Troxevasin^® (Capsules, Gel) Instructions for Use

ATC Code

C05CA04 (Troxerutin)

Active Substance

Troxerutin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug used for disorders of venous circulation. Angioprotector

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 diapedesis of blood cells. It reduces exudative inflammation in the vascular wall by decreasing platelet adhesion to its surface. It inhibits aggregation and increases the degree of erythrocyte deformation.

The use of troxerutin is possible both in the initial and late stages of treatment of chronic venous insufficiency; it can be used as one of the components of complex therapy. Troxerutin reduces swelling and the feeling of heaviness in the legs, decreases the intensity of pain and cramps, and improves tissue trophism.

Troxerutin alleviates symptoms associated with hemorrhoids (pain, exudation, itching, bleeding).

Due to its effect on the permeability and resistance of capillary walls, Troxerutin helps slow the progression of diabetic retinopathy.

The influence of troxerutin on the rheological properties of blood contributes to the prevention of the development of microthrombosis of retinal vessels.

Pharmacokinetics

Troxerutin is rapidly absorbed after oral administration. The C_max of troxerutin in blood plasma is reached on average 1.75±0.46 hours after oral intake. Absorption is approximately 10-15%. Bioavailability increases with increasing dose. The T_1/2 is 6.77±2.37 hours. The therapeutic concentration of the drug in blood plasma is maintained for 8 hours. A second peak in the plasma concentration of the drug is observed 30 hours after troxerutin intake, due to enterohepatic recirculation. It is partially metabolized in the liver to form a glucuronide and trihydroxyethylquercetin. It is excreted mainly through the intestine (up to 65-70%), a smaller part (up to 25%) of the drug is excreted unchanged by the kidneys.

Indications

As part of complex therapy for the following diseases: chronic venous insufficiency; trophic disorders in chronic venous insufficiency and trophic ulcers; varicose veins; superficial thrombophlebitis, periphlebitis; postthrombotic syndrome; post-traumatic edema and hematomas of soft tissues; as an auxiliary treatment after sclerotherapy and/or removal of varicose veins of the lower extremities; hemorrhoids (to alleviate symptoms); diabetic angiopathy, retinopathy.

ICD codes

Dosage Regimen

Capsules

The drug is taken orally, with meals. Capsules should be swallowed whole with a sufficient amount of water.

At the beginning of treatment, 300 mg (1 capsule) 3 times/day is prescribed. The effect usually develops within 2 weeks, after which treatment is continued at the same dose or reduced to the minimum maintenance dose of 600 mg, or suspended (the achieved effect is maintained for at least 4 weeks). The course of treatment averages 3-4 weeks; the need for longer treatment is determined individually.

For diabetic retinopathy, it is prescribed at a dose of 0.9-1.8 g/day.

Gel

For external use.

The gel is applied to the affected area 2 times/day, in the morning and evening, gently rubbing until completely absorbed. If necessary, the gel can be applied under bandages or elastic stockings.

The success of treatment with the drug largely depends on its regular application over a long period.

It is recommended to combine it with the intake of Troxevasin^® capsules to enhance the effect. If the symptoms of the disease worsen or do not improve after 6-7 days of daily use of the drug, the patient should consult a doctor.

Adverse Reactions

From the immune system hypersensitivity reactions.

From the nervous system headache.

From the vascular system flushing.

From the digestive system nausea, vomiting, stomach pain, flatulence, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract.

From the skin and subcutaneous tissues erythema, skin itching, skin rash.

Contraindications

Hypersensitivity to troxerutin; peptic ulcer of the stomach, duodenum, chronic gastritis in the acute phase; first trimester of pregnancy; period of breastfeeding; children under 18 years of age.

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

In the treatment of superficial thrombophlebitis or deep vein thrombosis, the use of troxerutin does not exclude the need for anti-inflammatory and antithrombotic therapy.

Troxerutin is not effective for edema caused by concomitant diseases of the liver, kidneys, and heart.

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.