Troxerutin Velpharm, capsules 300 mg 50 pcs

Pharmacotherapeutic group: venotonic and venoprotective agent.

TAC code: C05CA04.

Pharmacological properties

Pharmacodynamics

. Semisynthetic bioflavonoid (rutin derivative) of benzopyran class; it possesses P-vitamin activity, has venotinizing, angioprotective, anti-inflammatory and anti-edema effect, decreases capillary permeability and fragility.

His pharmacodynamic properties are associated with the participation of bioflavonoids of troxerutin in redox processes and hyaluronidase inhibition. Inhibiting hyaluronidase, troxerutin stabilizes hyaluronic acid of cell membranes and reduces their permeability. It has antioxidant activity, as a result of which it prevents oxidation of ascorbic acid, adrenaline and lipids. In addition, it reduces the permeability and fragility of capillaries, prevents damage to the basal membrane of endothelial cells when it is exposed to various factors. Troxerutin increases the density of the vascular wall, reduces the exudation of the liquid part of the plasma and diapedesis of the blood cells. Reduces exudative inflammation in the vascular wall by reducing platelet adhesion to its surface. Inhibits aggregation and increases the degree of red blood cell deformation.

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

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

According to its influence on the permeability and resistance of capillary walls, troxerutin helps to slow down the progression of diabetic retinopathy.

The influence of troxerutin on the rheological properties of the blood helps to prevent the development of retinal vascular microthrombosis.

Pharmacokinetics

Troxerutin is quickly absorbed when the drug is taken orally. Maximum plasma concentration (Cmax) of troxerutin is reached on average 1.75 ± 0.46 hours after oral administration. Absorption is approximately 10-15%. Bioavailability of the drug increases with increasing dose. The half-life (T1/2) is 6.77 ± 2.37 hours. Therapeutic concentration of the drug in blood plasma is maintained for 8 hours. In 30 hours after troxerutin administration a second maximum of the drug concentration in plasma is observed due to enterohepatic recirculation. It is partially metabolized in the liver to form glucuronide and trihydroethylquercitin. It is excreted mainly through intestine (up to 65-70%), a smaller part (up to 25%) of the drug is excreted unchanged by the kidneys.

Indications

– varicose veins;

– chronic venous insufficiency with such manifestations as heaviness in the legs, trophic skin lesions (dermatitis, trophic ulcers);

– superficial thrombophlebitis, periphlebitis;

– hemorrhoids;

– postthrombotic syndrome;

– post-traumatic edema, hematoma;

– prevention of complications after sclerotherapy and/or removal of varicose veins of the lower extremities;

– as part of the complex treatment of retinopathy in patients with diabetes mellitus, arterial hypertension and atherosclerosis.

Active ingredient

Composition

The active ingredient: troxerutin – 300 mg.

Excipients: macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000), magnesium stearate.

The contents of the gelatin capsule: body: titanium dioxide, gelatin; cap: sunset yellow dye, quinoline yellow dye, titanium dioxide, gelatin.

How to take, the dosage

The drug is taken orally, with meals. Capsules should be swallowed whole with enough water.

In the initial phase of treatment, 1 capsule (300 mg) 3 times a day is taken. The effect usually develops within 2 weeks. Further treatment is continued in the same dose, or it is reduced to an average therapeutic dose – 1 capsule 2 times a day (600 mg), or it is suspended (in which case the effect is maintained for at least 4 weeks). If necessary, the dose can be increased after consultation with the doctor. The course of treatment averages 3-4 weeks.

For maintenance therapy it is enough to take 1 capsule (300 mg) per day for 3 to 4 weeks.

In diabetic retinopathy the drug is used 0.9 to 1.8 g daily which corresponds to taking 1-2 capsules three times a day. The course of treatment is approximately 3 to 4 weeks.

The need for longer treatment is determined after consultation with the doctor and on an individual basis.

Interaction

Concomitant use increases the effect of ascorbic acid on the resistance and permeability of the vascular wall.

Special Instructions

There is insufficient experience in using the drug in children under 18 years of age.

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

Troxerutin is ineffective in edema due to concomitant liver, kidney and heart disease.

The maximum periods and recommended doses should not be exceeded when using the drug alone.

If symptoms do not decrease or get worse while using the drug, you should see a physician immediately.

If the drug has no effect on motor and mental reactions, it does not interfere with driving vehicles and other complex mechanisms.

Synopsis

Solid gelatin capsules № 1 with a white body and a yellow cap. The contents of the capsule are from greenish-yellow or yellow to yellow-green or yellow-brown in the form of a powder with varying particle sizes and granules or powder compacted into cylinders that disintegrate on pressure.

Contraindications

– hypersensitivity to troxerutin and other components of the drug;

– gastric ulcer, duodenal ulcer, chronic gastritis in the acute phase;

– pregnancy (1st trimester);

– period of breast-feeding;

– children under 18 years of age (experience of using the drug is limited).

With caution

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

Side effects

Troxerutin is very well tolerated, in rare cases mild adverse reactions occur.

Immune system disorders: hypersensitivity reactions.

Nervous system disorders: headache.

vascular disorders: blood rushes to the face.

Gastrointestinal tract disorders: nausea, vomiting, stomach pain, flatulence, diarrhea, erosive-ulcerative lesions of the gastrointestinal tract.

Skin and subcutaneous tissue disorders: erythema, skin itching, skin rash.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

In case of overdose, consult a doctor immediately.

Troxerutin has very low toxicity. Overdose may cause the following symptoms: agitation, nausea, headache, “rushes” of blood to the face.

Treatment: it is necessary to flush the stomach, take activated charcoal (within an hour after intake), consult a doctor, symptomatic and supportive treatment is carried out if necessary.

Pregnancy use

The use of the drug during the first trimester of pregnancy is contraindicated. The possibility of using the drug in the second and third trimesters of pregnancy is determined by a physician and is possible only if the expected benefits to the mother exceed the potential risk to the fetus.

If it is necessary to use the drug in the second and third trimesters of pregnancy, a physician should be consulted.

There are no data on the penetration of troxerutin into breast milk. Use of the drug during breastfeeding is contraindicated.

Similarities