Alfasigma S.p.A


Zuellig Pharma


Full Prescribing Info
Excipients/Inactive ingredients: Capsules: Sodium lauryl sarcosinate, silicon dioxide, triacetin, gelatin, glycerol, sodium ethyl p-oxybenzoate, sodium propyl p-oxybenzoate, titanium dioxide E171 and red iron oxide E172.
Inj: Sodium chloride, water for injections.
Pharmacotherapeutic group: Antithrombotics/heparinoids.
Pharmacology: Sulodexide is a glycosaminoglycan with a strong antithrombotic effect on both arteries and veins.
Several clinical studies carried out by administering the product orally and by injection show that its antithrombotic activity is due to dose-dependent inhibition of some coagulative factors, above all activated X factor; as interference with thrombin remains at an insignificant level, the consequences of anticoagulative action are generally avoided. Antithrombotic action is also sustained by the inhibition of platelet aggregation and the activation of the circulating and parietal fibrinolytic system.
Sulodexide also brings back to normal the viscosimetric parameters that are usually altered in patients with vascular pathologies with thrombotic risk, mainly by reducing fibrinogen levels.
A normalising effect on modified lipidic levels by activation of lipoproteinlipase completes sulodexide's pharmacological profile.
Vascular pathologies with thrombotic risk.
Arterial Disorder: Peripheral arterial obstructive disorder (PAOD).
Venous Disorders: Deep venous thrombosis, venous leg ulcers.
Diabetes Vascular Complications: Diabetes retinopathy, neuropathy and nephropathy.
Dosage/Direction for Use
Capsule: 1-2 cap twice daily to 4 capsules twice daily, not to be taken with meals.
Inj: 1 amp daily, IM or IV.
Generally, it is advisable to start the therapy with ampoules and after 15-20 days, continue with capsules for 30-40 days. For chronic conditions, it is possible to start the treatment directly with capsules. The complete therapeutic cycle should be repeated at least twice per year.
The quantity and frequency of doses may be modified at the physician's discretion.
Individual hypersensitivity towards the product, towards heparin and heparin-like products. Diathesis and haemorrhagic diseases.
Special Precautions
In all cases where anticoagulant treatment is under way, haemocoagulative parameters should be monitored periodically.
Use In Pregnancy & Lactation
Use in Pregnancy: The administration of Vessel is not recommended during pregnancy.
Side Effects
Occasionally Occurring: Capsule: Gastroenteric disorders with nausea, vomiting, diarrhea and epigastralgias.
Inj: Pain, burning sensation and haematoma at the injection site.
Rare cases of sensitization may also occur with cutaneous phenomena or in other sites.
Any different or more serious undesirable effect should be reported immediately to the physician.
Drug Interactions
Sulodexide is a heparin-like molecule and may therefore increase the anticoagulative effects of heparin itself and oral anticoagulants if administered simultaneously.
As sulodexide is an acid polysaccharide, if administered in extemporary association, it may react by forming complexes with the base substances. The incompatible substances commonly used for extemporary association for phleboclysis are: Vitamin K, B-complex vitamins, hydrocortisone, jaluronidase, calcium gluconate, quaternary ammonium salts, chloramphenicol, tetracyclines and streptomycin.
Store below 25°C.
ATC Classification
B01AB11 - sulodexide ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Soft-gelatin cap 250 LSU x 2 x 25's.
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