Lepirudin


Concise Prescribing Info
Indications/Uses
Thromboembolism in heparin-induced thrombocytopenia.
Dosage/Direction for Use
Adult : IV Initial: 400 mcg/kg. Maintenance: 150 mcg/kg/hr by continuous infusion, usually for 2-10 days. Target aPTT ratio: 1.5-2.5. Max infusion rate: 210 mcg/kg/hr.
Dosage Details
Intravenous
Thromboembolism in heparin-induced thrombocytopenia
Adult: Initially, 400 mcg/kg by slow IV inj, followed by a maintenance dose of 150 mcg/kg/hr by continuous IV infusion, adjusted according to response, usually for 2-10 days. Monitor response according to the aPTT ratio to achieve a target of 1.5-2.5. Max infusion rate: 210 mcg/kg/hr.
Renal Impairment
Initially, 200 mcg/kg as slow IV inj, maintenance infusion rate depends on CrCl. For CrCl <15 ml/min, avoid infusion; IV bolus doses of 100 mcg/kg may be used on alternate days in haemodialysis patients or cases of acute renal failure, according to response.
CrClDosage
15-29Infusion rate: 15% of normal rate.
30-44Infusion rate: 30% of normal rate.
45-60Infusion rate: 50% of normal rate.
Reconstitution
For reconstitution, Sterile Water for Inj USP or 0.9% Sodium Chloride Inj USP may be used. 0.9% Sodium Chloride Inj USP or 5% Dextrose Inj may be used for further dilution. After reconstitution, a clear, colourless solution is usually obtained in a few seconds, but in less than 3 minutes. To prepare the bolus inj, reconstituted solution should be diluted to achieve a final concentration of 5 mg/ml. Reconstituted solution should be used immediately; remains stable for up to 24 hr at room temperature (e.g. during infusion). Preparation should be warmed to room temperature before admin.
Incompatibility
Not to be mixed with other drugs except for Sterile Water for Inj USP, 0.9% Sodium Chloride Inj USP or 5% Dextrose Inj.
Contraindications
Hypersensitivity.
Special Precautions
Caution when used in patients with hepatic or renal impairment, patients who are bleeding or at serious risk of bleeding, haemorrhagic blood disorders, recent major bleeding, cerebrovascular disorders, bacterial endocarditis, severe hypertension. Recent major surgery or puncture of large vessels or organ biopsy. Strict monitoring of aPTT is important especially during prolonged therapy. Avoid IM inj as it may cause local haematoma. Pregnancy.
Adverse Reactions
Bleeding from puncture wounds and sites, haematuria, anaemia. Abnormal LFTs, fever, GI/rectal bleeding.
Potentially Fatal: Severe anaphylactic reactions may occur on re-challenge.
Overdosage
Increased risk of bleeding. Treatment is symptomatic.
Drug Interactions
Concurrent therapy with thrombolytics (e.g. streptokinase) may increase the risk of bleeding complications and prolong aPTT. Parenteral penicillins may increase bleeding time by inhibiting platelet aggregation.
Action
Description: Lepirudin is a recombinant hirudin that is a direct thrombin inhibitor. It is used as an anticoagulant in the management of thromboembolic disorders in patients with heparin-induced thrombocytopenia.
Pharmacokinetics:
Distribution: Mainly distributed to extracellular fluids; initial half-life: Approx 10 minutes.
Metabolism: Metabolised renally.
Excretion: Approx 45% of an IV dose is detected in the urine and about 35% is excreted unchanged. Terminal half-life: About 1.3 hr; may be increased in severe renal impairment.
Storage
Store unopened vials at 2-25°C.
Disclaimer: This information is independently developed by MIMS based on Lepirudin 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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