Active substanceTroxerutinTroxerutin
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  • Dosage form: & nbspTOthe apsules.
    Composition:Per one capsule:

    Active substance: troxerutin - 300 mg.

    Excipients: calcium stearate - 3,7 mg, talc - 9,25 mg, povidone (kollidon 90F, plasdon K 90) 3.7 mg, sodium carboxymethyl starch (sodium starch glycolate (type A), primogel) 9.25 mg, microcrystalline cellulose 44.1 mg.

    The composition of the gelatin capsule: iron oxide oxide yellow - 0.629%, titanium dioxide - 2%, gelatin - up to 100%.

    Description:

    Hard gelatin capsules №0 yellow, the contents of capsules - from greenish-yellow or yellow to yellow-green or yellow-brown in the form of a powder with different particle sizes and granules or powder pressed into cylinders, decomposing under pressure.

    Pharmacotherapeutic group:venotonic 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 action, 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 alleviates 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:

    A drug Troxerutin capsules 300 mg is used in the complex therapy of these 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;

    - pregnancy (I trimester);

    - the period of breastfeeding;

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

    Carefully:In patients with chronic renal failure (with prolonged use).
    Pregnancy and lactation:

    Application of the drug Troxerutin 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, consult a doctor.

    Data on the penetration of troxerutin into breast milk are absent. Application of the drug Troxerutin during the period of 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 - 1 capsule 2 times a day (600 mg), or suspended (while the effect is maintained 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 enough to take 1 capsule (300 mg) per day for 3-4 weeks.

    With diabetic retinopathy Troxerutin appoint 2 capsules (single dose of 600 mg) 3 times a day (daily dose of 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.

    Disturbances from the 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 if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    AT case of an overdose should be immediately consult a doctor.

    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: need to rinse the stomach, take Activated carbon (within an hour after admission), see a doctor and, if necessary, carry out symptomatic and supportive treatment.

    Interaction:

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

    Special instructions:

    Experience with the drug Troxerutin 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.

    Troxerutin is ineffective in edema 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 Troxerutin does not affect motor and mental reactions, does not interfere with the management of vehicles and other complex mechanisms.

    Form release / dosage:Capsules, 300 mg.
    Packaging:

    For 10, 15, 20 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 30, 50, 60, 90, 100 capsules in cans of polymeric.

    1 can, or 3, 5, 6 contour squares per 10 capsules, or 2, 4, 6 contour squares per 15 capsules, or 3, 5 out-of-round cell packs of 20 capsules with instructions for medical use placed in a pack of cardboard.

    Storage conditions:

    In the dark place 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 expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003824
    Date of registration:07.09.2016
    Expiration Date:07.09.2021
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp30.09.2016
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