Trombless Plus, gel 50 g

Pharmacodynamics

Trombless® Plus is a combined drug.

Sodium heparin is a direct acting anticoagulant, has anti-inflammatory, antiproliferative, antiedematous and analgesic effect.

Reduces platelet aggregation, binds with antithrombin III, preventing prothrombin conversion to thrombin. Inhibits thrombin activity.

Decreases hyaluronidase activity, increases fibrinolytic properties of blood.

It improves microcirculation and tissue exchange, thus accelerating the process of hematoma and thrombus resorption, and finally restores venous patency, clinically accompanied with pronounced analgesic and anti-inflammatory effect.

Dexpanthenol – provitamin B5 – converts in the skin into pantothenic acid, a member of coenzyme A, which is involved in acetylation processes, carbohydrate and fat metabolism, stimulates skin regeneration, normalizes cell metabolism, increases the strength of collagen fibers.

It has regenerating, vitamin, metabolic and anti-inflammatory effect, improves heparin absorption.

Troxerutin is a flavonoid (rutin derivative) with P-vitamin activity, has venotonic, angioprotective, anti-edema, antioxidant and anti-inflammatory effect.

It participates in redox processes, blocks hyaluronidase, stabilizes hyaluronic acid in cell membranes, decreases capillaries permeability and fragility and increases their tone.

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

Benzocaine is a local anesthetic for surface anesthesia. It decreases cell membrane permeability to sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, blocks nerve impulses.

Prevents the occurrence of pain impulses in the endings of sensitive nerves and their conduction along the nerve fibers. Benzocaine dilates superficial vessels, promoting absorption of heparin.

Pharmacokinetics

A small amount of heparin is absorbed from skin surface into systemic bloodstream.

Maximum concentration of the drug in blood is observed 8 hours after application.

Heparin excretion mainly occurs through the kidneys, the half-life period is 12 hours.

Troxerutin is well absorbed from the skin surface when used externally, penetration into the systemic blood flow is clinically insignificant.

Dexpanthenol when applied topically is quickly absorbed by skin and converted into pantothenic acid.

Its concentration in blood is 0.5-1 mg/l, in blood serum – 100 µg/l. Pantothenic acid is not metabolized in the body (except for its incorporation into coenzyme A) and is eliminated unchanged.

Benzocaine is practically not absorbed by skin application.

It has immediate analgesic effect: the speed of the effect begins 1 second after application and lasts on average 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”, leg fatigue, spider veins and spider veins, convulsions, paresthesia (a feeling of 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, muscle tissue.
Complications arising after surgical operations on the veins.

Pharmacological effect

Pharmacodynamics

Trombless® Plus is a combination drug.

Sodium heparin 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 thrombin activity.

Reduces the activity of hyaluronidase, increases the fibrinolytic properties of blood.

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

Dexpanthenol – provitamin B5 – is converted in the skin into pantothenic acid, which is part of coenzyme A, which is involved in the processes of acetylation, 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 (derivative of rutin), has P-vitamin activity; has venotonic, angioprotective, decongestant, antioxidant and anti-inflammatory effects.

Participates in redox processes, blocks hyaluronidase, stabilizes hyaluronic acid in cell membranes and reduces the 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 of platelets to its surface.

Benzocaine is a local anesthetic for superficial anesthesia. Reduces the permeability of the cell membrane to sodium ions, displaces calcium ions from receptors located on the inner surface of the membrane, and blocks the conduction of nerve impulses.

Prevents the occurrence of pain impulses at the endings of sensory nerves and their conduction along 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.

Heparin is eliminated primarily 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.

When applied topically, dexpanthenol is quickly absorbed by the skin and converted into pantothenic acid.

Its concentration in the blood is 0.5-1 mg/l, in the blood serum – 100 μg/l. Pantothenic acid is not metabolized in the body (except for inclusion in coenzyme A) and is excreted unchanged.

Benzocaine is practically not absorbed when applied to the skin.

It has an immediate analgesic effect: the onset of the effect begins 1 second after application and lasts on average 4-6 hours.

Special instructions

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

During breastfeeding, avoid applying the drug to the breast area to prevent the baby from swallowing the drug.

In case of accidental contact with eyes or other mucous membranes, rinse them thoroughly with running water.
Do not exceed the maximum duration 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 clotting time should be monitored (due to the presence of sodium heparin in the drug).

It is not recommended to use Trombless® Plus for deep vein thrombosis of the legs.

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

Impact on the ability to drive vehicles and operate machinery

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 vehicles, working with moving mechanisms).

Active ingredient

Benzocaine, Sodium Heparin, Dexpanthenol, Troxerutin

Composition

1 g of gel contains:

Active ingredients:

Heparin sodium – 1000 IU (8.33 mg with activity of heparin sodium 120 IU/mg),

Troxerutin – 20.0 mg,

Dexpanthenol – 100.0 mg,

Benzocaine – 1.0 mg;

Excipients:

Ethanol,

Methyl parahydroxybenzoate,

Trolamine,

Carbomer, glycerol, water.

Contraindications

hypersensitivity to Trombless components;
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.

If any of the side effects indicated in the instructions are aggravated or other side effects not listed in the instructions are noted, 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 the benzocaine included in the drug.

Benzocaine reduces the antibacterial activity of sulfonamides.

Overdose

No cases of overdose of Trombless® Plus gel have been reported.

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

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

Storage conditions

The drug should be stored at a temperature not exceeding 25°C.

Keep out of the reach of children.

Do not use after expiration date.

Shelf life

2 years.

Manufacturer

Nizhpharm JSC, Russia