Actilyse

Actilyse

alteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Alteplase (human recombinant tissue type plasminogen activator)
Indications/Uses
Thrombolytic treatment in acute MI; acute massive pulmonary embolism w/ haemodynamic instability & acute ischemic stroke.
Dosage/Direction for Use
Acute MI 90 min accelerated dose regimen (w/in 6 hr after symptom onset): 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: 100 mg. 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: 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: 1.5 mg/kg. Acute massive pulmonary embolism Body wt ≥65 kg 100 mg 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: 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: 1.5 mg/kg. Acute ischaemic stroke 0.9 mg/kg (max: 90 mg) starting w/ 10% of the total dose 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.
Contraindications
Hypersensitivity to alteplase, gentamicin. Cases where there is a high risk of haemorrhage eg, significant bleeding disorder at present or w/ the 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 a 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 the 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 activated partial thromboplastin time 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.
Special Precautions
Enhanced angioedema risk in the indication acute ischaemic stroke &/or 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 the patient during treatment. Discontinue therapy & terminate concomitant heparin administration immediately should serious bleeding occur, in particular cerebral haemorrhage. Do not give a 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/ an 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/ acetylsalicylic acid. BP monitoring. Patients who had a prior stroke or have uncontrolled diabetes; extensive infarctions. Cerebral oedema. Adolescent ≥16 yr. Elderly >80 yr.
Drug Interactions
May increase the risk of bleeding prior to, during or after therapy w/ drugs affecting coagulation/platelet function. May enhance the risk of suffering a 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.
Presentation/Packing
Form
Actilyse powd for infusion 50 mg
Packing/Price
(+ 50 mL sterile water for inj as solvent) 1's (P30,536.02/vial)
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