Active substanceArticaine + EpinephrineArticaine + Epinephrine
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  • Dosage form: & nbspinjection
    Composition:

    In 1 cartridge (1.8 ml) contains:

    Active substances: articaine hydrochloride - 72.0 mg, epinephrine hydrochloride - 0.0216 mg.

    Excipients: sodium chloride - 1,8 mg, sodium disulfite - 0,9 mg, water for injections - up to 1,8 ml.

    Description:A clear, colorless liquid.
    Pharmacotherapeutic group:Local anesthetic + α- and β-adrenomimetic
    ATX: & nbsp

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

    Pharmacodynamics:

    Alfacaine SP is a combined preparation for local anesthesia in dentistry. Included in its composition articaine - local anesthetic of the amide type of the thiafen group. The effect of the drug begins quickly - after 1 -3 minutes. The duration of anesthesia is at least 45 minutes. Wound healing proceeds without complications, which is due to good tissue tolerance and minimal vasoconstrictive effect.

    Due to the low content of epinephrine in the preparation, its effect on the cardiovascular system is not very pronounced: almostthere is an increase in blood pressure and an increase in heart rate.

    Pharmacokinetics:Articaine with submucosal administration in the oral cavity has a high diffusion capacity. The connection with proteins is 95%. Active substances penetrate to the minimum degree through the placental barrier, practically do not stand out with breast milk, the elimination half-life is 25 minutes.
    Indications:

    Infiltration and conductive anesthesia in dentistry (especially in patients with concomitant severe physical illnesses), including the following manipulations:

    - uncomplicated removal of one or more teeth;

    - filling of carious cavities, teeth grinding before preparation;

    - operations on the mucous membranes of the mouth or bone, requiring a more pronounced effect of ischemia;

    - Conduella-Lucas operation;

    - cystectomy;

    - percutaneous osteosynthesis.

    Contraindications:

    - Hypersensitivity to articaine, epinephrine, sulfites, as well as to any of the auxiliary components of the drug;

    - paroxysmal tachycardia and other tachyarrhythmias;

    - bronchial asthma with increased sensitivity to sulfites;

    - closed-angle glaucoma, simultaneous reception of non-selective beta-blockers;

    - severe form of hepatic insufficiency (porphyria);

    - hyperthyroidism;

    - concomitant therapy with monoamine oxidase inhibitors or tricyclic antidepressants;

    - cardiogenic shock.

    - children's age up to 4 years.

    Carefully:

    - Chronic heart failure;

    - intraventricular and atrioventricular blockade of the heart;

    - inflammation in the area of ​​suspected anesthesia;

    - deficiency of cholinesterase;

    - kidney failure;

    - diabetes;

    - arterial hypertension;

    - elderly age;

    - severe general condition, weakened patients.

    Pregnancy and lactation:

    Possible use of the drug during pregnancy. If necessary, the use of the drug in a nursing mother does not need to interrupt the feeding, since active substances are not excreted in breast milk in clinically significant amounts.

    Dosing and Administration:

    With uncomplicated removal of the teeth of the upper jaw, in the absence of inflammation, 1.8 ml of the drug (per tooth) is usually injected into the submucosa in the region of the transitional fold from the vestibular side.In some cases, additional administration of 1 to 1.8 ml of the drug may be required to achieve complete anesthesia. In most cases, there is no need to perform painful injections from the palatal side. For anesthesia in the palatine incisions and suturing with the purpose of creating a palatine depot is necessary about 0.1 ml of the drug for injection. When several adjacent teeth are removed, the number of injections is usually limited. In the case of removal of premolars of the lower jaw in the absence of inflammation, you can do without mandibular anesthesia. infiltration anesthesia, provided by injection of 1.8 ml per tooth, is usually sufficient. If this method fails to achieve the desired effect, an additional injection of 1-1.8 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, however, in this case, it was not possible to achieve complete anesthesia, it is necessary to blockade the mandibular nerve.

    To prepare the cavity of the tooth for sealing or treatment for the crown of any tooth, with the exception of lower molars, the administration of the drug in a dose of 0.5 to 1.8 ml per tooth by typeinfiltration anesthesia from the vestibular side. The exact amount depends on the desired depth 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. The duration of anesthesia, during which the intervention can be performed, is 30-45 minutes.

    Side effects:

    The drug is usually well tolerated by patients, but the development of the following side effects is possible

    From the central nervous system (depends on the magnitude of the applied dose): headache, impaired consciousness until its loss, violation of breathing until it stops, muscle tremor, involuntary twitching of the muscles, sometimes progressing up to generalized seizures.

