Wessel Doué F (Vessel Due F)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSulodexideSulodexide
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    capsules inwards 
    Alfa Wassermann SpA     Italy
  • Wessel Doué F
    solution w / m in / in 
    Alfa Wassermann SpA     Italy
    • Dosage form: & nbsp
    capsules
    Composition:Each capsule contains:

    Active substance: sulodexide 250 L *

    Excipients: sodium lauryl sarcosinate 3.30 mg, silicon dioxide colloid 2.00 mg, triacetin 83.87 mg. Components of the capsule shell: gelatin 53.15 mg, glycerol 22.07 mg, ethyl parahydroxybenzoate sodium 0.26 mg, sodium propylparahydroxybenzoate 0.13 mg, titanium dioxide (E171) 0.29 mg, iron oxide red (E172) 0.86 mg.

    * - lipoprotein lipase unit.

    Description:

    Oval soft gelatin capsules of brick-red color, containing a suspension of white-gray color. A pinkish or pinkish cream color of the contents of the capsules is allowed.

    Pharmacotherapeutic group:Anticoagulants - heparin and its derivatives
    ATX: & nbsp

       

    Pharmacodynamics:

    Wessel Douai F (sulodexide) is a biological drug that is a natural mixture of glycosaminoglycans (GAG): a heparin-like fraction with a molecular weight of 8,000 daltons (80%) and dermatan sulfate (20%).

    The mechanism of action of sulodexide is due to two main properties: high-speed heparin-like fraction has an affinity for antithrombin III (ATIII), and dermatoid - to the cofactor II of heparin (CGII). After oral administration at the recommended dosage, the amount of sulodexide and its derivatives after the first passage effect is sufficient to induce an antithrombin effect without affecting the usual coagulation parameters (activated partial thromboplastin time (APTT), thrombin time, activated factor X). Thus, it can be assumed that sulodexide when administered orally, it has no anticoagulant effect.

    pharmachologic effect: angioprotective, profibrinolytic, antithrombotic.

    Pharmacodynamics

    Angioprotective action is associated with the restoration of the structural and functional integrity of endothelial vascular cells, with the restoration of the normal density of negative electrical charge of the pores of the basal membrane of the vessels. In addition, the drug normalizes the rheological properties of the blood by reducing the level of triglycerides (stimulates lipolytic enzyme - lipoprotein lipase, hydrolyzing triglycerides, which are part of LDL).

    The effectiveness of the drug in diabetic nephropathy is determined by the ability of sulodexide to reduce the thickness of the basal membrane and the production of the extracellular matrix by reducing the proliferation of mesangium cells.

    Prefibrinolytic action is caused by a rise in the blood level of the tissue activator plasminogen and a decrease in the content of its inhibitor. Antithrombotic activity Sulodexide, administered orally, is mainly the result of all types of action that sulodexide exerts on the vascular wall (angioprotective action), fibrinolysis (profibrinolytic action) and inhibition of platelet adhesion.
    Pharmacokinetics:

    Sulodexide is absorbed in the small intestine. After taking the labeled drug, the first peak of the sulodexide in the blood plasma is observed after 2 hours, the second - from 4 to 6 hours, after which the drug is no longer detected in the plasma; the concentration is restored after approximately 12 hours, and then remains constant until about the 48th hour. A constant level in the blood plasma is detected after 12 hours, probably because of the slow release of the drug by the absorption organs and, in particular, the vascular endothelium. Sulodexide is distributed in the vascular endothelium in a concentration 20-30 times higher than the concentration in other tissues. Metabolised in the liver and excreted mainly by the kidneys. In the study of the radioactive labeled preparation, 55.23% of the sulodexide was excreted in the urine during the first 96 hours.

    Indications:

    - Angiopathy with an increased risk of thrombosis, including after a previous myocardial infarction;

    - disturbance of cerebral circulation, including acute period of ischemic stroke and period of early recovery; discirculatory encephalopathy due to atherosclerosis, diabetes mellitus, hypertension; vascular dementia;

    - occlusive lesions of peripheral arteries both atherosclerotic and diabetic;

    - phlebopathy, deep vein thrombosis;

    - microangiopathy (nephropathy, retinopathy, neuropathy) and macroangiopathy in diabetes mellitus (diabetic foot syndrome, encephalopathy, cardiopathy);

    - thrombophilic conditions, antiphospholipid syndrome (prescribe jointly with acetylsalicylic acid, and also after low molecular weight heparins);

    - treatment of heparin-induced thrombotic thrombocytopenia, because it does not cause or aggravate it.

