Metalyse: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tenecteplase

Indications/Uses

Thrombolytic treatment of acute MI initiated as soon as possible after symptom onset.

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Dosage/Direction for Use

Single IV bolus over 5-10 sec. 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).

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Overdosage

View Metalyse overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity to tenecteplase, gentamicin. Significant bleeding disorder (present or w/in past 6 mth), known haemorrhagic diathesis; history of CNS damage ie, neoplasm, aneurysm, intracranial or spinal surgery; severe uncontrolled arterial HTN; active GI disease ulceration; arterial aneurysm, arterial/venous malformation; neoplasm w/ increased bleeding risk; bacterial endocarditis, pericarditis; acute pancreatitis; haemorrhagic stroke or stroke of unknown origin; ischaemic stroke or transient ischaemic attack in the preceding 6 mth; major surgery, parenchymal organ biopsy or significant trauma w/in past 2 mth, recent head or cranial trauma. Patients on effective oral anticoagulants. Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis.

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Special Precautions

Discontinue use if anaphylactoid reaction occurs. Not to be given in primary percutaneous coronary intervention. Increased risk of bleeding; prolonged (>2 min) or traumatic CPR or cardiac massage, recent IM inj or small recent traumas eg, biopsies, major vessels puncture, systolic BP >160 mmHg, recent GI or genitourinary bleeding (w/in past 10 days), body wt <60 kg; thromboembolic events in patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation; arrhythmias. May cause allergic reactions due to polysorbates. Transfer patient to coronary intervention-capable facility for angiography & timely coronary intervention w/in 6-24 hr as primary coronary recanalization treatment. Avoid use of rigid catheters, IM inj. Concomitant use w/ oral anticoagulants; glycoprotein IIb/IIIa antagonists. Pregnancy & lactation. Elderly ≥75 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaphylactoid reaction; intracranial haemorrhage; eye haemorrhage; reperfusion arrhythmias, pericardial haemorrhage; haemorrhage, embolism; epistaxis, pulmonary haemorrhage; GI & retroperitoneal haemorrhage, nausea, vomiting; ecchymosis; urogenital haemorrhage; inj & puncture site haemorrhage; decreased BP, increased body temp; fat embolism; transfusion.

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Drug Interactions

Increased risk of bleeding w/ medicinal products affecting coagulation or altering platelet function.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Metalyse detailed prescribing information

Storage

View Metalyse storage conditions for details to ensure optimal shelf-life.

Description

View Metalyse description for details of the chemical structure and excipients (inactive components).

Action

View Metalyse mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

ATC Classification

B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.

Regulatory Classification

Presentation/Packing

Form

Metalyse powd for inj (vial) 50 mg (10,000 U)

Packing/Price

(+ WFI (pre-filled syringe) 10 mL x 1's) 1's

Metalyse

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH