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Indications - Streptokinase is indicated for use in the management of acute myocardial infarction, for the lysis of intracoronary thrombi, for the improvement of ventricular function, and reduction of mortality when administered by either the intravenous or intracoronary route. Earlier administration of streptokinase is correlated with greater clinical benefit, the greatest benefit (in terms of mortality reduction) being seen when Streptase is administered within the first 4 hours after onset of symptoms. The treatment should always commence within 6 hours of the onset of pain.

Dosage & Administration - Streptokinase can be reconstituted using 5 ml sodium chloride injection or 5% Dextrose Injection directing the diluent at the side of the vacuum packed vial rather than into drug powder 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 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

Side Effects - The following adverse reactions are based on experience from clinical trials and on post marketing experience of Streptokinase. General disorders: Common: Headache and back pain, muscle pain (including myalgia), chills and/or fever as well as asthenia/malaise. Haemorrhage and bleeding: Common: Haemorrhages at invaded or disturbed sites, including the injection site, and ecchymoses. Gastrointestinal or genitourinary bleedings (including aggravation of menstrual bleeding), epistaxis. Uncommon: Intracranial haemorrhages with their complications and possible fatal outcome, retinal haemorrhages, severe haemorrhages (also with fatal outcome) including liver haemorrhages, retroperitoneal bleedings, splenic rupture. Blood transfusions are rarely required. Immune system disorders: Very common: Development of antistreptokinase antibodies Common: Allergic-anaphylactic reactions such as rash, flushing, itching, urticaria, angioneurotic oedema, minor breathing difficulty, periorbital swelling, bronchospasm or hypotension. Nervous system disorders: Rare: Neurologic symptoms (e.g., dizziness, confusion, paralysis, hemiparesis, agitation or convulsion) in the context of cerebral haemorrhages or cardiovascular disorders with hypoperfusion of the brain. Cardiac complication and vascular disorders: Very common: Hypotension, heart rate and rhythm disorders, angina pectoris. Common: Recurrent ischaemia, heart failure, reinfarction, cardiogenic shock, pericarditis, pulmonary oedema. Uncommon: Cardiac arrest (leading to respiratory arrest), mitral insufficiency, pericardial effusion, cardiac tamponade, myocardial rupture, pulmonary or distal embolism. Respiratory disorders: Very rare: Non-cardiogenic pulmonary oedema after intracoronary thrombolytic therapy in patients with extensive myocardial infarction. Gastrointestinal disorders: Common: Nausea, diarrhoea, epigastric pain and vomiting.

Contraindications - As thrombolytic therapy increases the risk of bleeding, Streptokinase, administered either systemically or locally, is contraindicated in the following situations: Existing or recent haemorrhage and haemorrhagic diathesis (with the exception of consumption coagulopathy) Potential for internal bleeding (e.g., peptic ulcer, ulcerative colitis, diverticulitis or visceral tumours) All forms of reduced blood coagulability, in particular spontaneous fibrinolysis and extensive clotting disorders. Recent (within 2 months) cerebrovascular accident, recent (within 10 days) facial or head trauma, intracranial or intraspinal surgery, known intracranial neoplasm and all known neoplasms with risk of haemorrhage Invasive operations, e.g., recent organ biopsy, invasive diagnostic procedure, recent implantation of a vessel prosthesis, long-term traumatic closed-chest massage or other recent surgery (until the 6th to 10th post operative day, depending on the severity of surgical intervention) Arteriovenous malformation or aneurysm: Haemorrhagic diathesis including thrombocytopenia or pronounced hepatic or renal dysfunction Severe uncontrolled hypertension (systolic BP > 200 mm Hg, diastolic BP > 100 mm Hg), or hypertensive retinal changes grades III/IV), hypertonic fundus Severe liver or kidney damage: Simultaneous treatment with oral anticoagulants (International Normalized Ratio (INR) >1.3) Endocarditis or pericarditis (Immediately after streptococcal infections which have produced a high antiStreptokinase titre (acute rheumatic fever, acute glomerulo-nephritis, etc.). More than 5 days and less than 12 months since previous Streptokinase therapy.

Others - Pregnancy & Lactation Pregnancy category C. It is not known whether Streptokinase is excreted in the breast milk, nor whether it has harmful effects on the newborn. In the absence of further information, it is recommended that breast-feeding be discontinued in women who are to receive Streptokinase.