Enoxaparin sodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Prophylaxis of venous thromboembolism during surgical procedures Low to moderate risk: 20 mg once daily for 7-10 days or until the risk of thromboembolism has diminished w/ the 1st dose approx 2 hr pre-op. High risk: 40 mg once daily w/ the 1st dose approx 12 hr pre-op. Alternatively, 30 mg bid starting w/in 12-24 hr post-op. Continue treatment at 40 mg once daily for a further 3 wk after hip replacement surgery. Immobilised patients: 40 mg once daily for at least 6 days, continue treatment until patient becomes fully ambulant, up to max 14 days. Deep vein thrombosis 1 mg/kg 12 hrly or 1.5 mg/kg once daily for at least 5 days and until oral anticoagulants is established. Prophylaxis of clotting in the extracorporeal circulation during haemodialysis 1 mg/kg into the arterial line of the circuit at the start of dialysis session. Give a further 0.5-1 mg/kg dose if required. Unstable angina 1 mg/kg 12 hrly, continue treatment for 2-8 days. IV/SC Acute ST-elevation myocardial infarction Initial: 30 mg via IV w/ 1 mg/kg via SC given at the same time. Give a further 1 mg/kg via SC 12 hrly for 8 days or until hospital discharge. The first 2 SC doses should not exceed 100 mg each. Patients who undergo PCI: An additional 300 mcg/kg via IV given at the time of the procedure if the last SC dose was given >8 hr ago.
Dosage Details
Parenteral
Acute ST-elevation myocardial infarction
Adult: Initially, 30 mg (3,000 u) via IV w/ 1 mg/kg (100 u/kg) via SC given at the same time. Dose should be followed by 1 mg/kg (100 u/kg) via SC 12 hrly for 8 days or until hospital discharge. The 1st 2 SC doses should not exceed 100 mg (10,000 u) each. Patients who undergo PCI: An additional 300 mcg/kg (30 u/kg) via IV given at the time of the procedure if the last SC dose was given >8 hr ago.
Elderly: ≥75 yr SC: 750 mcg/kg (75 u/kg) 12 hrly, w/ max 75 mg (7500 u) for each of the 1st 2 doses.

Subcutaneous
Unstable angina
Adult: 1 mg/kg (100 u/kg) 12 hrly for 2-8 days.

Subcutaneous
Prophylaxis of venous thromboembolism during surgical procedures
Adult: Low to moderate risk: 20 mg (2,000 u) once daily for 7-10 days or until the risk of thromboembolism has diminished, w/ the 1st dose approx 2 hr pre-op. High risk: 40 mg (4,000 u) once daily w/ 1st dose approx 12 hr pre-op. Alternatively, 30 mg (3,000 u) bid starting w/in 12-24 hr post-op. Continue treatment at 40 mg (4,000 u) once daily for a further 3 wk after hip replacement surgery. Immobilised patients: 40 mg (4,000 u) once daily for at least 6 days, continue treatment until patient becomes fully ambulant, up to max of 14 days.
Child: <2 mth 750 mcg/kg (75 u/kg) 12 hrly; ≥2 mth 500 mcg/kg (50 u/kg) 12 hrly.

Subcutaneous
Deep vein thrombosis
Adult: 1 mg/kg (100 u/kg) 12 hrly or 1.5 mg/kg (150 u/kg) once daily for at least 5 days and until oral anticoagulants is established.
Child: <2 mth 1.5 mg/kg (150 u/kg) 12 hrly; ≥2 mth 1 mg/kg (100 u/kg) 12 hrly.

Subcutaneous
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis
Adult: 1 mg/kg (100 u/kg) into the arterial line of the circuit at the start of the dialysis session. Give a further 0.5-1 mg/kg (50-100 u/kg) dose if required. Reduce dose at high risk of haemorrhage patients.
Renal Impairment
Deep vein thrombosis; Prophylaxis of clotting in the extracorporeal circulation during haemodialysis; Unstable angina; Acute ST-elevation myocardial infarction:
CrCl Dosage
<30 1 mg/kg (100 u/kg) once daily.
30-80 No dosage adjustment needed.
Prophylaxis of venous thromboembolism during surgical procedures:
CrCl Dosage
<30 30 mg (3,000 u) once daily.
30-80 No dosage adjustment needed.
Incompatibility
Should not be mixed w/ other inj or infusions.
Contraindications
Hypersensitivity to enoxaparin, heparin. Patients w/ active major bleeding, acute bacterial endocarditis, recent haemorrhagic stroke, active gastric or duodenal ulceration, thrombocytopenia associated w/ positive in vitro test for platelet antibodies.
Special Precautions
Patients w/ low body wt (women: <45 kg; men: <57 kg), bleeding diathesis, diabetic retinopathy, history of recent GI ulceration, history of heparin-induced thrombocytopenia, uncontrolled arterial HTN, or haemorrhage. Hepatic and renal impairment. Elderly, pregnancy and lactation.
Adverse Reactions
Haemorrhage (including at the inj site), peripheral or unspecified oedema, anaemia, haematuria, ecchymosis, fever, confusion, nausea, diarrhoea, dyspnoea, inj site pain.
Potentially Fatal: Major haemorrhagic complications (e.g. retroperitoneal and intracranial bleeding).
IV/Parenteral/SC: B
MonitoringParameters
Monitor patients for signs and symptoms of neurological impairment during treatment or immediately following diagnostic lumbar puncture, spinal or epidural anaesth. Periodic monitoring of CBC e.g. platelet counts, stool occult blood tests. Monitor vascular access sites for signs of bleeding or haematoma during treatment.
Overdosage
Symptoms: Haemorrhagic complications. Management: Admin of protamine by slow IV inj.
Drug Interactions
Increased risk of bleeding w/ anticoagulants, platelet aggregation inhibitors (e.g. dipyridamole, salicylates, NSAIDs, sulfinpyrazone). May increase bleeding w/ vit E.
Action
Description: Enoxaparin is a low molecular weight heparin w/ anticoagulant properties. It acts by enhancing the inhibition rate of activated clotting factors including thrombin and factor Xa through its action on antithrombin III.
Onset: 3-5 hr.
Duration: Approx 12 hr.
Pharmacokinetics:
Absorption: Rapidly and almost completely absorbed. Bioavailability: Approx 100%. Peak plasma concentrations: 1-5 hr.
Distribution: Volume of distribution: 4.3 L. Plasma protein binding: Does not bind to heparin binding proteins.
Metabolism: Hepatically metabolised.
Excretion: Via urine (40% as unchanged drug; 10% as active metabolites). Elimination half-life: Approx 4-5 hr.
Storage
Store at 25°C.
References
Anon. Enoxaparin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/11/2013.

Buckingham R (ed). Enoxaparin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/11/2013.

Joint Formulary Committee. Enoxaparin Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/11/2013.

Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis. U.S. FDA. https://www.fda.gov/. Accessed 08/11/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Enoxaparin Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 08/11/2013.

Disclaimer: This information is independently developed by MIMS based on Enoxaparin sodium 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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