenance of general anesthesia during surgical interventions can be ensured by using 2-6% desfluorane concentration when used simultaneously with dinitrogen oxide.When used with oxygen or oxygen-enriched air, desflurane concentration may be 2.5 to 8.5%.

    Maintenance of general anesthesia in children is ensured by using 5.2-10% of desflurane concentration at the end of a calm inspiration. Simultaneous application of dinitrogen oxide can be used. Higher concentrations of desflurane - up to 18% - can be used for short periods of time. When using high concentrations of the drug with dinitrogen oxide, it is important to ensure that the inhalable mixture contains at least 25% oxygen.

    If an increase in muscle relaxation is required, additional doses of muscle relaxants may be used.

    Blood pressure and heart rate

    It is necessary to closely monitor blood pressure and heart rate in order to control the depth of anesthesia.

    Dosage regimen for renal and hepatic impairment

    1-4% concentration of desflurane in dinitrogen oxide / oxygen has been successfully used in patients with chronic renal and hepatic insufficiency, as well as during the kidney transplant operation. In connection with the minimal metabolism of desflurapa,The need for correction of drug concentrations in patients with chronic renal and hepatic insufficiency is absent. The use of general anesthesia should be individualized and take into account the patient's response.

    The use of desflurane in weakened patients, patients with hypovolemia and hypotension was not studied in detail. As with the use of other potent inhalation anesthetics, a dose of desflurane is recommended in these patients to be reduced.

    Side effects:

    Like all other highly active inhalation anesthetics, desflurane can cause a dose-dependent depression of respiration and cardiac activity. Most other adverse reactions are mild and transient.

    Data compiled in clinical trials

    Undesirable reactions are grouped by systems and organs, using the following frequency criteria: very often

    (> 1/10); often (> 1/100 - <1/10); infrequently (> 1/1 000 - <1/100); rarely (> 1/10 000 - <1/1 000); very rarely (< 1/10 000).

    Introductory anesthesia

    From the side of the psyche: often - holding the breath.

    On the part of the respiratory system, the organon of the thorax and the mediastinum: very often - cough, often laryngospasm, apnea, infrequently - hypoxia.

    From the gastrointestinal tract: very often - nausea, vomiting, often - increased salivation.

    Supportive anesthesia

    From the side of the psyche: often - a delay in breathing, infrequently - an alarm.

    From the side of the neural system: often - a headache, infrequently - dizziness.

    From the cardiovascular system: often - tachycardia, increased blood pressure, bradycardia, nodal rhythm, notoften - vasodilation, arrhythmia, myocardial ischemia, myocardial infarction.

    From the respiratory system, chest and mediastinum: often - apnea, cough, pharyngitis, infrequently - hypoxia.

    From the gastrointestinal tract: very often - nausea, vomiting, often - increased salivation.

    From the musculoskeletal system and connective tissue: infrequently - myalgia.

    From the side of the organ of vision: often - conjunctivitis.

    Laboratory and instrumental data: often - an increase in the activity of creatine phosphokinase, a decrease in the content of oxyhemoglobin in the blood <90%; ECG deviations.

    The data received in the post-registration period

    In the post-marketing period, the following unwanted reactions.

    From the side of the blood and lymphatic system: coagulopathy.

    From the side of metabolism and nutrition: hyperkalemia, hypokalemia, metabolic acidosis.

    From the nervous system: convulsions.

    From the side of the heart and blood vessels: cardiac arrhythmia, pirouette arrhythmia, ventricular failure, ventricular hypokinesia, atrial fibrillation, malignant hypertension, bleeding, hypotension, shock.

    From the respiratory system, chest and mediastinum: respiratory failure, respiratory distress syndrome, bronchospasm, hemoptysis.

    From the gastrointestinal tract: acute pancreatitis, abdominal pain.

    From the liver and bile ducts: hepatic insufficiency, necrotic hepatitis, cytolytic hepatitis, cholestasis, jaundice, a violation of liver function.

    From the skin and subcutaneous tissues: hives, redness.

    From the musculoskeletal system and connective tissue: acute necrosis of skeletal muscles.

    From the side of the organ of vision: icteric sclera.

    General disorders: malignant hyperthermia, asthenia, malaise.

    Laboratory and instrumental data: segment changes ST on the ECG, inversion of the T wave on the ECG. an increase in the activity of transaminases, an increase in the concentration of alanine aminotransferase, an increase in the concentration of aspartate aminotransferase, an increase in the concentration of bilirubin in the blood, a deviation from the norm of the results of tests for blood clotting, an increase in the concentration of ammonium.

    Trauma, intoxication and complications of manipulation *: Tachyarrhythmia, palpitations, burning sensation in the eyes, transient blindness, encephalopathy, ulcerative keratitis, conjunctival hyperemia, visual acuity, eye irritation, eye pain, dizziness, migraine, fatigue, unintended inhalation of the drug, burning sensation, mistakes.

    reactions that occur in individuals. who were not patients.

