Acute evolving transmural MI: Administer as soon as possible after symptom onset. The greatest benefit in mortality reduction was observed when Streptokinase was administered within 4 hours, but statistically significant benefit has been reported up to 24 hours. IV infusion – Administer a total dose of 1,500,000 IU within 60 minutes. Intracoronary infusion – Administer 20,000 IU by bolus followed by 2000 IU/min for 60 minutes for a total dose of 140,000 IU. PE, DVT, arterial thrombosis, or embolism: Institute treatment as soon as possible after thrombotic event onset, preferably within 7 days. Any delay in instituting lytic therapy to evaluate the effect of heparin therapy decreases the potential for optimal efficacy. Because 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 Streptokinase infused into a peripheral vein over 30 minutes was appropriate in over 90% of patients. 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. AV cannulae occlusion: Before using, try to clear the cannula by syringe technique, using heparinized saline solution. If adequate flow is not re-established, use Streptokinase. Allow the effect of any pretreatment anticoagulants to diminish. Slowly instill 250,000 IU in 2 mL solution into each occluded limb of the cannula. Clamp off cannula limb(s) for 2 hours. Observe closely for adverse effects. After treatment, aspirate contents of infused cannula limb(s), flush with saline, and reconnect cannula. Pediatric use: Controlled clinical studies have not been conducted in children to determine safety and efficacy. The evidence of clinical benefits and risks is solely based on anecdotal reports in patients ranging in age from less than 1 month to 16 years. The largest number of patient reports has pertained to the use of Streptokinase in arterial occlusions. For arterial occlusions, the most frequently used loading dose was 1000 IU/kg; fewer numbers of patients received 3000 IU/kg. Loading dose durations typically have ranged from 5 to 30 minutes. Continuous infusion doses were frequently 1000 IU/kg/h; fewer were at 1500 IU/kg/h. Infusions were maintained for 12 hours or less in approximately half of the published cases; a smaller proportion were between 12 and 24 hours. Reported adverse events associated with the use of Streptokinase in the pediatric population are similar in nature to those associated with its use in adults. Rates of all bleeding complications have been variable and as high as 50% at catheter sites in some studies. Occasionally, bleeding has required transfusion. Careful monitoring of patient status is necessary. Reconstitution (vials and infusion bottles):
1. Slowly add 5 mL NaCl injection or 5% dextrose injection to the Streptokinase vial, directing the diluent at the side of the vacuum-packed vial rather than into the drug powder.
2. 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; adjust the infusion pump rate accordingly. To facilitate setting the infusion pump rate, a total volume of 45 mL, or a multiple thereof, is recommended.
3. Withdraw the entire reconstituted contents of the vial; slowly and carefully dilute further to a total volume as recommended. Avoid shaking and agitation on dilution.
4. When diluting the 1,500,000 IU infusion bottle (50 mL), slowly add 5 mL NaCl injection or 5% dextrose injection, 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.
5. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration (the human albumin may impart a slightly yellow color to the solution).
6. The reconstituted solution can be filtered through a 0.8 mcm or larger pore size filter.
7. Because Streptokinase contains no preservatives, reconstitute immediately before use. The solution may be used for direct IV administration within 8 hours following reconstitution if stored at 2° to 8oC (36o to 46oF).
8. Do not add other medication to the container.
9. Discard unused reconstituted drug.
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S-Kinase 0.75 Million
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