Trombless Plus, gel for external use 50g

Composition

>of 1 g of gel contains: Active ingredients: Sodium heparin-1000 IU (8.33 mg with the activity of sodium heparin 120 IU/mg), Troxerutin-20.0 mg, Dexpanthenol-100.0 mg, Benzocaine-1.0 mg; Excipients: Ethanol, Methyl Parahydroxybenzoate, Trollamine, Carbomer, glycerol, water.

Pharmacological action

Pharmacodynamicatrombless ® Plus 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 B5-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, improves the absorption of heparin. Troxerutin is a flavonoid (a 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. Pharmacokinetic Sansignificant amounts of heparin are absorbed from the skin surface into the systemic circulation. The maximum concentration of the drug in the blood is noted 8 hours after application. Elimination of heparin mainly occurs through the kidneys, with a half-life of 12 hours. Troxerutin is well absorbed from the surface of the skin 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 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. It has an instant analgesic effect: the rate of onset of the effect begins 1 second after application and lasts an average of 4-6 hours.

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 Trombless;
• ulcerative-necrotic, purulent processes on the skin;
• traumatic violation of the integrity of the skin.
• With caution:
• increased tendency to bleeding;
• thrombocytopenia.

Side effects

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. Trombless ® Plus may also cause allergic reactions (possibly delayed) due to the presence of methyl parahydroxybenzoate in the composition. If any of the side effects listed in the instructions are aggravated or other side effects are noted that are not listed in the instructions, you should immediately consult a doctor.

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:

apply a thin layer on the skin over and around the affected area, spreading evenly 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.

The gel is applied evenly in a thin layer over the entire affected surface and a sterile gauze dressing is applied. The dressing is changed once a day.

With an open method of treatment, the drug is applied 1-2 times a day. The duration of treatment is determined by the dynamics of epithelialization.

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

Overdose

Overdose of Trombless Plus gel has not been reported. Extremely low systemic absorption of the active components of the drug with external use makes overdose almost impossible. In case of overdose, wash off the excess gel with plenty of running water and seek immediate medical attention; in case of accidental or intentional ingestion of the gel, flush the stomach and seek immediate medical attention.

Special instructions

It is not recommended to apply on the mucous membranes, open wounds and apply in the presence of purulent lesions in the intended place of application of the gel. During breastfeeding, avoid applying the drug to the area of the mammary glands in order to avoid ingestion of the drug by the infant. In case of accidental contact with the eyes and other mucous membranes, it is necessary to rinse them thoroughly with running water. Do not exceed the maximum time and recommended doses of the drug without consulting your doctor!With prolonged use of the drug on large areas of the skin and simultaneous use of indirect anticoagulants (warfarin, sinkumar, etc. ), prothrombin time and blood clotting time should be monitored (due to the presence of sodium heparin in the drug). It is not recommended to use the drug Trombless ® Plus for deep vein thrombosis of the legs. The drug is not intended for use in ophthalmology or for intravaginal use. Influence on the ability to drive vehicles and work with mechanisms The drug does not affect the ability to perform potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Form of production

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

Storage conditions

The drug should be stored at a temperature not exceeding 25°C. Keep out of reach of children. Do not use after the expiration date.

Shelf

life is 2 years.

Active ingredient

Heparin sodium, Dexpanthenol, Troxerutin

Dosage form

gel for external use

Purpose

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

Indications

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