Recombinant human prourokinase: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Acute myocardial infarction

Adult: Administer within 6 hours of symptom onset. Max total dose: 100,000 IU/kg. Double bolus regimen: ≤60 kg: 4,000,000 IU as single bolus inj; >60-75 kg: 4,000,000 IU then 1,000,000 IU as 2nd bolus; >75-90 kg: 4,000,000 IU then 2,000,000 IU as 2nd bolus; >90-110 kg: 4,000,000 IU then 3,000,000 IU as 2nd bolus; >110 kg: 4,000,000 IU then 4,000,000 IU as 2nd bolus. Administer 2nd dose, 25 minutes after the 1st bolus. Bolus plus infusion regimen: <60 kg: 2,000,000 IU as bolus, then calculate dose based on 100,000 IU/kg minus 2,000,000 IU to be given via infusion over 60 minutes; 60-85 kg: 2,000,000 IU as bolus then 4,000,000 IU via infusion over 60 minutes; >85 kg: 2,000,000 IU as bolus then 6,000,000 IU via infusion over 60 minutes.

Hepatic Impairment

Contraindicated.

Reconstitution

Reconstitute vial labelled as containing 2,000,000 IU with 20 mL NaCl 0.9% inj. Do not shake, gently tip the vial over 1-2 times. Further dilute with NaCl 0.9% inj for IV infusion to a final concentration not exceeding 100,000 IU/mL.

Contraindications

Hypersensitivity. Conditions manifested by increased bleeding (e.g. haemorrhagic diathesis, haemophilia, thrombocytopaenia and conditions with high risk of bleeding); active bleeding; extensive trauma up to 4 weeks; cardiogenic shock, puncture of uncompressed vessels, diabetic haemorrhagic retinopathy, previous haemorrhagic stroke, high blood pressure (≥180/110 mm Hg), suspicion of aortic dissection, septic endocarditis. Extensive surgical intervention; resuscitation measures that required intensive indirect cardiac massage. Hepatic impairment. Pregnancy and lactation.

Special Precautions

Renal impairment.

Adverse Reactions

Significant: Bleeding, arrhythmia.

Monitoring Parameters

Monitor for signs and symptoms of bleeding. Assess coagulation parameters (e.g. clotting time, prothrombin time, APTT) prior to initiation of treatment then periodically thereafter.

Overdosage

Symptoms: Haemorrhagic complications. Management: May administer fresh frozen plasma, whole blood, or antifibrinolytic agent for severe bleeding.

Drug Interactions

May increase risk of bleeding with antiplatelet agents, indirect anticoagulants, and high dose of heparin (>4,000 IU).

Action

Description:
Mechanism of Action: Human pro-urokinase, is a single chain structure urokinase-type plasminogen activator, prepared via recombinant DNA technology. It catalyses the transformation of plasminogen to plasmin protease that is capable of lysing fibrin clots.
Synonym: Saruplase.
Pharmacokinetics:
Excretion: Via urine. Half-life: 0.67-2.6 hours.

Storage

Store between 2-8°C. Protect from light.

MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

References

Buckingham R (ed). Saruplase. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/05/2018.

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