Artifreen (Artifrin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceArticaine + EpinephrineArticaine + Epinephrine
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    • Dosage form: & nbspinjection
    Composition:

    On 1 ml solution:

    Active substances: articaine hydrochloride (in terms of 100% substance) 40.00 mg; epinephrine (in terms of 100% substance in the form of hydrochloride) 0.006 mg

    Excipients: sodium disulfite 0.31 mg, glycine (in terms of 100% substance) 8.0 mg, sodium chloride 0.4 mg, 1 M solution of hydrochloric acid up to pH 3.5, water for injection up to 1.0 ml.

    Description:Transparent colorless or slightly yellowish-greenish liquid.
    Pharmacotherapeutic group:Local anesthetic + α- and β-adrenomimetic
    ATX: & nbsp

    N.01.B.B.58   Articaine in combination with other drugs

    Pharmacodynamics:

    Combined preparation for infiltration and conductive anesthesia in dentistry, containing articaine (amine type local anesthetic) and epinephrine (vasoconstrictor, epinephrine content in a solution of 1: 200,000), which is added to the formulation to prolong the duration of anesthesia.

    Articaine causes a reversible loss of sensitivity due to the cessation or reduction of sensory nerve impulses near the site of injection. Has a membrane-stabilizing effect for score Reducing the permeability of nerve cell membranes for sodium ions, the effect of the drug begins quickly - in 1-3 minutes. The duration of anesthesia is at least 45 minutes.

    The drug is characterized by good tissue tolerance.

    In a clinical study involving 210 children aged 3.5 to 16 years, the use of a combined preparation containing articaine and epinephrine (1: 200000) at a dose of 5 mg / kg of body weight provided sufficient local anesthetic effect when mandibular infiltration or maxillary conduction anesthesia was performed. The duration of anesthesia was comparable in all age groups and depended on the administered volume of the drug.

    Pharmacokinetics:

    Articaine with submucosal administration in the oral cavity has a high diffusion capacity. The concentration of articaine in the area of ​​dental alveoli after submucosal administration is thousands of times higher than the concentration of articaine in the systemic circulation.The inverse relationship between the time after injection and the concentration of articaine in the alveoli of the tooth is revealed.

    The binding of articaine with proteins is 95%. Articaine penetrates the placental barrier, practically does not excrete with breast milk.

    10% of articaine is metabolized in the liver, 90% of articaine is inactivated in tissues and blood by nonspecific plasma esterases by hydrolysis in the carboxyl group. The main metabolite, articaine acid, formed as a result of hydrolysis, does not have local anesthetic activity and systemic toxicity. General information the clearance of articaine after submucosal injection into the oral cavity is 23 5 ± 27 l / h.

    Excretion of articaine after submucosal administration occurs exponentially with a half-life (T1 / 2) of approximately 25 minutes. Displayed articaine mainly through the kidneys in the form of articaine slots (64.2 ± 14.4%), arkainic acid glucuronide (13.4 ± 5.0%) and modified articaine (1.45 ± 0.77%).

    Indications:Artifrin is indicated for local anesthesia (infiltration and conduction anesthesia) in dentistry. Planned interventions, such as uncomplicated removal of one or more teeth, carious cavity treatment, teeth grinding before prosthetics.
    Contraindications:

    General Contraindications

    Hypersensitivity to articaine or other amido type local anesthetics, except in cases where hypersensitivity to amine type local anesthetics is known, an allergy to articaine has been ruled out by appropriate studies conducted in accordance with the necessary rules and requirements.

    Hypersensitivity to epinephrine.

    Hypersensitivity to sulfites (in particular in patients with bronchial asthma and hypersensitivity to sulfites, since it is possible to develop acute allergic reactions, such as bronchospasm) and any other auxiliary components of the drug.

    Contraindications related to articaine

    - Severe dysfunction of the sinus node or conduction (pronounced bradycardia, atrioventricular blockage of 2-3 degrees).

    - Acute decompensated heart failure.

    - Severe arterial hypotension.

    - Children under 4 years old (lack of sufficient clinical experience).

    Contraindications related to epinephrine

    - Paroxysmal tachycardia, tachyarrhythmia.

    - Recently suffered (3-6 months ago) myocardial infarction.

    - Recently conducted (3 months ago) coronary artery bypass graft.

    - Simultaneous reception of non-cardioselective beta-blockers, for example, propranolol (risk of hypertensive crisis and severe bradycardia).

    - Closed-angle glaucoma.

    - Hyperthyroidism.

    - Pheochromocytoma.

    - Severe hypertension.

