Trombless Plus gel, 30 g

Chronic venous insufficiency, accompanied by such symptoms as swelling, pain, feeling of heaviness in the legs, feeling of 'fullness', tired legs, spider veins and nets, convulsions, paresthesia (feeling of numbness, tingling, 'creeping').

Varicose veins of the lower extremities.

Migratory phlebitis, thrombophlebitis.

Subcutaneous hematomas, localized edema and aseptic infiltrates, including on the face.

Injuries and bruises of joints, tendons, muscle tissue.

Complications after vein surgery.

It is applied externally.

Unless otherwise recommended by the doctor, then a strip of gel 1-3 cm long (depending on the area of ??the affected surface) is applied with a thin layer on the skin over the affected area and around it, evenly spreading over the skin surface with light circular movements 2 times a day.

With varicose veins, chronic venous insufficiency and thrombophlebitis, the course of treatment is 2-3 weeks, with a second course of treatment in case of relapse of the disease on the recommendation of a doctor.

In case of subcutaneous hematomas, localized edema, aseptic infiltrates, injuries, bruises, complications arising after surgical operations on the veins, the drug is used until the damaged tissues are completely restored and the hematomas resolve.

If after treatment there is no improvement or new symptoms appear, you should consult your doctor.

Use the drug only according to the route of administration and in the doses indicated above. If necessary, if you have any questions, consult your doctor before using the medicinal product.

1 g of gel contains:
active ingredients: sodium heparin - 1000 IU (8.33 mg with sodium heparin activity of 120 IU / mg), troxerutin - 20.0 mg, dexpanthenol - 100.0 mg, benzocaine - 1.0 mg;
excipients: ethanol, methyl parahydroxybenzoate, trolamine, carbomer, glycerol, water.

Hypersensitivity to the components of the drug, violation of the integrity of the skin at the site of the intended application of the drug (open wounds, ulcerative necrotic lesions), children under 18 years of age (due to the lack of data on the effectiveness and safety of the drug in this category of patients). Increased tendency to bleeding, thrombocytopenia.

Trade name: Trombless Plus

International non-proprietary name

Benzocaine + Sodium Heparin + Dexpanthenol + Troxerutin

Dosage form

gel for external use

Composition

1 g of gel contains:
active ingredients: sodium heparin - 1000 IU (8.33 mg with sodium heparin activity of 120 IU / mg), troxerutin - 20.0 mg, dexpanthenol - 100.0 mg, benzocaine - 1.0 mg;
excipients: ethanol, methyl parahydroxybenzoate, trolamine, carbomer, glycerol, water.

Description

Transparent or translucent gel from light yellow to yellow, greenish tint is allowed. Has a weak characteristic odor.

Pharmacotherapeutic group

direct-acting anticoagulant for topical use other drugs

Pharmacological properties

Pharmacodynamics
TromblessЃ Plus is a combined drug.

Heparin sodium is a direct anticoagulant that has anti-inflammatory, antiproliferative, decongestant and analgesic effects. Reduces platelet aggregation, binds to antithrombin III, preventing the transition of prothrombin to thrombin. Inhibits 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 of hematomas and blood clots, ultimately restoring the patency of the veins, clinically accompanied by a pronounced analgesic and anti-inflammatory effect.

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

Troxerutin is a flavonoid (a derivative of rutin) with P-vitamin activity; has a venotonic, angioprotective, decongestant, antioxidant and anti-inflammatory effect. Participates in redox processes, blocks hyaluronidase, stabilizes the hyaluronic acid of cell membranes and reduces the permeability and fragility of capillaries, increases their tone.

Increases the density of the vascular wall, reduces the exudation of the liquid part of the plasma and diapedesis of blood cells. Reduces inflammation in the vascular wall, limiting the adhesion of platelets to its surface.

Benzocaine is a local anesthetic for surface anesthesia. Reduces the permeability of the cell membrane for sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, and blocks the conduction of nerve impulses. Prevents the emergence of pain impulses in the endings of the sensory nerves and their conduction along the nerve fibers. Benzocaine dilates superficial vessels, promoting the absorption of heparin.

Pharmacokinetics
A small amount of heparin is absorbed from the skin surface into the systemic circulation. The maximum concentration of the drug in the blood is observed 8 hours after application. Excretion of heparin mainly occurs through the kidneys, with a half-life of 12 hours.

Troxerutin is well absorbed from the skin surface when applied externally, penetration into the systemic circulation is clinically insignificant.

Dexpanthenol, when applied topically, is rapidly 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 ?g / l. Pantothenic acid is not metabolized in the body (except for inclusion in coenzyme A), it is excreted unchanged.

