Boehringer Ingelheim


Zuellig Pharma
Concise Prescribing Info
Thrombolytic treatment in acute MI, acute massive pulmonary embolism w/ haemodynamic instability, & of acute ischaemic stroke.
Dosage/Direction for Use
Acute MI 90-min dose regimen (start w/in 6 hr after symptom onset): Patient weighing ≥65 kg 15 mg IV bolus immediately followed by 50 mg IV infusion over the 1st 30 min, followed by 35 mg IV infusion over 60 min until max dose of 100 mg, <65 kg 15 mg IV bolus immediately followed by 0.75 mg/kg IV infusion over 1st 30 min (max: 50 mg), followed by 0.5 mg/kg IV infusion over 60 min (max: 35 mg). 3-hr dose regimen (start between 6-12 hr after symptom onset): Patient weighing ≥65 kg 10 mg IV bolus immediately followed by 50 mg IV infusion over the 1st hr, followed by 40 mg IV infusion for the next 2 hr until max dose of 100 mg, <65 kg 10 mg IV bolus immediately followed by IV infusion up to max dose of 1.5 mg/kg. Acute massive pulmonary embolism Patient weighing ≥65 kg Total dose: 100 mg administered in 2 hr. Dose regimen: 10 mg as IV bolus over 1-2 min followed by 90 mg as IV infusion over 2 hr until total dose of 100 mg, <65 kg 10 mg as IV bolus over 1-2 min immediately followed by an IV infusion up to max total dose of 1.5 mg/kg. Acute ischaemic stroke Recommended total dose: 0.9 mg/kg (max: 90 mg) w/ 10% of total dose as an initial IV bolus, immediately followed by remainder of the total dose infused IV over 60 min. Initiate treatment as early as possible w/in 4.5 hr of symptom onset.
Hypersensitivity to alteplase or gentamicin. Significant bleeding disorder at present or w/in the past 6 mth, known haemorrhagic diathesis; patients receiving oral anticoagulants (eg, warfarin Na w/ INR >1.3); history of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery); history, evidence or suspicion of intracranial haemorrhage including subarachnoid haemorrhage; severe uncontrolled arterial HTN; major surgery or significant trauma in past 10 days, recent head or cranium trauma; prolonged or traumatic cardiopulmonary resuscitation (>2 min), obstetrical delivery w/in the past 10 days, recent puncture of a non-compressible blood vessel (eg, subclavian or jugular vein puncture); severe hepatic dysfunction, eg, hepatic failure, cirrhosis, portal HTN (oesophageal varices) & 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. Acute MI &/or acute massive pulmonary embolism: Haemorrhagic stroke or stroke of unknown origin; ischaemic stroke or transient ischemic attack (TIA) in the preceding 6 mth except current acute ischaemic stroke w/in 4.5 hr. Acute ischaemic stroke: Symptoms of ischaemic attack beginning >4.5 hr prior to infusion start or when time of symptom onset is unknown; rapidly improving or minor symptoms of acute ischaemic stroke before start of infusion; severe stroke (eg, NIHSS >25); seizure at onset of stroke; history of previous stroke or serious head-trauma w/in 3 mth; combination of previous stroke & DM; administration of heparin w/in 48 hr preceding the onset of stroke w/ elevated activated partial thromboplastin time (aPTT); platelet count <100,000/mm3; systolic BP >185 mmHg, or diastolic BP >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits; blood glucose <50 or >400 mg/dL; childn <16 yr.
Special Precautions
Risk of hypersensitivity especially in acute ischaemic stroke &/or by concomitant use w/ ACE inhibitors. Monitor for angio-oedema during & for up to 24 hr after infusion. Discontinue treatment & initiate appropriate treatment in case of severe hypersensitivity reaction (eg, angioedema). Bleeding; concomitant use w/ heparin anticoagulation. Avoid use of rigid catheters, IM inj & non-essential patient handling during treatment. Discontinue therapy & terminate concomitant heparin administration if serious bleeding particularly cerebral haemorrhage occurs; consider protamine administration if heparin has been administered w/in 4 hr before onset of bleeding. Consider cryoprecipitate, fresh frozen plasma, & platelet transfusion after each administration; antifibrinolytics. Do not give dose >100 mg in acute MI & pulmonary embolism & >90 mg in acute ischaemic stroke. Recent IM inj or small recent traumas eg, biopsies, puncture of major vessels, cardiac massage for resuscitation; conditions w/ increased haemorrhagic risk; patients receiving oral anticoagulant treatment. Systolic BP >160 mmHg & increased risk of intracerebral haemorrhage in elderly (in acute MI & acute massive pulmonary embolism only). Pregnancy & lactation. Acute MI: Reperfusion arrhythmias; increased risk of bleeding w/ concomitant use of GPIIb/IIIa antagonists; increased risk of thromboembolic events in patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation. Acute ischaemic stroke: Increased risk of intracranial haemorrhage particularly in late time-to-treatment onset, patients pre-treated w/ ASA, patients >80 yr. Monitor BP during treatment & up to 24 hr; initiate IV antihypertensive therapy if systolic BP >180 mmHg or diastolic BP >105 mmHg. Patients w/ prior stroke or uncontrolled diabetes; extensive infarctions. Cerebral oedema may occur upon ischaemic area reperfusion. Childn ≥16 yr.
Adverse Reactions
Bleeding (eg, superficial or internal). Rash, urticaria, bronchospasm, angiooedema, hypotension, shock or any symptom associated w/ hypersensitivity; intracranial haemorrhage eg, cerebral & subarachnoid haemorrhage, cerebral & intracranial haematoma, haemorrhagic stroke & haemorrhagic transformation stroke; eye haemorrhage; pericardial haemorrhage; haemorrhage (eg, haematoma), embolism, parenchymatous organ bleeding eg, hepatic haemorrhage; resp tract haemorrhage (eg, pharyngeal & pulmonary haemorrhage, haemoptysis, epistaxis); GI haemorrhage (eg, gastric, gastric ulcer, rectal & mouth haemorrhage, haematemesis, melaena, gingival bleeding), retroperitoneal haemorrhage (eg, retroperitoneal haematoma), nausea, vomiting; ecchymosis; urogenital haemorrhage (eg, haematuria, urinary tract haemorrhage); inj & puncture site haemorrhage eg, catheter site haematoma & haemorrhage; decreased BP, increased body temp; fat embolism; transfusion.
Drug Interactions
May increase risk of bleeding w/ drugs affecting coagulation or altering platelet function. Enhanced risk of hypersensitivity reaction w/ ACE inhibitors.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AD02 - alteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Actilyse inj 50 mg
1's;2 × 1's
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