Trombless Plus, gel for external use 30g

Composition

of 1 g: – heparin sodium 1000 IU (0.00833 g) – troxerutin 0.02 g-dexpanthenol 0.1 g-benzocaine 0.001 g

Auxiliary substances:

ethanol 0.1 g,

methyl parahydroxybenzoate 0.0015 g,

trollamine 0.007 g,

carbomer up to 0.01 g,

glycerol 0.05 g,

purified water up to 1 g

Pharmacological action

Pharmaceutical group:

 Drug with antithrombotic, angioprotective, venotonizing, local anesthetic and tissue regeneration-enhancing action for external use

Pharmacovigilance:

Trombless Plus gel is a combination drug.

Heparin sodium is a direct-acting 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 blood. Improves microcirculation and activates tissue metabolism, thereby accelerating the resorption of hematomas and blood clots, ultimately restoring the patency of the veins, clinically this is accompanied by a pronounced analgesic and anti-inflammatory effect.

Dexpanthenol-provitamin B 5-in the skin is converted into pantothenic acid, which is part of coenzyme A, which is involved in the processes of acetylation, carbohydrate and fat metabolism; it stimulates skin regeneration, normalizes cellular metabolism, and increases the strength of collagen fibers. It has regenerating, vitamin, metabolic and anti-inflammatory effects.

Troxerutin is a flavonoid (rutin derivative), has P-vitamin activity; it has venotonizing, angioprotective, decongestant, antioxidant and anti-inflammatory effects. It participates in redox processes, blocks hyaluronidase, stabilizes the hyaluronic acid of cell membranes, reduces the permeability and fragility of capillaries, and 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 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 the receptors located on the inner surface of the membrane, blocks the conduction of nerve impulses. Prevents the occurrence of pain impulses in the endings of sensitive nerves and their conduction through nerve fibers. Benzocaine dilates the surface vessels, promoting the absorption of heparin.

Pharmacokinetics:

A small amount of heparin is absorbed from the skin surface into the systemic circulation. Cmax of the drug in the blood is noted 8 hours after application. Elimination of heparin mainly occurs through the kidneys, T1/2 12 hours.

Troxerutin is well absorbed from the surface of the skin when used externally. 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 mcg/l. Pantothenic acid is not metabolized in the body (except for inclusion in coenzyme A), it is excreted unchanged. Benzocaine is practically not absorbed when applied on the skin.

Active ingredients

Heparin Sodium + Troxerutin + Dexpanthenol + Benzocaine

Indications

• Chronic venous insufficiency, accompanied by symptoms such as swelling, pain, a feeling of heaviness in the legs, a feeling of “fullness”, fatigue of the legs, vascular asterisks and meshes, convulsions, paresthesia (numbness, tingling, “crawling”).
• Varicose veins of the lower extremities.
• Migrating phlebitis, thrombophlebitis.
• Subcutaneous hematomas, localized edema and aseptic infiltrates, including on the face.
• Injuries and bruises of joints, tendons, and muscle tissue.
• Complications that occur after surgical operations on the veins.

Contraindications

-hypersensitivity to the components of the drug Trombless Plus;— open infected wounds or wounds with heavy exudation at the site of intended application— – children under 18 years of age (there are no data on the effectiveness and safety of the drug);- pregnancy and lactation. With caution: Increased tendency to bleeding, thrombocytopenia.

Side effects

In rare cases, there was a redness, itching or burning sensation at the site of application of the cream, however, these phenomena rarely led to the need to stop treatment.

The above symptoms should be distinguished from allergic reactions, such as urticaria, which occur rarely, but if they occur, treatment should be discontinued.

Interaction

Concomitant use of the gel with oral anticoagulants may cause prolongation of prothrombin time.

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

Benzocaine reduces the antibacterial activity of sulfonamides.

How to take, course of use and dosage

Externally, Trombless Metatarsal gel is applied in a thin layer to the skin above and around the affected area, evenly distributing it over the skin surface with light circular movements 2-3 times a day. The course of treatment is 2-3 weeks, with repetition in case of relapse of the disease.

For trophic ulcers with weak exudation, the wound surface is cleaned of exudate and necrotic tissues before use, if necessary, washed with a solution of hydrogen peroxide 3%, nitrofural 1: 5000 or chlorhexidine 0.05% and dried. Trombless Plus gel is applied evenly in a thin layer on the entire affected surface and a sterile gauze dressing is applied. The dressing is changed 1 time/day. With an open method of treatment, the drug is applied 1-2 times / day. The duration of treatment is determined by the dynamics of epithelialization.

For subcutaneous hematomas, localized edema, aseptic infiltrates, injuries, bruises and similar conditions, apply to the affected area 2-3 times / day. until the normal condition of the damaged tissues is fully restored.

Overdose

No overdose cases of Trombless Plus gel have been reported.

Description

Direct – acting anticoagulant for topical use + other medications

Description

Transparent or semi-transparent gel from light yellow to yellow in color, a greenish tint is allowed. It has a faint characteristic smell.

Functional features

With topical application of the cream, less than 5% of the dose is absorbed, so the systemic effect of the drug is minimal. With a single application on the surface of the skin with an area of 30 cm 2,3.5% of the dose is detected in the urine. The drug quickly penetrates the skin and accumulates in the sebaceous glands.

Complete set

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

Special instructions

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or premature discontinuation, there is a risk of recurrent infection. If there are no signs of improvement after 1-2 weeks of therapy, the diagnosis should be verified.

The cream is intended for external use only.

Avoid contact with the mucous membrane of the eyes, nose, mouth. If the drug gets on the mucous membrane – rinse with water and, if necessary, consult a doctor.

Storage conditions

At a temperature not exceeding 20 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use the product after the expiration date indicated on the package.

Active ingredient

Heparin sodium, Dexpanthenol, Troxerutin

Dosage form

gel for external use

Description

For adults, Nursing mothers as prescribed by a doctor, For pregnant women

Indications

Bruises, Varicose veins, Swelling after injuries and operations, Hematomas, Thrombophlebitis, Tendon inflammation, Dislocations and sprains