Actilyse

Actilyse

alteplase

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Alteplase (recombinant human tissue-type plasminogen activator)
Indications/Uses
Thrombolytic treatment in acute MI, acute massive pulmonary embolism w/ haemodynamic instability & acute ischaemic stroke.
Dosage/Direction for Use
MI Patient in whom treatment can be started w/in 6 hr after symptom onset Initially 15 mg IV bolus then 50 mg IV infusion over the 1st 30 min, immediately followed by 35 mg infusion over 60 min until max total dose of 100 mg. Patient <65 kg Initially 15 mg IV bolus & 0.75 mg/kg over 30 min (max: 50 mg) immediately followed by 0.5 mg/kg infusion over 60 min (max: 35 mg). 3-hr dose regimen: 10 mg IV bolus then 50 mg IV infusion over the 1st hr, immediately followed by 40 mg IV infusion for the next 2 hr until max total dose of 100 mg; over 3 hr. Max: 1.5 mg/kg in patient <65 kg. Pulmonary embolism 10 mg IV bolus over 1-2 min then 90 mg IV infusion over 2 hr until the max total dose of 100 mg. Max: 1.5 mg/kg in patient <65 kg. Acute ischaemic stroke 0.9 mg/kg (max: 90 mg) infused over 60 min w/ 10% of total dose as initial IV bolus. Initiate therapy w/in 4.5 hr after onset of symptoms.
Contraindications
Hypersensitivity to active substance alteplase, gentamicin (a trace residue), significant bleeding at present or w/in the past 6 mth, known haemorrhagic diathesis, patient treatment w/ oral anticoagulants (warfarin INR >1.3), CNS damage (neoplasm, aneurysm, intracarnial or spinal surgery), intracranial haemorrhage, uncontrolled arterial HTN, major surgery or significant trauma in the past 10 days, prolonged or traumatic cardiopulmonary resuscitation (>2 min), obstetrical delivery, w/in the past 10 days, severe hepatic dysfunction, bacterial endocarditis, pericarditis, acute pancreatitis, history ulcerative GI disease during the last 3 mth, arterial aneurysms, arterial/venous malformations, neoplasm w/ increased bleeding risk. Combination of previous stroke & DM, administration of heparin w/in 48 hr pre-stroke onset w/ elevated activated partial thromboplastin time; platelet count <100,000/mm3; BP >185/>110 mmHg; blood glucose <50 or >400 mg/dL. Childn & adolescent <18 yr.
Special Precautions
Hypersensitivity. Bleeding, systolic BP >160 mmHg. Arrhythmias, GP IIb/IIIa antagonists, thromboembolism, uncontrolled diabetes, prior stroke, extensive infraction, cerebral oedema, paed population, patients pre-treated w/ ASA. Pregnancy & lactation. Childn.
Adverse Reactions
Bleeding, haemorrhage, intracranial haemorrhagic neurological symptoms, fat embolism, anaphylactoid reactions; eye, pericardial, resp tract, GI, retroperitoneal, urogenital, inj site, intracranial haemorrhage; haematoma, embolism, bleeding of parenchymatous organs, nausea, vomiting, ecchymosis, decreased BP, increased body temp, fat embolism, transfusion, reperfusion arrhythmia.
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 infusion 50 mg
Packing/Price
(+vial 50 mL water for inj & Cannula Transfer) 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in