Contraindications
Hypersensitivity, bleeding disorder (at present or within 6 months), history of CNS damage (e.g. neoplasm, aneurysm, intracranial or spinal surgery), haemorrhagic diathesis, active internal bleeding, history of CVA, severe uncontrolled hypertension; major surgery, parenchymal organ biopsy or significant trauma (within 2 months); recent trauma to the head or cranium; prolonged cardiopulmonary resuscitation (>2 minutes) within 2 weeks; acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, active peptic ulceration, arterial aneurysm, arterial or venous malformation, neoplasm with bleeding risk, active bleeding (except menstruation), suspected aortic dissection; history of haemorrhagic stroke or stroke of unknown origin; history of ischaemic stroke or TIA within 3 months; dementia. Severe hepatic impairment (e.g. hepatic failure, cirrhosis, portal hypertension [oesophageal varices], active hepatitis).
|
Special Precautions
Patient with significant hypertension on presentation (systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg); history of chronic, severe, poorly controlled hypertension; cerebrovascular disease, recent gastrointestinal or genitourinary bleeding (within 10 days), increased risk of left heart thrombus (e.g. mitral stenosis or atrial fibrillation), recent IM inj (within 2 days), major surgery (<3 weeks), noncompressible vascular punctures, lumbar puncture (within 10 days), low body weight (<60 kg). Patient taking oral anticoagulants. Readministration of therapy. Patients should be transferred without delay to a coronary intervention capable facility for angiography and timely coronary intervention within 6-24 hours or earlier if needed (if used as a primary coronary recanalization treatment). Should not be given if primary PCI is scheduled according to the current relevant treatment guidelines. Avoid using rigid catheters, IM inj and nonessential handling of the patient. Elderly. Pregnancy and lactation. Monitoring Parameters Monitor CBC, aPTT, ECG; signs and symptoms of bleeding especially on potential bleeding sites (e.g. infusion or puncture site); neurological status (e.g. intracranial haemorrhage), vital signs, hypersensitivity reaction.
|
Adverse Reactions
Significant: Hypersensitivity reaction (e.g. angioedema, anaphylaxis, laryngeal oedema, urticaria, rash), cholesterol embolization, increased risk of thromboembolic events.
Gastrointestinal disorders: Gastrointestinal haemorrhage (e.g. gastric, gastric ulcer, mouth or rectal haemorrhage, haematemesis, melaena).
General disorders and administration site conditions: Inj or puncture site haemorrhage.
Renal and urinary disorders: Urogenital haemorrhage (e.g. haemorrhage urinary tract, haematuria).
Respiratory, thoracic and mediastinal disorders: Epistaxis.
Skin and subcutaneous tissue disorders: Ecchymosis.
Potentially Fatal: Coronary thrombolysis resulting in reperfusion arrhythmia, haemorrhage. |
Drug Interactions
Increased risk of bleeding with GPIIb/IIIa antagonists, drugs affecting coagulation or alters platelet function (e.g. clopidogrel, ticlopidine, LMWH).
|
ATC Classification
B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
|