Sulodexide
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Clinical Pharmacology
Anticoagulant direct action. The active substance of the drug Wessel Due F - sulodexide - is a natural product, extracted and isolated from the mucous membrane of the small intestine of the pig. It is a natural mixture of glycosaminoglycans: a heparin-like fraction with a molecular weight of 8,000 daltons (80%) and dermatan sulfate (20%).
It has an anticoagulant, antithrombotic, angioprotective and profibrinolytic action.
The anticoagulant action is manifested due to the affinity for heparin cofactor II, which inactivates thrombin.
The mechanism of antithrombotic action is associated with the suppression of activated X factor, increased synthesis and secretion of prostacyclin (PG I2), with a decrease in plasma fibrinogen levels.
The profibrinolytic effect is due to an increase in the level of tissue plasminogen activator in the blood and a decrease in the content of its inhibitor.
The mechanism of angioprotective action is associated with the restoration of the structural and functional integrity of the vascular endothelium cells, the restoration of the normal density of the negative electric charge of the pores of the basal membrane of the vessels.
In addition, the drug normalizes the rheological properties of blood by lowering the level of triglycerides (because it stimulates the lipolytic enzyme - lipoprotein lipase, which hydrolyzes triglycerides that make up LDL).
The efficacy 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.
Suggested use
At the beginning of therapy, the drug is injected parenterally IM or / in (bolus or drip) 2 ml (1 ampoule) of solution for injection (600 LU) for 15-20 days. To prepare the solution for the on / in the introduction of the contents of 1 vial diluted in 150-200 ml of saline.
Then move on to the drug inside. Take 1 capsule (250 LU) 2 times / day for 30-40 days.
Capsules take between meals.
The full course of treatment should be repeated at least 2 times a year.
Depending on the results of the patient’s clinical diagnostic examination, the dosing regimen may be changed.
Indications
- angiopathies with an increased risk of thrombosis, including and after myocardial infarction;
- violation of cerebral circulation, including an acute period of ischemic stroke and a period of early recovery;
- dyscirculatory encephalopathy due to atherosclerosis, diabetes mellitus, arterial hypertension;
- vascular dementia;
- occlusive lesions of peripheral arteries of both atherosclerotic and diabetic genesis;
- phlebopathy, deep vein thrombosis;
- microangiopathies (nephropathy, retinopathy, neuropathy);
- macroangiopathy in diabetes mellitus (diabetic foot syndrome, encephalopathy, cardiopathy);
- thrombophilic conditions, antiphospholipid syndrome (prescribed in conjunction with acetylsalicylic acid, as well as following low molecular weight heparins);
- treatment of heparin-induced thrombotic thrombocytopenia (since the drug does not cause or aggravate it).
Composition
1 capsule contains sulodexide 250 LE (lipoproteinase unit)
Sulodexide is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Vessel Due F | capsules | ||
Angioflux | Mitim | Italy | capsules |
Angioflux | Mitim | Italy | ampoules |
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Dosage and Administration
The full course of treatment should be repeated at least 2 times a year.
Depending on the results of the clinical and diagnostic examination of the patient, at the discretion of the doctor, the dosage regimen can be changed.
Adverse reactions
According to clinical studiesData on the incidence of adverse drug reactions associated with the use of sulodexide were obtained in clinical studies involving patients treated with standard doses of the drug with the usual duration of therapy.
Adverse reactions associated with the use of sulodexide were classified according to the systemic 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, very rarely - loss of consciousness.
Hearing organ: often - dizziness.
Gastrointestinal tract: often - pain in the upper abdomen, diarrhea, nausea, infrequently - abdominal discomfort, dyspepsia, flatulence, vomiting, very rarely - stomach bleeding.
Allergic reactions: often - skin rash of various localization, infrequently - eczema, erythema, urticaria.
According to post-registration observations.
During the post-registration use of sulodexide, additional adverse events have been reported. The frequency of these undesirable effects cannot be estimated due to the fact that information about them comes in the form of spontaneous messages. Accordingly, the frequency of these adverse events is classified as “unknown” (cannot be calculated from the available data).
Contraindications
Anemia, metabolic disorders of plasma proteins, gastrointestinal tract disorders, melena, angioedema, ecchymosis, genital edema, genital erythema, polymenorrhea.
Special instructions
- Brand name: Vessel Due F
- Active ingredient: Sulodexide
- Manufacturer: Grünentalh GmbH
Studies and clinical trials of Sulodexide (Click to expand)
- Review of pharmacodynamics, pharmacokinetics, and therapeutic properites of sulodexide
- [14C] acetylation of a glycosaminoglycan sulphate: Sulodexide
- Oral erosive/ulcerative lichen planus: preliminary findings in an open trial of sulodexide compared with cyclosporine (ciclosporin) therapy
- Recurrent aphthous stomatitis unresponsive to topical corticosteroids: a study of the comparative therapeutic effects of systemic prednisone and systemic sulodexide
- Antithrombotic and thrombolytic activity of sulodexide in rats
- Effect of sulodexide on endothelial glycocalyx and vascular permeability in patients with type 2 diabetes mellitus
- Protective effect of sulodexide on podocyte injury in adriamycin nephropathy rats
- Oral lichen planus: clinical and histological evaluation in an open trial using a low molecular weight heparinoid (sulodexide)
- Rationale for and study design of the sulodexide trials in Type 2 diabetic, hypertensive patients with microalbuminuria or overt nephropathy
- Sulodexide: A Renewed Interest in This Glycosaminoglycan
- Sulodexide induces hepatocyte growth factor release in humans
- Sulodexide prevents peripheral nerve damage in streptozotocin induced diabetic rats
- The effect of insulin and sulodexide (Vessel Due F) on diabetic foot syndrome: pilot study in elderly patients
- Sulodexide for Kidney Protection in Type 2 Diabetes Patients With Microalbuminuria: A Randomized Controlled Trial
- Sulodexide for Diabetic Nephropathy: Another One Bites the Dust
- Erratum regarding “Sulodexide for Kidney Protection in Type 2 Diabetes Patients With Microalbuminuria: A Randomized Controlled Trial” (Am J Kidney Dis 2011; 58:729-736)
- Game Not Over for Sulodexide
- Discounting the Efficacy of Sulodexide in Diabetic Nephropathy Is Premature
- In Reply to ‘Discounting the Efficacy of Sulodexide in Diabetic Nephropathy Is Premature’ and ‘Surrogate Versus Clinical End Points and Venture Capital Companies: The Doubts of a Clinician'
- Efficacy of sulodexide as adjunct in trabeculectomy.: A two-year randomized clinical study
- Additive thrombin inhibition by fast moving heparin and dermatan sulfate explains the anticoagulant effect of sulodexide, a natural mixture of glycosaminoglycans
- VASCULAR DEMENTIA ITALIAN SULODEXIDE STUDY (VA.D.I.S.S.) CLINICAL AND BIOLOGICAL RESULTS
- Glycosaminoglycan sulodexide decreases albuminuria in diabetic patients
- SULODEXIDE TREATMENT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INTERMITTENT CLAUDICATION