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| alteplase
Generic name: tissue plasminogen activator |
There
are significant precautions associated with the use of alteplase.
The most common side effect in all approved indications is bleeding.
If bleeding occurs during therapy with alteplase that cannot be
controlled by pressure, it is recommended that alteplase (and
heparin, if applicable) should be discontinued immediately. Arterial
punctures are of particular concern and an upper extremity
accessible to manual compression is preferred. The usual precautions
and procedures following arterial catheterization are extremely
important. It is recommended that other invasive procedures be
avoided or minimized. Non-compressible venous sites should be
avoided. Alteplase is contraindicated in patients with bleeding
diathesis such as concurrent use of warfarin and a prothrombin time
(PT) greater than 15 seconds, heparin administration within 48 hours
preceding the onset of stroke and an elevated activated partial
thromboplastin time (aPTT) at presentation, or a platelet count less
than 100,000/mm3.
The use of alteplase is contraindicated
for the treatment of acute myocardial infarction or pulmonary
embolism in the presence of active internal bleeding or known
bleeding diathesis; severe uncontrolled hypertension; or a history
of cerebrovascular accident; intracranial or intraspinal surgery or
trauma within the past two months; intracranial neoplasm;
arteriovenous malformation or aneurysm. Reperfusion arrhythmias may
occur and antiarrhythmic therapy should be available when alteplase
is administered.
For the treatment of acute ischemic stroke, the use of alteplase is
contraindicated in patients with evidence or history of intracranial
hemorrhage (ICH); suspicion of subarachnoid hemorrhage; recent
intracranial surgery or serious head trauma or recent stroke;
uncontrolled hypertension at the time of treatment (SBP > 185 mm
Hg or DBP > 110 mm Hg); seizure at the onset of stroke; active
internal bleeding; intracranial neoplasm, arteriovenous
malformation, or aneurysm. The risks of alteplase-associated
toxicity may be increased in patients with severe neurological
deficit at presentation or major early infarct signs on computerized
cranial tomography (CT). Treatment of acute ischemic stroke more
than 3 hours after the onset of symptoms is not recommended.
The risks and benefits of alteplase therapy should be carefully
considered when the following are present: major surgery,
cerebrovascular disease, gastrointestinal or genitourinary bleeding,
and trauma (including cardiopulmonary resuscitation) - any of the
preceding within the previous 10 days; hypertension (SBP > 180 or
DBP > 110); high likelihood of left heart thrombus (such as in
mitral stenosis with atrial fibrillation); subacute bacterial
endocarditis or acute pericarditis; hemostatic defects including
those secondary to severe hepatic or renal disease; pregnancy; age
> 75 years; diabetic hemorrhagic retinopathy or other hemorrhagic
ophthalmic conditions; septic thrombophlebitis or occluded
arteriovenous cannula at seriously infected sites; patients
currently receiving oral anticoagulants (such as warfarin); or any
condition associated with a significant risk of bleeding or
difficulty in management because of its location.
Cholesterol embolism (which can be fatal) resulting from invasive
vascular procedures has been reported rarely.
Sustained antibody formation following a single alteplase dose has
not been documented and data concerning readministration are not
available. Readministration of alteplase should be undertaken
cautiously and in the event of an anaphylactoid reaction, the
infusion should be discontinued immediately and appropriate
resuscitative measures initiated.
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