Active substanceTroxerutinTroxerutin
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  • Dosage form: & nbspcapsules
    Composition:

    Composition per one capsule:

    Active substance: troxerutin - 300.0 mg.

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

    Hard gelatin capsules № 0

    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 of yellow-cream color, lid of lilac color, opaque.

    Contents of capsules from 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 when pressed.

    Pharmacotherapeutic group:venotonic and venoprotective agent
    ATX: & nbsp

    C.05.C.A   Bioflavonoids

    C.05.C.A.04   Troxerutin

    Pharmacodynamics:

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

    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 reduces exudative inflammation in the vascular wall, reducing the adhesion of platelets to its surface. Inhibits aggregation and increases the degree of erythrocyte deformation.

    With chronic venous insufficiency troxerutin reduces the feeling of heaviness and swelling 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 influence of troxerutin on the rheological properties of blood contributes to the prevention of microthrombosis of the retinal vessels.

    Pharmacokinetics:

    Troxerutin is rapidly absorbed when taking the drug inside. The maximum concentration of troxerutin is set at an average of 1.75 ± 0.46 hours after ingestion. Absorption is approximately 10-15%. Bioavailability of the drug increases with increasing dose. The half-life 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:

    - Chronic venous insufficiency

    - Postphlebitic syndrome

    - Trophic disorders in varicose leg disease and trophic ulcers

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

    - Post-traumatic edema and hematoma of soft tissues.

    - Hemorrhoids (for relief of symptoms).

    - In the complex treatment of retinopathy in patients with diabetes mellitus,

    arterial hypertension and atherosclerosis.

    Contraindications:

    - Hypersensitivity to troxerutin or excipients included in the preparation.

    - Stomach ulcer and duodenal ulcer and chronic gastritis in the phase of exacerbation.

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

    - Pregnancy (I trimester) and lactation.

    - Children's age (under 18 years of age, experience is insufficient).

    Carefully:

    - Chronic renal failure.

    Pregnancy and lactation:

    In experimental studies, teratogenicity and fetotoxicity of preparations containing troxerutin. Studies of teratogenicity and fetotoxicity of the drug Troxerutin in humans were not performed, 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. In the first trimester of pregnancy, the use of a medicinal product Troxerutin it is contraindicated. In the II and III trimesters of pregnancy, the drug Troxerutin is possible only if the expected benefit to the mother exceeds the potential risk for the child.

    Data on the penetration of troxerutin into breast milk are absent. A drug Troxerutin should not be used during breastfeeding.

    Dosing and Administration:

    Inside, with food. Capsules are swallowed whole, washed down with sufficient

    amount of water.

    At the initial stage of treatment appoint 1 capsule (300 mg) 2-3 times a day until the symptoms disappear completely. For maintenance treatment, a dose of 1 capsule per day is recommended. The course of treatment is on average 3-4 weeks, the need for longer treatment is determined individually.

    With diabetic retinopathy Troxerutin appoint 2 capsules (300 mg) 3 times a day (daily dose of 1.8 g).

    Side effects:

    Allergic reactions: skin rashes;

    From the central nervous system: headache;

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

    From the skin: erythema and itching;

    Other: flushes of blood to the face.

    Overdose:

    Symptoms: nausea, headache, "tides" of blood to the face.

    Treated: need to rinse the stomach, take Activated carbon, with need to start symptomatic treatment.

    Interaction:

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

    Special instructions:

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

    Experience with the drug Troxerutin in children under 18 is not enough.

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

    Application of the drug Troxerutin does not affect motor and mental reactions. A drug Troxerutin does not affect the ability to drive vehicles and work with machinery.

    Form release / dosage:

    Capsules 300.0 mg.

    Packaging:

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

    For 10, 20, 30, 50, 60 or 100 capsules in cans of polymeric for medicines.

    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).

    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 expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002185
    Date of registration:19.08.2013
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.10.2015
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