Sulodexide

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Available since: 2019-09-19

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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

1-2 capsules 2 times a day before meals for 30-40 days. Usually, 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 and diagnostic examination of the patient, at the discretion of the doctor, the dosage regimen can be changed.

Adverse reactions

According to clinical studies
Data 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

Caution should be exercised when administering the drug to patients with low blood pressure due to the possibility of developing the hypotensive effect of novocaine, which is released in the body from sulfocamphocaine.