Active substanceHalothaneHalothane
Similar drugsTo uncover
  • Halothane
    liquid d / inhal. 
  • Fluorotane
    liquid d / inhal. 
    ALTAYHIMPROM, JSC     Russia
  • Dosage form: & nbspfinhality for inhalation
    Composition:

    One bottle contains:

    active substance: halothane 99.99% (v / v);

    auxiliary substance: thymol 0.01% (v / v).

    Description:

    Transparent, colorless, mobile, heavy liquid with a specific odor.

    Pharmacotherapeutic group:Means for inhalation of general anesthesia
    ATX: & nbsp

    N.01.A.B.01   Halothane

    N.01.A.B   Halogenated hydrocarbons

    Pharmacodynamics:

    Halothane is a means for inhalation anesthesia from a group of fluorine-containing aliphatic compounds. It causes a rapid introduction to anesthesia without or with a minimal stage of excitation.

    It has analgesic and mild muscle relaxant action (in connection with this, additional use of muscle relaxants is necessarily required). It blocks the ganglia of the sympathetic nervous system, expands the arteries of the skin and muscles. Increases the tone of the vagus nerve, causing a bradycardia. Due to direct negative inotropic action reduces myocardial contractility and stroke volume of blood. By increasing the sensitivity of cardiomyocytes to catecholamines, it increases the likelihood of arrhythmias.Proportional to the depth of general anesthesia weakens the contractile capacity of the uterus.

    At a concentration of 0.5 to 3 - 4% by volume, the surgical stage of anesthesia is usually achieved in 4-6 minutes. After stopping the feed, awakening occurs 3-5 minutes later.

    The duration of post-natal depression is usually 5-10 minutes after a short-term and 30-40 minutes after prolonged anesthesia. Excitation is rare and weak.

    In the phase of induction of halothane anesthesia, a moderate decrease in blood pressure often occurshalothane dose-dependent manner lowers blood pressure). With a decrease in the concentration of vapors to the level of anesthesia, there is a tendency to increase blood pressure, but usually it remains at a level below preoperative. This hypotensive effect allows you to get a clean surgical field, reducing blood loss.

    Pharmacokinetics:

    When inhaled, it is easily absorbed into the bloodstream from the lumen of the alveoli, the concentration in the alveoli and blood is quickly balanced, distributed to organs with good vascularization (brain, heart, liver), musculature, adipose tissue.Fast passes the histohematological barriers, including blood-brain and placental. After the cessation of intake into the body, a decrease in its concentration has an exponential character. Output is light 60-80% unchanged; kidneys - 20% in the form of inactive metabolites. Halothane metabolized by oxidation in the liver, the main metabolites are trifluoroacetic acid, chlorides, bromides. At a low voltage of oxygen halothane is metabolized to the free radical chlorotrifluoroethyl, which is able to react with the components of the hepatocyte membrane.

    Indications:

    Introductory and supportive general anesthesia in adults and children.

    Contraindications:

    Hypersensitivity, unexplained jaundice, fever or fever after the introduction of halothane in a history, pheochromocytoma, hyperkatecholamineemia, arterial hypotension, myasthenia gravis, halothane for general anesthesia less than 3 months ago, pregnancy (I trimester), period of labor and early postpartum period, dental manipulation for children and adolescents under 18 years outside of the stationary conditions.

    The drug is contraindicated in patients with known or suspected genetic predisposition to malignant hyperthermia.

    Pregnancy and lactation:

    Do not use in the first trimester of pregnancy, during childbirth, in the early postpartum period. In the second and third trimesters of pregnancy halothane perhaps apply for life indications and under strict control. After the preparation of inhalation anesthesia should stop breastfeeding for 24 hours.

    Dosing and Administration:

    Suitable for all types of inhalation anesthesia. The correct dose is achieved with a calibration evaporator located outside the closed circulation system (to avoid overdose).

    Adults

    Induction.

    To introduce into anesthesia at a flow rate of 8 liters / minute, starting with halothane at a concentration of 0.5% by volume (with oxygen), then gradually increase the concentration of halotane vapor in the mixture to 0.5-3% by volume.

    As a supporting concentration, usually, for adults, 0.5-1.5% by volume is sufficient.

    Children

    During induction, the concentration of 1.5-2.0 vol.% Is used for children.

    Elderly

    Older patients require a lower dosage of halothane, but the actual dose is based on the patient's physical condition.

    The surgical stage of anesthesia is usually achieved in 4-6 minutes.

    The minimum alveolar concentration (MAC) for adults with a mixture with oxygen is 0.77% by volume, in a mixture with nitrous oxide - 0.3% by volume. MAC halothane in a mixture with oxygen for children up to 6 months. - 1.08% by volume; up to 10 years - 0.92% vol .; for persons over 70 years of age - 0.64% vol.

    At the end of the operation, the flow of oxygen is increased to more quickly eliminate the drug and eliminate possible hypercapnia.

    In order to avoid side effects associated with the excitation of the vagus nerve (bradycardia, arrhythmia), the patient is given an anesthesia atropine or metocinium iodide.

    For premedication, it is preferable to use not morphine, but trimeridin, which excites the centers of the vagus nerve less.

    Side effects:

    Disorders from the cardiovascular system: violation of the heart rhythm - bradycardia, ventricular arrhythmias in hypoxia, hypercapnia; arterial hypotension.

    Disorders from the central nervous system: after awakening headache, tremor, increased intracranial pressure.

    Disorders from the digestive system: liver function disorder before the development of jaundice, hepatitis, liver necrosis, especially with repeated injections; after awakening, nausea and postoperative vomiting are possible.

