Description
Composition
Active substance:
Sulodexide 250 LE *.
Excipients:
sodium lauroyl sarcosinate 3.30 mg colloidal silicon dioxide 2.00 mg 83.87 mg triacetin. The components of the capsule shell: Gelatin 53.15 mg Glycerol 22.07 mg, 0.26 mg sodium ethyl parahydroxybenzoate, propyl parahydroxybenzoate 0.13 mg sodium, titanium dioxide (E171) 0.29 mg iron oxide red (E172) 0.86 mg . * – lipoproteinlipaznaya unit.
Description:
Oval soft gelatin capsule brick-red slurry containing white-gray color. Allowed pinkish or pinkish cream tint of capsules.
Product form:
Capsules 250 LE.
20 or 25 capsules per blister made of PVC / PVDC and aluminum film bases coated with a layer of transparent PVDC; 3 blisters with 20 capsules or blisters 2 or 4 to 25 capsules together with instructions for use placed in a pile of cardboard.
Contraindications
– hypersensitivity; – hemorrhagic diathesis and diseases accompanied by reduced blood clotting; – I trimester of pregnancy.
Carefully:
In a joint application with anticoagulants of clotting parameters should be monitored.
Indications
– suffering a myocardial infarction; – the cerebral circulation, including the acute phase of ischemic stroke and the early recovery period; encephalopathy caused by atherosclerosis, diabetes, hypertension; vascular dementia; – peripheral arterial occlusive disease like atherosclerosis and diabetic origin; – phlebopathy, deep vein thrombosis; – microangiopathy (nephropathy, retinopathy, neuropathy), and macroangiopathy in diabetes (diabetic foot syndrome, encephalopathy, cardiomyopathy); – thrombophilic state, antiphospholipid syndrome (administered together with acetylsalicylic acid, and after LMWH); – the treatment of heparin-induced thrombocytopenia, thrombotic, because it does not cause or aggravate it.
Interaction with other drugs
Significant drug interactions Vessel® Due F with other drugs is not established. In the application of sulodexide it is not recommended to use both drugs affecting hemostasis as anticoagulants (direct and indirect).
Overdose
Bleeding is the only phenomenon that can occur when an overdose. In the case of bleeding must administering protamine sulphate (1% solution) applied at bleedings caused by heparin.
pharmachologic effect
Pharmacological group:
Anticoagulants – heparin and its derivatives.
Pharmacological properties:
Vessel® Due F (sulodexide) is a biological drug, which is a natural mixture of glycosaminoglycans (GAGs) heparin 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 characteristics: a high-speed heparin fraction has an affinity for antithrombin III (ATIII) and dermatanovaya – to heparin cofactor II (KGII).
After oral administration the recommended dosage amount of sulodexide and its derivatives after the first pass effect is sufficient to induce antithrombin activities without affecting normal coagulation parameters (activated partial thromboplastin time (APTT), thrombin time, activated Factor X). Thus, it can be assumed that sulodexide upon oral administration has no anticoagulation action.
Angioprotective, pro-fibrinolytic, antithrombotic effect.
Pharmacodynamics:
Angioprotective effect due to the reduction of the structural and functional integrity of the vascular endothelial cells with recovery of normal density of negative electric charge pore basal vascular membrane. Furthermore, the preparation normalizes blood rheology by reducing triglycerides (stimulates lipolytic enzyme – lipoprotein lipase, the hydrolysis of triglycerides belonging to the LDL).
The efficacy of the drug for diabetic nephropathy sulodexide determined by the ability to reduce the thickness of the basement membrane and extracellular matrix production by reducing the proliferation of mesangium cells.
Profibrinolytic effect due to an increase in blood levels of tissue plasminogen activator and its inhibitor content reduction.
Antithrombotic activity sulodexide appointed inward, is mainly the result of all kinds of actions that sulodexide exerts on the vascular wall (angioprotective action), fibrinolysis (profibrinolytic activity) and inhibition of platelet adhesion.
Pharmacokinetics:
Sulodexide absorbed in the small intestine. After oral administration of the drug labeled sulodexide first peak in the plasma is observed after 2 hours; the second – from 4 to 6 hours, after which the drug is no longer detected in the plasma; concentration is reduced by approximately 12 hours and then remained constant until about the 48th hour. Constant plasma levels detected through 12 hours probably due to a slow release drug absorption bodies, and in particular, vascular endothelium. Sulodexide is distributed in the vascular endothelium at a concentration of 20-30 times the concentration in other tissues. It is metabolized in the liver and excreted mainly by the kidneys. In the study of radioactive labeled drug sulodexide 55.23% excreted in urine during the first 96 hours.
Pregnancy and breast-feeding
When pregnancy is appointed under the strict supervision of a physician. There is a positive experience with the drug for the treatment and prevention of vascular complications in patients with type I diabetes in II and III trimesters of pregnancy, the development of late toxicosis pregnant.
Conditions of supply of pharmacies
Prescription.
side effects
According to clinical studies
Data on the frequency of adverse 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 course.
Adverse reactions associated with the use of sulodexide, were classified by system-organ class and distributed in frequency of occurrence as follows: Very common (> 1/10), common (> 1/100 to 1/1000 to 1/10000 to
Nervous system: rarely – headache, very rare – loss of consciousness.
organ of hearing: often – dizziness.
Gastrointestinal tract: often – pain in the upper abdomen, diarrhea, nausea, rarely – a feeling of abdominal discomfort, dyspepsia, flatulence, vomiting, very rarely – gastric bleeding.
Allergic reactions: often – a rash of various localization, rarely – eczema, erythema, urticaria.
According to postmarketing observations.
During post-marketing use of sulodexide have been reported more adverse events. The frequency of the undesirable effects of data can not be estimated due to the fact that information about them comes in the form of spontaneous messages. Accordingly, the frequency of these adverse events are classified as “unknown” (may not be calculated on the basis of the available data).
Anemia, metabolic disorders of plasma proteins, disorders of the gastrointestinal tract, melena, angioneurotic edema, ecchymosis, edema genital, genital erythema, polimenorreya.
special instructions
Due to the pharmacological and toxicological properties of sulodexide, use of the drug does not require special precautions. However, when combined with other anticoagulants should periodically monitor the clotting of blood.
Effect on the ability to drive mechanisms and
On the ability to drive vehicles and mechanisms of drug
Vessel® Due F is not affected.
Storage conditions
At a temperature of not higher than 30 ° C.
Keep out of the reach of children!.
Dosing and Administration
1-2 capsules 2 times a day before meal for 30-40 days. Generally, treatment is initiated with 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.
A full course of treatment should not be repeated at least 2 times a year.
Depending on the results of clinical and diagnostic examination of a patient, the physician’s discretion dosing regimen can be changed.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist
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