Active substanceTroxerutinTroxerutin
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  • Dosage form: & nbspcapsules
    Composition:

    Composition per 1 capsule:

    Active substance: trokserutin - 300.00 mg.

    Excipients: lactose monohydrate (sugar milk) - 39,50 mg; sodium carboxymethyl starch - 7.00 mg; magnesium stearate - 3.50 mg.

    Capsule body composition: iron dye oxide red - 0.0071%; ferric oxide yellow oxide - 0.1227%; titanium dioxide - 2.0000%; gelatin - up to 100%.

    Composition of cap capsule: color of diamond blue - 0.0190%; dye red charming - 0,0450%; titanium dioxide - 3.0000%; gelatin - up to 100%.

    Description:

    Capsules hard gelatinous № 0.

    The case is light yellow with a brownish hue, the lid is light purple, opaque.

    Contents of the capsules: granular powder or a mixture of powder and granules from yellow to greenish-yellow, it is allowed to compact the contents of the capsule into lumps.

    Pharmacotherapeutic group:Venotonizing and venoprotective agent
    ATX: & nbsp

    C.05.C.A   Bioflavonoids

    C.05.C.A.04   Troxerutin

    Pharmacodynamics:

    Semisynthetic bioflavonoid (derivative of routine) of the class of benzopyrans, has P-vitamin activity, it has venotonic, angioprotective, anti-inflammatory and anti-edematous effect, reduces permeability and fragility of capillaries.

    Its pharmacodynamic properties are associated with the participation of trouxerutin bioflavonoids in oxidation-reduction processes and inhibition of hyaluronidase. By suppressing hyaluronidase, troxerutin stabilizes the hyaluronic acid of cell membranes and reduces their permeability. It has antioxidant activity, which 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 various factors influence it. Troxerutin increases the density of the vascular wall, reduces exudation of the liquid part of the plasma and diapedesis of blood cells. Reduces exudative inflammation in the vascular wall, reducing the adhesion of platelets to its surface. Inhibits aggregation and increases the degree of erythrocyte deformation.

    The use of troxerutin is possible, both at the initial and late stages of treatment of chronic venous insufficiency, it is possible to use complex treatment as one of the components. Troxerutin reduces puffiness and a feeling of heaviness in the legs, reduces the intensity of pain and seizures, improves trophic tissue. Troxerutin facilitates the symptoms associated with hemorrhoids (pain, exudation, itching, bleeding).

    Due to the effect on the permeability and resistance of the capillary walls troxerutin helps slow the progression of diabetic retinopathy. The effect of troxerutin on the rheological properties of the blood contributes to the prevention of the development of microtrombosis of the retinal vessels.

    Pharmacokinetics:

    Troxerutin is rapidly absorbed when taking the drug inside. The maximum concentration of troxerutin in the blood plasma (CmOh) is set at an average of 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. The therapeutic concentration of the drug in the blood plasma is maintained for 8 hours. Thirty hours after the administration of troxerutin, a second maximum concentration of the drug in the blood plasma is observed, due to enterohepatic recirculation. Partially metabolized in the liver with the formation of glucuronide and trihydroethylcercitin. 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:

    The preparation Flebopress® capsules 300 mg is used as part of complex therapy specified diseases:

    - chronic venous insufficiency;

    - trophic disorders in chronic venous insufficiency and trophic ulcers;

    - phlebeurysm;

    - superficial thrombophlebitis, periphlebitis;

    - postthrombotic syndrome;

    - post-traumatic edema and soft tissue hematomas;

    - as an auxiliary treatment after sclerotherapy and / or removal of varicose veins of the lower limbs;

    - hemorrhoids (for relief of symptoms);

    - diabetic angiopathy, retinopathy.

    Contraindications:

    - Hypersensitivity to troxerutin and other components of the drug;

    - peptic ulcer of the stomach, duodenal ulcer, chronic gastritis in the phase of exacerbation;

    - lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

    - pregnancy (I trimester);

    - the period of breastfeeding;

    - children under 18 years of age (experience of use is limited).

