Detralex® (Detralex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsptfilm-covered laths
Composition:

One tablet, film-coated, contains:

Active substance: purified, micronized flavonoid fraction, calculated on a dry matter, 1000.00 mg, consisting of: diosmin 900 mg (90%), flavonoids in recalcification for hesperidin 100 mg (10%).

Excipients: purified water 40.00 mg, gelatin 62.00 mg, magnesium stearate 8.00 mg, cellulose microcrystalline 124.00 mg, sodium carboxymethyl starch type A 54.00 mg, talc 12.00 mg.

Tablet core weight: 1340 mg1).

Film Sheath: sodium lauryl sulfate 0.130 mg, premix for a film shell of orange-pink color OY-S-8761, consisting of: glycerol 1.628 mg, hypromellose 27.039 mg, macrogol 6000 0.651 mg, magnesium stearate 1.628 mg, iron oxide red oxide 0.211 mg, titanium dioxide 5.255 mg, iron oxide dye yellow 0.633 mg.

Auxiliary agent for polishing tablets: macrogol 6000 1,300 mg.

The weight of the film-coated tablet is 1378.425 mg.

1) Given the average moisture content of the purified, micronized flavonoid fraction - 4%, (or 40 mg per tablet), the amount of substance per tablet is 1040.00 mg.

Description:

Oval tablets covered with a film coating of orange-pink color with a risk on both sides.

Type of tablet on the break: from pale yellow to yellow, heterogeneous structure.

Pharmacotherapeutic group:Venotonizing and venoprotective agent
ATX: & nbsp
  • Diosmin in combination with other drugs
    • Pharmacodynamics:

    Detralex® has venotonic and angioprotective properties. The drug reduces the extensibility of veins and venous congestion, reduces the permeability of capillaries and increases their resistance. The results of clinical studies confirm the pharmacological activity of the drug with respect to the indices of venous hemodynamics.

    The statistically significant dose-dependent effect of Detralex® was demonstrated for the following venous plethysmographic parameters: venous capacity, venous dilatability, venous emptying time. The optimal "dose-effect" ratio is observed when taking 1000 mg per day.

    Detralex® increases the venous tone: a decrease in the time of venous emptying has been shown with venous occlusion plethysmography. In patients with signs of severe disturbance of microcirculation, after treatment with Detralex®, there is a (statistically significant compared with placebo) increase in capillary resistance, estimated by angiostereiometry.

    The therapeutic effectiveness of Detralex ® in the treatment of chronic diseases of the veins of the lower extremities, as well as in the treatment of hemorrhoids, is proved.

    Pharmacokinetics:

    The main release of the drug occurs with feces. With urine, on average, about 14% of the amount taken.

    The half-life is 11 hours.

    The drug is subject to active metabolism, which is confirmed by the presence of phenolic acids in the urine.

    Indications:

    Detralex® is indicated for the treatment of symptoms of chronic venous diseases (elimination and alleviation of symptoms).

    Therapy of symptoms of venous-lymphatic insufficiency:

    - pain;

    - convulsions of the lower limbs;

    - sensation of heaviness and raspiraniya in the legs;

    - "fatigue" of the feet.

    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 to the excipients included in the preparation.

    It is not recommended to take the drug for lactating women.

    Pregnancy and lactation:

    Pregnancy

    Experiments on animals did not reveal teratogenic effects.

    To date, there have been no reports of undesirable effects in the use of the drug by pregnant women.

    Lactation

    Due to the lack of data on the excretion of the drug with breast milk, lactating women are not recommended taking the drug.

    Influence on reproductive function

    Reproductive toxicity studies showed no effect on reproductive function in rats of both sexes.

    Dosing and Administration:

    Inside.

    The recommended dose for venous-lymphatic insufficiency - 1 tablet a day, preferably in the morning, during a meal.

    The risk on the pill is intended exclusively for dividing in order to facilitate swallowing.

    The duration of treatment can be several months (up to 12 months). In case of recurrence of symptoms, on the recommendation of a doctor, the course of treatment can be repeated.

    Recommended dose for acute hemorrhoids - 3 tablets per day (1 tablet in the morning, afternoon and evening) for 4 days, then 2 tablets per day (1 tablet in the morning and evening) for the next 3 days.

    Recommended dose for chronic hemorrhoids - 1 tablet a day.

    Side effects:

    The side effects of Detralex®, observed during clinical trials, were mild. Most noted violations of the gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting).

    During the reception of Detralex®, the following side effects were reported, in the form of the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1,000, <1/100); rarely (≥1 / 10,000, <1/1 000); extremely rare (<1/10 000), unspecified frequency (the frequency can not be calculated from the available data).

    From the central nervous system:

    Rarely: dizziness, headache, general malaise.

    From the gastrointestinal tract:

    Often: diarrhea, dyspepsia, nausea, vomiting.

    Infrequently: colitis.

    Unspecified frequency: abdominal pain.

    From the skin:

    Rarely: rash, itching, hives.

    Unspecified frequency: isolated edema of the face, lips, eyelids.

    In exceptional cases angioedema.

    Overdose:

    Cases of overdose are not described.

    If an overdose occurs, seek medical help immediately.

    Interaction:

    Not noted.

    YOU SHOULD INFORM THE TREATMENT OF THE DOCTOR ON ALL YOUR MEDICINAL DRUGS ACCEPTED BY YOUAX.

    Special instructions:

    - Before taking Detralex®, it is recommended that you consult with your doctor.

    - With exacerbation of hemorrhoids, the purpose of Detralex® does not replace the specific treatment of other anal disorders. Duration of treatment should not exceed the time specified in the section "Method of administration and dose". In the event that the symptoms do not disappear after the recommended course of therapy, you should undergo an examination with a proctologist who will choose further therapy.

    - In the presence of violations of venous circulation, the maximum effect of treatment is provided by combining therapy with a healthy (balanced) way of life: it is desirable to avoid long stay in the sun, a prolonged stay on the legs, and it is also recommended to reduce excess body weight. Hiking and, in some cases, wearing special stockings contribute to improving blood circulation.

    - Seek medical attention immediately if your condition worsens during treatment or there is no improvement.

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

    Does not affect.

    Form release / dosage:

    Tablets, film-coated, 1000 mg.

    Packaging:

    In the production of the Servier Industrial Laboratory, France

    For 10 tablets in a blister (PVC / Al). For 3 or 6 blisters with instructions for medical use in a pack of cardboard.

    For 9 tablets in a blister (PVC / Al). For 3 blisters with instructions for medical use in a pack of cardboard.

    In the production of LLC "Serdiks", Russia

    For 10 tablets in a blister (PVC / Al). For 3 or 6 blisters with instructions for medical use in a pack of cardboard.

    For 9 tablets in a blister (PVC / Al). For 3 blisters with instructions for medical use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003635
    Date of registration:17.05.2016
    Expiration Date:17.05.2021
    The owner of the registration certificate:Servier LaboratoriesServier Laboratories France
    Manufacturer: & nbsp
    Representation: & nbspServier Laboratories Servier Laboratories France
    Information update date: & nbsp25.03.2017
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