Eptase 1.5 million unit (Powder for Injection)

Indications

• Management of acute myocardial infarction
• Lysis of intracoronary thrombi
• Improvement of ventricular function
• Reduction of mortality

Pharmacology

• Streptokinase forms a complex with plasminogen
• Plasmin breaks down clots and fibrinogen

Dosage & Administration

• Acute Myocardial Infarction:
  • IV infusion:
    • Vial size (IU): 15,00,000
    • Total solution volume: 45 ml
    • Infusion rate: Infuse 45 ml within 60 mins
  • Intracoronary infusion:
    • Vial size (IU): 2,50,000
    • Total solution volume: 125 ml
    • Infusion rates:
      • 20,000 IU bolus, Infusion rate: Loading dose of 10 ml
      • 2,000 IU/min. for 60 minutes, Infusion rate: 60 ml/hour
• Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism:
  • 2,50,000 IU loading dose over 30 min
  • Vial size (IU): 15,00,000
  • Total solution volume 90 ml
  • Infusion rate: Infuse 30 ml/hour for 30 min
  • 1,00,000 IU/hour for maintenance dose, Infusion rate: Infuse 6 ml/hour

Interaction

• Increased risk of hemorrhage with anticoagulants or platelet inhibitors
• Neutralization of Heparin with Protamine Sulphate
• Benefit of combination therapy with Aspirin for myocardial infarction

Contraindications

• Existing or recent hemorrhage
• Hemorrhagic diathesis
• Potential for internal bleeding
• Reduced blood coagulability
• Recent cerebrovascular accident
• Recent facial or head trauma
• Invasive operations
• Arteriovenous malformation or aneurysm
• Severe uncontrolled hypertension
• Severe liver or kidney damage
• Endocarditis or pericarditis
• More than 5 days and less than 12 months since previous Streptokinase therapy

Side Effects

• General disorders:
  • Headache
  • Back pain
  • Muscle pain
  • Chills
  • Fever
  • Asthenia/Malaise
• Haemorrhage and bleeding:
  • Ecchymoses
  • Gastrointestinal or genitourinary bleeding
  • Epistaxis
  • Intracranial hemorrhages
  • Retinal hemorrhages
  • Severe hemorrhages including liver hemorrhages
• Immune system disorders:
  • Development of antiEptase antibodies
  • Allergic-anaphylactic reactions
• Nervous system disorders:
  • Neurologic symptoms in the context of cerebral hemorrhages or cardiovascular disorders
• Cardiac complication and vascular disorders:
  • Hypotension
  • Heart rate and rhythm disorders
  • Angina pectoris
  • Recurrent ischemia
  • Heart failure
  • Cardiogenic shock
  • Pericarditis
  • Pulmonary edema
  • Cardiac arrest
  • Mitral insufficiency
  • Pericardial effusion
  • Cardiac tamponade
  • Myocardial rupture
  • Pulmonary or distal embolism
• Respiratory disorders:
  • Non-cardiogenic pulmonary edema after intracoronary thrombolytic therapy
• Gastrointestinal disorders:
  • Nausea
  • Diarrhea
  • Epigastric pain
  • Vomiting

Pregnancy & Lactation

• Pregnancy category C
• Discontinuation of breastfeeding recommended

Precautions & Warnings

• Likelihood of resistance due to antiEptase antibodies
• No thrombolytic treatment before the 10th postoperative day
• Increased danger of bleeding by simultaneous or previous treatment with anticoagulants
• Retreatment may not be effective if given during peak antiEptase antibody period

Use in Special Populations

• Safety & effectiveness in children not established

Overdose Effects

• Cease Eptase infusion if uncontrollable bleeding occurs
• Use of aminocaproic acid or aprotinin may be useful

Therapeutic Class

Fibrinolytics (Thrombolytics)

Reconstitution

• Careful reconstitution and dilution required
• Reconstituted product should be used immediately if stored at 2-8°C
• No addition of other medication to the container of Eptase

Storage Conditions

• Eptase vial: Stored at 2 to 25°C
• Reconstituted with physiological saline: Physico-chemical stability for 24 hours at 2 to 8°C
• Reconstituted product: Used immediately if stored at 2-8°C, not to exceed 24 hours
• Safety: Keep out of the reach of children

Related Brands

• STK 1.5 million unit (Powder for Injection) - incepta-pharmaceuticals-ltd