Streptokinase Injection

Description:
Streptase, Streptokinase, is a sterile, purified preparation of a bacterial protein elaborated by group C (beta) -hemolytic streptococci. It is supplied as a lyophilized white powder containing 25 mg cross-linked gelatin polypeptides, 25 mg sodium L-glutamate, sodium hydroxide to adjust pH, and 100 mg Albumin (Human) per vial or infusion bottle as stabilizers. The preparation contains no preservatives and is intended for intravenous and intracoronary administration.

Indications:
Acute Evolving Transmural Myocardial Infarction: Streptase, Streptokinase, is indicated for use in the management of acute myocardial infarction (AMI) in adults, for the lysis of intracoronary thrombi, the improvement of ventricular function, and the reduction of mortality associated with AMI, when administered by either the intravenous or the intracoronary route, as well as for the reduction of infarct size and congestive heart failure associated with AMI when administered by the intravenous route. Earlier administration of Streptokinase is correlated with greater clinical benefit. (See CLINICAL PHARMACOLOGY.)

• Pulmonary Embolism:   Streptase, Streptokinase, is indicated for the lysis of objectively diagnosed (angiography or lung scan) pulmonary emboli, involving obstruction of blood flow to a lobe or multiple segments, with or without unstable hemodynamics.
• Deep Vein Thrombosis:   Streptase, Streptokinase, is indicated for the lysis of objectively diagnosed (preferably ascending venography), acute, extensive thrombi of the deep veins such as those involving the popliteal and more proximal vessels.
• Arterial Thrombosis or Embolism:   Streptase, Streptokinase, is indicated for the lysis of acute arterial thrombi and emboli. Streptokinase is not indicated for arterial emboli originating from the left side of the heart due to the risk of new embolic phenomena such as cerebral embolism.
• Occlusion of Arteriovenous Cannulae:   Streptase, Streptokinase, is indicated as an alternative to surgical revision for clearing totally or partially occluded arteriovenous cannulae when acceptable flow cannot be achieved.

Dosage and Administration : Acute Evolving Transmural Myocardial Infarction:   Administer Streptokinase as soon as possible after onset of symptoms. The greatest benefit in mortality reduction was observed when Streptokinase was administered within four hours, but statistically significant benefit has been reported up to 24 hours (see CLINICAL PHARMACOLOGY ).

Warnings:
Bleeding:   Following intravenous high-dose brief-duration Streptokinase therapy in acute myocardial infarction, severe bleeding complications requiring transfusion are extremely rare (0.3-0.5%), and combined therapy with low dose aspirin does not appear to increase the risk of major bleeding. The addition of aspirin to Streptokinase may cause a slight increase in the risk of minor bleeding (3.1% without aspirin vs. 3.9% with) (2) .

• Streptokinase will cause lysis of hemostatic fibrin deposits such as those occurring at sites of needle punctures, particularly when infused over several hours, and bleeding may occur from such sites. In order to minimize the risk of bleeding during treatment with Streptokinase, venipunctures and physical handling of the patient should be performed carefully and as infrequently as possible, and intramuscular injections must be avoided.
• Should an arterial puncture be necessary during intravenous therapy, upper extremity vessels are preferable. Pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding.
• In the following conditions the risks of therapy may be increased and should be weighed against the anticipated benefits.
• Recent (within 10 days) major surgery, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels

• Recent (within 10 days) serious gastrointestinal bleeding
• Recent (within 10 days) trauma including cardiopulmonary resuscitation
• Hypertension: systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg
• High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation
• Subacute bacterial endocarditis
• Hemostatic defects including those secondary to severe hepatic or renal disease
• Pregnancy
• Age >75 years
• Cerebrovascular disease