    Carefully:

    Angina pectoris, chronic heart failure, coronary heart disease, myocardial infarction in history, cardiac arrhythmias, arterial hypertension, atherosclerosis, cerebral circulation, history of anamnesis, history of epilepsy, chronic bronchitis, emphysema, diabetes mellitus (potential risk of changes in glucose concentration in the blood), cholinesterase insufficiency (application is possible only in case of emergency, as it is likely prolongation and excessive strengthening of the drug), violated blood coagulability, severe impairment of liver and kidney function, marked excitement, joint use with halogen-containing agents in the conduct of inhalation anesthesia.

    Pregnancy and lactation:

    Articaine and epinephrine penetrate through the placental barrier.

    In studies on animals using articaine 40 mg / ml and epinephrine 0.01 mg / ml, there was no effect on fertility in males and females. It is not expected that human fertility will be affected by the use of articaine and epinephrine in therapeutic doses.

    Due to the lack of clinical data, the decision to prescribe the drug by a dentist can be made after a thorough assessment of the relationship of benefit to the mother and the risk to the fetus.

    If it is necessary to use during pregnancy, it is better to use articaine preparations without epinephrine or preparations with a lower concentration of epinephrine. With a random intravascular injection of the drug epinephrine can reduce blood supply to the uterus.

    The concentration of articaine in the serum in newborns (after the administration of the mother's drug) is approximately 30% of the concentration of articaine in the mother's blood serum.

    In breast milk there are no clinically significant concentrations articaine and epinephrine. The abolition of breastfeeding with short-term use of the drug, as a rule, is not required.

    Dosing and Administration:

    The drug can not be administered intravenously.

    Artifreen is intended for use in the oral cavity and can be administered only to tissues that lack inflammation. Do not inject into inflamed tissues.

    Before administering the drug, an aspiration test should always be performed (e two stages). The main systemic reactions that can develop as a result of accidental intravascular injection of the drug can be avoided by observing the technique of injection: after the aspiration test, slowly inject 0.1-0.2 ml of the drug, then slowly inject, not earlier than 20-30 seconds later the rest of the drug. Injection pressure should correspond to the sensitivity of tissues.

    When applying the drug for the first time, a skin test is performed: 0.02 ml of drug is intradermally injected and the local reaction is observed for 15 minutes. In the presence of severe hyperemia, pruritus and other intolerance, the use of the drug in this patient is contraindicated.

    With uncomplicated removal of the upper jaw teeth in the absence of inflammation, it is usually sufficient to create an Artifrin depot in the region of the transitional fold by inserting it into the submucosa from the vestibular side at 1.7 ml per each tooth.In rare cases, in order to achieve complete anesthesia, additional administration of 1 to 1.7 ml of the drug may be required. In most cases this allows you not to carry a painful palatine injection. When several adjacent teeth are removed, the number of injections is usually limited.

    With incisions and suturing in the palate with the goal of creating a palatine depot, about 0.1 ml of the drug for each injection is needed.

    If you remove the premolars of the lower jaw in the absence of inflammation, you can avoid mandibular anesthesia, since infiltration anesthesia provided by injection of 1.7 ml per tooth is usually sufficient. If this is not the way to achieve the desired effect, an additional injection of 1-1.7 ml of the drug into the submucosa should be performed in the region of the transitional fold of the lower jaw from the vestibular side. If, in this case, too, it was not possible to achieve complete anesthesia, it is necessary to conduct a conductive blockade of the mandibular nerve.

    When treating the cavity and grinding teeth for crowns, with the exception of lower molars, the administration of the drug in a dose of 0.5 to 1.7 ml per tooth according to the type of infiltration anesthesia from the vestibular side is shown. The exact amount depends on the desired depth of anesthesia and duration of the procedure.

    When performing one treatment procedure, adults can administer up to 7 mg of articaine per 1 kg of body weight. Patients well tolerated doses up to 500 mg (corresponding to 12.5 ml solution for injection).

    Children older than 4 years of age, the drug is administered in doses depending on the age and body weight, the dose of articaine should not exceed 7 mg per 1 kg of body weight (0.175 ml / kg). Use the minimum doses necessary to achieve adequate anesthesia.

    For elderly patients and / or patients with severe hepatic and renal insufficiency, it is possible to create elevated plasma concentrations of articaine, so for such patients, the minimum doses necessary to achieve sufficient depth of anesthesia should be used.

    Side effects:

    The incidence of adverse reactions is presented in accordance with the classification recommended by the World Health Organization: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including individual messages; the frequency is unknown (it is not possible to determine the frequency of occurrence according to the available data).

    From the central nervous system: often - paresthesia, hypesthesia, headache, mainly due to the presence of epinephrine in the formulation; infrequently - dizziness. The frequency is unknown - dose-dependent reactions from the central nervous system - agitation, nervousness, stupor, sometimes progressing to loss of consciousness, coma, respiratory disorders, sometimes progressing to a stop in breathing, muscle tremor, muscle twitching, sometimes progressing to generalized seizures. If the correct technique of injection is violated when introducing a local anesthetic in dental practice, it is sometimes possible to damage the facial nerve, which can lead to the development of paralysis of the facial nerve.

