Recombinant human prourokinase


Concise Prescribing Info
Indications/Uses
Acute MI.
Dosage/Direction for Use
Adult : IV Administer within 6 hours of symptom onset. Max total dose: 100,000 IU/kg. Double bolus regimen: ≤60 kg: 4,000,000 IU as single bolus inj; >60-75 kg: 4,000,000 IU then 1,000,000 IU as 2nd bolus; >75-90 kg: 4,000,000 IU then 2,000,000 IU as 2nd bolus; >90-110 kg: 4,000,000 IU then 3,000,000 IU as 2nd bolus; >110 kg: 4,000,000 IU then 4,000,000 IU as 2nd bolus. Administer 2nd dose, 25 minutes after the 1st bolus. Bolus plus infusion regimen: <60 kg: 2,000,000 IU as bolus, then calculate dose based on 100,000 IU/kg minus 2,000,000 IU to be given via infusion over 60 minutes; 60-85 kg: 2,000,000 IU as bolus then 4,000,000 IU via infusion over 60 minutes; >85 kg: 2,000,000 IU as bolus then 6,000,000 IU via infusion over 60 minutes.
Dosage Details
Intravenous
Acute myocardial infarction
Adult: Administer within 6 hours of symptom onset. Max total dose: 100,000 IU/kg. Double bolus regimen: ≤60 kg: 4,000,000 IU as single bolus inj; >60-75 kg: 4,000,000 IU then 1,000,000 IU as 2nd bolus; >75-90 kg: 4,000,000 IU then 2,000,000 IU as 2nd bolus; >90-110 kg: 4,000,000 IU then 3,000,000 IU as 2nd bolus; >110 kg: 4,000,000 IU then 4,000,000 IU as 2nd bolus. Administer 2nd dose, 25 minutes after the 1st bolus. Bolus plus infusion regimen: <60 kg: 2,000,000 IU as bolus, then calculate dose based on 100,000 IU/kg minus 2,000,000 IU to be given via infusion over 60 minutes; 60-85 kg: 2,000,000 IU as bolus then 4,000,000 IU via infusion over 60 minutes; >85 kg: 2,000,000 IU as bolus then 6,000,000 IU via infusion over 60 minutes.
Hepatic Impairment
Contraindicated.
Reconstitution
Reconstitute vial labelled as containing 2,000,000 IU with 20 mL NaCl 0.9% inj. Do not shake, gently tip the vial over 1-2 times. Further dilute with NaCl 0.9% inj for IV infusion to a final concentration not exceeding 100,000 IU/mL.
Contraindications
Hypersensitivity. Conditions manifested by increased bleeding (e.g. haemorrhagic diathesis, haemophilia, thrombocytopaenia and conditions with high risk of bleeding); active bleeding; extensive trauma up to 4 weeks; cardiogenic shock, puncture of uncompressed vessels, diabetic haemorrhagic retinopathy, previous haemorrhagic stroke, high blood pressure (≥180/110 mm Hg), suspicion of aortic dissection, septic endocarditis. Extensive surgical intervention; resuscitation measures that required intensive indirect cardiac massage. Hepatic impairment. Pregnancy and lactation.
Special Precautions
Renal impairment.
Adverse Reactions
Significant: Bleeding, arrhythmia.
MonitoringParameters
Monitor for signs and symptoms of bleeding. Assess coagulation parameters (e.g. clotting time, prothrombin time, APTT) prior to initiation of treatment then periodically thereafter.
Overdosage
Symptoms: Haemorrhagic complications. Management: May administer fresh frozen plasma, whole blood, or antifibrinolytic agent for severe bleeding.
Drug Interactions
May increase risk of bleeding with antiplatelet agents, indirect anticoagulants, and high dose of heparin (>4,000 IU).
Action
Description: Human pro-urokinase, is a single chain structure urokinase-type plasminogen activator, prepared via recombinant DNA technology. It catalyses the transformation of plasminogen to plasmin protease that is capable of lysing fibrin clots.
Synonym: Saruplase.
Pharmacokinetics:
Excretion: Via urine. Half-life: 0.67-2.6 hours.
Storage
Store between 2-8°C. Protect from light.
Disclaimer: This information is independently developed by MIMS based on Recombinant human prourokinase 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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