    Interaction:

    Inhalation anesthetics

    The combined use with dinitrogen oxide reduces MAK desflurane.

    Depolarizing and nondepolarizing muscle relaxants

    Desflurane in the concentration that causes the surgical stage of anesthesia, increased the effect of muscle relaxants, which was manifested by a decrease in ED95. The ED index95 characterizes the effective dose of muscle relaxant, that is, a dose that causes inhibition of neuromuscular conduction by 95%. ED95 pancuronium bromide, atracurium bezylate, suxamethonium and vecuronium bromide for different desfluurane concentrations are shown in Table 2. With the exception of vecuronium bromide, these doses are similar to doses when applied simultaneously with isoflurane. ED95 Vecuronium bromide is 14% lower with desflurane than with isoflurane. In addition, recovery from neuromuscular blockade with desflurane is longer than with isoflurane. Table 2 - ED95 (mg / kg) of muscle relaxants when used simultaneously with desflurane

    MAK desflue

    Pan-

    kuro-

    Atra-

    Souk sa-

    Veku-kuro

    the

    curia

    me-

    the

    wound

    bromide

    ni

    then- the

    bromide

    0,65

    0,026

    0,133

    no

    no

    POPPY/

    Dan

    given

    60%

    of the

    of the

    N20/02

    1,25

    0,018

    0,119

    no

    no

    POPPY/

    Dan

    given

    60%

    puffy

    of the

    N20/02

    1,25

    0,022

    0,120

    0,36

    0,019

    POPPY/

    0

    100%

    02

    Preparations for premedication

    Clinically Significant Interactions desflurane with preparations, applicable for premedication, as well as drugs injected during general anesthesia (preparishes for intravenous administration, mediafor the local

    anesthesia), it was not revealed It was. The effect of desflurane on the distribution ofNo more drugs were found.

    Narcotic analgesics and benzodiazepines

    In patients receiving narcotic analgesics, benzodiazepines or other dative drugs, it is necessary appliedlower doses of desflurane. In patientsThe anesthesia with different concentrations of desflurane and the simultaneous administration of fentanyl in increasing doses showed a distinct decrease in the need for anesthetic or MAC. With intravenous administration of increasing doses of midazolam, there was a slight decrease in MAF of desflurane. The results are shown in Table 3. The observed decrease in MAC is similar to that which occurred when isoflurane was administered. It can be assumed that other narcotic analgesics and drugs. benzodnazepine derivatives will affect MAC in a similar manner.

    Table 3 - Effect of fentanyl and midazolam on the MAA of desflurane:

    18 -30 years old

    31 - 65 years old

    Cf.

    %

    Cf.

    %

    significance

    come down

    significance

    come down

    the

    zhe

    the

    zhe

    MAC ±

    nanny

    MAC ±

    the

    CO *

    CO *

    Without a fent

    6,4 ±

    -

    6,3 ±

    -

    nil

    0,0 %

    0,4 %

    Fentanyl

    3,5 ±

    46

    3.1 ±

    51

    (3 μg / kg)

    1,9%

    0,6 %

    Fentanyl

    3.0 ±

    53

    2,3 ±

    64

    (6 μg / kg)

    1,2%

    1,0%

    Without a Mid

    6,9 ±

    -

    5,9 ±

    -

    ash

    0,1 %

    0,6 %

    Midazo-

    -

    -

    4,9 ±

    16

    Lam (25

    0,9 %

    mkg / kg)

    MidazoLam (50 μg / kg)

    -

    -

    4,9 ± 0,5 %

    17

    *CO is the standard deviation

    Increased glucose

    As in the case of and with other halogenated anesthetics, the use of desflurane is associated with some increase in glucose levels during surgical interventions.

    Use with beta-blockers

    The simultaneous use of beta-blockers can enhance the cardiovascular effects of inhalational anesthetics, including hypotension and negative inotropic effects.

    Use with monoamine oxidase inhibitors

    The concomitant use of monoamine oxidase (MAO) inhibitors and inhalational anesthetics may increase the risk of hemodynamic instability during surgery or medical procedures.

