Metalyse

Metalyse

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tenecteplase
Indications/Uses
Thrombolytic treatment of acute MI. Treatment should be initiated as soon as possible after symptom onset.
Dosage/Direction for Use
Administered on the basis of body wt. Max dose: 10,000 U (50 mg). Patient weighing ≥90 kg 50 mg, ≥80 to <90 kg 45 mg, ≥70 to <80 kg 40 mg, ≥60 to <70 kg 35 mg, <60 kg 30 mg. Given as a single IV bolus over 5-10 sec. Adjunctive therapy is recommended in patients w/ ST-elevation MI.
Contraindications
Hypersensitivity to tenecteplase or gentamicin. Significant bleeding disorder at present or w/in the past 6 mth, known haemorrhagic diathesis. Concomitant use w/ oral anticoagulant therapy (INR >1.3). History of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery). Severe uncontrolled arterial HTN. Major surgery, biopsy of a parenchymal organ or significant trauma w/in the past 2 mth, recent trauma to the head or cranium. Prolonged or traumatic CPR (>2 min) w/in the past 2 wk. Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis. Active peptic ulceration. Arterial aneurysm & known arterial/venous malformation. Neoplasm w/ increased bleeding risk. Acute pericarditis &/or subacute bacterial endocarditis. Acute pancreatitis. Haemorrhagic stroke or stroke of unknown origin at any time. Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 mth.
Special Precautions
Discontinue use if anaphylactoid reaction occurs. Bleeding; concomitant use of heparin anticoagulation. Monitor all possible bleeding sites. Avoid use of rigid catheters, IM inj & non-essential handling of patient during therapy. Systolic BP >160 mmHg; recent GI or GUT bleeding; recent IM inj; advanced age ie, >75 yr; low body wt <60 kg; cerebrovascular disease; concomitant use w/ oral anticoagulant. Reperfusion arrhythmias. Concomitant use of GPIIb/IIIa antagonists; increased risk of thromboembolic events in patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation. Pregnancy & lactation.
Adverse Reactions
Haemorrhage at any site or body cavity. Intracranial hemorrhagic neurological symptoms eg, somnolence, aphasia, hemiparesis, convulsion; anaphylactoid reactions including rash, urticaria, bronchospasm, laryngeal oedema; intracranial haemorrhage eg, cerebral & subarachnoid haemorrhage, cerebral & intracranial haematoma, haemorrhagic & haemorrhagic transformation stroke; eye hemorrhage; reperfusion arrhythmias eg, asystole, accelerated idioventricular arrhythmia, arrhythmia, extrasystoles, atrial fibrillation, AV block 1st degree, bradycardia, tachycardia, ventricular arrhythmia, fibrillation; pericardial haemorrhage; haemorrhage, embolism; epistaxis, pulmonary haemorrhage; GIT haemorrhage; nausea &/or vomiting, retroperitoneal haemorrhage; ecchymosis, urogenital haemorrhage; inj & puncture site haemorrhage; decreased BP, increased body temp; fat embolism; transfusion.
Drug Interactions
May increase risk of bleeding w/ drugs that affect coagulation & alter platelet function.
ATC Classification
B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Presentation/Packing
Form
Metalyse powd for inj 8000 U
Packing/Price
1's
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