PROVENAL® Sulodexide

PROVENAL ® is a drug based on Sulodexide (Glucuronilglucosaminglicano sulfato).

THERAPEUTIC GROUP: Antithrombotics

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications PROVENAL ® Sulodexide

PROVENAL ® is indicated for the treatment of chronic venous ulcers and vascular diseases with thrombotic risk.

Mechanism of action PROVENAL ® Sulodexide

Sulodexide, taken through PROVENAL ® represents a complex mixture of heparin and dermatan sulfate (which has pharmacokinetic properties very similar to heparin). Introduced by mouth, it is absorbed in the intestine, subsequently metabolized by the liver and finally excreted through the urine.

Its antithrombotic properties are to be found in the metabolic effect on the lipid component of the plasma. It has been shown, in fact, how this glucoronylglucosaminoglycan can on the one hand promote the expression and activation of lipoprotein lipase, maximizing lipid metabolism, and on the other hand preventing, through a steric hindrance, the intake of lipoproteins by the vascular walls, consequently reducing the risk of thrombosis also thanks to the strong fibrinolytic action.

All these effects take the form of a decrease in blood viscosity, a reduced tendency to platelet aggregation and a metabolic improvement in the hepatic, cardiac and especially vascular situation; moreover, the fibrinolytic action prevents the formation of the thrombus in the vascular wall.

These different mechanisms suggest the antithrombotic and anti-atherosclerotic effect of PROVENAL ®

Studies carried out and clinical efficacy

SULODEXIDE AND OXIDATIVE STRESS

Oxidative stress is a pathological condition that always accompanies atherogenesis, amplifying and accelerating its course. In this study it was shown that sulodexide can, among other actions, significantly reduce some markers of oxidative stress in patients with stable coronary artery disease.

SULODEXIDE IN THE TREATMENT OF VENOUS ULCERS

Venous ulcers are one of the most troublesome clinical manifestations of peripheral vasculopathy. In addition to bandaging and surgery, drug therapy appears to have a positive impact on the prevention of this condition and on its course. In detail, sulodexide proved to be capable of reducing the ulcerated skin surface, normalizing the normal vascular coagulation capacities.

3.SULODEXIDE AND EDEMA IN DIABETIC PATHOLOGY

Diabetic pathology is often accompanied by edematous conditions, determined by an increase in vascular permeability, partly sustained also by damage to the glycocalyx. In this study, the administration of 200mg / day of sulodexide guaranteed a normalization of the glycocalyx size, also correcting the permeabilization capacities of the vessels. This study traces the pathway for the characterization of the potential vaso-protective action of sulodexide, fundamental for example in the treatment of chronic venous ulcers.

Method of use and dosage

PROVENAL ® 250 ULS glucuronylglucosaminoglycan capsules: the standard dosage is to take two capsules a day before meals.

IN ANY CASE, BEFORE TAKING PROVENAL ® Sulodexide - THE REQUIREMENT AND CHECK OF YOUR DOCTOR IS NECESSARY.

Warnings PROVENAL ® Sulodexide

The anticoagulant therapies, in general, are characterized by an important interindividual variability and by a different susceptibility to the drug; therefore, before the treatment and throughout the therapeutic course, it is advisable to monitor the coagulation parameters, and eventually to correct the dosage or to stop the therapy.

PREGNANCY AND BREASTFEEDING

Despite the absence of teratogenic or toxic effects on the health of the fetus, hemodynamic changes, including the reduction of blood viscosity, induced by PROVENAL ® could increase the risk of fetal bleeding, even with a lethal outcome.

In this regard we do not recommend taking PROVENAL ® during the period of pregnancy and breastfeeding.

Interactions

The structural analogy with heparin could determine a substantial increase in the anticoagulant effects of heparin itself, if the two drugs were administered simultaneously.

On the other hand, particularly significant and clinically relevant interactions with other active ingredients are not described.

Contraindications PROVENAL ® Sulodexide

PROVENAL ® is contraindicated in case of individual hypersensitivity to one of its components or in case of hypersensitivity to heparin.

Undesirable effects - Side effects

PROVENAL ® appears to be well tolerated, as described by scientific experimentation.

The most frequently described adverse reactions are generally due to hypersensitivity phenomena to the active ingredient, with the development of skin rashes and allergic manifestations that tend to disappear rapidly following discontinuation of therapy.

Hemorrhagic events, decidedly less frequent than other oral anticoagulants, could occur in the case of a much higher dosage than the therapeutic one.