Fluorotane (Phthorothanum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHalothaneHalothane
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  • Halothane
    liquid d / inhal. 
    Piramal Enterprise Limited     India
  • Fluorotane
    liquid d / inhal. 
    ALTAYHIMPROM, JSC     Russia
    • Dosage form: & nbspLiquid for inhalation.
    Composition:As active substance - Halothane;
    adjuvant - Thymol.
    Description:Transparent colorless, heavy, mobile, highly volatile liquid with a smell resembling chloroform.
    Pharmacotherapeutic group:Means for inhalation of general anesthesia
    ATX: & nbsp

    N.01.A.B.01   Halothane

    N.01.A.B   Halogenated hydrocarbons

    Pharmacodynamics:Causes rapid administration to anesthesia without or with minimal manifestation of the stage of excitation. Possesses analgesic and miorelaksiruyuschim action (does not create a sufficient relaxation of the muscles, in connection with which necessarily requires additional use of muscle relaxants). Increases the tone of n.vagus, causes 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 achieved in 4-6 minutes, after the completion of general anesthesia, awakening occurs after 5-15 minutes.
    Pharmacokinetics:When inhaled, it is absorbed from the lumen of the alveoli into the bloodstream, and the concentration in the alveoli and blood quickly equilibrates. It is distributed in 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 in the plasma has an exponential character. Outputs lungs - 60 and 80% unchanged; kidneys - 20% in the form of inactive metabolites.
    Metabolized by oxidation in the liver, the main metabolites are trifluoroacetic acid, chlorides, bromides. It is excreted mostly light in unchanged form and with urine in the form of metabolites. 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 maintenance anesthesia in adults and children.
    Contraindications:Hypersensitivity, unexplained jaundice, fever or fever after administration of halothane in the anamnesis; pheochromocytoma, hyperkatecholamineemia, arterial hypotension,myasthenia gravis, the use of halothane for general anesthesia less than 3 months ago, pregnancy (1 trimester), the period of childbirth and the early postpartum period, dental manipulation of children and adolescents under 18 years outside the stationary conditions.
    Carefully:Acceptance of cardiac glycosides. The drug is contraindicated in patients with known or suspected genetic predisposition to malignant hyperthermia.
    Pregnancy and lactation:Contraindicated in the 1st trimester of pregnancy, during childbirth and in the early postpartum period. After anesthesia, 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
    For introduction into anesthesia at a flow rate of 8 l / min. begin with the supply of halotane in a concentration of 0.5% (with oxygen), then gradually increase the concentration of halotane vapor in the mixture to 0.5 - 3% by volume. As a maintenance concentration, as a rule, adult 0.5 - 1.5% vol. Is sufficient.
    Children
    During induction, children, beginning with newborns, need a greater concentration than adults.
    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 (MAK) for adults with a mixture with oxygen is 0.77% by volume, with a mixture with nitrous oxide 0.3% by volume. MAC halothane with a mixture with oxygen for children up to 6 months. - 1.08% by volume; up to 10 years - 0.92% vol .; for persons older than 70 years - 0.64 о6.%.
    At the end of the operation, the flow of oxygen is increased to more quickly eliminate fluorotan 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 metacin. For premedication, it is preferable to use not morphine, but promedol, which excites the centers of the vagus nerve less. If necessary, to enhance muscle relaxation, it is preferable to prescribe the relaxants of the depolarizing action type (ditilin); when using drugs nedepolyarizuyuschego (competitive) type, the dose of the latter is reduced against the usual.Concentration of fluorotan with the use of muscle relaxants (with controlled respiration) should not exceed 1 - 1.5% vol.
    Side effects:From the side of the central nervous system: after awakening, there may be headache, tremor; increased intracranial pressure.
    From the cardiovascular system: arterial hypotension, bradycardia, cardiac arrhythmias.
    From the digestive system: impaired liver function until the development of jaundice, hepatitis, liver necrosis, especially with repeated injections; after awakening nausea, postoperative vomiting Other: depressed breathing, increased intracranial pressure, eosinophilia, possibly development of malignant hyperthermia. Malignant hyperthermia is a very severe, often fatal, complication of narcosis, 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 brain edema 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.
