Troxerutin-ACOS, capsules 300 mg 50 pcs

Pharmacotherapeutic group

Venotonic and venoprotective agent

ATX code: C05CA

Pharmacodynamics:

The flavonoid (rutin derivative) has P-vitamin activity; it has venotonizing angioprotective anti-inflammatory and anti-edema effects; reduces capillary permeability and fragility.

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, which prevents oxidation of ascorbic acid adrenaline and lipids. It also reduces capillary permeability and fragility and prevents damage to the basal membrane of endothelial cells when it is exposed to various factors. Troxerutin reduces the exudative inflammation in the vascular wall by reducing the adhesion of platelets to its surface. It inhibits aggregation and increases the degree of red blood cell deformation.

In chronic venous insufficiency troxerutin reduces the feeling of heaviness and swelling in the legs reduces the intensity of pain and cramps improves tissue trophism. Troxerutin relieves symptoms associated with hemorrhoids (pain, exudation, itching, bleeding).

Interference in the permeability and resistance of capillary walls can slow down the progression of diabetic retinopathy. The effect of troxerutin on the rheological properties of the blood helps to prevent microthrombosis of the retinal vessels.

Pharmacokinetics:

Troxerutin is quickly absorbed when the drug is taken orally. The maximum concentration of troxerutin is established on average 175±046 hours after oral administration. Absorption is about 10-15%. Bioavailability of the drug increases with increasing dose. Half-life of the drug is 677±237 hours. Therapeutic concentration of the drug in plasma is maintained for 8 hours. In 30 hours after troxerutin intake there is a second maximum of drug concentration in plasma due to enterohepatic recirculation. It is partially metabolized in the liver to form glucuronide and trihydroethylquercitin. 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

– Chronic venous insufficiency

– Postphlebitic syndrome

– Trophic disorders in varicose veins of the legs and trophic ulcers

– As an adjuvant treatment after sclerotherapy and/or removal of varicose veins of the lower extremities

– Post-traumatic swelling and soft tissue hematomas.

– Hemorrhoids (to relieve symptoms).

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

Pharmacological effect

Pharmacotherapeutic group

venotonic and venoprotective agent

ATX code: C05CA

Pharmacodynamics:

Flavonoid (rutin derivative) has P-vitamin activity; has a venotonic, angioprotective, anti-inflammatory and anti-edematous effect; reduces permeability and fragility of capillaries.

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

In case of chronic venous insufficiency, troxerutin reduces the feeling of heaviness and swelling in the legs, reduces the intensity of pain and cramps, improves tissue trophism. Troxerutin relieves 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 effect of troxerutin on the rheological properties of blood helps to prevent microthrombosis of retinal vessels.

Pharmacokinetics:

Troxerutin is rapidly absorbed when the drug is taken orally. The maximum concentration of troxerutin is established on average 175±046 hours after oral administration. Absorption is approximately 10-15%. The bioavailability of the drug increases with increasing dose. The half-life is 677±237 hours. The therapeutic concentration of the drug in the blood plasma is maintained for 8 hours. 30 hours after taking troxerutin, a second maximum concentration of the drug in the blood plasma is observed due to enterohepatic recirculation. Partially metabolized in the liver to form glucuronide and trihydroethylquercetin. It is excreted mainly through the intestines (up to 65-70%), a smaller part (up to 25%) of the drug is excreted unchanged by the kidneys.

Special instructions

If during the period of use of the drug the severity of the symptoms of the disease does not decrease, you should consult your doctor.

There is insufficient experience with the use of the drug Troxerutin in children under 18 years of age.

Impact on the ability to drive vehicles. Wed and fur.:

The use of the drug Troxerutin does not affect motor and mental reactions. The drug Troxerutin does not affect the ability to drive vehicles or operate machinery.

Active ingredient

Troxerutin

Composition

For one capsule:

Active substance: troxerutin – 300.0 mg.

Excipients: lactose monohydrate (milk sugar) – 39.5 mg, sodium carboxymethyl starch – 7.0 mg, magnesium stearate – 3.5 mg.

Hard gelatin capsules No. 0

Composition of the capsule body: red iron oxide dye – 0.0071%; iron oxide yellow dye – 0.1227%; titanium dioxide – 2.0000%; gelatin – up to 100%.

Composition of the capsule cap: brilliant blue dye – 0.0190%; charming red dye – 0.0450%; titanium dioxide – 3.0000%; gelatin – up to 100%.

Pregnancy

In experimental studies, teratogenicity and fetotoxicity of drugs containing troxerutin were not noted. Studies of the teratogenicity and fetotoxicity of the drug Troxerutin in humans have not been conducted; however, there are indications of a possible association between taking troxerutin during pregnancy and abnormalities in the structure of the external ear in children. In the first trimester of pregnancy, the use of the drug Troxerutin is contraindicated. In the second and third trimesters of pregnancy, the use of the drug Troxerutin is possible only if the expected benefit to the mother outweighs the potential risk to the child.

There are no data on the penetration of troxerutin into breast milk. Troxerutin should not be used during breastfeeding.

Contraindications

– Hypersensitivity to troxerutin or excipients included in the drug.

– Peptic ulcer of the stomach and duodenum and chronic gastritis in the acute phase.

– Lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

– Pregnancy (first trimester) and lactation period.

– Children’s age (under 18 years of age, experience of use is insufficient).

With caution:

– Chronic renal failure.

Side Effects

Allergic reactions: skin rashes;

From the central nervous system: headache;

From the gastrointestinal tract: nausea, vomiting, pain in the stomach, flatulence, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract;

From the skin: erythema and itching;

Other: flushing of the face.

Interaction

When used simultaneously, it enhances the effect of ascorbic acid on the resistance and permeability of the vascular wall.

Overdose

Symptoms: nausea, headache, flushing of blood to the face.

Treated: it is necessary to rinse the stomach, take activated charcoal, if necessary, begin symptomatic treatment.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Sintez, Russia