Alteplase

Hypersensitivity to alteplase or any component of the formulation. Significant bleeding disorder (at present or within the past 6 months), known haemorrhagic diathesis, known history or evidence of or suspected intracranial haemorrhage (including subarachnoid haemorrhage); history of CNS damage (e.g. neoplasm, aneurysm, intracranial or spinal surgery); recent (<10 days) traumatic or prolonged CPR (>2 minutes), obstetrical delivery; recent puncture of non-compressible blood-vessel (e.g. subclavian or jugular vein puncture); severe uncontrolled arterial hypertension, acute pancreatitis, bacterial endocarditis, pericarditis, aortic dissection; history of ulcerative gastrointestinal disease (within the last 3 months), oesophageal varices, arterial aneurysm, arterial/venous malformations; neoplasms that predispose to bleeding; major surgery or significant trauma in the past 10 days (including any trauma associated with the current MI), recent head or cranial trauma. Severe hepatic impairment (including hepatic failure, cirrhosis, portal hypertension, and active hepatitis). Patient receiving effective oral anticoagulant (e.g. warfarin) therapy (INR >1.3). Acute MI and pulmonary embolism additional contraindications: Known history of haemorrhagic stroke or stroke of unknown origin, known history of ischaemic stroke or TIA in the preceding 6 months (except for current acute ischaemic stroke within 4.5 hours). Acute ischaemic stroke additional contraindications: Symptoms of ischaemic attack presenting >4.5 hours before the start of infusion or when time of symptom onset is unknown; minor neurological deficit or symptoms rapidly improving prior to infusion, severe stroke as determined clinically (e.g. National Institutes of Health Stroke Scale [NIHSS] >25) and/or by appropriate imaging techniques; recent intracranial or intraspinal surgery or previous stroke or serious head trauma (within the last 3 months); seizure at onset of stroke, history of stroke and concomitant diabetes, platelet count <100,000/mm³; systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, hypertension requiring aggressive management (IV pharmacotherapy); blood glucose <50 mg/dL or >400 mg/dL; administration of heparin within 48 hours preceding the onset of stroke with high aPTT at presentation.

Patient with small recent traumas (e.g. biopsies, IM injections, puncture of major vessels); extensive infarctions, left heart thrombus (e.g. mitral stenosis, atrial fibrillation), systolic blood pressure >160 mmHg, uncontrolled diabetes, other conditions with high risks of haemorrhage (which are not mentioned under contraindications). For clearance of central venous lines: Patients with thrombocytopenia, other haemostatic defects, or any condition for which bleeding poses a significant hazard or would cause difficult management due to location, or those at risk for embolic complications (e.g. venous thrombosis in the region of the catheter), known or suspected catheter infection; patients who have active internal bleeding or have had surgery, obstetrical delivery, percutaneous biopsy of viscera or deep tissues, or puncture of non-compressible vessels within 48 hours before instillation. Avoid excessive pressure during instillation into the catheter. Appropriate formulation of alteplase should be chosen and used according to the intended indication. Children (when used for clearance of central venous lines) and elderly. Pregnancy and lactation. Monitoring Parameters Monitor vital signs, neurological exam, head CT, prothrombin time/INR, glucose, and ECG before, during, and after therapy; blood pressure during and for 24 hours after therapy; infusion site (including other potential bleeding sites). Assess for haemorrhage during and 24 hours after therapy. Closely monitor for hypersensitivity reactions during and for several hours after infusion. For central venous catheter clearance: Evaluate catheter function by attempting to aspirate blood.

Significant: Increased risk of thromboembolic events (in patients with left heart thrombus). Eye disorders: Rarely, eye haemorrhage. Gastrointestinal disorders: Gingival bleeding. Nervous system disorders: Cerebral oedema (in the infarcted zone). Renal and urinary disorders: Haematuria. Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, epistaxis. Skin and subcutaneous tissue disorders: Ecchymosis. Vascular disorders: Hypotension.
Potentially Fatal: Internal bleeding (e.g. intracranial/intracerebral, retroperitoneal, respiratory, gastrointestinal, genitourinary), external bleeding (particularly at arterial and venous puncture sites); sepsis (in patients with infected catheters); recurrent ischaemia or angina pectoris, heart failure, cardiac arrest, cardiogenic shock, reinfarction, mitral regurgitation, reperfusion arrhythmias (which may also lead to cardiac arrest). Rarely, hypersensitivity reactions (e.g. anaphylaxis, angioedema, urticaria), cholesterol embolisation.

Increased risk of haemorrhage with oral anticoagulants, platelet aggregation inhibitors, unfractionated heparin or LMWH, glycoprotein IIb/IIIa inhibitors. May increase the risk of intracerebral haemorrhage in aspirin pre-treated patients (particularly if alteplase treatment is delayed). May increase the risk of hypersensitivity reactions (particularly angioedema) with ACE inhibitors.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

S01XA13 - alteplase ; Belongs to the class of other ophthalmologicals.
B01AD02 - alteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.