When applied to the skin, benzocaine is practically not absorbed. It has an immediate analgesic effect: the speed of the onset of the effect begins 1 second after application and lasts an average of 4-6 hours.

Indications for use

Chronic venous insufficiency, accompanied by such symptoms as swelling, pain, feeling of heaviness in the legs, feeling of 'fullness', tired legs, spider veins and nets, convulsions, paresthesia (feeling of numbness, tingling, 'creeping').

Varicose veins of the lower extremities.

Migratory phlebitis, thrombophlebitis.

Subcutaneous hematomas, localized edema and aseptic infiltrates, including on the face.

Injuries and bruises of joints, tendons, muscle tissue.

Complications after vein surgery.

Contraindications

Hypersensitivity to the components of the drug, violation of the integrity of the skin at the site of the intended application of the drug (open wounds, ulcerative necrotic lesions), children under 18 years of age (due to the lack of data on the effectiveness and safety of the drug in this category of patients). Increased tendency to bleeding, thrombocytopenia.

Application during pregnancy and during breastfeeding

The use of the drug TromblessЃ Plus during pregnancy and lactation is possible if the potential benefit to the mother outweighs the potential risk to the fetus and child. Do not apply to the area of ??the mammary glands to avoid getting the drug into the baby's body.

Method of administration and dosage

It is applied externally.

Unless otherwise recommended by the doctor, then a strip of gel 1-3 cm long (depending on the area of ??the affected surface) is applied with a thin layer on the skin over the affected area and around it, evenly spreading over the skin surface with light circular movements 2 times a day.

With varicose veins, chronic venous insufficiency and thrombophlebitis, the course of treatment is 2-3 weeks, with a second course of treatment in case of relapse of the disease on the recommendation of a doctor.

In case of subcutaneous hematomas, localized edema, aseptic infiltrates, injuries, bruises, complications arising after surgical operations on the veins, the drug is used until the damaged tissues are completely restored and the hematomas resolve.

If after treatment there is no improvement or new symptoms appear, you should consult your doctor.

Use the drug only according to the route of administration and in the doses indicated above. If necessary, if you have any questions, consult your doctor before using the medicinal product.

Side effect

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

The drug TromblessЃ Plus can also cause allergic reactions (possibly delayed) due to the presence of methyl parahydroxybenzoate in the composition.

If any of the side effects indicated in the instructions are aggravated or other side effects not indicated in the instructions are noted, you should immediately consult a doctor.

Overdose

No cases of overdose of TromblessЃ Plus gel have been reported.

The extremely low systemic absorption of the active components of the drug when applied externally makes an overdose almost impossible.

In case of an overdose, wash off the excess gel with plenty of running water and seek immediate medical attention; in case of accidental or deliberate ingestion of the gel, rinse the stomach and immediately seek medical help.

Interaction with other medicinal products

The combined use of the gel with oral anticoagulants can cause prolongation of the prothrombin time. Non-narcotic analgesics and anticholinesterase drugs enhance the effect of benzocaine included in the drug. Benzocaine reduces the antibacterial activity of sulfonamides.

special instructions

It is not recommended to apply to mucous membranes, open wounds and use in the presence of purulent lesions at the intended site of application of the gel.

During breastfeeding, you should avoid applying the drug to the area of ??the mammary glands to avoid swallowing the drug by the infant.

In case of accidental contact with eyes and other mucous membranes, rinse them abundantly with running water.

Do not exceed the maximum periods and recommended doses of the drug without consulting your doctor!

With prolonged use of the drug on large areas of the skin and the simultaneous use of indirect anticoagulants (warfarin, syncumar, etc.), prothrombin time and blood coagulation time should be monitored (due to the presence of sodium heparin in the drug).

It is not recommended to use the drug TromblessЃ Plus for deep vein thrombosis of the legs.

The drug is not intended for use in ophthalmology and for intravaginal administration.

Influence on the ability to drive vehicles and work with mechanisms
The drug does not affect the ability to perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (including driving, working with moving mechanisms).

Release form

Gel for external use 1 mg / g + 1000 IU / g + 100 mg / g + 20 mg / g
10, 20, 30, 40, 50 or 100 g in aluminum tubes or in polyethylene laminate tubes. Each tube, along with instructions for medical use of the drug, is placed in a cardboard box.

Storage conditions

At a temperature not higher than 25 ? C.
Keep out of the reach of children.

Shelf life

2 years. Do not use the drug after the expiration date.

Vacation conditions

Available without a prescription.