    On the part of the digestive system: nausea, vomiting, diarrhea.

    From the side of the organ of vision: rarely - "clouding" in the eyes, transient blindness, diplopia.

    From the side of the cardiovascular system: Moderately severe disorders of hemodynamics, manifested in lowering blood pressure, tachycardia or bradycardia, inhibition of cardiovascular activity, which in extreme manifestation can lead to collapse and cardiac arrest, which threatens the patient's life.

    Allergic reactions: edema or inflammation at the injection site, in other areas - redness of the skin, itching, conjunctivitis, rhinitis, angioedema, of varying severity (including edema of the upper and / or lower lip and / or cheeks, swallowing difficulty, hives, difficulty breathing) . All these phenomena can progress to the development of anaphylactic shock.

    Local reactions: edema or inflammation at the injection site; the appearance of ischemic zones at the injection site (up to the development of tissue necrosis - with a random intravascular injection).

    Other: headaches often associated with the presence of epinephrine in the formulation are often observed; other side effects caused by the action of epinephrine (tachycardia, arrhythmia, increased blood pressure), are extremely rare; nerve damage (up to the development of paralysis) - occurs only when the technique of injection is disturbed.

    Overdose:

    Symptoms: dizziness, motor anxiety, impaired consciousness, decreased blood pressure, tachycardia, bradycardia, respiratory failure, convulsions, shock.

    Treatment: when there are first signs of an overdose during the injection,it is necessary to stop the introduction of the drug, give the patient a horizontal position, provide free patency of the airways, control the heart rate and blood pressure. If there is a violation of breathing - oxygen, endotracheal intubation, artificial ventilation, (central analeptics are contraindicated); with convulsions - intravenously slowly barbiturates of short action with simultaneous supply of oxygen and control of hemodynamics; with severe circulatory disturbances and shock - intravenous infusion of solutions of electrolytes and plasma substitutes, glucocorticosteroids, albumin; with vascular collapse and increasing bradycardia - intravenously slowly epinephrine 0.1 mg, then intravenously drip under the control of heart rate and blood pressure; with severe tachycardia and tachyarrhythmia - intravenous beta-blockers (selective); with increased blood pressure - peripheral vasodilators.

    Oxygenotherapy and monitoring of circulatory parameters are necessary in all cases.

    Interaction:

    The hypertensive effect of sympathomimetic amines such as epinephrine can be enhanced by tricyclic antidepressants and monoamine oxidase inhibitors. Interactions of this type are described for epinephrine and norepinephrine when used as vasoconstrictors at concentrations of 1: 25,000 and 1: 80,000, respectively.

    Do not prescribe the drug on the background of treatment with non-selective beta-blockers, since in this case the risk of hypertensive crisis and severe bradycardia is high.

    The local anesthetic effect of articaine is enhanced and lengthened by vasoconstrictive drugs.

    Special instructions:

    Alfacaine SP contains sulfites, which can enhance anaphylactic reaction. The drug can not be administered intravenously. Do not inject into the area of ​​inflammation. Food intake is possible only after restoration of sensitivity.

    To prevent infection (including hepatitis), it is always necessary to use new sterile syringes and needles every time you take a solution from vials or ampoules. Open cartridges can not be used again for other patients (hepatitis risk).

    Do not use a damaged cartridge.

    It has no harmful effect on the fetus (with the possible exception of bradycardia) in any application and dosage technique.

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

    In special tests, there was no clear effect of the drug on the concentration of attention and the speed of motor reactions. However, due to the fact that preoperative anxiety and stress caused by surgical intervention can influence the effectiveness of the activity, the dentist should individually, in in each case, to decide whether the patient is allowed to drive or work with machinery.

    Form release / dosage:

    Solution for injection with (epinephrine) 1: 100000.

    Packaging:1.8 ml in cartridges of transparent neutral glass, sealed with two ends of stoppers made of bromobutyl rubber. The plug closing the neck of the cartridge is protected by an aluminum foil ring. 10 cartridges are placed in a blister. 10 blisters with instructions for use are placed in a cardboard box.
    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years.Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N009007
    Date of registration:09.02.2012 / 28.12.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:DENTSPLY France S.A.S.DENTSPLY France S.A.S. France
    Manufacturer: & nbsp
    Representation: & nbspDENTSPLY Russia LimitedDENTSPLY Russia LimitedRussia
    Information update date: & nbsp17.07.2017
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