Description
The drug Detralex is used for violations of the venous circulation. Reduces distensibility of veins and venostasis, increases their tone, improves lymphatic outflow
Active ingredients
Hesperidin + Diosmin
Release form
Pills
Composition
One film-coated tablet contains: Active ingredient: Purified, micronized flavonoid fraction, calculated on the dry matter, 1000.00 mg, consisting of: diosmin 900 mg (90%), flavonoids in terms of hesperidin 100 mg (10% ). Excipients: purified water 40.00 mg, gelatin 62.00 mg, magnesium stearate 8.00 mg, microcrystalline cellulose 124.00 mg, sodium carboxymethyl starch type A 54.00 mg, talc 12.00 mg. The mass of the tablet core: 1340 mg1). Film casing: sodium lauryl sulfate 0.130 mg, premix for orange-pink film membrane OY-S-8761, consisting of: glycerol 1,628 mg, hypromellose 27.039 mg, macrogol 6000 0.651 mg, magnesium stearate 1.628 mg, dye iron red oxide 0.211 mg , titanium dioxide 5.205 mg, iron dye yellow oxide 0.633 mg. Polishing adjuvant for pills: macrogol 6000 1,300 mg. The mass of the tablet, film coated 1378,425 mg. 1) Given the average moisture content of the purified, micronized flavonoid fraction — 4% (or 40 mg per tablet), the amount of the substance per tablet is 1040.00 mg.
Pharmacological effect
Detralex® has venotonic and angioprotective properties. The drug reduces the elasticity of the veins and venous congestion, reduces capillary permeability and increases their resistance. The results of clinical studies confirm the pharmacological activity of the drug in relation to venous hemodynamic parameters. The statistically significant dose-dependent effect of the drug Detralex® was demonstrated for the following venous plethysmographic parameters — venous capacity, venous distensibility, and time of venous emptying. The optimal dose-effect ratio is observed when taking 1000 mg per day. Detralex® increases venous tone: using venous occlusive plethysmography, a decrease in venous emptying time has been shown. In patients with signs of marked impairment of microcirculation, after treatment with Detralex®, there is a (statistically significant compared with placebo) increase in capillary resistance assessed by angiostereometry. The therapeutic efficacy of Detralex® has been proven in the treatment of chronic venous diseases of the lower limbs, as well as in the treatment of hemorrhoids.
Pharmacokinetics
The main release of the drug occurs with feces. With urine, on average, about 14% of the accepted amount of the drug is excreted. The half-life is 11 hours. The drug is subjected to active metabolism, as evidenced by the presence of phenolic acids in the urine.
Indications
Detralex® is indicated for the treatment of symptoms of chronic venous disease (elimination and relief of symptoms). Treatment of symptoms of venous lymphatic insufficiency: - pain. - cramps of the lower extremities. - a feeling of heaviness and fullness in the legs. - "tired" legs. Therapy of manifestations of venous lymphatic insufficiency: - swelling of the lower extremities. - trophic changes in the skin and subcutaneous tissue. - venous trophic ulcers. Symptomatic therapy of acute and chronic hemorrhoids.
Contraindications
- Hypersensitivity to the active ingredients or excipients that make up the drug. The use of the drug is not recommended for lactating women.
Use during pregnancy and lactation
Animal experiments revealed no teratogenic effects. To date, there have been no reports of adverse effects in the use of the drug in pregnant women. Due to the lack of data on the release of the drug in breast milk, nursing women are not recommended to take the drug. Reproductive toxicity studies showed no effect on reproductive function in rats of both sexes.
Dosage and administration
The drug is prescribed inside. Tablets should be swallowed with water. The recommended dose for venous lymphatic insufficiency - 1 tab. / day, preferably in the morning, during the meal. The risk on the tablet is intended solely for dividing in order to facilitate swallowing. The duration of the course of treatment can be several months (up to 12 months). In the case of recurrence of symptoms, according to the recommendation of the doctor, the treatment can be repeated. The recommended dose for acute hemorrhoids - 3 tab. / day (1 tab. in the morning, noon and evening) for 4 days, then - 2 tab. / day (1 tab. in the morning and in the evening) in the next 3 days. The recommended dose for chronic hemorrhoids - 1 tab. per day
Side effects
The side effects of Detralex®, observed during clinical trials, were mild.Disturbances from a gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting) were mainly noted. The following side effects were reported while taking the drug Detralex®: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100) , rarely (≥1 / 10,000, <1/1000), extremely rarely (<10,000), unspecified frequency (frequency cannot be calculated from available data). From the side of the central nervous system: rarely - dizziness, headache, general malaise. On the part of the gastrointestinal tract: often - diarrhea, dyspepsia, nausea, vomiting. infrequently - colitis. unspecified frequency - abdominal pain. For the skin: rarely - rash, itching, urticaria. unspecified frequency - isolated swelling of the face, lips, eyelids. in exceptional cases, angioedema. The patient should be informed that when any therapy appears in the background of therapy, including unwanted reactions and sensations not mentioned in the instructions, as well as changes in laboratory parameters, should be reported to the doctor.
Overdose
Cases of overdose are not described. In case of overdose, the patient should immediately seek medical attention.
Interaction with other drugs
Clinical studies on the interaction of the drug Detralex® with other drugs have not been conducted. To date, no cases of drug interactions have been reported.
special instructions
Before starting the use of Detralex®, the patient is advised to consult a doctor. In case of exacerbation of hemorrhoids, the prescription of the drug Detralex® does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the time specified in the section "Dosage regimen". In the event that the symptoms do not disappear after the recommended course of therapy, an examination should be carried out by a proctologist who will select further therapy. In the presence of disorders of the venous circulation, the maximum effect of treatment is provided by a combination of therapy with a healthy (balanced) lifestyle: it is advisable to avoid long exposure to the sun, prolonged standing, and it is recommended to reduce overweight. Walking and, in some cases, wearing special stockings helps to improve blood circulation.The patient should immediately consult a doctor if the condition worsens during the treatment process or if there is no improvement. Impact on the ability to drive motor vehicles and control mechanismsClinical studies on the effect of the drug Detralex® on the ability to drive and perform work requiring high speed mental and physical reactions have not been conducted. However, based on the available safety data, it can be concluded that Detralex® does not affect (has no significant effect) on these processes.
Storage conditions
At a temperature not higher than 30 ° C. Keep out of reach of children.
3 years. Do not use after the expiration date printed on the package.
