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PRESCRIBING INFORMATION
COMPOSITON
Ampoule: Each ampoule contains Sulodexide 600 LSU.
Capsule: Each capsule contains Sulodexide 250 LSU.
MECHANISM OF ACTION
| Therapeutic Effect | The Mechanism of Action | Properties |
| Antithrombotic |
|
Antithrombotic |
| Fibrinolytic |
|
Antithrombotic |
| Hemorrheologic |
|
Anti-atheriosclerosis |
| Antiproliferative |
|
Anti-atheriosclerosis |
| Membrane Permselectivity Maintenance |
|
Antiproteinuria |
DOSAGE
For ampoule: 1 ampoule once daily (IM/IV)
For capsule: Starting dose: 2 capsules twice daily for first 4 months. Maintenance dose: 1 capsule twice daily. The dose can be adjusted according to patient’s individual response.
CONTRAINDICATION Individual hypersensitivity towards the product, heparin, or heparin-like drugs. Diathesis and hemorrhagic diseases.
SPECIAL PRECAUTIONS Given to the low toxicity of the substance, there are no particular precautions for use. However, when treatment with anticoagulants is underway, hemocoagulative parameters should be monitored periodically.
ADVERSE REACTION
Capsules: Disturbances of the gastro enteric system with nausea, vomiting and epigastralgia.
Ampoules: Pain, burning sensation and hematomas at the site of the injection. Also, in rare case, sensitisation may occur with cutaneous reactions or reactions on other sites.
USE IN PREGNANCY As a precaution, the use of the substance is not advisable during pregnancy even though studies on fetal toxicity have not revealed any embryo-fetotoxic effects.
SYMPTOMS AND TREATMENT OF OVERDOSAGE Haemorrhage is the only effect which may occur with an overdosage. In the case of a haemorrhage, it is necessary to inject 1% protamine sulphate (3ml IV = 30mg) as it used in heparin haemorrhages.
STORAGE CONDITION Store below 30°C.
EXPIRY PERIOD 5 years from the date of manufacture.
PACKING
Ampoule: 10 ampoules in a box.
Capsule: 25 capsules in blister. 2 blisters per box. 60 capsules per box.
