Reteplase


Concise Prescribing Info
Indications/Uses
Acute MI.
Dosage/Direction for Use
Adult : IV 10 units via slow inj over 2 minutes, immediately after onset of symptoms, followed by second dose, 30 minutes later.
Dosage Details
Intravenous
Acute myocardial infarction
Adult: 10 units via slow inj over 2 minutes, immediately after onset of symptoms, followed by second dose, 30 minutes later.
Renal Impairment
Severe: Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
Reconstitution
Reconstitute vial labelled as containing 10 U with 10 mL of sterile water for inj.
Incompatibility
Incompatible with heparin.
Contraindications
Active intracranial bleeding, history of cerebrovascular accident, recent or within 2 months of intracranial/intraspinal surgery or trauma, arteriovenous malformations or aneurysm, known bleeding diathesis, severe uncontrolled hypertension, within 3 months of ischemic stroke or significant closed head or facial trauma, active bleeding, suspected aortic dissection, active peptic ulceration, acute pancreatitis, pericarditis, bacterial endocarditis. Severe renal and hepatic impairment. Concomitant use with anticoagulants.
Special Precautions
Patient with conditions that increase bleeding risk, MI. Renal and hepatic impairment. Elderly, children. Pregnancy and lactation.
Adverse Reactions
Significant: Arrhythmias, bleeding. Rarely, anaphylaxis.
Cardiac disorders: Recurrent ischaemia/angina, hypotension, heart failure, pulmonary oedema.
Gastrointestinal disorders: Gastrointestinal bleeding.
General disorders and administration site conditions: Inj site bleeding/haematoma, inj site reactions (e.g. burning sensation).
IV/Parenteral: C
MonitoringParameters
Monitor for signs of bleeding (e.g. haematuria, gastrointestinal, or gingival bleeding); CBC, prothrombin time, ECG.
Drug Interactions
Potentially Fatal: Increased risk of haemorrhage with anticoagulants (e.g. warfarin).
Lab Interference
May alter coagulation and fibrinolytic activity test results.
Action
Description: Reteplase is a nonglycosylated plasminogen activator (tPA) and proteolytic enzyme produced using E. coli recombinant DNA. It that converts plasminogen to plasmin, which in turn degrades the fibrin, thereby exerting its thrombolytic action.
Onset: Thrombolysis: 30-90 minutes.
Pharmacokinetics:
Excretion: Via faeces and urine. Elimination half-life: 13-16 minutes. Initial half-life: 14 minutes. Terminal half-life: Approx 1.6 hours (patients with MI).
Storage
Store between 2-25°C. Protect from light.
ATC Classification
B01AD07 - reteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
References
Anon. Reteplase. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com.

Buckingham R (ed). Reteplase. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com.

Retavase (Chiesi USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/.

Disclaimer: This information is independently developed by MIMS based on Reteplase 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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