    Special instructions:
    As the anesthesia deepens, blood pressure decreases and respiratory activity is inhibited.
    Desflurane, like other inhaled anesthetics, can increase the pressure of cerebrospinal fluid or intracranial pressure in patients with voluminous neoplasms. Such patients should be administered no more than 0.8 MAF of desflurane in combination with induction with barbiturates and hyperventilation (hypocapnia) in the period before cranial decompression.It is necessary to give due attention to the maintenance of cerebral perfusion pressure. In order to avoid myocardial ischemia in patients with coronary heart disease, it is important to maintain normal hemodynamics in the process of maintaining general anesthesia.
    Desflurane should not be used as the only drug for induction of anesthesia in patients at risk of coronary heart disease or in situations where an increase in heart rate or blood pressure in patients is undesirable. In such cases desflurane It is recommended to be used simultaneously with other anesthetics, preferably intravenously injected with narcotic analgesics and sedatives. In some patients desflurane anesthesia can cause the state of skeletal muscle hypermetabolism, which leads to high oxygen consumption and the development of clinical syndrome of malignant hyperthermia (MH). Determined that desflurane is a potential provoking factor of malignant hyperthermia. The syndrome includes such non-specific signs as hypercapnia, muscle rigidity, tachycardia, tachypnea, cyanosis,arrhythmia and unstable blood pressure. An increase in total metabolism may be accompanied by an increase in body temperature. Such non-specific signs as acute hypoxia, hypercapnia and hypovolemia, may appear with shallow anesthesia. Treatment consists in the abolition of the drug provoking MH, intravenous administration of dantrolene and the appointment of maintenance therapy. Subsequently, renal failure may occur, and therefore, it is necessary to constantly monitor and maintain diuresis. When desflurane is used as an anesthetic, this effect is observed in very rare cases, therefore desflurane Do not use in people with a known predisposition to MH. Cases of fatal outcome of MH with desflurane are described. In very rare cases, the use of funds for inhalation anesthesia was accompanied by an increase in potassium levels in the serum, which led to cardiac arrhythmias and death in the postoperative period. This condition was observed in patients with latent or obvious neuromuscular diseases, especially in Duchenne's myodystrophy.In most, but not in all of these cases, there was a connection with the use of suxamethonium. In these patients, the phenomena of muscle disorders were noted, accompanied by an increase in serum creatinophosphokinase and myoglobinuria. Despite the similarity in manifestation with malignant hyperthermia, none of these patients showed signs or symptoms of muscle rigidity or hypermetabolic status. It is recommended to immediately begin treatment of hyperkalemia and arrhythmia. In the future, it is necessary to conduct a survey to clarify the diagnosis of a hidden neuromuscular disease and the purpose of appropriate treatment.
    As with other halogenated anesthetics, desflurane can cause the development of hepatitis, liver dysfunction, liver necrosis in patients sensitized by the previous exposure to halogenated anesthetics. Therefore, it is recommended that alternatives to halogenated anesthetics be used to administer and maintain general anesthesia in patients with cirrhosis, viral forms of hepatitis, and other liver diseases.During general anesthesia, due to the rapid increase in the concentrations of desflurane at the end of a calm inspiration, there may be an increase in heart rate and blood pressure. These changes disappear themselves within about four minutes due to the activation of the sympathoadrenal system. The increase in heart rate and blood pressure before or without a rapid increase in the concentration of desflurane at the end of a calm inspiration can be regarded as mild anesthesia. Reduction of blood pressure and respiratory depression increase with the deepening of general anesthesia.
    There is evidence that desflurane, like other means of inhalation anesthesia, interacts with dry absorbents of carbon dioxide to form carbon monoxide. which can lead to an increase in the content of carboxyhemoglobin in some patients. In order to minimize the risk of formation of carbon monoxide in the breathing circuit and the possibility of increasing the level of carboxyhemoglobin, do not use dried carbon dioxide absorbents. As with other means for general anesthesia of rapid action, attention should be paid to adequate analgesic therapy in patients whose postoperative condition involves the onset of pain.
    Care should be taken when carrying out repeated anesthesin with desfluraioma in a short time interval. Care should be taken when conducting general anesthesia; the concentration of desflurane in the environment can reach 2-3%, resulting in the occurrence of dizziness and headache. If desflurane hits the skin or eyes, rinse immediately with plenty of water. The use of desflurane in weakened patients. patients with hypovolemia and hypotension were not studied in detail. As with the use of other potent inhalation anesthetics, a dose of desflurane is recommended in these patients to be reduced. In children with asthma or having a history of a recent infection of the upper respiratory tract desflurane Use with caution because of possible narrowing of the airways and increased respiratory tract resistance.
    As with the use of other halogenated inhalation anesthetics, the use of desflurane may lead to a transient increase in the concentration of glucose and the number of leukocytes in the blood. Due to the inadequacy of the available data for non-intubated children, desflurane Has not received permission for use to maintain anesthesia in children without intubation. Caution should be exercised when using desflurane to maintain anesthesia with a laryngeal mask (LM) in children, especially in children 6 or younger, because of the increased likelihood of unwanted respiratory reactions, i.e., cough and laryngospasm, in Features when removing LM on a background of deep anesthesia. Due to the limited number of patients studied, the safety of desflurane in obstetric procedures has not been established. Desflurane causes relaxation of the muscles of the uterus and reduces placental blood flow.
    Form release / dosage:Liquid for inhalation.
    Packaging:
    • (240 ml) - bottles of dark glass (6) - cardboard boxes
    • (240 ml) - aluminum bottles (6) - cardboard boxes
    Storage conditions:At a temperature of 15-30 degrees.
    Shelf life:3 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001900
    Date of registration:12.11.2012
    Date of cancellation:2017-11-12
    The owner of the registration certificate:Baxter Healthcare CorporationBaxter Healthcare Corporation Puerto Rico
    Manufacturer: & nbsp
    Information update date: & nbsp16.01.2016
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