    From the side of the organ of vision: frequency unknown - visual disorders (blurred vision, mydriasis, blindness, double vision), usually reversible and occurring during or shortly after an infection of the local anesthetic.

    From the gastrointestinal tract: often - nausea, vomiting.

    From the cardiovascular system: infrequently due to the content of the drug epinephrine, it is possible to develop tachycardia, heart rhythm disturbances, increase blood pressure.The frequency is unknown - lowering blood pressure, bradycardia, heart failure and shock.

    On the part of the immune system, frequency is unknown - allergic and allergic reactions can develop. At the injection site, they can manifest as swelling or inflammation of the mucous membrane. Manifestations not associated with the place of administration may include skin flushing, itching, conjunctivitis, rhinitis and angioedema. Angioedema may be manifested by swelling of the upper and / or lower lip, cheeks, edema of the vocal cords with a sensation of "lump in the throat" and difficulty swallowing, hives and difficulty breathing. Any of these manifestations can progress to anaphylactic shock.

    General disorders and disorders at the site of administration: it is often unknown - in some cases, with occasional intravascular injection, ischemia can occur at the site of injection, up to tissue necrosis.

    Children

    In the clinical studies conducted, the safety profile of children and adolescents aged 4 to 18 years was comparable to that of adults patients. However, due to prolonged anesthesia of the soft tissues of the oral cavity, children suffered more frequent soft tissue damage (16% of children), especially between the ages of 3 and 7 years.In a retrospective study of 211 children aged 1 to 4 years, dental interventions performed using 4.2 ml of 4% articaine and 0.005 mg / ml epinephrine did not cause adverse reactions.

    Overdose:

    Symptoms: stimulation of the central nervous system (anxiety, anxiety, confusion, hyperpnoea, tachycardia, increased blood pressure with reddening face, nausea, vomiting, tremor, convulsive disorders), hearing impairment, dizziness, CNS depression (loss of ability to speak, loss of consciousness, coma, muscle atony , vasomotor palsy, including weakness, pallor, dyspnea, death due to respiratory paralysis); symptoms of cardiovascular depression (bradycardia, arrhythmia, ventricular fibrillation, lowering blood pressure, cyanosis, heart failure).

    At the first manifestations of the toxic effect of the drug, it is necessary to stop the injection and give the patient a horizontal position with raised lower limbs and provide airway patency. It is necessary to monitor the parameters of hemodynamics (number of heartbeats, blood pressure).It is always recommended, even if the symptoms of intoxication do not seem to be severe, to put an intravenous catheter in order, if necessary, to be able to immediately perform intravenous administration of the required medications.

    In the case of breathing disorders, depending on their severity, oxygen is recommended, if there is an indication for an artificial respiration, an endotracheal intubation and artificial ventilation. The use of analeptic drugs of central action is contraindicated.

    In case of involuntary muscular twitching or generalized convulsions, intravenous administration of barbiturates of short or ultrashort action is indicated. The introduction should be done slowly under the constant control of the parameters of hemodynamics and respiration and with the simultaneous supply of oxygen.

    Often a bradycardia or a sharp drop in blood pressure can be eliminated by giving the patient a horizontal position with raised legs. With severe circulatory disturbances and shock, oute depending on their cause, the injection of the drug should be discontinued,to provide the patient with a horizontal position with raised legs, oxygen inhalation and intravenous infusion of balanced electrolyte solutions, glucocorticosteroids (250-1000 mg of methylprednisolone), if necessary, plasma substitutes, albumin. With the development of circulatory collapse and increasing bradycardia, a slow intravenous injection of a solution of epinephrine (0.0025-0.1 mg) under the control of cardiac rhythm and blood pressure was shown. If it is necessary to administer doses exceeding 0.1 mg epinephrine should be administered infusion, the infusion rate should correlate with the heart rate and blood pressure level.

    Severe tachycardias and tachyarrhythmias can be stopped by the administration of antiarrhythmic drugs, with the exception of nonselective beta-blockers.

    Increase in blood pressure in patients with arterial hypertension, if necessary, should be reduced with the help of vasodilators.

    Interaction:

    The appointment of the drug on the background of treatment with non-cardioselective beta-blockers, for example propranolol, is contraindicated, since in this case the risk of developing a hypertensive crisis and severe bradycardia is high.

    The hypertensive effect of epinephrine can be enhanced by tricyclic antidepressants and monoamine oxidase inhibitors. Similar observations were described for concentrations of norepinephrine 1: 25,000 and epinephrine 1: 80,000 when used as vasoconstrictors. The concentration of epinephrine in the Artifrin formulation is lower than those indicated (1: 200,000), however, the possibility of enhancing its hypertensive effect should be considered.