    Carefully:

    - Chronic renal failure (with prolonged use).

    Pregnancy and lactation:

    Pregnancy

    In experimental studies, teratogenicity and fetotoxicity of preparations containing troxerutin. Studies of the teratogenicity and fetotoxicity of the drug Flebopress® in humans have not been carried out, but there are indications of a possible association between reception of troxerutin during pregnancy and anomalies in the structure of the external ear in children.

    The use of the drug Flebopress® during the first trimester of pregnancy is contraindicated. The possibility of using the drug during the II and III trimester of pregnancy is determined by the doctor and is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

    If it is necessary to use the drug in the II and III trimesters of pregnancy should consult with a doctor.

    Breastfeeding period

    Data on the penetration of troxerutin into breast milk are absent. The use of the drug Flebopress® during breastfeeding is contraindicated.

    Dosing and Administration:

    Inside. Capsules should be swallowed whole, with food, with plenty of water.

    At the initial stage of treatment appoint 1 capsule (300 mg) 3 times a day. The effect usually develops within 2 weeks. Further, the treatment is continued at the same dose or reduced to an average therapeutic dose of 1 capsule 2 timesper day (600 mg), or suspended (with the effect achieved lasting for at least 4 weeks). If necessary, the dose can be increased, after consulting a doctor. The course of treatment is on average 3-4 weeks.

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

    When diabetic retinopathy Phlebopress® is prescribed 2 capsules (single dose 600 mg) 3 times a day (daily dose 1.8 g).

    On average, the duration of the therapeutic course is 3-4 weeks.

    The need for longer treatment is determined after consultation with the doctor and individually.

    Side effects:

    Troxerutin is very well tolerated, in rare cases, light unwanted reactions occur.

    Immune system disorders: hypersensitivity reactions.

    Impaired nervous system: headache.

    Vascular disorders: "tides" of blood to the face.

    Disorders from the gastrointestinal tract: nausea, vomiting, stomach pain, flatulence, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract.

    Disturbances from the skin and subcutaneous tissues: erythema, itchy skin, skin rash.

    If any of the side effects listed in the manual are aggravated or you notice any other side effects, not specified in the instructions, report on this doctor.

    Overdose:

    Symptoms. Troxerutin has very low toxicity. In case of an overdose, the following symptoms may appear: agitation, nausea, headache, "flushes" of blood to the face.

    Treatment. It is necessary to rinse the stomach, take Activated carbon (within an hour after administration). If necessary, conduct symptomatic and supportive treatment.

    In case of overdose, immediately consult a doctor.

    Interaction:

    With simultaneous application enhances the effect of ascorbic acid on the resistance and permeability of the vascular wall.

    Special instructions:

    The experience of using the preparation of Flebopress ® in children under the age of 18 is not enough. In the treatment of superficial thrombophlebitis or deep vein thrombosis, the use of the drug does not exclude the need for the administration of anti-inflammatory and antithrombotic therapies.

    Flebopress® is ineffective in swelling caused by concomitant diseases of the liver, kidneys and heart.

    When using the drug alone, do not exceed the maximum time and recommended doses.

    If during the period of using the drug the severity of the symptoms of the disease does not decrease or the symptoms of the disease become heavier, it should immediately consult a doctor.

    Effect on the ability to drive transp. cf. and fur:

    Reception of the drug Flebopress® has no effect on motor and mental reaction, does not interfere with the management of vehicles and other complex mechanisms.

    Form release / dosage:

    Capsules 300 mg.

    Packaging:

    For 10, 30 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    10, 20, 30, 50, 60 or 100 capsules in cans of polyethylene terephthalate or polypropylene for medicines sealed with high-pressure polyethylene caps with a first opening control or polypropylene caps with a push-turn system or low-pressure polyethylene caps with control of the first autopsy.

    One jar or 1, 2, 3, 5, 6 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

    It is allowed to bundle 2 or 3 cardboard packages (packs) into a group package (shipping container) from cardboard for consumer packaging.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004834
    Date of registration:07.05.2018
    Expiration Date:07.05.2023
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.05.2018
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