Dosage/Direction for Use
Oral Diabetic neuropathy Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Deep vein thrombosis Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Myocardial infarction Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Cerebrovascular disorders Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Diabetic nephropathy Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Peripheral arterial occlusive disease Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Diabetic retinopathy Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Transient ischaemic attack Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Oral Venous leg ulcer Adult: 1-2 capsules (250-500 lipasemic units [LSU]; 10 LSU is equivalent to 1 mg) bid for 30-40 days. Generally, therapy starts with the inj for 15-20 days and then continued with the oral form. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Venous leg ulcer Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Transient ischaemic attack Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Diabetic retinopathy Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Peripheral arterial occlusive disease Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Diabetic nephropathy Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Cerebrovascular disorders Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Myocardial infarction Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Deep vein thrombosis Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. Parenteral Diabetic neuropathy Adult: 1 amp (600 LSU) via IM or IV inj daily for 15-20 days. Continue with the oral form for 30-40 days. Repeat the treatment cycle at least twice yearly. Dosage quantity and frequency may vary according to the physician's evaluation. |
Administration
Should be taken on an empty stomach (i.e. At least one hour before food or two hours after food).
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Contraindications
Hypersensitivity to heparin and heparinoids. Haemorrhagic disease or diathesis. Pregnancy.
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Special Precautions
Monitoring Parameters Monitor haemocoagulative parameters periodically.
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Adverse Reactions
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, epigastralgia.
General disorders and administration site conditions: Burning sensation, pain, and haematoma at inj site.
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Drug Interactions
May increase the anticoagulation effects of heparin and oral anticoagulants.
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Action
Sulodexide is a sulfated polysaccharide complex consisting of 80% low molecular weight heparin and 20% dermatan sulfate. It exerts its antithrombotic activity through dose-dependent inhibition of activated coagulation factor X, as well as inhibition of platelet aggregation and activation of the circulating and parietal fibrinolytic system. Sulodexide also normalises the viscosimetric parameters that are usually altered in patients with vascular pathologies with thrombotic risk, mainly by reducing fibrinogen levels.
Absorption: Rapidly absorbed. Bioavailability: 20-60%. Time to peak plasma concentration: 4 hours (oral). Distribution: Widely distributed, particularly in the monocellular endothelial layer. Metabolism: Metabolised in the liver. Excretion: Mainly via urine (55.3 ± 2.9%); bile (23.5 ± 2.3%) and faeces (23.5 ± 2.8%). Elimination half-life: 18.7 ± 4. 1 hours (50 mg dose); 25.8 ± 1.9 hours (100 mg dose). |
Storage
Oral: Store below 25°C. Parenteral: Store below 25°C.
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ATC Classification
B01AB11 - sulodexide ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
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