    Artikain can enhance the effect of drugs that depress the central nervous system. Narcotic analgesics increase the effect of articaine with an increased risk of respiratory depression.

    By the simultaneous use of antithrombotic agents (heparin, acetylsalicylic acid) accidental puncture of the vessel during local anesthesia can cause bleeding at the injection site.

    When used simultaneously with cholinesterase inhibitors, the metabolism of articaine slows down, resulting in prolongation and a marked increase in the action of articaine.

    Epinephrine can inhibit the secretion of insulin by the pancreas, thereby reducing the effectiveness of oral antidiabetic drugs.

    Some means for inhalation anesthesia (for example, halothane) May increase the sensitivity of the myocardium to catecholamines, and the risk of arrhythmia after injection Artifrin drug.

    When treating the injection site with disinfectant solutions containing heavy metals, the risk of developing local reactions - edema, tenderness - increases., soft tissue damage to the teeth (biting) due to a long decrease in the sensitivity of tissues due to the action of the drug.

    It should be noted that 1 ml of the drug solution contains 0.232 mg of sodium.

    Special instructions:

    The drug is intended for use only for local anesthesia in dentistry. Regional and local anesthesia should be performed by experienced specialists in suitably equipped premises with access to ready for immediate use of equipment and drugs necessary for monitoring heart activity and resuscitation. Personnel performing anesthesia should be qualified and trained in the technique of performing anesthesia, should be familiar with the diagnosis and treatment of systemic toxic reactions, adverse events and reactions, and other complications.

    The drug can not be administered intravenously, and also into the inflamed area! To avoid intravascular injection, a two-stage aspiration test should be carried out.

    To prevent infection (including viral hepatitis), when taking a solution from an ampoule, new sterile syringes and needles should always be used. Open cartridges can not be reused for other patients, nor can a damaged cartridge be used.

    Patients with cardiovascular diseases (chronic heart failure, coronary artery disease, angina pectoris, cardiac arrhythmias, a history of myocardial infarction, hypertension), atherosclerosis, cerebrovascular disorders, the presence of a history of history, chronic bronchitis, emphysema, diabetes, hyperthyroidism, as well as in the presence of severe anxiety disorders, it is advisable to use articaine preparations that do not contain epinephrine, or with a lower content of epinephrine (0.005 mg / ml).

    Take food can only after the termination of the local anesthesia (restoration of sensitivity).

    The drug contains sodium disulfite, therefore its use is contraindicated in patients with bronchial asthma and hypersensitivity to sulfites, since it is possible to develop acute allergic reactions such as bronchospasm.

    In order to reduce the risk of adverse reactions, it is necessary to apply the minimum effective dose of the drug.

    Children and their parents should be warned about the risk of accidental damage to soft tissues by teeth (biting) due to a prolonged decrease in the sensitivity of tissues due to the action of the drug. It should be noted that 1 ml of the drug solution contains 0.232 mg of sodium.

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

    AT Special tests did not reveal a clear effect of the drug on operator activity. However, due to the fact that the preoperative anxiety of the patient and the stress caused by surgery can influence the effectiveness of the activity, the dentist must individually, in each case, decide whether to admit the patient to the management of transport or work with the mechanisms.

    Form release / dosage:Injection.
    Packaging:

    For the production of OOO "Pharmaceutical company" Health ", Ukraine:

    Injection. For 1.7 ml in ampoules. By 1.7 ml in the cartridges.

    For 10 ampoules, together with the instructions for use and the disc with a ceramic or knife ampoule ceramic placed in a packet with partitions.

    By 5 ampoules per contour cell pack of polyvinylchloride film or a polyvinylchloride film and aluminum foil, contoured cell packs of 5 ampoules together with instructions for use are placed in a pack of cardboard.

    For 10 cartridges, along with the instructions for use are placed in a stack with partitions.

    10 cartridges per contour cell packaging made of polyvinylchloride film and aluminum foil or paper with a polymer coating or paper laminated.

    1 or 5 circuit cells per 10 cartridges, together with instructions for use, are placed in a pack of cardboard.

    It is allowed when packing the drug in ampoules with a ring of fracture or a point and a notch disc cutting ceramic or an ampoule ceramic knife not to invest.

    For the production of Pharmex Group LLC, Ukraine:

    Injection. By 1.7 ml in the cartridges.

    10 cartridges per contour cell packaging made of polyvinylchloride film and aluminum foil or paper with a polymer coating or paper laminated.

    5 outline carton packs of 10 cartridges along with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000031
    Date of registration:03.04.2007 / 30.09.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:HEALTH PHARMACEUTICAL COMPANY, LTD. HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp09.10.2017
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