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Dosage form: & nbspgel for external use
Composition:

1 g of gel contains:

active ingredients: heparin Sodium 1000 ME (8.33 mg with a heparin sodium activity of 120 IU / mg), troxerutin 20.0 mg, dexpanthenol 100.0 mg, benzocaine 1.0 mg;

Excipients: ethanol 100.0 mg, methyl parahydroxybenzoate 1.5 mg, trolamine 7.0 mg, carbomer to 10.0 mg, glycerol 50.0 mg, water to 1.0 g.

Description:

Transparent or translucent gel from light yellow to yellow, a greenish shade is allowed. It has a weak characteristic odor.

Pharmacotherapeutic group:anticoagulant direct action for topical application + other drugs
ATX: & nbsp
  • Heparin in combination with other drugs
  • Pharmacodynamics:

    Sodium Heparin - an anticoagulant of direct action, has anti-inflammatory, antiproliferative, anti-edematous and analgesic effect. Reduces platelet aggregation, binds to antithrombin III, preventing the passage of prothrombin in thrombin. Oppresses the activity of thrombin. Reduces the activity of hyaluronidase, increases the fibrinolytic properties of the blood. Improves microcirculation and activates tissue metabolism, thereby accelerating the processes of resorption hematomas and thrombi, eventually restores the permeability of the veins, clinically it is accompanied by a pronounced analgesic and anti-inflammatory effect.

    Dexpanthenol - provitamin B5 - in the skin it turns into pantothenic acid, which is part of coenzyme A, which participates in the processes of acetylation, carbohydrate and fat metabolism; stimulates the regeneration of the skin, normalizes the cellular metabolism, increases the strength of collagen fibers. It has a regenerating, vitamin, metabolic and anti-inflammatory effect.

    Troxerutin - flavonoid (derivative routine), has P-vitamin activity; has venotonic, angioprotective, anti-edematous, antioxidant and anti-inflammatory effects. It participates in oxidation-reduction processes, blocks hyaluronidase, stabilizes hyaluronic acid of cell membranes and reduces permeability and fragility of capillaries, increases their tone. Increases the density of the vascular wall, reduces exudation of the liquid part of the plasma and diapedesis of blood cells. Reduces inflammation in the vascular wall, limiting the adhesion to its surface of platelets.

    Benzocaine - local anesthetic for superficial anesthesia. Reduces the permeability of the cell membrane for sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, blocks the conduct of nerve impulses.Prevents the appearance of painful impulses in the endings of the sensory nerves and their conduction along nerve fibers. Benzocaine expands the surface vessels, contributing to the absorption of heparin.

    Pharmacokinetics:

    An insignificant amount of heparin is absorbed from the surface of the skin into the systemic circulation. The maximum concentration of the drug in the blood is noted 8 hours after APPlicensing. The elimination of heparin, mainly occurs through the kidneys, half-life of 12 hours.

    Troxerutin is well absorbed from the surface of the skin when used externally. Dexpanthenol when topically applied quickly absorbed by the skin and converted to pantothenic acid. Its concentration in the blood is 0.5-1 mg / l, in the blood serum - 100 μg / l. Pantothenic acid is not exposed in the body to metabolism (except for inclusion in coenzyme A), is excreted unchanged.

    Benzocaine during the skin application is almost not absorbed.

    Indications:

    Symptomocomplex of chronic venous insufficiency (including against the background of varicose veins of the lower extremities), migrating phlebitis, thrombophlebitis of superficial veins.

    Subcutaneous hematomas, localized edema and aseptic infiltrates.

    Injuries and bruises of joints, tendons, muscle tissue.

    Complications that arose after surgical operations on the veins.

    Contraindications:

    Hypersensitivity to the components of the drug, open infected wounds or wounds with heavy exudation at the site of the intended application, children under 18 years of age (no data on the efficacy and safety of the drug), pregnancy and lactation.

    Carefully:

    Increased tendency to bleeding, thrombocytopenia.

    Pregnancy and lactation:

    The use of the drug Tromblex® Plus during pregnancy and lactation is contraindicated.

    Dosing and Administration:

    Outerly, apply a thin layer on the skin above the affected area and around it, evenly spreading on the surface of the skin with light circular motions 2-3 times a day. The course of treatment is 2-3 weeks, with the recurrence of a relapse of the disease.

    With trophic ulcers with weak exudation before use, the wound surface is cleaned from exudate and necrotic tissues, if necessary, washed with hydrogen peroxide solution 3%, nitrofural 1: 5000 or chlorhexidine 0,05% and dried.The gel is applied in a uniform thin layer over the entire affected area and a sterile gauze bandage is applied. Change dressings produced 1 time per day. With the open method of treatment, the drug is applied 1-2 times a day. The duration of treatment is determined by the dynamics of epithelialization.

    With subcutaneous hematomas, localized edema, aseptic infiltrates, injuries, bruises and similar states Apply to the affected area 2-3 times a day until the normal state of the damaged tissue is completely restored.

    Side effects:

    With prolonged use of the drug, local reactions in the form of skin hyperemia, decreased sensitivity (at the site of application), allergic reactions (skin rash, itching) are possible.

    Overdose:

    No cases of an overdose of the Tromblex® Plus drug have been reported.

    Interaction:

    The combined use of a gel with oral anticoagulants can cause prolonged prothrombin time.

    Non-narcotic analgesics and anticholinesterase drugs increase the effect of the benzocaine included in the preparation.

    Benzocaine reduces the antibacterial activity of sulfonamides.

    Special instructions:

    Not intended for use in ophthalmology, for intravaginal administration.

    Form release / dosage:

    Gel for external use.

    Packaging:

    By 10, 20, 30, 40, 50 or 100 g in tubes of aluminum or in tubes of polyethylene laminate.

    Each tube together with instructions for medical use of the drug is placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001786
    Date of registration:31.07.2012 / 19.02.2015
    Date of cancellation:2017-07-31
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp08.02.2016
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