    Contraindications:

    - Hypersensitivity;

    - hemorrhagic diathesis and diseases accompanied by reduced blood coagulability;

    - pregnancy I trimester.

    Carefully:

    When combined with anticoagulants, it is necessary to control the parameters of blood clotting.

    Pregnancy and lactation:

    When pregnancy is prescribed under the strict supervision of a doctor. There is a positive experience with the use of the drug for the treatment and prevention of vascular complications in patients with type I diabetes in the II and III trimesters of pregnancy, with the development of late toxicosis of pregnant women.

    Dosing and Administration:

    1-2 capsules 2 times a day before meals for 30-40 days. Usually, the treatment begins with the use of the drug in the dosage form "solution for intravenous and intramuscular administration" of 1 ampoule per day, intramuscularly or intravenously, for 15-20 days.

    The full course of treatment should be repeated at least 2 times a year.

    Depending on the results of clinical and diagnostic examination of the patient, the dosage regimen can be changed at the doctor's discretion.

    Side effects:

    According to clinical studies

    Data on the incidence of undesirable drug reactions associated with the use of sulodexide were obtained in clinical trials involving patients treated with standard doses of the drug at the usual duration of therapy.

    Undesirable reactions associated with the use of sulodexide were classified according to the system-organ class and distributed according to the frequency of occurrence in the following order: very often (≥ 1/10), often (≥ 1/100 to <1/10) infrequently (≥ 1 / 1000 to <1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000).

    Nervous System: infrequently - headache, rarely - loss of consciousness.

    Hearing organ: often - dizziness.

    Gastrointestinal tract: often - pain in the upper abdomen, diarrhea, nausea, infrequently - a feeling of discomfort in the abdomen, dyspepsia, flatulence, vomiting, rarely - gastric bleeding.

    Allergic reactions: often - skin rash of different localization, infrequently - eczema, erythema, urticaria.

    According to post-registration observations.

    During the post-marketing application of sulodexide, additional undesirable phenomena were recorded.The frequency of these undesirable effects can not be estimated due to the fact that information about them comes in the form of spontaneous messages. Accordingly, the frequency of these undesirable phenomena is classified as "unknown" (it can not be calculated on the basis of available data).

    Anemia, metabolic disorders of plasma proteins, disorders of the gastrointestinal tract, melena, angioedema, ecchymosis, genital edema, genital erythema, polymenorrhea.

    Overdose:

    Bleeding is the only phenomenon that can occur with an overdose. In case of development of bleeding it is necessary to administer protamine sulfate (1% solution), used for bleeding caused by heparin.

    Interaction:

    Significant interaction of the preparation of Wessel Doué F with other drugs has not been established. When using sulodexide, it is not recommended to simultaneously use drugs that affect the hemostasis system as anticoagulants (direct and indirect).

    Special instructions:

    Due to the pharmaco-toxicological properties of sulodexide, the use of the drug does not require special precautions.However, when combined with other anticoagulants, blood coagulability should be monitored periodically.

    Effect on the ability to drive transp. cf. and fur:
    The ability to control vehicles and mechanisms, the preparation of Wessel Douai F is not affected.
    Form release / dosage:
    Capsules 250 LE.
    Packaging:

    For 20 or 25 capsules in PVC / PVDC blisters and aluminum film with a coating layer of transparent PVDC; 3 blisters for 20 capsules or 2 or 4 blisters of 25 capsules, together with instructions for use, are placed 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:

    5 years

    Do not use after expiry date!

    Terms of leave from pharmacies:On prescription
    Registration number:П N012490 / 01
    Date of registration:04.04.2008 / 28.06.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Alfa Wassermann SpAAlfa Wassermann SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspALPHA VASSERMANN LLC ALPHA VASSERMANN LLC Italy
    Information update date: & nbsp25.09.2017
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