    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 dithiline. In some patients, the first sign of muscle damage is trisus, which develops during intubation. Although a rise in temperature is the result of contractile muscle activity, it can grow very quickly.
    Overdose:Symptoms: severe bradycardia, arrhythmias, hypotension, hyperthermic crisis, depressed breathing.
    Treatment: IVL with pure oxygen, symptomatic therapy.
    Interaction:Sympathomimetics increase the risk of arrhythmias. Strengthens the effect of muscle relaxants non-depolarizing action, hypotensive drugs, bradycardia under the influence of digitalis preparations and inhibitors of cholinesterase (neostigmine), weakens the effect of uterotonizing agents. Morphine and derivatives of phenothiazines increase the depressor effect on the central nervous system.
    Increases the risk of liver damage on the background of phenytoin. Aminoglycosides, lincomycin and polymyxins deepen the neuromuscular blockade (can cause apnea). Ketamine increases half-life, methyldopa, nitrous oxide, morphine and phenothiaziasin-the strength of general anesthesia. The likelihood of malignant hyperthermia increases suxamethonium, arrhythmia - xatin.
    Strengthens and lengthens the action and toxicity of tubocurarine chloride.
    Ganglia-blockers are prescribed in smaller doses, since their action is potentiated by fluorotan.
    With a combination of oxytocin and fluorotane, arterial hypotension, sinus bradycardia, and abnormal atrioventricular rhythm in the mothers are possible.
    In combination with MAO inhibitors, the risk of increasing blood pressure increases.
    In addition, MAO inhibitors aggravate the toxic effects of fluorotan. The use of thymolol in the form of eye drops before the operation of beta-adrenoblocker during the fluorotane anesthesia may cause hypotension and a bradycardia.
    Sympathomimetics and theophylline increase the likelihood of heart rhythm disturbances.Aminoglycosides and antidepolarizing muscle relaxants enhance neuromuscular blockade, opioid analgesics and nitrous oxide, an anesthetic effect.
    At gynecological operations it is necessary to consider, that фторотан can cause depression of a tone of a musculation of a uterus and the raised bleeding.
    Fluorotane relaxes the uterus, so it is used in obstetric practice only in those cases when the relaxation of the uterus is shown. Under the influence of fluorotane, the sensitivity of the uterus decreases to the drugs that cause its reduction (ergot alkaloids, oxytocin).
    Special instructions:Fluorotane has hepatotoxicity, since in the liver, lipid peroxidation initiators are converted to free radicals, and also forms metabolites (fluoroethanol) covalently bound 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 increase in intracranial 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 unsystematic tachycardia in children.
    Monitoring of the patient's condition in anesthesia is carried out by monitoring the pulse, arterial pressure (measured manually or automatically, by direct and indirect methods), by continuous ECG recording, by oxygen content in the blood (observing the color of the skin and mucous membranes, using a pulse oximeter or analysis blood), the temperature of the "core" and the surface of the body, the response of the pupils, the rate of diuresis, blood tests for gases, electrolyte composition and acid-base state.
    Do not store in evaporators; before the new use, the evaporator must be cleaned of the residues of fluorotan and the products of its decomposition. Timol (used for stabilization) does not evaporate, remains in the evaporator, coloring the solution in a yellowish color, it is readily soluble, eliminated by ether.It is necessary to cancel levodopa 6-8 hours before the start of general anesthesia.
    Patients with chronic alcoholism for anesthesia require large doses.
    Effect on the ability to drive transp. cf. and fur:
    Within a day after anesthesia, you should refrain from managing motor vehicles, cars and mechanisms.
    Form release / dosage:Liquid for inhalation.
    Packaging:For 50 ml in bottles of droppers orange glass or bottles of brown glass for medical products, packed with instructions for use in packs of cardboard for consumer packaging according to GOST 7933-89.
    Storage conditions:Store in a dry, dark place at a temperature of up to 15 ° C
    Fluorotane is used only in medical and preventive institutions.
    Shelf life:Shelf life 3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-005207/08
    Date of registration:03.07.2008 / 06.08.2014
    The owner of the registration certificate:ALTAYHIMPROM, JSC ALTAYHIMPROM, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.08.2014
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