Active substanceLidocaineLidocaine
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  • Dosage form: & nbspgel for topical application
    Composition:1 g sterile gel contains 20 mg (in terms of anhydrous compound) of lidocaine hydrochloride and auxiliary substances - methyl parahydroxybenzoate, propyl parahydroxybenzoate, hypromellose, glycerol 85%, water for injection.
    Description:Transparent from colorless to light yellow color gelatinous mass.
    Pharmacotherapeutic group:Local anesthetic
    ATX: & nbsp

    N.01.B.B   Amides

    N.01.B.B.02   Lidocaine

    C.01.B.B.01   Lidocaine

    C.01.B.B   Antiarrhythmic drugs Ib class

    Pharmacodynamics:Locally anesthetic agent of amide type. The mechanism of action is associated with the stabilization of the permeability of the membrane of neurons for sodium ions. As a result, the threshold of neuron excitability rises and the nerve impulse is blocked. The degree of anesthesia depends on the dose of the drug and the duration of the application.
    Pharmacokinetics:When applied to mucous membranes, absorbed and enters the systemic circulation. Metabolised in the liver (by 90-95%) with the participation of microsomal enzymes by dealkylation of the amino group and breaking of the amide bond to form active metabolites (monoethylglycinexylidine and glycinexylidin),with half-life periods of 2 hours and 10 hours, respectively. With liver diseases, the intensity of metabolism decreases and ranges from 50% to 10% of the normal value.
    Indications:Superficial anesthesia of mucous membranes, including intubation of trachea, endoscopy, catheterization, replacement of fistula catheters and probing.
    Contraindications:

    - hypersensitivity to local anesthetics such as acid amides and alkyl-4-hydroxybenzoates (parabolic group allergy);
    - pronounced bradycardia;

    - ulcerative lesions of the mucous membrane at the site of application.

    - children under 18 years (due to lack of data).

    Carefully:Damage or inflammation of the mucous membrane at the site of application, weakened patients, elderly age.
    Pregnancy and lactation:Lidocaine It should be used during pregnancy only with strict statement of indications for use. When using the drug in therapeutic doses, lidocaine penetrates into breast milk in quantities that do not pose a risk to the child.
    Dosing and Administration:

    Locally.

    To the preparation Helikain (packing 30 grams), three sterile packaged applicators are attached,with the help of which the gel can be introduced into the ureter. Immediately after use, the applicator must be unscrewed from the tube and disposed of. For the next application, take a sterile applicator from the package and screw it onto the tube. After use, the tubes should be immediately closed. With proper application, the contents of the tube remain sterile and after repeated gel-taking. Tools after use must be wiped off immediately with a damp cloth to avoid sticking the gel.

    Doses and duration of application

    The maximum daily dose of Helicaine should not exceed 30 g of gel (600 mg of lidocaine) per patient.

    For performing medical and diagnostic manipulations, for example, with intubation, endoscopy, catheterization, probing:

    to avoid drying and to achieve optimal glide, Helikain, in accordance with the size of medical instruments, is applied to them immediately before their application.

    Instillation in the ureter (for performing diagnostic and therapeutic manipulation):

    the tissues around are cleaned and disinfected. With the help of the applicator, Helikain is introduced into the ureter. Women are installing 5 g of Helicaine. In men, 10-15 g of Helicaine is installed.Reverse flow of the gel from the ureter is prevented by squeezing the glans penis or by applying a clamp. After a few minutes, if necessary, the administration of Helicaine can be continued.

    Side effects:Allergic reactions: contact dermatitis, angioedema, urethritis (after topical application).
    Overdose:When using the gel in dosages exceeding the recommended, as well as severe inflammatory processes of the mucous membranes at the site of application, the following symptoms are possible: dizziness, headache, dysphoria, confusion, drowsiness, tinnitus, paresthesia, diplopia, tremor, facial mimic trisme, convulsions, loss of consciousness; lowering blood pressure, bradycardia, vasodilation, arrhythmia, collapse, chest pain, cardiac arrest. Treatment is symptomatic. Hemodialysis is ineffective.
    Interaction:There is no information on therapeutically important interaction.
    Special instructions:The contents of the tube are sterile. Tubes and applicators are sterilized with gas and can therefore also be used intraoperatively in a sterile environment.After the first opening of the tube and the correct use, the contents of the tube can be used for another 4 weeks (the date of the first autopsy should be recorded). Helicain does not affect the transparency of instrument optics. Light deformation of tubes is due to manufacturing technology and does not affect product quality.
    Form release / dosage:Gel for topical application 2%.
    Packaging:By 30 g or 100 g of gel in a cylindrical aluminum tube with an inner protective coating and a sealed film and a white lid with a perforating spike, placed in a blister. Tub 30 g in a blister and three white applicators in a blister or tube 100 g in a blister in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. The drug should not be used after the expiry date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010498/08
    Date of registration:24.12.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:DeltaSelect GmbHDeltaSelect GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspSVYCH LLC SVYCH LLC Russia
    Information update date: & nbsp2016-08-18
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