"The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart "...
(Generic versions may still be available.)
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 ).
|Intravenous infusion||1,500,000 IU||1,500,000 IU within 60 min.|
|Intracoronary infusion||140,000 IU||20,000 IU by bolus followed by |
2,000 IU/min. for 60 min.
Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism: Streptase, Streptokinase, treatment should be instituted as soon as possible after onset of the thrombotic event, preferably within 7 days. Any delay in instituting lytic therapy to evaluate the effect of heparin therapy decreases the potential for optimal efficacy. Since human exposure to streptococci is common, antibodies to Streptokinase are prevalent. Thus, a loading dose of Streptokinase sufficient to neutralize these antibodies is required. A dose of 250,000 IU of Streptokinase infused into a peripheral vein over 30 minutes has been found appropriate in over 90% of patients. Furthermore, if the thrombin time or any other parameter of lysis after 4 hours of therapy is not significantly different from the normal control level, discontinue Streptokinase because excessive resistance is present.
|Indication||Loading Dose||IV Infusion |
|Pulmonary Embolism||250,000 IU/30 min.||100,000 IU/hr for 24 hr |
(72 hrs if concurrent DVT is suspected).
|Deep Vein Thrombosis||250,000 IU/30 min.||100,000 IU/hr for 72 hr|
|Arterial Thrombosis or Embolism||250,000 IU/30min.||100,000 IU/hr for 24-72 hr|
Arteriovenous Cannulae Occlusion: Before using Streptase, Streptokinase, an attempt should be made to clear the cannula by careful syringe technique, using heparinized saline solution. If adequate flow is not re-established, Streptokinase may be employed. Allow the effect of any pretreatment anticoagulants to diminish. Instill 250,000 IU Streptokinase in 2 mL of solution into each occluded limb of the cannula slowly. Clamp off cannula limb(s) for 2 hours. Observe the patient closely for possible adverse effects. After treatment, aspirate contents of infused cannula limb(s), flush with saline, reconnect cannula.
Pediatric Patients: Specific dosage and administration recommendations cannot be made based on the limited data available. However, published experience generally used loading and continuous infusion doses administered on a weight-adjusted basis. See Precautions, Pediatric Use.
Reconstitution and Dilution: The protein nature and lyophilized form of Streptase, Streptokinase, require careful reconstitution and dilution. Slight flocculation (described as thin translucent fibers) of reconstituted Streptokinase occurred occasionally during clinical trials but did not interfere with the safe use of the solution. The following reconstitution and dilution procedures are recommended:
Vials and Infusion Bottles
- Slowly add 5 mL Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to the Streptase, Streptokinase, vial, directing the diluent at the side of the vacuum-packed vial rather than into the drug powder.
- Roll and tilt the vial gently to reconstitute. Avoid shaking. (Shaking may cause foaming.) (If necessary, total volume may be increased to a maximum of 500 mL in glass or 50 mL in plastic containers, and the infusion pump rate in Table 1 should be adjusted accordingly.) To facilitate setting the infusion pump rate, a total volume of 45 mL, or a multiple thereof, is recommended.
- Withdraw the entire reconstituted contents of the vial; slowly and carefully dilute further to a total volume as recommended in Table 1. Avoid shaking and agitation on dilution.
- When diluting the 1,500,000 IU infusion bottle (50 mL), slowly add 5 mL Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, directing it at the side of the bottle rather than into the drug powder. Roll and tilt the bottle gently to reconstitute. Avoid shaking as it may cause foaming. Add an additional 40 mL of diluent to the bottle, avoiding shaking and agitation. (Total volume = 45 mL). Administer by infusion pump at the rate indicated in Table 1.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (The Albumin (Human) may impart a slightly yellow color to the solution.)
- The reconstituted solution can be filtered through a0.8 µ m or larger pore size filter.
- Because Streptase, Streptokinase, contains no preservatives, it should be reconstituted immediately before use. The solution may be used for direct intravenous administration within eight hours following reconstitution if stored at 2-8°C (36-46°F).
- Do not add other medication to the container of Streptase, Streptokinase.
- Unused reconstituted drug should be discarded.
TABLE 1: SUGGESTED DILUTIONS AND INFUSION RATES
|I. Acute Myocardial Infarction|
|A. Intravenous Infusion||1,500,000||45 mL||Infuse 45 mL within 60 min.|
|B. Intracoronary Infusion||250,000||125 mL|
|1. 20,000 IU bolus||>1. Loading Dose of 10 mL|
|2. 2,000 IU/minute for 60 minutes||>2. Then 60 mL/hour|
|II. Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism|
|A. 1. 250,000 IU loading dose over 30 minutes||1,500,000||90 mL||>1. Infuse 30 mL/hour for 30 minutes|
|2. 100,000 IU/hour maintenance dose||2. Infuse 6 mL per hour|
|B. SAME||1,500,000 infusion
|45 mL|| 1. 15 mL/hour for 30 minutes |
2. Infuse 3 mL per hour
For Use In Arteriovenous Cannulae: Slowly reconstitute the contents of 250,000 IU Streptase, Streptokinase, vacuum-packed vial with 2 mL Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
Streptase, Streptokinase, is supplied as a lyophilized white powder in 50 mL infusion bottles (1,500,000 IU) or in 6.5 mL vials with a color-coded label corresponding to the amount of purified Streptokinase in each vial as follows:
green 250,000 IU NDC 0186-1770-01 box of 1
blue 750,000 IU NDC 0186-1771-01 box of 1
red 1,500,000 IU NDC 0186-1773-01 box of 1 (vials)
red 1,500,000 IU NDC 0186-1774-01 box of 1 (infusion bottles)
Store unopened vials at controlled room temperature (15-30°C or 59-86°F).
- GISSI: Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet I: 397-402, 1986.
- ISIS-2 Collaborative Group: Randomized trial of streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet II:349-360, 1988.
- White, H., Norris, R., Brown, M., et al: Effect of intravenous streptokinase on left ventricular function and early survival after acute myocardial infarction. N Engl J Med 317: 850-5, 1987.
- The I.S.A.M. Study Group: A prospective trial of intravenous streptokinase in acute myocardial infarction (I.S.A.M.). N Engl J Med 314: 1465-1471, 1986.
- Anderson, J., Marshall, H., Bray, B., et al: A randomized trial of intracoronary streptokinase in the treatment of acute myocardial infarction. N Engl J Med 308: 1312-8, 1983.
- Kennedy, J., Ritchie, J., Davis, K., Fritz, J.: Western Washington randomized trial of intracoronary streptokinase in acute myocardial infarction. N Engl J Med 309: 1477-82, 1983.
- Sharma, G., Burleson, V., Sasahara, A.: Effect of thrombolytic therapy on pulmonary-capillary blood volume in patients with pulmonary embolism. N Engl J Med 303: 842-5, 1980.
- Arnesen, H., Heilo, A., Jakobsen, E., et al: A prospective study of streptokinase and heparin in the treatment of venous thrombosis. Acta Med Scand 203: 457-463, 1978.
Manufactured for: Aventis Behring L.L.C., King of Prussia, PA 19406
By: Aventis Behring GmbH, Marburg, Germany
U.S. License No. 1287
(Revised June, 2002)
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Streptase Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.