Metalyse

Metalyse

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Tenecteplase
Indications/Uses
Thrombolytic treatment of acute MI. Treatment initiated as soon as possible after symptom onset.
Dosage/Direction for Use
Patient ≥90 kg 50 mg (10,000 U), ≥80 to <90 kg 45 mg (9,000 U), ≥70 to <80 kg 40 mg (8,000 U), ≥60 to <70 kg 35 mg (7,000 U), <60 kg 30 mg (6,000 U). Given as a single IV bolus over 5-10 sec.
Contraindications
Hypersensitivity to tenecteplase & gentamicin (trace of residue from manufacturing process). History of or current significant bleeding disorder, known haemorrhagic diathesis. Severe uncontrolled arterial HTN. Major surgery, parenchymal organ biopsy or significant trauma w/in past 2 mth, recent head or cranium trauma. Prolonged or traumatic CPR (>2 min) w/in past 2 wk. Active peptic ulceration. Arterial aneurysm & known arterial/venous malformation. Neoplasm w/ increased bleeding risk. Acute pericarditis &/or subacute bacterial endocarditis. Acute pancreatitis. Haemorrhagic stroke/stroke of unknown origin, ischaemic stroke or transient ischaemic attack (TIA) in preceding 6 mth. Concomitant oral anticoagulant therapy (INR >1.3). History of CNS damage. Severe hepatic dysfunction.
Special Precautions
Flush preexisting IV line after Metalyse inj for proper delivery. Incompatible w/ dextrose soln. Do not mix w/ other drugs. As primary coronary recanalization treatment, patient should be transferred immediately to a coronary intervention capable facility for angiography & timely coronary intervention w/in 6-24 hr. Monitor all possible bleeding sites. Immediately terminate concomitant heparin treatment if serious bleeding occurs. Systolic BP >160 mmHg; cerebrovascular disease; known or suspected history of stroke or TIA; recent GI or GUT bleeding; recent IM inj; advanced age ie, >75 yr; low body wt <60 kg. Cerebrovascular disease. Anticoagulant treatment. Primary percutaneous coronary intervention. Arrhythmias. GPIIb/IIIa antagonists. Patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation. Hypersensitivity & anaphylactoid reactions. Pregnancy & lactation. Childn.
Adverse Reactions
Haemorrhage (superficial/internal bleeding), reperfusion arrhythmias, embolism, ecchymosis, superficial or internal bleeding, intracranial haemorrhage, eye haemorrhage, pericardial haemorrhage, epistaxis, pulmonary haemorrhage, GI haemorrhage, nausea, vomiting, retroperitoneal haemorrhage, urogenital haemorrhage, inj/puncture site haemorrhage, decreased BP, increased body temp, fat embolism, anaphylactoid reactions.
Drug Interactions
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 (vial) 50 mg (10000 U)
Packing/Price
(& (pre-filled syringe) WFI 10 mL x 1's) 1's
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