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Troxerutin (Gel) Instructions for Use

ATC Code

C05CA04 (Troxerutin)

Active Substance

Troxerutin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Venotonic drug for topical application

Pharmacotherapeutic Group

Angioprotectors; capillary stabilizing agents; bioflavonoids

Pharmacological Action

A treatment for chronic venous insufficiency, a semi-synthetic bioflavonoid (a derivative of rutin) of the benzopyran class, possesses P-vitamin activity, and exerts venotonic, angioprotective, anti-inflammatory, and anti-edematous effects, reducing capillary permeability and fragility.

Its pharmacodynamic properties are associated with the participation of the bioflavonoids of troxerutin in redox processes and the inhibition of hyaluronidase. By suppressing hyaluronidase, Troxerutin stabilizes the hyaluronic acid of cell membranes, reducing their permeability. It possesses antioxidant activity, thereby preventing the oxidation of ascorbic acid, adrenaline, and lipids. Furthermore, it reduces the permeability and fragility of capillaries, preventing damage to the basement membrane of endothelial cells when exposed to various factors. Troxerutin increases the density of the vascular wall, reduces the exudation of the liquid part of plasma and the diapedesis of blood cells. It reduces exudative inflammation in the vascular wall by decreasing platelet adhesion to its surface.

It reduces swelling and the feeling of heaviness in the legs, decreases the intensity of pain and cramps, and improves tissue trophism.

Pharmacokinetics

When applied topically, the active substance quickly penetrates the epidermis, is detected in the dermis after 30 minutes, and in the subcutaneous adipose tissue after 2-5 hours.

Indications

Varicose veins, chronic venous insufficiency accompanied by swelling, pain, a feeling of heaviness in the legs, thrombophlebitis, periphlebitis, varicose dermatitis, pain and swelling after injuries (bruises, ligament damage).

ICD codes

ICD-10 code Indication
I80.0 Phlebitis and thrombophlebitis of superficial vessels of lower extremities
I83 Varicose veins of lower extremities
I87.2 Venous insufficiency (chronic) (peripheral)
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
ICD-11 code Indication
BD70.0 Superficial thrombophlebitis of lower extremities
BD74.1Z Varicose veins of lower extremities, unspecified
BD74.Z Chronic venous insufficiency of lower extremities, unspecified
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
ND56.0 Superficial injury of unspecified body region
ND56.3 Dislocation, sprain or strain of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the gel externally to the affected skin areas. Use a sufficient amount to cover the entire treatment area with a thin, uniform layer.

Apply the gel 3 to 4 times daily. Gently massage until fully absorbed to enhance penetration.

The standard treatment course is up to 10 days. Do not exceed this duration without medical supervision.

For chronic venous insufficiency and varicose veins, apply the gel along the entire length of the affected vein, focusing on areas with pain, swelling, or heaviness.

For post-traumatic conditions like bruises or sprains, apply the gel directly to the site of injury and the surrounding area.

Before initial use, perform a skin tolerance test. Apply a small amount to a limited area of skin. Discontinue use if signs of irritation or allergic reaction occur.

Wash hands thoroughly before and after application. Avoid contact with eyes, mucous membranes, and open wounds.

If symptoms persist or worsen after the recommended treatment course, consult a physician for re-evaluation.

Adverse Reactions

When applied topically rarely – allergic reactions (urticaria, eczema, dermatitis).

Contraindications

Hypersensitivity to troxerutin; impaired skin integrity in the application area.

With caution

In patients with chronic renal failure (with long-term use).

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is contraindicated. The possibility of use in the second and third trimesters of pregnancy is determined by the doctor and is only possible if the intended benefit to the mother outweighs the potential risk to the fetus.

Data on the penetration of troxerutin into breast milk are absent. Use during breastfeeding is contraindicated.

Use in Renal Impairment

In patients with chronic renal failure (with long-term use).

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Avoid getting the drug containing Troxerutin on open wounds, in the eyes, and on mucous membranes.

Drug Interactions

With simultaneous use, it enhances the effect of ascorbic acid on the resistance and permeability of the vascular wall.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Danson-BG (Bulgaria)

Dosage Form

Bottle OTC Icon Troxerutin DS Gel for external use 2%: tube 40 g

Dosage Form, Packaging, and Composition

Gel for external use 2% 1 g
Troxerutin 20 mg

40 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle OTC Icon Troxerutin-AKOS Gel for external use 2%: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use from yellow or greenish-yellow to light brown, transparent, homogeneous; the presence of air bubbles is allowed.

100 g
Troxerutin 2 g

Excipients : carbomer (carbopol) (type A), trolamine (triethanolamine), disodium edetate (disodium salt of ethylenediaminetetraacetic acid [trilon B]), benzalkonium chloride, purified water.

30 g – aluminum tubes (1) with caps – cardboard packs.
50 g – aluminum tubes (1) with caps – cardboard packs.

Marketing Authorization Holder

Zelenaya Dubrava, CJSC (Russia)

Dosage Form

Bottle OTC Icon Troxerutin ZD Gel for external use 2%: tubes 30 g, 40 g, or 50 g

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, transparent, from yellow to light brown or yellow-green.

100 g
Troxerutin 2 g

Excipients : carbomer – 0.6 g, sodium hydroxide – 0.132 g, benzalkonium chloride – 0.0575 g, disodium edetate dihydrate – 0.05 g, purified water – up to 100 g.

30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

Dosage Form

Bottle OTC Icon Troxerutin Vramed Gel for external use 2%: tube 40 g

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, yellow.

40 g
Troxerutin 0.8 g

Excipients : carbomers – 0.24 g, disodium edetate – 0.02 g, benzalkonium chloride – 0.023 g, sodium hydroxide – 0.084 g, purified water – 38.833 g.

40 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Vetprom, AD (Bulgaria)

Dosage Form

Bottle OTC Icon Troxerutin VP Gel for external use 2%: tubes 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, transparent, from yellow to yellow-green.

100 g
Troxerutin 2 g

Excipients : carbomer 940 – 0.6 g, trolamine – 0.7 g, disodium edetate – 0.05 g, benzalkonium chloride (50% solution) – 0.2 g, purified water – 96.45 g.

30 g – lacquered aluminum tubes (1) – cardboard packs.
40 g – lacquered aluminum tubes (1) – cardboard packs.
50 g – lacquered aluminum tubes (1) – cardboard packs.
60 g – lacquered aluminum tubes (1) – cardboard packs.
70 g – lacquered aluminum tubes (1) – cardboard packs.
80 g – lacquered aluminum tubes (1) – cardboard packs.
90 g – lacquered aluminum tubes (1) – cardboard packs.
100 g – lacquered aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Troxerutin Vertex Gel for external use 2%: tubes 50 or 100 g

Dosage Form, Packaging, and Composition

Gel for external use from yellow or greenish-yellow to light brown, homogeneous, transparent.

1 g
Troxerutin 20 mg

Excipients : trolamine (triethanolamine) – 7 mg, carbomer – 6 mg, benzalkonium chloride 50% solution – 1 mg, disodium edetate – 0.5 mg, purified water – up to 1 g.

50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Troxerutin Renewal Gel for external use 20 mg/1 g: tubes 35 g, 40 g, 45 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, transparent, from yellow to yellow-green.

1 g
Troxerutin 20 mg

Excipients : trolamine (triethanolamine), carbomer (carbopol 940), benzalkonium chloride, disodium edetate, purified water.

35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
45 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.

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