Trokserutin
Producer: LLC Ozon Russia
Code of automatic telephone exchange: C05CA04
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active agent: троксерутин - 300,0 mg.
Excipients: lactoses monohydrate (sugar milk) - 39,5 mg, sodium carboxymethylstarch - 7,0 mg, magnesium stearate - 3,5 mg.
Structure of the case of the capsule: dye ferrous oxide red - 0,0071%; dye ferrous oxide yellow - 0,1227%; titanium dioxide - 2,0000%; gelatin - to 100%.
Structure of a lid of the capsule: dye diamond blue - 0,0190%; dye red charming - 0,0450%; titanium dioxide - 3,0000%; gelatin - to 100%.
Pharmacological properties:
Pharmacodynamics. The flavonoid (derivative a routine), has R-vitamin activity; renders venotonizi-ruyushchy, angioprotektorny, antiinflammatory and antiedematous action; reduces permeability and fragility of capillaries. Pharmakodinamichesky properties are connected with participation of bioflavonoids of a trokserutin in oxidation-reduction processes and hyaluronidase inhibition. Suppressing hyaluronidase, trokseru-oozes stabilizes hyaluronic acid of cellular covers and reduces their permeability. Has antioxidant activity therefore prevents oxidation of ascorbic acid, adrenaline and lipids. Besides, reduces permeability and fragility of capillaries, prevents damage of a basal membrane of endothelial cells at impact on it of various factors. Trokserutin reduces an exudative inflammation in a vascular wall, reducing adhesion of thrombocytes to its surface. Inhibits aggregation and increases extent of deformation of erythrocytes. At chronic venous insufficiency of trokse-routines reduces heavy feeling and puffinesses in legs, reduces intensity of pain and spasms, improves a trophicity of fabrics. Trokserutin facilitates the symptoms connected with hemorrhoids (pain, an ekksudation, an itch, bleedings).
Thanks to impact on permeability and resistance of walls of capillaries троксерутин promotes delay of progressing of a diabetic retinopathy. Influence of a trokserutin on rheological properties of blood promotes prevention of microthrombosis of vessels of a retina.
Pharmacokinetics. Trokserutin is quickly soaked up at administration of drug inside. The maximum concentration of a trokserutin is established on average in 1,75±0,46 hours after intake. Absorption makes about 10-15%. Bioavailability of drug increases with increase in a dose. The elimination half-life makes 6,77±2,37 hours. Therapeutic concentration of drug in a blood plasma remains within 8 hours. In 30 hours after reception of a trokserutin the second maximum of concentration of drug in a blood plasma caused by enterogepati-chesky recirculation is observed. It is partially metabolized in a liver with formation of a glucuronide and trigidroetilkvertsitin. It is removed generally through intestines (to 65-70%), a smaller part (to 25%) drug is removed in not changed look by kidneys.
Indications to use:
• Chronic venous insufficiency
• Postflebitichesky syndrome
• Trophic disturbances at a varicosis of legs and trophic ulcers
• As auxiliary treatment after sclerotherapy and/or removal varicose expanded veins of the lower extremities
• Posttraumatic hypostasis and hematomas of soft tissues.
• Hemorrhoids (for relief of symptoms).
• In complex treatment of a retinopathy at patients with a diabetes mellitus, arterial hypertension and atherosclerosis.
Route of administration and doses:
Inside, during food. Capsules are swallowed entirely, washing down with enough water. At the initial stage of treatment appoint on 1 capsule (300 mg) 2-3 times a day before total disappearance of symptoms. For the supporting treatment the dose on 1 capsule a day is recommended. The course of treatment averages 3-4 weeks, need of more prolonged treatment is defined individually.
At a diabetic retinopathy Trokserutin appoint 2 capsules (300 mg) 3 times a day (a daily dose of 1,8 g).
Features of use:
If during drug use expressiveness of symptoms of a disease does not decrease, it is necessary to consult with the doctor.
Experience of use of drug Trokserutin at children is younger than 18 years is insufficient.
Influence on ability to manage vehicles and work with mechanisms drug Use Trokserutin does not exert impact on motor and mental reactions. Drug Trokserutin does not influence ability to manage vehicles and to work with mechanisms.
Side effects:
- Allergic reactions: skin rashes;
- From the central nervous system: headache;
- From digestive tract: nausea, vomiting, stomach ache, meteorism, diarrhea, digestive tract erosive cankers;
- From integuments: erythema and itch;
- Other: rushes of blood to the person.
Interaction with other medicines:
At simultaneous use strengthens effect of ascorbic acid on resistance and permeability of a vascular wall /
Contraindications:
• Hypersensitivity to the trokserutin or excipients which are a part of drug.
• A peptic ulcer of a stomach and duodenum and chronic gastritis in an aggravation phase.
• Lactose intolerance, insufficiency of lactase or syndrome of glyukozo-galaktozny malabsorption.
• Pregnancy (I trimester) and lactation period.
• Children's age (up to 18 years, experience of use is insufficient).
With CARE Chronic renal failure.
USE AT PREGNANCY And during BREASTFEEDING In pilot studies teratogenecity and a fetotoksichnost of the drugs containing троксерутин is noted. Researches of teratogenecity and a fetotoksichnost of drug Trokserutin at the person were not conducted, however there are instructions on possible association between reception trokseru-ooze during pregnancy and anomalies of a structure of an outside ear for children. In the I trimester of pregnancy medicine use Trokserutin is contraindicated. In II and III trimesters of pregnancy drug use Trokserutin is possible only if the expected advantage for mother exceeds potential risk for the child. Data on penetration of a trokserutin into breast milk are absent. Drug Trokserutin should not be used during breastfeeding.
Overdose:
Symptoms: nausea, a headache, "inflows" of blood to the person.
Treatment: it is necessary to wash out a stomach, to accept absorbent carbon, if necessary to begin a symptomatic treatment.
Storage conditions:
In the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
Capsules of 300,0 mg.
On 10, 30 capsules in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished.
On 10, 20, 30, 50, 60 or 100 capsules in banks polymeric for medicines. To one bank or 1, 2, 3, 5, 6 or 10 blister strip packagings together with the application instruction place in cardboard packaging (pack).