    Disturbances from the respiratory system: depressed breathing.

    Laboratory indicators: eosinophilia, increased transaminases.

    Other: malignant hyperthermia may develop.

    Malignant hyperthermia is a very severe, often fatal, complication of anesthesia, especially in children and adolescents. Clinically, this complication is manifested by severe tachycardia, a drop in blood pressure, a violation of gas exchange, and a sudden increase in the child's body temperature to 40-42 ° C. Malignant hyperthermia can quickly lead to edema of the brain and death.

    The syndrome of malignant hyperthermia, as a rule, is observed in persons with hereditary predisposition to malignant hyperthermia. Body temperature rises rapidly to 42 ° C (!) And higher, generalized rhabdomyolysis occurs, and marked acidosis develops.

    In some patients, the first sign of muscle damage is trisus, which develops during intubation. The increase in body temperature can occur very quickly, despite the fact that this process is the result of contractile muscle activity. As an antidote for the development of malignant hyperthermia, intravenous dantrolene is recommended.

    Overdose:

    Symptoms: severe bradycardia, arrhythmia, hypotension, hyperthermic crisis, depressed breathing.

    Treatment: IVL with pure oxygen, symptomatic therapy.

    Interaction:

    Sympathomimetics and theophylline increase the risk of arrhythmias.

    The risk of arrhythmias also increases if halothane are administered to patients who receive dopaminomimetics (eg levodopa).

    A pronounced hypotensive effect can be observed when using halothane simultaneously with ganglion blocking agents, with alpha and beta adrenoblockers, antipsychotics or calcium channel blockers.

    Halothane potentiates the muscle relaxant effect tubocurarine and other antidepolarizing muscle relaxants, so their doses should be reduced.

    With simultaneous application with phenytoin the risk of hepatotoxic effect increases.

    Aminoglycosides, lincomycin, polymyxins strengthen neuromuscular blockade (can cause apnea).

    Morphine and chlorpromazine increase the inhibitory effect of halothane on breathing.

    When a combination of oxytocin and halothane is possible, development of arterial hypotension, sinus bradycardia, abnormal atrioventricular rhythm in the mother in childbirth.

    Under the influence of halothane, the sensitivity of the uterus to the drugs that cause it to decrease (ergot alkaloids, oxytocin).

    In combination with MAO inhibitors increases the risk of increasing blood pressure and exacerbating the toxic effects of halothane.

    The use of thymolol beta-adrenoblocker in the form of eye drops before surgery during halothane anesthesia can cause hypotension and bradycardia.

    Suxamethonium increases the likelihood of developing malignant hyperthermia.

    Ketamine increases the half-life.

    Special instructions:

    Halothane has hepatotoxicity, as it is converted into free radicals, initiators of lipid peroxidation, in the liver, and also forms metabolites (fluoroethanol) that covalently bind to biomacromolecules. The incidence of hepatitis is 1 case per 10 000 anesthesia in adult patients. In children, liver damage develops much more rarely.

    It causes muscle relaxation, so it should be used with caution in patients with myasthenia gravis and / or with simultaneous use with aminoglycoside antibiotics.

    During anesthesia, there may be an increase in blood flow in the vessels of the brain and / or an increaseintracranial pressure. These effects are usually more pronounced in the presence of intracranial neoplasms. To counteract these effects in neurosurgery, moderate hyperventilation is used.

    There is a risk of arrhythmias in children.

    Use with caution when taking cardiac glycosides.

    Treatment with MAO inhibitors should be discontinued 2 weeks before surgery.

    It is necessary to cancel levodopa 6-8 hours before the start of general anesthesia.

    When gynecological operations should be taken into account that halothane can cause a decrease in the tone of the myometrium and, as a consequence, an increased risk of bleeding.

    Halothane relaxes the myometrium, so it is used in obstetric practice only in cases when the relaxation of the uterus is indicated.

    Patients with chronic alcoholism for anesthesia require large doses.

    The possibility of developing malignant hyperthermia should be remembered with insufficient muscle relaxation at the beginning of anesthesia, as well as in the occurrence of fasciculations in response to the introduction of ditiline (suxamethonium).

    The monitoring of the patient's condition in anesthesia is carried out by monitoring the pulse, blood pressure (measured manually or automatically,direct and indirect methods), continuous ECG recording, oxygen content in the blood (observing the color of the skin and mucous membranes, using a pulse oximeter or a blood test), body temperature, pupil response, diuresis rate, blood gas analysis, electrolyte composition and acid -basic state.

    Do not store in evaporators; before the new use, the evaporator must be cleaned of the halotane residues and the products of its decomposition. Timol (used for stabilization) does not evaporate, remains in the evaporator, staining the solution in a yellowish color, it is readily soluble, eliminated by ether.

    Effect on the ability to drive transp. cf. and fur:

    Within a day after anesthesia, patients are prohibited from driving vehicles, servicing machines and mechanisms, working at height, etc.

    Form release / dosage:

    Liquid for inhalation.

    Packaging:

    50 ml or 250 ml of the drug are placed in amber-colored glass bottles, Type III, sealed with an aluminum lacquered screw cap with a first-opening control ring.

    On 1 bottle together with the instruction on medical application place in a cardboard pack.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C, in a bottle with a tightly closed screw cap, in a vertical position.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:LP-003912
    Date of registration:20.10.2016
    Expiration Date:20.10.2021
    The owner of the registration certificate:Piramal Enterprise LimitedPiramal Enterprise Limited India
    Manufacturer: & nbsp
    Representation: & nbspMEDINTORG, ZAOMEDINTORG, ZAO
    Information update date: & nbsp15.03.2017
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