Actilyse

Thrombolytic treatment in acute MI; acute massive pulmonary embolism w/ haemodynamic instability & acute ischaemic stroke.

Acute MI 90 min accelerated dose regimen (w/in 6 hr after symptom onset): Body wt ≥65 kg 15 mg as IV bolus, immediately followed by 50 mg as IV constant rate infusion over the 1st 30 min, immediately followed by 35 mg as IV constant rate infusion over 60 min, max total dose: 100 mg. Body wt <65 kg 15 mg as IV bolus, immediately followed by 0.75 mg/kg as IV constant rate infusion over the 1st 30 min, immediately followed by 0.5 mg/kg as IV constant rate infusion over 60 min. 3 hr dose regimen (between 6 & 12 hr after symptom onset): Body wt >65 kg 10 mg as IV bolus, immediately followed by 50 mg as IV constant rate infusion over the 1st hr, immediately followed by 40 mg as IV constant rate infusion over 60 min, max total dose: 100 mg. Body wt <65 kg 10 mg as IV bolus, immediately followed by an IV constant rate infusion over 3 hr up to max total dose: 1.5 mg/kg. Acute massive pulmonary embolism Body wt ≥65 kg 100 mg total dose to be administered in 2 hr: 10 mg as IV bolus over 1-2 min, immediately followed by 90 mg as IV constant rate infusion over 2 hr until, max total dose: 100 mg. Body wt <65 kg 10 mg as IV bolus over 1-2 min, immediately followed by an IV constant rate infusion over 2 hr up to max total dose: 1.5 mg/kg. Acute ischaemic stroke Total dose of 0.9 mg/kg (max: 90 mg) w/ 10% of the total dose administered as initial IV bolus, immediately followed by the 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. Cases where there is high risk of haemorrhage eg, significant bleeding disorder at present or w/ past 6 mth, known haemorrhagic diathesis; patients receiving effective oral anticoagulant treatment eg, warfarin Na (INR >1.3); any history of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery); history or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage; severe uncontrolled arterial HTN; major surgery or significant trauma in the past 10 days (includes any trauma associated w/ current acute MI), recent trauma to head or cranium; prolonged or traumatic CPR (>2 min), obstetrical delivery w/in the past 10 days, recent puncture of non-compressible blood-vessel (eg, subclavian or jugular vein puncture); severe hepatic dysfunction, including 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 & acute massive pulmonary embolism: Haemorrhagic stroke or stroke of unknown origin at any time; ischaemic stroke or transient ischaemic attack in the preceding 6 mth, except current acute ischaemic stroke w/in 4.5 hr. Acute ischaemic stroke: Symptoms of ischaemic attack began >4.5 hr prior to infusion start or when time of symptom onset is unknown; acute ischaemic stroke that were either rapidly improving or only minor before start of infusion; severe stroke as assessed clinically (eg, NIHSS >25) &/or by appropriate imaging techniques; 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 onset of stroke w/ elevated aPTT at presentation; platelet count of <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 mg/dL or >400 mg/dL. Childn <16 yr.

Enhanced angiooedema risk in indication acute ischaemic stroke &/or by concomitant treatment w/ ACE inhibitors. Monitor for angiooedema during & for up to 24 hr after infusion. Discontinue if severe hypersensitivity reaction (eg, angiooedema) occurs. Concomitant use of heparin anticoagulation. Avoid use of rigid catheters, IM inj & non-essential handling of patient during treatment. Discontinue fibrinolytic therapy & terminate concomitant heparin administration immediately should serious bleeding occur, in particular cerebral haemorrhage. Do not give dose exceeding 100 mg in acute MI as well as 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 risk of haemorrhage. Patients receiving oral anticoagulant treatment. Pregnancy & lactation. Acute MI & acute massive pulmonary embolism: Systolic BP >160 mmHg. Elderly. Acute MI: Reperfusion arrhythmias. Concomitant use of GPIIb/IIIa antagonists. Thromboembolic events in patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation. Acute ischaemic stroke: Intracerebral haemorrhages. Patients pre-treated w/ ASA. BP monitoring during treatment administration & up to 24 hr. Patients who had prior stroke or have uncontrolled diabetes; extensive infarctions. Cerebral oedema. Childn ≥16 yr. Elderly >80 yr.

Bleeding.

May increase risk of bleeding prior to, during or after therapy w/ drugs affecting coagulation/platelet function. May enhance risk of suffering hypersensitivity reaction w/ ACE inhibitors.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AD02 - alteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.

Rx