Boehringer Ingelheim


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 (started w/in 6 hr after symptom onset): Patient ≥65 kg 15 mg IV bolus immediately followed by 50 mg IV infusion over 1st 30 min, followed by 35 mg IV infusion over 60 min until max: 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 up to max: 35 mg. 3-hr dose regimen (started between 6-12 hr after symptom onset): Patient ≥65 kg 10 mg IV bolus immediately followed by 50 mg IV infusion over 1st hr followed by 40 mg IV infusion for next 2 hr until max: 100 mg, <65 kg 10 mg IV bolus immediately followed by up to max: 1.5 mg/kg IV infusion. Acute massive pulmonary embolism Patient ≥65 kg 10 mg IV bolus over 1-2 min immediately followed by 90 mg IV infusion over 2 hr until total dose: 100 mg, <65 kg 10 mg IV bolus over 1-2 min immediately followed by up to max: 1.5 mg/kg IV infusion. Acute ischaemic stroke Total dose: 0.9 mg/kg IV infusion over 60 min w/ 10% of total dose administered initially as early as possible w/in 4.5 hr of symptom onset. Max: 90 mg. Adjunctive therapy If heparin is required for other indications (eg, DVT prevention), dose not to exceed 10,000 IU daily SC.
Hypersensitivity to alteplase, gentamicin. Significant bleeding disorder (present or w/in past 6 mth), known haemorrhagic diathesis; 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 cranial trauma; prolonged or traumatic CPR (>2 min), obstet delivery w/in past 10 days, recent puncture of non-compressible blood vessel eg, subclavian or jugular vein puncture; bacterial endocarditis, pericarditis; acute pancreatitis; documented ulcerative GI disease during last 3 mth; arterial aneurysms, arterial/venous malformations; neoplasm w/ increased bleeding risk. Patients receiving oral anticoagulants. Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis. Acute MI & pulmonary embolism: Haemorrhagic stroke or stroke of unknown origin; ischaemic stroke or transient ischaemic attack in the preceding 6 mth. Acute ischaemic stroke: Symptoms of ischaemic attack beginning >4.5 hr prior to infusion or when time of symptom onset is unknown; acute ischaemic stroke rapidly improving or only minor before start of infusion; severe stroke, seizure at onset of stroke, history of previous stroke or serious head trauma w/in 3 mth; combination of previous stroke & DM; heparin administration w/in 48 hr before stroke onset w/ elevated aPTT; platelet count <100,000 mm3; systolic BP >185 mmHg or diastolic BP >110 mmHg, or aggressive management eg, IV medication; blood glucose <50 or >400 mg/dL. Childn <16 yr.
Special Precautions
Discontinue use if severe hypersensitivity reaction occurs. Increased risk of bleeding. Recent IM inj or small recent traumas eg, biopsies, major vessels puncture, cardiac massage for resuscitation; conditions w/ increased haemorrhagic risk; patients on oral anticoagulants. Avoid use of rigid catheters, IM inj. Pregnancy & lactation. Childn ≥16 yr. Increased risk of intracerebral haemorrhage in advanced age & elderly. Acute MI & pulmonary embolism: Systolic BP >160 mmHg. Acute MI: Arrythmias. Increased risk thromboembolic events. Concomitant use w/ glycoprotein IIb/IIIa antagonists. Acute ischaemic stroke: High risk of haemorrhage; late time-to-treatment onset; greater risk of intracerebral haemorrhage in patients pre-treated w/ acetylsalicylic acid; prior stroke; uncontrolled diabetes; extensive infarctions; cerebral oedema. Monitor BP during treatment & up to 24 hr. Not to be initiated >4.5 hr after symptom onset.
Adverse Reactions
Haemorrhage eg, haematoma. Resp tract haemorrhage eg, pharyngeal haemorrhage; GI haemorrhage eg, gastric, gastric ulcer, rectal & mouth haemorrhage, haematemesis, melena, gingival bleeding; ecchymosis; urogenital haemorhage eg, haematuria, urinary tract haemorrhage; inj & puncture site haemorrhage.
Drug Interactions
Increased risk of bleeding w/ medicinal products 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 powd for infusion (vial) 50 mg
(+ WFI 50 mL x 1's) 2 × 1's
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