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Wessel Due f solution for injection 600 units/2ml 2ml amp 10 pcs

Pharmacological group:

Anticoagulants – heparin and its derivatives.
Pharmacological properties:
Wessel® Due F (sulodexide) is a biological drug that is a natural mixture of glycosaminoglycans (GAGs): a heparin-like fraction with a molecular weight of 8000 daltons (80%) and dermatan sulfate (20%).

The mechanism of action of sulodexide is due to two main properties: the fast-acting heparin-like fraction has an affinity for antithrombin III (ATIII), and the dermatan fraction has an affinity for heparin cofactor II (CHII).

Angioprotective, profibrinolytic, anticoagulant, antithrombotic effect.

Pharmacodynamics:

The angioprotective effect is associated with the restoration of the structural and functional integrity of vascular endothelial cells, with the restoration of the normal density of the negative electrical charge of the pores of the vascular basement membrane. In addition, the drug normalizes the rheological properties of the blood by reducing the level of triglycerides (stimulates the lipolytic enzyme - lipoprotein lipase, which hydrolyzes triglycerides that 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 basement membrane and the production of extracellular matrix by reducing the proliferation of mesangium cells.

The profibrinolytic effect is due to an increase in the blood level of tissue plasminogen activator and a decrease in the content of its inhibitor.

The anticoagulant effect of the solution for intravenous and intramuscular administration, which is weakly expressed in the proposed dosage (one ampoule per day), is manifested due to its affinity for antithrombin and cofactor II of heparin, which consistently reduces the concentrations of activated factor X and thrombin.

Antithrombotic activity is the result of all types of action that sulodexide has on the vascular wall (angioprotective effect), fibrinolysis (profibrinolytic effect), blood coagulation (weak anticoagulant effect) and inhibition of platelet adhesion.

Pharmacokinetics:

Absorption of sulodexide administered intravenously or intramuscularly is quite rapid and depends on the speed of blood circulation at the injection site.

Plasma concentrations of sulodexide after internal bolus administration of a single dose of 50 mg after 15, 30 and 60 minutes were 3.86 ± 0.37 mg/L, 1.87 ± 0.39 mg/L and 0.98 ± 0.09 mg/L, respectively. Sulodexide is distributed in the vascular endothelium in a concentration 20-30 times higher than the concentration in other tissues. Metabolized in the liver and excreted mainly by the kidneys. In a radiolabeled study, 55.23% of sulodexide was excreted in urine during the first 96 hours.

Wessel Due F capsules 250ED No. 60

Compound

Active substance: sulodexide - 250 LE*.
Excipients: sodium lauryl sarcosinate - 3.3 mg, colloidal silicon dioxide - 2 mg, triglycerides - 83.87 mg. * lipoprotein lipase unit.

Pharmacokinetics

Suction

Absorption of sulodexide administered intravenously or intramuscularly is quite rapid and depends on the speed of blood circulation at the injection site. The concentration of sulodexide in plasma after intravenous bolus administration in a single dose of 50 mg after 15, 30 and 60 minutes was 3.86 ± 0.37 mg/l, 1.87 ± 0.39 mg/l and 0.98 ± 0.09 mg/l, respectively.

When administered orally, sulodexide is absorbed from the small intestine. After ingestion of the labeled drug, the first peak of sulodexide in the blood plasma is observed after 2 hours, the second - from 4 to 6 hours, after which the drug is no longer detectable in the plasma; the concentration is restored after approximately 12 hours and then remains constant until approximately the 48th hour.

Distribution, metabolism and excretion

Sulodexide is distributed in the vascular endothelium in a concentration 20-30 times higher than the concentration in other tissues. When taken orally, a constant level in the blood plasma is detected after 12 hours, probably due to the slow release of the drug by the absorption organs and, in particular, by the vascular endothelium.

Metabolized in the liver and excreted mainly by the kidneys. In a radiolabeled study, 55.23% of sulodexide was excreted in urine during the first 96 hours.

Indications for use

angiopathy with an increased risk of thrombosis, incl. after myocardial infarction;
cerebrovascular accident, including the acute period of ischemic stroke and the period of early recovery;
discirculatory encephalopathy caused by atherosclerosis, diabetes mellitus, arterial hypertension;
vascular dementia;
occlusive lesions of peripheral arteries of both atherosclerotic and diabetic origin;
phlebopathy, deep vein thrombosis;
microangiopathies (nephropathy, retinopathy, neuropathy);
macroangiopathy in diabetes mellitus (diabetic foot syndrome, encephalopathy, cardiopathy);
thrombophilic conditions, antiphospholipid syndrome (prescribed together with acetylsalicylic acid, as well as after low molecular weight heparins);
treatment of heparin-induced thrombotic thrombocytopenia (as the drug does not cause or aggravate it).

