Sulodexide Soft Capsules

Sulodex is a glycosaminoglycan with strong antithrombotic effect on both arteries and veins. The antithrombotic effect of sulodexide is mainly related to the dose-dependent inhibition of some coagulation factors, especially the inhibition of activated factor X. Its interference with thrombin is secondary, thus basically avoiding the consequences caused by general anticoagulant effects. The antithrombotic effect of sulodexide is not only through the action of antithrombin (ATIII) on free thrombin, but also through the action of heparin factor II (HCII) on thrombin bound to fibrin. Therefore, the antithrombotic effect of sulodexide produced by inhibiting thrombin is reflected in preventing thrombosis and thrombus growth. The antithrombotic effect of sulodexide also works by inhibiting platelet aggregation and activating the fibrinolytic system of the circulation and vascular wall. In addition, sulodexide can improve blood circulation by reducing high fibrinogen and very low density lipoprotein concentrations, so that the blood viscosity parameters of patients with vascular lesions at risk of thrombosis can return to normal. Sulodex also has the pharmacological effects of maintaining the permeability of the vascular wall by preserving the normal negative charge on the vascular wall and inhibiting cell proliferation and the subsequent loss of function of the vascular wall basement membrane and extracellular matrix. Sulodex's selective effect of maintaining the permeability of the vascular wall can prevent the common transvascular leakage of different macromolecules (such as albumin, fibrinogen and lipoprotein), which is an early symptom of atherosclerosis, manifested in kidney lesions as proteinuria. Acute toxicity: Mice and rats received oral doses of up to 240 mg/kg body weight without any symptoms of poisoning. The median lethal dose (LD50) of mice exceeded 9000 mg/kg body weight (oral) and 1980 mg/kg body weight (intraperitoneal injection); the median lethal dose (LD50) of rats exceeded 9000 mg/kg body weight (oral) and 2385 mg/kg body weight (intraperitoneal injection). Subacute toxicity: Dogs were given 10 mg/kg orally for 21 consecutive days, and no intolerance was found, and no changes were found in blood chemical parameters and pathological anatomy of major organs. Long-term toxicity: Rats and dogs were given 20 mg/kg body weight orally for 180 days, and there were no significant changes in blood, urine and fecal parameters and histological parameters of major organs after the end of the treatment. Fetal toxicity: Fetal toxicity tests were conducted on rats and rabbits (25 mg/kg body weight, oral), and no embryo-fetal toxicity was found. Mutagenicity: The following tests were conducted and no mutagenicity was found: Ames test; unprogrammed DNA repair synthesis test in human lymphocytes; Aspergillus separation test; Aspergillus exchange test; Aspergillus methionine inhibitor test.

It is a brick-red soft capsule containing a suspension of white to gray fine particles.

Vascular disease with risk of thrombosis.

Soft capsules, one capsule per day, twice a day, with a long time between meals, such as taking at 10 am and 10 pm.

The following adverse reactions are rare. Injection: pain, burning sensation and hematoma at the injection site, and more rarely, skin allergy at the injection site or other sites. Soft capsules: symptoms of gastrointestinal disturbances such as nausea, vomiting and upper abdominal pain.

It is contraindicated for patients who are allergic to this product, heparin or heparin-like drugs, or who have bleeding diathesis or bleeding diseases.