Alteplase


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Acute MI Accelerated regimen: 15 mg as bolus, then 50 mg (0.75 mg/kg in patients <65 kg) via infusion over 30 min, followed by 35 mg (0.5 mg/kg in patients <65 kg) via infusion over 1 hr. 3-hr regimen: 10 mg as bolus, then 50 mg via infusion over 1 hr, followed by 10 mg via infusion over 2 hr until max dose. Max total: 100mg. Acute massive pulmonary embolism Initial: 10 mg as bolus over 1-2 min, followed by 90 mg via infusion over 2 hr. Max total: 100mg. Acute ischaemic stroke 0.9 mg/kg via infusion over 60 min, given w/in 3-4.5 hr after onset of symptoms, w/ 10% of the dose given as bolus over the 1st min. Max total: 90 mg. Inj Clearance of central venous lines As 1 mg/mL soln: ≥30 kg: Instill 2 mg into the catheter, repeat after 2 hr if needed. <30 kg: 110% of the internal lumen volume of the catheter, repeat after 2 hr if needed.
Dosage Details
Injection
Clearance of central venous lines
Adult: As 1 mg/mL soln: ≥30 kg: As 1 mg/mL soln: 2 mg instilled into the catheter, may repeat after 2 hr if needed. Max total dose: 4 mg. <30 kg: 110% of the internal lumen volume of the catheter, may repeat after 2 hr if needed. Max total dose: 2 mg.

Intravenous
Acute myocardial infarction
Adult: Accelerated regimen (admin w/in 6 hr of symptom onset): ≥65 kg: 15 mg as bolus, then 50 mg via infusion over 30 min, followed by 35 mg via infusion over 1 hr; <65 kg: 15 mg as bolus, then 0.75 mg/kg (max 50 mg) via infusion over 30 min, followed by 0.5 mg/kg (max 35 mg) via infusion over 1 hr. Max total dose: 100 mg. 3-hr regimen (admin between 6-12 hr after symptom onset): 10 mg as bolus, then 50 mg via infusion over 1 hr, followed by 10 mg via infusion over 30 min until max dose over 3 hr. Max total dose: 100 mg (1.5 mg/kg in patients <65 kg).

Intravenous
Acute massive pulmonary embolism
Adult: Initially, 10 mg as bolus over 1-2 min, followed by 90 mg via infusion over 2 hr. Max total dose: 100 mg (1.5 mg/kg in patients <65 kg).

Intravenous
Acute ischaemic stroke
Adult: 0.9 mg/kg via infusion over 60 min, given w/in 3-4.5 hr after onset of symptoms, w/ 10% of the dose given initially as bolus over the 1st min. Max total dose: 90 mg.
Hepatic Impairment
Intravenous:
Severe: Contraindicated.
Reconstitution
IV infusion: Add 50 mL of sterile water for inj to a vial containing 50 mg to obtain a final concentration of 1 mg/mL. It may be further diluted w/ sterile NaCl 0.9% soln for inj to a concentration of approx 0.5 mg/mL. Swirl gently and/or invert slowly until complete dissolution. Inj into occluded catheter: Add 2.2 mL of sterile water for inj to a vial containing 2 mg to provide a concentration of 1 mg/mL.
Incompatibility
Incompatible w/ bacteriostatic water, Lactated Ringer’s, and glucose 5%. Y-site admin: Incompatible w/ bivalirudin, dobutamine, dopamine, heparin, morphine.
Contraindications
Bleeding disorder (at present or w/in 6 mth), severe stroke, haemorrhagic diathesis, intracranial and subarachnoid haemorrhage, aneurysm, history of CNS damage (i.e. neoplasm, spinal injury), severe uncontrolled HTN, bacterial endocarditis, pericarditis, acute pancreatitis, ulcerative GI disease, oesophageal varices, major surgery or significant trauma in the past 3 mth. Use of rigid catheters. Severe hepatic impairment, including hepatic failure, cirrhosis, portal HTN and active hepatitis.
Special Precautions
Patient w/ mild stroke, thrombocytopenia, haemostatic defect. Patient who recently had surgery, obstetrical delivery, percutaneous biopsy of deep tissues, puncture of non-compressible blood vessels, cardiac massage. Venous thrombosis in the region of catheter, presence of infection in the catheter. Pregnancy and lactation.
Adverse Reactions
Superficial haematoma or ecchymoses, gingival bleeding, melaena, haematuria, haemoptysis, epistaxis. Rarely, eye and pericardial haemorrhage, rash, urticaria, bronchospasm, angioedema, pyrexia.
Potentially Fatal: Severe spontaneous bleeding (intracranial, retroperitoneal, GI, resp tract, genitourinary), recurrent ischaemia/angina pectoris, heart failure, pulmonary oedema, cardiogenic shock, cardiac arrest and reinfarction, reperfusion arrhythmia, sepsis, cholesterol embolisation.
IV/Parenteral: C
MonitoringParameters
Assess vital signs and ECG prior to, during, and after therapy. Perform neurologic assessments every 15 min during infusion and every 30 min thereafter for the next 6 hr, then hrly until 24 hr of treatment. Monitor BP and heart rate continually for at least 24 hr. Assess catheter function (by attempting to aspirate blood), and bleeding potential through clinical evidence and monitoring of prothrombin time (PT) and aPTT.
Overdosage
Symptoms: Reduction in blood coagulation components (e.g. fibrinogen), severe bleeding. Management: Treat severe bleeding w/ infusion of fresh frozen plasma. Synthetic antifibrinolytics may be beneficial.
Drug Interactions
Increased risk of haemorrhage w/ coumarin derivatives, oral anticoagulants, platelet aggregation inhibitors, and unfractioned heparin/LMWH. Increased risk of anaphylactoid reaction w/ ACE inhibitors. Concomitant use w/ IV glyceryl trinitrate may result in impaired thrombolysis.
Action
Description: Alteplase, a recombinant human tissue plasminogen activator (t-PA), activates fibrin-bound plasminogen into plasmin, initiating fibrinolysis and dissolution of thrombus (fibrin clots).
Duration: Up to 1 hr.
Pharmacokinetics:
Metabolism: Metabolised mainly in the liver.
Excretion: Elimination half-life: 4-5 min (initial); approx 40 min (terminal).
Storage
Store below 30°C or between 2-8°C. Protect from light.
ATC Classification
B01AD02 - alteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Disclaimer: This information is independently developed by MIMS based on Alteplase 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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