Troxevenol (Gel) Instructions for Use

Marketing Authorization Holder

Samaramedprom, OJSC (Russia)

ATC Code

C05CA04 (Troxerutin)

Active Substance

Troxerutin (Rec.INN registered by WHO)

Dosage Form

Troxevenol

Gel for external use 2%: tubes or jars 40 g

Dosage Form, Packaging, and Composition

Gel for external use from yellow to light brown or yellow-green in color.

Excipients: carbomer 940 – 0.6 g, disodium edetate – 0.05 g, benzalkonium chloride – 0.0575 g, sodium hydroxide 30% – 0.7 g, purified water – up to 100 g.

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

Clinical-Pharmacological Group

Venotonic drug for topical application

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

A drug for the treatment of chronic venous insufficiency, a semi-synthetic bioflavonoid (a derivative of rutin) of the benzopyran class, has P-vitamin activity, exerts a venotonic, angioprotective, anti-inflammatory and anti-edematous effect, reduces the permeability and fragility of capillaries.

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 hyaluronic acid in cell membranes, reducing their permeability. It has 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 externally, 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

Dosage Regimen

Apply the gel externally to the affected skin areas.

Administer a thin layer of the gel and gently rub it in until fully absorbed.

Apply the gel three to four times daily for optimal therapeutic effect.

The maximum duration of continuous treatment is 10 days unless otherwise directed by a physician.

Use the gel only on intact skin; strictly avoid application on open wounds, mucous membranes, or in the eyes.

Wash hands thoroughly before and after each application to prevent unintended exposure.

Discontinue use and consult a physician if no improvement is observed after the recommended treatment course or if symptoms worsen.

Do not use occlusive dressings or bandages over the applied gel unless specifically instructed by a doctor.

Adverse Reactions

With external use 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.