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See related Actilyse inj information |
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Manufacturer |
Boehringer Ingelheim |
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Distributor |
Zuellig |
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Contents |
Alteplase |
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Indications |
Thrombolytic treatment in acute MI & acute massive pulmonary embolism w/ haemodynamic instability. Thrombolytic treatment of acute ischaemic stroke.
Click to view Actilyse detailed prescribing infomation |
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Dosage |
MI: 90-min dose regimen (where treatment can be started w/in 6 hr after symptom onset): IV bolus 15 mg, then infuse 50 mg over the 1st 30 min, followed by an infusion of 35 mg over 60 min until the max dose of 100 mg. Patient w/ body wt <65 kg IV bolus 15 mg, then infuse 0.75 mg/kg over 30 min (max: 50 mg), followed by an infusion of 0.5 mg/kg over 60 min (max: 35 mg). 3-hr dose regimen (where treatment can be started between 6 & 12 hr after symptom onset): IV bolus 10 mg, then infuse 50 mg over the 1st hr, followed by infusion of 10 mg over 30 min until the max dose of 100 mg over 3 hr. Patient w/ body wt <65 kg Total dose ≤1.5 mg/kg. Max accepted dose: 100 mg. Adjunctive therapy is recommended for patients w/ ST-elevation MI. Pulmonary embolism A total dose of 100 mg should be administered in 2 hr. The most experience available is w/ the following regimen: IV bolus 10 mg over 1-2 min then infuse 90 mg over 2 hr. Patient w/ body wt <65 kg Total dose ≤1.5 mg/kg. Adjust infusion to maintain aPTT between 50-70 sec. Ischemic stroke Treatment should only be initiated w/in 4.5 hr of onset of stroke symptoms & after exclusion of intracranial haemorrhage by appropriate imaging techniques. Recommended dose: 0.9 mg/kg (max: 90 mg) infused over 60 min w/ 10% of the total dose administered as an initial IV bolus.
Click to view Actilyse detailed prescribing infomation |
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Overdosage |
View Actilyse overdosage for action to be taken in the event of an overdose. |
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Contraindications |
Significant bleeding disorder, known haemorrhagic diathesis; patients receiving oral anticoagulants; any history of CNS damage; history or evidence or suspicion of intracranial haemorrhage; severe uncontrolled arterial HTN; major surgery or significant trauma in past 10 days, recent trauma to head or cranium; prolonged or traumatic cardiopulmonary resuscitation (>2 min), obstetrical delivery, recent puncture of a noncompressible blood vessel; severe hepatic dysfunction, including hepatic failure, cirrhosis, portal HTN & active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; documented ulcerative GI disease during the last 3 mth; arterial aneurysms, arterial/venous malformations; neoplasm w/ increased bleeding risk. In the treatment of acute MI & pulmonary embolism: Haemorrhagic stroke or stroke of unknown origin at any time, ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 mth, except current acute ischaemic stroke w/in 4.5 hr. Hypersensitivity to alteplase.
Click to view Actilyse detailed prescribing infomation |
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Special Precautions |
Bleeding. Recent IM inj or small recent traumas eg biopsies, puncture of major vessels, cardiac massage for resuscitation. Conditions w/ increased haemorrhagic risk, systolic BP >160 mmHg. Elderly, childn. Pregnancy & lactation. In treatment of acute MI: Coronary thrombolysis may result in arrhythmia associated w/ reperfusion, thromboembolic risk may be increased in patients w/ left heart thrombus eg mitral stenosis or atrial fibrillation. Concomitant use of GPIIb/IIIa antagonists increases risk of bleeding.
Click to view Actilyse detailed prescribing infomation |
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Adverse Drug Reactions |
Bleeding, intracranial hemorrhagic neurological symptoms eg somnolence, aphasia, hemiparesis, convulsion. Cholesterol crystal embolisation, reperfusion arrhythmias, nausea, vomiting, drop in BP, increased temp, epistaxis, ecchymosis.
View ADR Monitoring Form |
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Side Effects |
View Actilyse side effects |
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Drug Interactions |
Agents affecting coagulation or altering platelet function. Concomitant use w/ ACE inhibitors may enhance anaphylactoid reactions.
View more drug interactions with Actilyse |
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Pregnancy Category (US FDA) |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
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Storage |
View Actilyse storage conditions for details to ensure optimal shelf-life. |
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Description |
View Actilyse description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View Actilyse mechanism of action for pharmacodynamics and pharmacokinetics details. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Actilyse injection |
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Actilyse 50 mg x 1's |
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Actilyse 50 mg x 2's |
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Manufacturer: |
Boehringer Ingelheim |
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Distributor: |
Zuellig |
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