Composition
Per 1 capsule:
Active ingredient: troxerutin-300 mg.
Excipients: calcium stearate, talc, povidone (grade 90), sodium carboxymethyl starch (sodium starch glycolate (type A), primogel), microcrystalline cellulose M 102.
Composition of gelatin capsule No. 0: iron oxide yellow dye, titanium dioxide, gelatin.
Pharmacological action
Pharmacotherapeutic group: venotonizing and venoprotective sredstvo Kod ATX: C 05 CA 04Pharmacological properties
Pharmacodynamics
Semi-synthetic bioflavonoid (rutin derivative) of the benzopyran class, has P-vitamin activity, has venotonizing, angioprotective, anti-inflammatory and anti-edematous effects, reduces capillary permeability and fragility.
Its pharmacodynamic properties are associated with the involvement 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, as a result of which it prevents the oxidation of ascorbic acid, epinephrine and lipids. In addition, it reduces the permeability and fragility of capillaries, prevents damage to the basement membrane of endothelial cells when exposed to various factors. Troxerutin increases the density of the vascular wall, reduces the exudation of the liquid part of the plasma and blood cell diapedesis. Reduces exudative inflammation in the vascular wall, reducing platelet adhesion to its surface. Inhibits aggregation and increases the degree of deformation of red blood cells.
The use of troxerutin is possible both at the initial and late stages of treatment of chronic venous insufficiency, it can be used as one of the components of complex treatment. Troxerutin reduces swelling and heaviness in the legs, reduces the intensity of pain and cramps, and improves tissue trophism.
Troxerutin relieves the symptoms associated with hemorrhoids (pain, exudation, itching, bleeding).
Troxerutin helps slow the progression of diabetic retinopathy due to its effect on the permeability and resistance of capillary walls.
The effect of troxerutin on the rheological properties of blood helps prevent the development of retinal vascular microthrombosis.
Pharmacokinetics
Troxerutin is rapidly absorbed when the drug is taken orally. The maximum concentration of troxerutin in blood plasma (cmax) is established on average in 1.75 ± 0.46 hours after oral use. Absorption is approximately 10-15%. The bioavailability of the drug increases with increasing dose. The elimination 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. 30 hours after taking troxerutin, the second maximum concentration of the drug in blood plasma is observed, due to enterohepatic recirculation. Partially metabolized in the liver to form glucuronide and trihydroethylquercitin. It is mainly excreted through the intestines (up to 65-70%), a smaller part (up to 25%) of the drug is excreted unchanged by the kidneys.
Indications
The drug Troxerutin capsules 300 mg is used as part of the complex therapy of these diseases:
– chronic venous insufficiency;
– trophic disorders in chronic venous insufficiency and venous ulcers;
– varicose veins;
– superficial thrombophlebitis, periflebit;
– post-thrombotic syndrome;
post– traumatic swelling and bruising of soft tissues;
as an adjunctive treatment after sclerotherapy and/or removal of varicose
veins of the lower extremities;
– hemorrhoids (for the relief of symptoms);
diabetic angiopathy, retinopathy.
Use during pregnancy and lactation
The use of Troxerutin during the first trimester of pregnancy is contraindicated. The possibility of using the drug during the second and third trimesters 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 second and third trimesters of pregnancy, you should consult your doctor.
There are no data on the penetration of troxerutin into breast milk. The use of Troxerutin during breastfeeding is contraindicated.
Contraindications
-hypersensitivity to troxerutin and other components of the drug;
– peptic ulcer of the stomach, duodenum, chronic gastritis in
the acute phase;
– pregnancy (I trimester);
– breastfeeding;
– children under 18 years of age (limited experience).
With caution
In patients with chronic renal failure (with prolonged use).
Side effects
Troxerutin is very well tolerated, with mild adverse reactions occurring in rare cases.
Immune system disorders: hypersensitivity reactions.
Nervous system disorders: headache.
Vascular disorders: “hot flashes” of blood to the face.
Gastrointestinal disorders: nausea, vomiting, stomach pain, flatulence, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract.
Skin and subcutaneous tissue disorders: erythema, pruritus, skin rash.
If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.
Interaction
When used simultaneously, it enhances the effect of ascorbic acid on resistance and permeability of the vascular wall.
How to take, course of use and dosage
Inside. Capsules should be swallowed whole, with a meal, with a sufficient amount of water.
At the initial stage of treatment,1 capsule (300 mg) is prescribed 3 times a day. The effect usually develops within 2 weeks. Further, treatment is continued at the same dose or reduced to the average therapeutic dose-1 capsule 2 times a day (600 mg), or suspended (while the achieved effect persists for at least 4 weeks). If necessary, the dose can be increased after consulting your doctor. The average course of treatment is 3-4 weeks.
For maintenance therapy, it is sufficient to take 1 capsule (300 mg) per day for 3-4 weeks.
In diabetic retinopathy, Troxerutin is prescribed 2 capsules (a single dose of 600 mg) 3 times a day (a 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 a doctor and individually.
Overdose
In case of overdose, you should immediately consult a doctor.
Troxerutin has very low toxicity. In case of overdose, the following symptoms may occur: agitation, nausea, headache, “flushes” of blood to the face.
Treatment: it is necessary to wash the stomach, take activated charcoal (within an hour after ingestion), consult a doctor, if necessary, conduct symptomatic and supportive treatment.
Description
Solid gelatin capsules No. 0 are yellow in color, the contents of the capsules are from greenish-yellow or yellow to yellow-green or yellow-brown in the form of powder with various particle sizes and granules, or powder pressed into cylinders that disintegrate when pressed.
Special instructions
Experience with the use of Troxerutin in children under the age of 18 years is insufficient.
In the treatment of superficial thrombophlebitis or deep vein thrombosis, the use of the drug does not exclude the need to prescribe anti-inflammatory and antithrombotic therapy.
Troxerutin is ineffective for edema caused by concomitant diseases of the liver, kidneys and heart.
When using the drug independently, the maximum time and recommended doses should not be exceeded.
If the severity of the symptoms of the disease does not decrease or the symptoms of the disease become more severe during the use of the drug, you should immediately consult a doctor.
Influence on the ability to drive vehicles and mechanisms
Taking the drug Troxerutin does not affect motor and mental reactions, does not interfere with driving vehicles and other complex mechanisms.
Storage conditions
In the original packaging, at a temperature not exceeding 25 ° C.
Keep out of reach of children.
Shelf
life is 3 years. Do not use after the expiration date.
Active ingredient
Troxerutin
Dosage form
Capsules
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Side effects of Troxerutin capsules 300mg, 100pcs.
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