Contraindications

hemorrhagic diathesis and diseases accompanied by decreased blood clotting;
I trimester of pregnancy;
hypersensitivity to the components of the drug.

With caution: when used together with anticoagulants, blood clotting parameters should be monitored.

Directions for use and doses

1-2 capsules 2 times a day before meals for 30-40 days. Typically, treatment begins with the use of the drug in the dosage form “solution for intravenous and intramuscular use”, 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 the clinical diagnostic examination of the patient, the dosage regimen may be changed at the discretion of the physician.

Storage conditions

Store out of the reach of children at a temperature not exceeding 30°C.

Best before date

5 years. Do not use after expiration date.

special instructions

At the beginning and end of treatment, it is advisable to determine the following indicators: aPTT, antithrombin III, bleeding time and clotting time.

Wessel® Due F increases normal APTT values by approximately 1.5 times.

Description

Direct acting anticoagulant.

Dosage form

Soft gelatin capsules, brick-red, oval; the contents of the capsules are a white-gray suspension; a pinkish or pinkish-creamy tint is allowed.

Use in children

Use from 12 years of age.

Action

Wessel® Due F (sulodexide) is a biological medicinal product that is a natural mixture of glycosaminoglycans (GAGs): a heparin-like fraction with a molecular weight of 8000 daltons (80%) and dermatan sulfate (20%).

It has angioprotective, profibrinolytic, anticoagulant, antithrombotic effects.

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

The profibrinolytic effect is due to an increase in the blood level of tissue plasminogen activator and a decrease in the content of its inhibitor.

The anticoagulant effect of the solution for intravenous and intramuscular administration, which is weakly expressed in the proposed dose (1 ampoule/day), is manifested due to the affinity for antithrombin and cofactor II of heparin, which consistently reduces the concentrations of activated factor X and thrombin.

After oral administration at the recommended dose, the amount of sulodexide and its derivatives after the first-pass effect is sufficient to induce antithrombin action without affecting conventional coagulation parameters (aPTT, thrombin time, activated factor X). Thus, it can be assumed that sulodexide, when administered orally, does not have an anticoagulant effect.

Side effects

According to clinical studies

Data on the incidence of adverse drug reactions associated with the use of sulodexide were obtained from clinical studies involving patients treated with standard doses of the drug for the usual duration of therapy.

Adverse reactions associated with the use of sulodexide were classified into system-organ classes and distributed according to frequency of occurrence in the following order: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1 /1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).

From the nervous system: infrequently – headache; very rarely - loss of consciousness.

On the part of the hearing organ: often – dizziness.

From the digestive system: often – pain in the upper abdomen, diarrhea, nausea; infrequently – a feeling of discomfort in the abdomen, dyspepsia, flatulence, vomiting; very rarely – gastric bleeding.

Allergic reactions: often - skin rash of various locations; uncommon – eczema, erythema, urticaria.

Other: infrequently - pain at the injection site, hematoma at the injection site; very rarely - peripheral edema.

According to post-registration observations

Additional adverse events have been reported during post-marketing use of sulodexide. The frequency of these undesirable effects cannot be assessed due to the fact that information about them comes in the form of spontaneous reports. Accordingly, the frequency of these adverse events is classified as “unknown” (cannot be calculated based on available data).

When using the drug parenterally

From the psyche: derealization.

From the nervous system: convulsions, tremor.

From the organ of vision: visual disturbances.

From the cardiovascular system: palpitations, hot flashes.

From the respiratory system: hemoptysis.

From the skin and subcutaneous tissues: itching, purpura, generalized erythema.

From the urinary system: stenosis of the bladder neck, dysuria.

Other: chest pain, pain, burning at the injection site.

When using the drug orally

Frequency unknown: anemia, disorders of plasma protein metabolism, gastrointestinal disorders, melena, angioedema, ecchymosis, swelling of the external genitalia, genital erythema, polymenorrhea.

Use during pregnancy and breastfeeding

During pregnancy, it is prescribed under the strict supervision of a doctor. There is positive experience in using the drug for the treatment and prevention of vascular complications in patients with type 1 diabetes mellitus in the 2nd and 3rd trimesters of pregnancy, with the development of late toxicosis of pregnancy.

Interaction

No significant interaction of Wessel® Due F with other drugs has been established.

When using sulodexide, it is not recommended to simultaneously use drugs that affect the hemostasis system as anticoagulants (direct and indirect).

Overdose

Symptoms: Bleeding is the only symptom that may occur with an overdose.

Treatment: in case of bleeding, it is necessary to administer protamine sulfate (1% solution), which is used for bleeding caused by heparin.

Impact on the ability to drive vehicles and operate machinery

Wessel® Due F does not affect the ability to drive vehicles and machines.