Sulodexide: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular, Intravenous
Cerebrovascular disease, Deep vein thrombosis, Diabetic nephropathy, Diabetic neuropathy, Diabetic retinopathy, Myocardial infarction, Peripheral arterial occlusive disease, Transient ischaemic attack, 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.

Oral
Cerebrovascular disease, Deep vein thrombosis, Diabetic nephropathy, Diabetic neuropathy, Diabetic retinopathy, Myocardial infarction, Peripheral arterial occlusive disease, Transient ischaemic attack, 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.

Administration

Should be taken on an empty stomach.

Contraindications

Hypersensitivity to heparin and heparinoids. Haemorrhagic disease or diathesis. Pregnancy.

Adverse Reactions

Gastrointestinal disorders: Diarrhoea, nausea, vomiting, epigastralgia.
General disorders and administration site conditions: Burning sensation, pain and haematoma at inj site.

Monitoring Parameters

Monitor haemocoagulative parameters periodically.

Drug Interactions

May increase the anticoagulation effects of heparin and oral anticoagulants.

Action

Description:
Mechanism of 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.
Pharmacokinetics:
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).

Chemical Structure

Storage

Store below 25°C.

MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

ATC Classification

B01AB11 - sulodexide ; Belongs to the class of heparin group. Used in the treatment of thrombosis.

References

Angioflux 250 LSU Softgel Capsule (Aesculapius Farmaceutici S.r.l.). MIMS Philippines. http://www.mims.com/philippines. Accessed 29/06/2022.

Anon. Sulodexide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/06/2022.

Buckingham R (ed). Sulodexide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/06/2022.

Vessel (Alfasigma S.p.A). MIMS Thailand. http://www.mims.com/thailand. Accessed 29/06/2022.

Vessel Due F (AlfaSigma). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 29/06/2022.

Vessel Due F 250 LSU Capsule (EP Plus Group Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 29/06/2022.

Vessel Due-F (AlfaSigma). MIMS Philippines. http://www.mims.com/philippines. Accessed 29/06/2022.

Disclaimer: This information is independently developed by MIMS based on Sulodexide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com